3/13/2019
1
Keeping Ophthalmic Instruments Safe
Nancy Chobin, RN, AAS, ACSP, CSPM, CFER
CEO Sterile Processing University
Lebanon, NJ
Copyright 2019
Objectives
Identify AAMI recommended cleaning protocols to prevent TASS
Review the AAMI preparation recommendations for instruments and sets
Review care and handling of ophthalmic instruments
Background
Time to perform a cataract procedure has decreased15-20 minutes.
The cost for a set of instruments can range from $6,000 to $8,000 or more
Urgency to turn the instruments around for the next case.
Instruments come in contact with the eye and thus body fluids.
They are considered contaminated and must receive the entire cleaning and sterilization process between patients.
Manufacturer’s Instructions
Instrument manufacturer should:
specify the pH of detergent (e.g. neutral pH)
may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)
specify if any special cleaning implements are needed (e.g. to clean out lumens).
Specify water quality for cleaning and rinsing
However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.
Manufacturer’s Instructions
Also known as Instructions for Use (IFUs)
Keep on file - readily available to processing personnel.
Ensure IFUs followed each and every time the instrument is processed.
Employee training should complement the AAMI guidelines as well as manufacturers’ instructions
Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.
Example of Steam Sterilization IFU
Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.
NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.
Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.
High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.
Training and Competencies
Employee competencies should be verified in the processing protocols for processing ophthalmic instruments
Competencies should be verified initially and annually
Utilize resources such as ophthalmic instrument company's educational materials
Reconcile with national standards
Cleaning
Removal of contamination from an item to the extent necessary for further processing or for the intended use.
Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.
Due to their design, eye instrument challenging to clean
Very small lumens, very delicate tips, can easily break/damage
Pre-Cleaning in Room
Treat with demineralized water to prevent drying of bioburden.
Saline, disinfectants, and chlorinated solutions can cause pitting
and corrosion and should never be used for soaking instruments
Instruments should not remain in water for lengthy periods of time.
–– Biofilms may form, particularly within lumens.
Decontamination
According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]
NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood
First and most critical step in breaking the chain of disease transmission
Why Is Cleaning Important?
Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item
Protein left on items can be “baked on” in the sterilizer
Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?
TASS – Focus
Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN
TASS - an acute inflammatory response of the anterior chamber of the eye.
May lead to severe visual impairment if it is not recognized and treated in a timely manner.
Many causes including detergents, water quality, steam quality, instruments, etc.
Major concern is when endotoxins form
Causes of TASS (ASCRS)*
Detergent residues (in general)
Endotoxins
Preservatives
Residues from sterilization processing
Residues of detergents inside a reusable cannula or instrument
Cement sealant on bags of irrigating solution which has leached out
All can induce TASS and cause severe damage to ocular tissue
* American Society of Cataract and Refractive Surgeons
TASS
Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.
TASS
Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer
Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).
Also in AAMI ST-79 as an Annex
ASCRS Recommendations
An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.
Major issue in surgery centers
Insufficient inventory of instruments leads to short cuts in cleaning
ASCRS Recommendations
Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.
ASCRS Recommendations
A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.
Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments
ASCRS Recommendations
Instruments should be pre-cleaned immediately following use.
Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure
ASCRS Recommendations
Only cleaning agents that have been recommended by the manufacturer should be used.
Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.
ASCRS Recommendations
Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.
The water used to clean or rinse instruments should be discarded after each use.
ASCRS Recommendations
If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.
Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.
ASCRS Recommendations
Cleaning and sterilization equipment should be properly maintained.
Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS
Water Quality
Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed
devices.
Can lead to pyrogenic reactions (i.e., fever) in patients.
Adequate cleaning and rinsing should result in low bioburden
Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.
Physical Area
Separate area – dedicated to cleaning of ophthalmic instruments
Away from any other type of surgical instruments
Temp 60-65oF
Humidity 30-60%
Air exchanges 10/hour negative
Monitor temperature and humidity daily and document
FIRST STEP
Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended
Steps in the Cleaning Process
Pre-Cleaning in room
Contain contaminated items at the point of use
Transport to Decontamination (confined and contained)
Sort
Soak
Wash
Rinse/Dry
Pre-Cleaning - Transport
Instruments should be pre-cleaned immediately following use
Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)
Keep instruments moist to avoid drying of soils
Many now recommend cleaning immediately or within 30 minutes of use
Transport in closed container (confine/contain)
Container should be labeled as biohazard (OSHA)
Soaking
Can pre-soak with a detergent
Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer
Assists in the loosening of soils to facilitate cleaning
Do NOT soak in fluids for prolonged periods of time - biofilms can form
Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems
use enzymatic gels or foam
Biofiolms
Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates
Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow
Cleaning
Need to take special precautions with eye instruments due to
Delicate nature of the design
Sensitivity of eye tissue
Cleaning becomes a challenge
Manual cleaning may be only validated method
Manual cleaning is not as controlled (standardized) as mechanical cleaning
Dilemma
Some eye instrument manufacturer’s do not recommend ANY detergent
Source of confusion for end user
Need to challenge manufacturers
Enzymatic Cleaners
Organic substances which assist in the breakdown of soils
Facilitate the removal of blood and protein soils
Excellent for devices with lumens
Effectiveness dependent upon concentration, use temperature and contact time
Enzymatic Cleaners
Sold as liquid concentrates or powder
Generally more effective in warm water (110-140oF)
Enzyme activity can be inactivated above certain maximum temperatures (140oF)
Follow manufacturer’s directions
Use a thermometer – monitor water temperature
Principles of Cleaning
Must have manufacturer’s written instructions for cleaning of all devices processed
Follow all recommended steps using equipment recommended
Must wear PPE
Impervious gown, head cover, shoe covers, cuffed gloves, face shield
Manual Cleaning Process
May be the only cleaning process available
Items should be submerged, disassembled
Preferable to use 3-sink method; wash, rinse, rinse
Can also be used to remove deposits which were not removed during the pre-soak
Brush all serrations, crevices, tips, handles, and hinges.
Brushing should be done under the surface of the water to prevent aerosolization of contaminants.
Manual Cleaning – General Instructions
Handle instruments one at a time or in small numbers to avoid damage
Open hinged instruments
Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning
Brush and flush all lumened devices
Clean all surfaces
Specialty Items
Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.
Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface
Manual Cleaning Detergents
Usually used for manual cleaning and as a pre-soak
Range from low foam to high foam products
Generally have neutral pH of 7 to 9
Sold as concentrates
Free rinsing
Always measure and dilute the detergent as specified by the detergent manufacturer
Water used to clean instruments should be discarded after each use
Manual Cleaning Implements
Soft bristle brushes, various sizes and lengths (no metal brushes)
Soft cloths
No abrasive items
No sponges
No materials which are permeable; i.e.. Wood
Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use
Mechanical Cleaners
Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.
Can result in damage to instruments
Specialty Cleaner
Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces
Effectively cleans and rinses lumens
Must disinfect according to IFUs and document
Diamond Knives
The diamond knife is designed to make precision atraumatic cuts
The diamond knife has the sharpest cutting edge possible
Cost can range from $800 - $2,500 or more
Diamond Blade Knives
Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.
Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.
The blade should not touch any other instruments or the sides of the cleaner.
Diamond Blade Knives
Never completely submerge a diamond knife in an ultrasonic cleaner.
At all time, (except cleaning) the blade should be in the retracted position to prevent damage.
Inspect with microscope.
Ultrasonic Cleaning
Uses sound waves transmitted through a solution
Sound waves produce tiny bubbles which implode - results in scouring action that cleans
Mechanical process = cavitation
Ultrasonic Cleaning
Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)
Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming
Water temperatures usually 100 - 140 o F.
Can be used after manual cleaning
Ultrasonic Cleaning
Solution should be changed at least daily preferably after each use
Outbreaks of TASS have been associated with contaminated sonic baths
Unit should have a cover to contain aerosols
Items should not be stacked
Need to “de-gas” water
Ultrasonic Cleaning
Containers/baskets should have perforations; should be all metal mesh; no plastic
Should be located in Decontamination Area
cleaning process
more efficient than manual cleaning
Test the sonic for efficacy (daily???)
Testing Sonic
Rinsing
The most important part of the cleaning process
Essential to remove loosened debris
Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)
Water used to rinse instruments should be discarded after each use
Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS
Lubrication
The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.
However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.
Principles of Inspection/Assembly
All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)
All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.
Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.
Inspection
Best method is to use a microscope
Principles of Inspection/Assembly
All parts are present and functional
Use perforated or mesh bottom trays
All scissors should be tested for sharpness each time they are processed
Test that ratchets hold on clamps
Inspect hand held forceps that tips approximate
Test needle holders; ratchets hold and tips hold suture needle
Principles of Inspection/Assembly
Inspect that joints are not stiff
Use a lighted magnifying lamp or microscope to inspect
Inspect for rust, pitting, cracked box lock, etc.
Demagnetization of eye instruments may be needed
Separate delicate, sharp items
Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material
Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water
Ophthalmic Instruments
Look for defects:
Rusting common (especially if IUSS frequently used
Corrosion
Damage to tips/ teeth
Cords
Lumens (e.g. Phaco handpieces)
Stiffness
Sharpness
Spotting – Staining - Rust
Delicate Tips Require Protection
Can use small containers with silicone mat for individual instruments to provide protection.
General Guidelines for Packaging
Instrument Sets
Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.
The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers
The basket or container of the correct size to prevent instrument damage
Handling Eye Instruments
Place instruments in the tray so that they do not touch each other.
Locate each instrument in the tray to prevent movement and possible damage during handling.
Always keep delicate tips protected with a tip guard when the instrument is not in use.
Protective Container - Cataract Set
Finger Mats May Not Provide Adequate Protection
Paper Plastic Pouches
Widely used because of the visibility of the contents.
However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.
If packaging instruments separately, select the correct size pouch.
Allow approximately 1” distance from the device and the pouch edges.
Must ensure instruments packaged to protect from damage
General Guidelines for Packaging
Individual Instruments/Small Items
Use correct size packaging
Do not use rubber bands to secure instruments
Paper Plastic Pouches
Double pouching is not required (AORN, AAMI)
May be used for small items which would be difficult to keep together
If double pouching, do not fold over the edges of inside pouch
Inside pouch must lay flat
Tip Protectors
Obtain the manufacturer’s instructions for use.
Some can “catch” onto the instruments – can result in damage
You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.
Make sure device can be held open with protector on (e.g. scissors, clamps).
Must have manufacturer’s data that sterilant will penetrate through the tip protector.
Chemical Indicators (Types)
External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not
Internal chemical indicators (Type 3-4-5)
Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.
Type 3 – responds to one parameter
Type 4 – responds to 2 or more parameters
Should use at least a Type 4 CI
Chemical Indicators
Type 5 – integrating indicators – correlate to the action of a biological test
Cannot substitute for a BI test
Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time
Labeling Packages
Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).
Need documentation that marker is non-toxic.
Packages - label on the indicator tape used to close the package, never on the wrapping material itself.
Paper–plastic pouches - label only on the plastic side or on sterilization tape.
If a package is labeled directly on the packaging material, the
marker could damage the packaging material.
Exception is the plastic side of paper plastic pouches.
Table Top Sterilizers
Many ASCs use table top sterilizers
A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).
Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.
Also found in doctors’ and dental offices.
Cycles
The device manufacturer’s sterilization instructions should always be followed
If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.
Conventional Steam Sterilizers
Read the IFUs for exposure time, temperature and cycle time
Many have CJD cycles ONLY
Many have European temperatures only (e.g. 273oF)
Must reconcile IFU information
May have to separate sets to meet IFUs
E.g. some instruments require 10 minutes exposure
Water Quality
Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.
Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.
Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.
Maintenance
Perform all the recommended maintenance of the tabletop sterilizer
Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.
Documentation
All cycles run should be documented
All items processed must be documented
Specific name of device/tray
Quantity
All items must be identified with a lot control number (to facilitate recall)
Must include date sterilized, sterilizer #, load number
Expiration date or event related statement
Traceability to the patient if posterior eye tissue surgery (CJD)
Summary
Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS
Manufacturers IFUs
Effective cleaning
Correct packaging methods and materials
Effective sterilization –
Processing equipment in good condition
Proper handling after sterilization
Monitoring of staff compliance with all stated policies and manufacturers’ instructions
Training and competencies for staff
Conclusion - The End
Successful patient outcomes require we develop effective policies, train staff and monitor for compliance
Careful handling of ophthalmic instruments will keep patients safe and reduce costs.
References
AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.
AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.
Centers for Disease Control (Hospital Infection Control Guidelines) 2008
American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).
The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.
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3/13/2019
2
Keeping Ophthalmic Instruments Safe
Nancy Chobin, RN, AAS, ACSP, CSPM, CFER
CEO Sterile Processing University
Lebanon, NJ
Copyright 2019
Objectives
Identify AAMI recommended cleaning protocols to prevent TASS
Review the AAMI preparation recommendations for instruments and sets
Review care and handling of ophthalmic instruments
Background
Time to perform a cataract procedure has decreased15-20 minutes.
The cost for a set of instruments can range from $6,000 to $8,000 or more
Urgency to turn the instruments around for the next case.
Instruments come in contact with the eye and thus body fluids.
They are considered contaminated and must receive the entire cleaning and sterilization process between patients.
Manufacturer’s Instructions
Instrument manufacturer should:
specify the pH of detergent (e.g. neutral pH)
may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)
specify if any special cleaning implements are needed (e.g. to clean out lumens).
Specify water quality for cleaning and rinsing
However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.
Manufacturer’s Instructions
Also known as Instructions for Use (IFUs)
Keep on file - readily available to processing personnel.
Ensure IFUs followed each and every time the instrument is processed.
Employee training should complement the AAMI guidelines as well as manufacturers’ instructions
Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.
Example of Steam Sterilization IFU
Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.
NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.
Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.
High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.
Training and Competencies
Employee competencies should be verified in the processing protocols for processing ophthalmic instruments
Competencies should be verified initially and annually
Utilize resources such as ophthalmic instrument company's educational materials
Reconcile with national standards
Cleaning
Removal of contamination from an item to the extent necessary for further processing or for the intended use.
Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.
Due to their design, eye instrument challenging to clean
Very small lumens, very delicate tips, can easily break/damage
Pre-Cleaning in Room
Treat with demineralized water to prevent drying of bioburden.
Saline, disinfectants, and chlorinated solutions can cause pitting
and corrosion and should never be used for soaking instruments
Instruments should not remain in water for lengthy periods of time.
–– Biofilms may form, particularly within lumens.
Decontamination
According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]
NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood
First and most critical step in breaking the chain of disease transmission
Why Is Cleaning Important?
Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item
Protein left on items can be “baked on” in the sterilizer
Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?
TASS – Focus
Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN
TASS - an acute inflammatory response of the anterior chamber of the eye.
May lead to severe visual impairment if it is not recognized and treated in a timely manner.
Many causes including detergents, water quality, steam quality, instruments, etc.
Major concern is when endotoxins form
Causes of TASS (ASCRS)*
Detergent residues (in general)
Endotoxins
Preservatives
Residues from sterilization processing
Residues of detergents inside a reusable cannula or instrument
Cement sealant on bags of irrigating solution which has leached out
All can induce TASS and cause severe damage to ocular tissue
* American Society of Cataract and Refractive Surgeons
TASS
Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.
TASS
Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer
Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).
Also in AAMI ST-79 as an Annex
ASCRS Recommendations
An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.
Major issue in surgery centers
Insufficient inventory of instruments leads to short cuts in cleaning
ASCRS Recommendations
Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.
ASCRS Recommendations
A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.
Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments
ASCRS Recommendations
Instruments should be pre-cleaned immediately following use.
Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure
ASCRS Recommendations
Only cleaning agents that have been recommended by the manufacturer should be used.
Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.
ASCRS Recommendations
Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.
The water used to clean or rinse instruments should be discarded after each use.
ASCRS Recommendations
If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.
Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.
ASCRS Recommendations
Cleaning and sterilization equipment should be properly maintained.
Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS
Water Quality
Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed
devices.
Can lead to pyrogenic reactions (i.e., fever) in patients.
Adequate cleaning and rinsing should result in low bioburden
Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.
Physical Area
Separate area – dedicated to cleaning of ophthalmic instruments
Away from any other type of surgical instruments
Temp 60-65oF
Humidity 30-60%
Air exchanges 10/hour negative
Monitor temperature and humidity daily and document
FIRST STEP
Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended
Steps in the Cleaning Process
Pre-Cleaning in room
Contain contaminated items at the point of use
Transport to Decontamination (confined and contained)
Sort
Soak
Wash
Rinse/Dry
Pre-Cleaning - Transport
Instruments should be pre-cleaned immediately following use
Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)
Keep instruments moist to avoid drying of soils
Many now recommend cleaning immediately or within 30 minutes of use
Transport in closed container (confine/contain)
Container should be labeled as biohazard (OSHA)
Soaking
Can pre-soak with a detergent
Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer
Assists in the loosening of soils to facilitate cleaning
Do NOT soak in fluids for prolonged periods of time - biofilms can form
Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems
use enzymatic gels or foam
Biofiolms
Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates
Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow
Cleaning
Need to take special precautions with eye instruments due to
Delicate nature of the design
Sensitivity of eye tissue
Cleaning becomes a challenge
Manual cleaning may be only validated method
Manual cleaning is not as controlled (standardized) as mechanical cleaning
Dilemma
Some eye instrument manufacturer’s do not recommend ANY detergent
Source of confusion for end user
Need to challenge manufacturers
Enzymatic Cleaners
Organic substances which assist in the breakdown of soils
Facilitate the removal of blood and protein soils
Excellent for devices with lumens
Effectiveness dependent upon concentration, use temperature and contact time
Enzymatic Cleaners
Sold as liquid concentrates or powder
Generally more effective in warm water (110-140oF)
Enzyme activity can be inactivated above certain maximum temperatures (140oF)
Follow manufacturer’s directions
Use a thermometer – monitor water temperature
Principles of Cleaning
Must have manufacturer’s written instructions for cleaning of all devices processed
Follow all recommended steps using equipment recommended
Must wear PPE
Impervious gown, head cover, shoe covers, cuffed gloves, face shield
Manual Cleaning Process
May be the only cleaning process available
Items should be submerged, disassembled
Preferable to use 3-sink method; wash, rinse, rinse
Can also be used to remove deposits which were not removed during the pre-soak
Brush all serrations, crevices, tips, handles, and hinges.
Brushing should be done under the surface of the water to prevent aerosolization of contaminants.
Manual Cleaning – General Instructions
Handle instruments one at a time or in small numbers to avoid damage
Open hinged instruments
Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning
Brush and flush all lumened devices
Clean all surfaces
Specialty Items
Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.
Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface
Manual Cleaning Detergents
Usually used for manual cleaning and as a pre-soak
Range from low foam to high foam products
Generally have neutral pH of 7 to 9
Sold as concentrates
Free rinsing
Always measure and dilute the detergent as specified by the detergent manufacturer
Water used to clean instruments should be discarded after each use
Manual Cleaning Implements
Soft bristle brushes, various sizes and lengths (no metal brushes)
Soft cloths
No abrasive items
No sponges
No materials which are permeable; i.e.. Wood
Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use
Mechanical Cleaners
Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.
Can result in damage to instruments
Specialty Cleaner
Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces
Effectively cleans and rinses lumens
Must disinfect according to IFUs and document
Diamond Knives
The diamond knife is designed to make precision atraumatic cuts
The diamond knife has the sharpest cutting edge possible
Cost can range from $800 - $2,500 or more
Diamond Blade Knives
Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.
Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.
The blade should not touch any other instruments or the sides of the cleaner.
Diamond Blade Knives
Never completely submerge a diamond knife in an ultrasonic cleaner.
At all time, (except cleaning) the blade should be in the retracted position to prevent damage.
Inspect with microscope.
Ultrasonic Cleaning
Uses sound waves transmitted through a solution
Sound waves produce tiny bubbles which implode - results in scouring action that cleans
Mechanical process = cavitation
Ultrasonic Cleaning
Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)
Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming
Water temperatures usually 100 - 140 o F.
Can be used after manual cleaning
Ultrasonic Cleaning
Solution should be changed at least daily preferably after each use
Outbreaks of TASS have been associated with contaminated sonic baths
Unit should have a cover to contain aerosols
Items should not be stacked
Need to “de-gas” water
Ultrasonic Cleaning
Containers/baskets should have perforations; should be all metal mesh; no plastic
Should be located in Decontamination Area
cleaning process
more efficient than manual cleaning
Test the sonic for efficacy (daily???)
Testing Sonic
Rinsing
The most important part of the cleaning process
Essential to remove loosened debris
Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)
Water used to rinse instruments should be discarded after each use
Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS
Lubrication
The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.
However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.
Principles of Inspection/Assembly
All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)
All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.
Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.
Inspection
Best method is to use a microscope
Principles of Inspection/Assembly
All parts are present and functional
Use perforated or mesh bottom trays
All scissors should be tested for sharpness each time they are processed
Test that ratchets hold on clamps
Inspect hand held forceps that tips approximate
Test needle holders; ratchets hold and tips hold suture needle
Principles of Inspection/Assembly
Inspect that joints are not stiff
Use a lighted magnifying lamp or microscope to inspect
Inspect for rust, pitting, cracked box lock, etc.
Demagnetization of eye instruments may be needed
Separate delicate, sharp items
Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material
Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water
Ophthalmic Instruments
Look for defects:
Rusting common (especially if IUSS frequently used
Corrosion
Damage to tips/ teeth
Cords
Lumens (e.g. Phaco handpieces)
Stiffness
Sharpness
Spotting – Staining - Rust
Delicate Tips Require Protection
Can use small containers with silicone mat for individual instruments to provide protection.
General Guidelines for Packaging
Instrument Sets
Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.
The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers
The basket or container of the correct size to prevent instrument damage
Handling Eye Instruments
Place instruments in the tray so that they do not touch each other.
Locate each instrument in the tray to prevent movement and possible damage during handling.
Always keep delicate tips protected with a tip guard when the instrument is not in use.
Protective Container - Cataract Set
Finger Mats May Not Provide Adequate Protection
Paper Plastic Pouches
Widely used because of the visibility of the contents.
However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.
If packaging instruments separately, select the correct size pouch.
Allow approximately 1” distance from the device and the pouch edges.
Must ensure instruments packaged to protect from damage
General Guidelines for Packaging
Individual Instruments/Small Items
Use correct size packaging
Do not use rubber bands to secure instruments
Paper Plastic Pouches
Double pouching is not required (AORN, AAMI)
May be used for small items which would be difficult to keep together
If double pouching, do not fold over the edges of inside pouch
Inside pouch must lay flat
Tip Protectors
Obtain the manufacturer’s instructions for use.
Some can “catch” onto the instruments – can result in damage
You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.
Make sure device can be held open with protector on (e.g. scissors, clamps).
Must have manufacturer’s data that sterilant will penetrate through the tip protector.
Chemical Indicators (Types)
External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not
Internal chemical indicators (Type 3-4-5)
Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.
Type 3 – responds to one parameter
Type 4 – responds to 2 or more parameters
Should use at least a Type 4 CI
Chemical Indicators
Type 5 – integrating indicators – correlate to the action of a biological test
Cannot substitute for a BI test
Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time
Labeling Packages
Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).
Need documentation that marker is non-toxic.
Packages - label on the indicator tape used to close the package, never on the wrapping material itself.
Paper–plastic pouches - label only on the plastic side or on sterilization tape.
If a package is labeled directly on the packaging material, the
marker could damage the packaging material.
Exception is the plastic side of paper plastic pouches.
Table Top Sterilizers
Many ASCs use table top sterilizers
A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).
Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.
Also found in doctors’ and dental offices.
Cycles
The device manufacturer’s sterilization instructions should always be followed
If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.
Conventional Steam Sterilizers
Read the IFUs for exposure time, temperature and cycle time
Many have CJD cycles ONLY
Many have European temperatures only (e.g. 273oF)
Must reconcile IFU information
May have to separate sets to meet IFUs
E.g. some instruments require 10 minutes exposure
Water Quality
Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.
Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.
Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.
Maintenance
Perform all the recommended maintenance of the tabletop sterilizer
Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.
Documentation
All cycles run should be documented
All items processed must be documented
Specific name of device/tray
Quantity
All items must be identified with a lot control number (to facilitate recall)
Must include date sterilized, sterilizer #, load number
Expiration date or event related statement
Traceability to the patient if posterior eye tissue surgery (CJD)
Summary
Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS
Manufacturers IFUs
Effective cleaning
Correct packaging methods and materials
Effective sterilization –
Processing equipment in good condition
Proper handling after sterilization
Monitoring of staff compliance with all stated policies and manufacturers’ instructions
Training and competencies for staff
Conclusion - The End
Successful patient outcomes require we develop effective policies, train staff and monitor for compliance
Careful handling of ophthalmic instruments will keep patients safe and reduce costs.
References
AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.
AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.
Centers for Disease Control (Hospital Infection Control Guidelines) 2008
American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).
The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.
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3/13/2019
3
Keeping Ophthalmic Instruments Safe
Nancy Chobin, RN, AAS, ACSP, CSPM, CFER
CEO Sterile Processing University
Lebanon, NJ
Copyright 2019
Objectives
Identify AAMI recommended cleaning protocols to prevent TASS
Review the AAMI preparation recommendations for instruments and sets
Review care and handling of ophthalmic instruments
Background
Time to perform a cataract procedure has decreased15-20 minutes.
The cost for a set of instruments can range from $6,000 to $8,000 or more
Urgency to turn the instruments around for the next case.
Instruments come in contact with the eye and thus body fluids.
They are considered contaminated and must receive the entire cleaning and sterilization process between patients.
Manufacturer’s Instructions
Instrument manufacturer should:
specify the pH of detergent (e.g. neutral pH)
may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)
specify if any special cleaning implements are needed (e.g. to clean out lumens).
Specify water quality for cleaning and rinsing
However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.
Manufacturer’s Instructions
Also known as Instructions for Use (IFUs)
Keep on file - readily available to processing personnel.
Ensure IFUs followed each and every time the instrument is processed.
Employee training should complement the AAMI guidelines as well as manufacturers’ instructions
Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.
Example of Steam Sterilization IFU
Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.
NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.
Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.
High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.
Training and Competencies
Employee competencies should be verified in the processing protocols for processing ophthalmic instruments
Competencies should be verified initially and annually
Utilize resources such as ophthalmic instrument company's educational materials
Reconcile with national standards
Cleaning
Removal of contamination from an item to the extent necessary for further processing or for the intended use.
Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.
Due to their design, eye instrument challenging to clean
Very small lumens, very delicate tips, can easily break/damage
Pre-Cleaning in Room
Treat with demineralized water to prevent drying of bioburden.
Saline, disinfectants, and chlorinated solutions can cause pitting
and corrosion and should never be used for soaking instruments
Instruments should not remain in water for lengthy periods of time.
–– Biofilms may form, particularly within lumens.
Decontamination
According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]
NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood
First and most critical step in breaking the chain of disease transmission
Why Is Cleaning Important?
Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item
Protein left on items can be “baked on” in the sterilizer
Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?
TASS – Focus
Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN
TASS - an acute inflammatory response of the anterior chamber of the eye.
May lead to severe visual impairment if it is not recognized and treated in a timely manner.
Many causes including detergents, water quality, steam quality, instruments, etc.
Major concern is when endotoxins form
Causes of TASS (ASCRS)*
Detergent residues (in general)
Endotoxins
Preservatives
Residues from sterilization processing
Residues of detergents inside a reusable cannula or instrument
Cement sealant on bags of irrigating solution which has leached out
All can induce TASS and cause severe damage to ocular tissue
* American Society of Cataract and Refractive Surgeons
TASS
Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.
TASS
Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer
Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).
Also in AAMI ST-79 as an Annex
ASCRS Recommendations
An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.
Major issue in surgery centers
Insufficient inventory of instruments leads to short cuts in cleaning
ASCRS Recommendations
Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.
ASCRS Recommendations
A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.
Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments
ASCRS Recommendations
Instruments should be pre-cleaned immediately following use.
Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure
ASCRS Recommendations
Only cleaning agents that have been recommended by the manufacturer should be used.
Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.
ASCRS Recommendations
Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.
The water used to clean or rinse instruments should be discarded after each use.
ASCRS Recommendations
If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.
Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.
ASCRS Recommendations
Cleaning and sterilization equipment should be properly maintained.
Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS
Water Quality
Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed
devices.
Can lead to pyrogenic reactions (i.e., fever) in patients.
Adequate cleaning and rinsing should result in low bioburden
Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.
Physical Area
Separate area – dedicated to cleaning of ophthalmic instruments
Away from any other type of surgical instruments
Temp 60-65oF
Humidity 30-60%
Air exchanges 10/hour negative
Monitor temperature and humidity daily and document
FIRST STEP
Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended
Steps in the Cleaning Process
Pre-Cleaning in room
Contain contaminated items at the point of use
Transport to Decontamination (confined and contained)
Sort
Soak
Wash
Rinse/Dry
Pre-Cleaning - Transport
Instruments should be pre-cleaned immediately following use
Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)
Keep instruments moist to avoid drying of soils
Many now recommend cleaning immediately or within 30 minutes of use
Transport in closed container (confine/contain)
Container should be labeled as biohazard (OSHA)
Soaking
Can pre-soak with a detergent
Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer
Assists in the loosening of soils to facilitate cleaning
Do NOT soak in fluids for prolonged periods of time - biofilms can form
Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems
use enzymatic gels or foam
Biofiolms
Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates
Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow
Cleaning
Need to take special precautions with eye instruments due to
Delicate nature of the design
Sensitivity of eye tissue
Cleaning becomes a challenge
Manual cleaning may be only validated method
Manual cleaning is not as controlled (standardized) as mechanical cleaning
Dilemma
Some eye instrument manufacturer’s do not recommend ANY detergent
Source of confusion for end user
Need to challenge manufacturers
Enzymatic Cleaners
Organic substances which assist in the breakdown of soils
Facilitate the removal of blood and protein soils
Excellent for devices with lumens
Effectiveness dependent upon concentration, use temperature and contact time
Enzymatic Cleaners
Sold as liquid concentrates or powder
Generally more effective in warm water (110-140oF)
Enzyme activity can be inactivated above certain maximum temperatures (140oF)
Follow manufacturer’s directions
Use a thermometer – monitor water temperature
Principles of Cleaning
Must have manufacturer’s written instructions for cleaning of all devices processed
Follow all recommended steps using equipment recommended
Must wear PPE
Impervious gown, head cover, shoe covers, cuffed gloves, face shield
Manual Cleaning Process
May be the only cleaning process available
Items should be submerged, disassembled
Preferable to use 3-sink method; wash, rinse, rinse
Can also be used to remove deposits which were not removed during the pre-soak
Brush all serrations, crevices, tips, handles, and hinges.
Brushing should be done under the surface of the water to prevent aerosolization of contaminants.
Manual Cleaning – General Instructions
Handle instruments one at a time or in small numbers to avoid damage
Open hinged instruments
Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning
Brush and flush all lumened devices
Clean all surfaces
Specialty Items
Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.
Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface
Manual Cleaning Detergents
Usually used for manual cleaning and as a pre-soak
Range from low foam to high foam products
Generally have neutral pH of 7 to 9
Sold as concentrates
Free rinsing
Always measure and dilute the detergent as specified by the detergent manufacturer
Water used to clean instruments should be discarded after each use
Manual Cleaning Implements
Soft bristle brushes, various sizes and lengths (no metal brushes)
Soft cloths
No abrasive items
No sponges
No materials which are permeable; i.e.. Wood
Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use
Mechanical Cleaners
Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.
Can result in damage to instruments
Specialty Cleaner
Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces
Effectively cleans and rinses lumens
Must disinfect according to IFUs and document
Diamond Knives
The diamond knife is designed to make precision atraumatic cuts
The diamond knife has the sharpest cutting edge possible
Cost can range from $800 - $2,500 or more
Diamond Blade Knives
Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.
Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.
The blade should not touch any other instruments or the sides of the cleaner.
Diamond Blade Knives
Never completely submerge a diamond knife in an ultrasonic cleaner.
At all time, (except cleaning) the blade should be in the retracted position to prevent damage.
Inspect with microscope.
Ultrasonic Cleaning
Uses sound waves transmitted through a solution
Sound waves produce tiny bubbles which implode - results in scouring action that cleans
Mechanical process = cavitation
Ultrasonic Cleaning
Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)
Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming
Water temperatures usually 100 - 140 o F.
Can be used after manual cleaning
Ultrasonic Cleaning
Solution should be changed at least daily preferably after each use
Outbreaks of TASS have been associated with contaminated sonic baths
Unit should have a cover to contain aerosols
Items should not be stacked
Need to “de-gas” water
Ultrasonic Cleaning
Containers/baskets should have perforations; should be all metal mesh; no plastic
Should be located in Decontamination Area
cleaning process
more efficient than manual cleaning
Test the sonic for efficacy (daily???)
Testing Sonic
Rinsing
The most important part of the cleaning process
Essential to remove loosened debris
Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)
Water used to rinse instruments should be discarded after each use
Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS
Lubrication
The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.
However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.
Principles of Inspection/Assembly
All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)
All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.
Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.
Inspection
Best method is to use a microscope
Principles of Inspection/Assembly
All parts are present and functional
Use perforated or mesh bottom trays
All scissors should be tested for sharpness each time they are processed
Test that ratchets hold on clamps
Inspect hand held forceps that tips approximate
Test needle holders; ratchets hold and tips hold suture needle
Principles of Inspection/Assembly
Inspect that joints are not stiff
Use a lighted magnifying lamp or microscope to inspect
Inspect for rust, pitting, cracked box lock, etc.
Demagnetization of eye instruments may be needed
Separate delicate, sharp items
Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material
Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water
Ophthalmic Instruments
Look for defects:
Rusting common (especially if IUSS frequently used
Corrosion
Damage to tips/ teeth
Cords
Lumens (e.g. Phaco handpieces)
Stiffness
Sharpness
Spotting – Staining - Rust
Delicate Tips Require Protection
Can use small containers with silicone mat for individual instruments to provide protection.
General Guidelines for Packaging
Instrument Sets
Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.
The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers
The basket or container of the correct size to prevent instrument damage
Handling Eye Instruments
Place instruments in the tray so that they do not touch each other.
Locate each instrument in the tray to prevent movement and possible damage during handling.
Always keep delicate tips protected with a tip guard when the instrument is not in use.
Protective Container - Cataract Set
Finger Mats May Not Provide Adequate Protection
Paper Plastic Pouches
Widely used because of the visibility of the contents.
However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.
If packaging instruments separately, select the correct size pouch.
Allow approximately 1” distance from the device and the pouch edges.
Must ensure instruments packaged to protect from damage
General Guidelines for Packaging
Individual Instruments/Small Items
Use correct size packaging
Do not use rubber bands to secure instruments
Paper Plastic Pouches
Double pouching is not required (AORN, AAMI)
May be used for small items which would be difficult to keep together
If double pouching, do not fold over the edges of inside pouch
Inside pouch must lay flat
Tip Protectors
Obtain the manufacturer’s instructions for use.
Some can “catch” onto the instruments – can result in damage
You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.
Make sure device can be held open with protector on (e.g. scissors, clamps).
Must have manufacturer’s data that sterilant will penetrate through the tip protector.
Chemical Indicators (Types)
External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not
Internal chemical indicators (Type 3-4-5)
Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.
Type 3 – responds to one parameter
Type 4 – responds to 2 or more parameters
Should use at least a Type 4 CI
Chemical Indicators
Type 5 – integrating indicators – correlate to the action of a biological test
Cannot substitute for a BI test
Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time
Labeling Packages
Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).
Need documentation that marker is non-toxic.
Packages - label on the indicator tape used to close the package, never on the wrapping material itself.
Paper–plastic pouches - label only on the plastic side or on sterilization tape.
If a package is labeled directly on the packaging material, the
marker could damage the packaging material.
Exception is the plastic side of paper plastic pouches.
Table Top Sterilizers
Many ASCs use table top sterilizers
A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).
Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.
Also found in doctors’ and dental offices.
Cycles
The device manufacturer’s sterilization instructions should always be followed
If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.
Conventional Steam Sterilizers
Read the IFUs for exposure time, temperature and cycle time
Many have CJD cycles ONLY
Many have European temperatures only (e.g. 273oF)
Must reconcile IFU information
May have to separate sets to meet IFUs
E.g. some instruments require 10 minutes exposure
Water Quality
Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.
Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.
Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.
Maintenance
Perform all the recommended maintenance of the tabletop sterilizer
Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.
Documentation
All cycles run should be documented
All items processed must be documented
Specific name of device/tray
Quantity
All items must be identified with a lot control number (to facilitate recall)
Must include date sterilized, sterilizer #, load number
Expiration date or event related statement
Traceability to the patient if posterior eye tissue surgery (CJD)
Summary
Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS
Manufacturers IFUs
Effective cleaning
Correct packaging methods and materials
Effective sterilization –
Processing equipment in good condition
Proper handling after sterilization
Monitoring of staff compliance with all stated policies and manufacturers’ instructions
Training and competencies for staff
Conclusion - The End
Successful patient outcomes require we develop effective policies, train staff and monitor for compliance
Careful handling of ophthalmic instruments will keep patients safe and reduce costs.
References
AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.
AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.
Centers for Disease Control (Hospital Infection Control Guidelines) 2008
American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).
The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.
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3/13/2019
4
Keeping Ophthalmic Instruments Safe
Nancy Chobin, RN, AAS, ACSP, CSPM, CFER
CEO Sterile Processing University
Lebanon, NJ
Copyright 2019
Objectives
Identify AAMI recommended cleaning protocols to prevent TASS
Review the AAMI preparation recommendations for instruments and sets
Review care and handling of ophthalmic instruments
Background
Time to perform a cataract procedure has decreased15-20 minutes.
The cost for a set of instruments can range from $6,000 to $8,000 or more
Urgency to turn the instruments around for the next case.
Instruments come in contact with the eye and thus body fluids.
They are considered contaminated and must receive the entire cleaning and sterilization process between patients.
Manufacturer’s Instructions
Instrument manufacturer should:
specify the pH of detergent (e.g. neutral pH)
may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)
specify if any special cleaning implements are needed (e.g. to clean out lumens).
Specify water quality for cleaning and rinsing
However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.
Manufacturer’s Instructions
Also known as Instructions for Use (IFUs)
Keep on file - readily available to processing personnel.
Ensure IFUs followed each and every time the instrument is processed.
Employee training should complement the AAMI guidelines as well as manufacturers’ instructions
Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.
Example of Steam Sterilization IFU
Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.
NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.
Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.
High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.
Training and Competencies
Employee competencies should be verified in the processing protocols for processing ophthalmic instruments
Competencies should be verified initially and annually
Utilize resources such as ophthalmic instrument company's educational materials
Reconcile with national standards
Cleaning
Removal of contamination from an item to the extent necessary for further processing or for the intended use.
Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.
Due to their design, eye instrument challenging to clean
Very small lumens, very delicate tips, can easily break/damage
Pre-Cleaning in Room
Treat with demineralized water to prevent drying of bioburden.
Saline, disinfectants, and chlorinated solutions can cause pitting
and corrosion and should never be used for soaking instruments
Instruments should not remain in water for lengthy periods of time.
–– Biofilms may form, particularly within lumens.
Decontamination
According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]
NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood
First and most critical step in breaking the chain of disease transmission
Why Is Cleaning Important?
Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item
Protein left on items can be “baked on” in the sterilizer
Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?
TASS – Focus
Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN
TASS - an acute inflammatory response of the anterior chamber of the eye.
May lead to severe visual impairment if it is not recognized and treated in a timely manner.
Many causes including detergents, water quality, steam quality, instruments, etc.
Major concern is when endotoxins form
Causes of TASS (ASCRS)*
Detergent residues (in general)
Endotoxins
Preservatives
Residues from sterilization processing
Residues of detergents inside a reusable cannula or instrument
Cement sealant on bags of irrigating solution which has leached out
All can induce TASS and cause severe damage to ocular tissue
* American Society of Cataract and Refractive Surgeons
TASS
Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.
TASS
Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer
Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).
Also in AAMI ST-79 as an Annex
ASCRS Recommendations
An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.
Major issue in surgery centers
Insufficient inventory of instruments leads to short cuts in cleaning
ASCRS Recommendations
Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.
ASCRS Recommendations
A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.
Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments
ASCRS Recommendations
Instruments should be pre-cleaned immediately following use.
Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure
ASCRS Recommendations
Only cleaning agents that have been recommended by the manufacturer should be used.
Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.
ASCRS Recommendations
Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.
The water used to clean or rinse instruments should be discarded after each use.
ASCRS Recommendations
If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.
Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.
ASCRS Recommendations
Cleaning and sterilization equipment should be properly maintained.
Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS
Water Quality
Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed
devices.
Can lead to pyrogenic reactions (i.e., fever) in patients.
Adequate cleaning and rinsing should result in low bioburden
Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.
Physical Area
Separate area – dedicated to cleaning of ophthalmic instruments
Away from any other type of surgical instruments
Temp 60-65oF
Humidity 30-60%
Air exchanges 10/hour negative
Monitor temperature and humidity daily and document
FIRST STEP
Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended
Steps in the Cleaning Process
Pre-Cleaning in room
Contain contaminated items at the point of use
Transport to Decontamination (confined and contained)
Sort
Soak
Wash
Rinse/Dry
Pre-Cleaning - Transport
Instruments should be pre-cleaned immediately following use
Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)
Keep instruments moist to avoid drying of soils
Many now recommend cleaning immediately or within 30 minutes of use
Transport in closed container (confine/contain)
Container should be labeled as biohazard (OSHA)
Soaking
Can pre-soak with a detergent
Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer
Assists in the loosening of soils to facilitate cleaning
Do NOT soak in fluids for prolonged periods of time - biofilms can form
Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems
use enzymatic gels or foam
Biofiolms
Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates
Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow
Cleaning
Need to take special precautions with eye instruments due to
Delicate nature of the design
Sensitivity of eye tissue
Cleaning becomes a challenge
Manual cleaning may be only validated method
Manual cleaning is not as controlled (standardized) as mechanical cleaning
Dilemma
Some eye instrument manufacturer’s do not recommend ANY detergent
Source of confusion for end user
Need to challenge manufacturers
Enzymatic Cleaners
Organic substances which assist in the breakdown of soils
Facilitate the removal of blood and protein soils
Excellent for devices with lumens
Effectiveness dependent upon concentration, use temperature and contact time
Enzymatic Cleaners
Sold as liquid concentrates or powder
Generally more effective in warm water (110-140oF)
Enzyme activity can be inactivated above certain maximum temperatures (140oF)
Follow manufacturer’s directions
Use a thermometer – monitor water temperature
Principles of Cleaning
Must have manufacturer’s written instructions for cleaning of all devices processed
Follow all recommended steps using equipment recommended
Must wear PPE
Impervious gown, head cover, shoe covers, cuffed gloves, face shield
Manual Cleaning Process
May be the only cleaning process available
Items should be submerged, disassembled
Preferable to use 3-sink method; wash, rinse, rinse
Can also be used to remove deposits which were not removed during the pre-soak
Brush all serrations, crevices, tips, handles, and hinges.
Brushing should be done under the surface of the water to prevent aerosolization of contaminants.
Manual Cleaning – General Instructions
Handle instruments one at a time or in small numbers to avoid damage
Open hinged instruments
Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning
Brush and flush all lumened devices
Clean all surfaces
Specialty Items
Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.
Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface
Manual Cleaning Detergents
Usually used for manual cleaning and as a pre-soak
Range from low foam to high foam products
Generally have neutral pH of 7 to 9
Sold as concentrates
Free rinsing
Always measure and dilute the detergent as specified by the detergent manufacturer
Water used to clean instruments should be discarded after each use
Manual Cleaning Implements
Soft bristle brushes, various sizes and lengths (no metal brushes)
Soft cloths
No abrasive items
No sponges
No materials which are permeable; i.e.. Wood
Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use
Mechanical Cleaners
Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.
Can result in damage to instruments
Specialty Cleaner
Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces
Effectively cleans and rinses lumens
Must disinfect according to IFUs and document
Diamond Knives
The diamond knife is designed to make precision atraumatic cuts
The diamond knife has the sharpest cutting edge possible
Cost can range from $800 - $2,500 or more
Diamond Blade Knives
Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.
Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.
The blade should not touch any other instruments or the sides of the cleaner.
Diamond Blade Knives
Never completely submerge a diamond knife in an ultrasonic cleaner.
At all time, (except cleaning) the blade should be in the retracted position to prevent damage.
Inspect with microscope.
Ultrasonic Cleaning
Uses sound waves transmitted through a solution
Sound waves produce tiny bubbles which implode - results in scouring action that cleans
Mechanical process = cavitation
Ultrasonic Cleaning
Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)
Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming
Water temperatures usually 100 - 140 o F.
Can be used after manual cleaning
Ultrasonic Cleaning
Solution should be changed at least daily preferably after each use
Outbreaks of TASS have been associated with contaminated sonic baths
Unit should have a cover to contain aerosols
Items should not be stacked
Need to “de-gas” water
Ultrasonic Cleaning
Containers/baskets should have perforations; should be all metal mesh; no plastic
Should be located in Decontamination Area
cleaning process
more efficient than manual cleaning
Test the sonic for efficacy (daily???)
Testing Sonic
Rinsing
The most important part of the cleaning process
Essential to remove loosened debris
Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)
Water used to rinse instruments should be discarded after each use
Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS
Lubrication
The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.
However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.
Principles of Inspection/Assembly
All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)
All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.
Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.
Inspection
Best method is to use a microscope
Principles of Inspection/Assembly
All parts are present and functional
Use perforated or mesh bottom trays
All scissors should be tested for sharpness each time they are processed
Test that ratchets hold on clamps
Inspect hand held forceps that tips approximate
Test needle holders; ratchets hold and tips hold suture needle
Principles of Inspection/Assembly
Inspect that joints are not stiff
Use a lighted magnifying lamp or microscope to inspect
Inspect for rust, pitting, cracked box lock, etc.
Demagnetization of eye instruments may be needed
Separate delicate, sharp items
Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material
Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water
Ophthalmic Instruments
Look for defects:
Rusting common (especially if IUSS frequently used
Corrosion
Damage to tips/ teeth
Cords
Lumens (e.g. Phaco handpieces)
Stiffness
Sharpness
Spotting – Staining - Rust
Delicate Tips Require Protection
Can use small containers with silicone mat for individual instruments to provide protection.
General Guidelines for Packaging
Instrument Sets
Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.
The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers
The basket or container of the correct size to prevent instrument damage
Handling Eye Instruments
Place instruments in the tray so that they do not touch each other.
Locate each instrument in the tray to prevent movement and possible damage during handling.
Always keep delicate tips protected with a tip guard when the instrument is not in use.
Protective Container - Cataract Set
Finger Mats May Not Provide Adequate Protection
Paper Plastic Pouches
Widely used because of the visibility of the contents.
However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.
If packaging instruments separately, select the correct size pouch.
Allow approximately 1” distance from the device and the pouch edges.
Must ensure instruments packaged to protect from damage
General Guidelines for Packaging
Individual Instruments/Small Items
Use correct size packaging
Do not use rubber bands to secure instruments
Paper Plastic Pouches
Double pouching is not required (AORN, AAMI)
May be used for small items which would be difficult to keep together
If double pouching, do not fold over the edges of inside pouch
Inside pouch must lay flat
Tip Protectors
Obtain the manufacturer’s instructions for use.
Some can “catch” onto the instruments – can result in damage
You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.
Make sure device can be held open with protector on (e.g. scissors, clamps).
Must have manufacturer’s data that sterilant will penetrate through the tip protector.
Chemical Indicators (Types)
External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not
Internal chemical indicators (Type 3-4-5)
Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.
Type 3 – responds to one parameter
Type 4 – responds to 2 or more parameters
Should use at least a Type 4 CI
Chemical Indicators
Type 5 – integrating indicators – correlate to the action of a biological test
Cannot substitute for a BI test
Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time
Labeling Packages
Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).
Need documentation that marker is non-toxic.
Packages - label on the indicator tape used to close the package, never on the wrapping material itself.
Paper–plastic pouches - label only on the plastic side or on sterilization tape.
If a package is labeled directly on the packaging material, the
marker could damage the packaging material.
Exception is the plastic side of paper plastic pouches.
Table Top Sterilizers
Many ASCs use table top sterilizers
A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).
Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.
Also found in doctors’ and dental offices.
Cycles
The device manufacturer’s sterilization instructions should always be followed
If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.
Conventional Steam Sterilizers
Read the IFUs for exposure time, temperature and cycle time
Many have CJD cycles ONLY
Many have European temperatures only (e.g. 273oF)
Must reconcile IFU information
May have to separate sets to meet IFUs
E.g. some instruments require 10 minutes exposure
Water Quality
Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.
Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.
Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.
Maintenance
Perform all the recommended maintenance of the tabletop sterilizer
Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.
Documentation
All cycles run should be documented
All items processed must be documented
Specific name of device/tray
Quantity
All items must be identified with a lot control number (to facilitate recall)
Must include date sterilized, sterilizer #, load number
Expiration date or event related statement
Traceability to the patient if posterior eye tissue surgery (CJD)
Summary
Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS
Manufacturers IFUs
Effective cleaning
Correct packaging methods and materials
Effective sterilization –
Processing equipment in good condition
Proper handling after sterilization
Monitoring of staff compliance with all stated policies and manufacturers’ instructions
Training and competencies for staff
Conclusion - The End
Successful patient outcomes require we develop effective policies, train staff and monitor for compliance
Careful handling of ophthalmic instruments will keep patients safe and reduce costs.
References
AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.
AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.
Centers for Disease Control (Hospital Infection Control Guidelines) 2008
American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).
The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.
Questions??????
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3/13/2019
5
Keeping Ophthalmic Instruments Safe
Nancy Chobin, RN, AAS, ACSP, CSPM, CFER
CEO Sterile Processing University
Lebanon, NJ
Copyright 2019
Objectives
Identify AAMI recommended cleaning protocols to prevent TASS
Review the AAMI preparation recommendations for instruments and sets
Review care and handling of ophthalmic instruments
Background
Time to perform a cataract procedure has decreased15-20 minutes.
The cost for a set of instruments can range from $6,000 to $8,000 or more
Urgency to turn the instruments around for the next case.
Instruments come in contact with the eye and thus body fluids.
They are considered contaminated and must receive the entire cleaning and sterilization process between patients.
Manufacturer’s Instructions
Instrument manufacturer should:
specify the pH of detergent (e.g. neutral pH)
may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)
specify if any special cleaning implements are needed (e.g. to clean out lumens).
Specify water quality for cleaning and rinsing
However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.
Manufacturer’s Instructions
Also known as Instructions for Use (IFUs)
Keep on file - readily available to processing personnel.
Ensure IFUs followed each and every time the instrument is processed.
Employee training should complement the AAMI guidelines as well as manufacturers’ instructions
Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.
Example of Steam Sterilization IFU
Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.
NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.
Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.
High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.
Training and Competencies
Employee competencies should be verified in the processing protocols for processing ophthalmic instruments
Competencies should be verified initially and annually
Utilize resources such as ophthalmic instrument company's educational materials
Reconcile with national standards
Cleaning
Removal of contamination from an item to the extent necessary for further processing or for the intended use.
Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.
Due to their design, eye instrument challenging to clean
Very small lumens, very delicate tips, can easily break/damage
Pre-Cleaning in Room
Treat with demineralized water to prevent drying of bioburden.
Saline, disinfectants, and chlorinated solutions can cause pitting
and corrosion and should never be used for soaking instruments
Instruments should not remain in water for lengthy periods of time.
–– Biofilms may form, particularly within lumens.
Decontamination
According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]
NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood
First and most critical step in breaking the chain of disease transmission
Why Is Cleaning Important?
Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item
Protein left on items can be “baked on” in the sterilizer
Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?
TASS – Focus
Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN
TASS - an acute inflammatory response of the anterior chamber of the eye.
May lead to severe visual impairment if it is not recognized and treated in a timely manner.
Many causes including detergents, water quality, steam quality, instruments, etc.
Major concern is when endotoxins form
Causes of TASS (ASCRS)*
Detergent residues (in general)
Endotoxins
Preservatives
Residues from sterilization processing
Residues of detergents inside a reusable cannula or instrument
Cement sealant on bags of irrigating solution which has leached out
All can induce TASS and cause severe damage to ocular tissue
* American Society of Cataract and Refractive Surgeons
TASS
Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.
TASS
Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer
Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).
Also in AAMI ST-79 as an Annex
ASCRS Recommendations
An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.
Major issue in surgery centers
Insufficient inventory of instruments leads to short cuts in cleaning
ASCRS Recommendations
Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.
ASCRS Recommendations
A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.
Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments
ASCRS Recommendations
Instruments should be pre-cleaned immediately following use.
Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure
ASCRS Recommendations
Only cleaning agents that have been recommended by the manufacturer should be used.
Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.
ASCRS Recommendations
Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.
The water used to clean or rinse instruments should be discarded after each use.
ASCRS Recommendations
If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.
Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.
ASCRS Recommendations
Cleaning and sterilization equipment should be properly maintained.
Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS
Water Quality
Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed
devices.
Can lead to pyrogenic reactions (i.e., fever) in patients.
Adequate cleaning and rinsing should result in low bioburden
Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.
Physical Area
Separate area – dedicated to cleaning of ophthalmic instruments
Away from any other type of surgical instruments
Temp 60-65oF
Humidity 30-60%
Air exchanges 10/hour negative
Monitor temperature and humidity daily and document
FIRST STEP
Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended
Steps in the Cleaning Process
Pre-Cleaning in room
Contain contaminated items at the point of use
Transport to Decontamination (confined and contained)
Sort
Soak
Wash
Rinse/Dry
Pre-Cleaning - Transport
Instruments should be pre-cleaned immediately following use
Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)
Keep instruments moist to avoid drying of soils
Many now recommend cleaning immediately or within 30 minutes of use
Transport in closed container (confine/contain)
Container should be labeled as biohazard (OSHA)
Soaking
Can pre-soak with a detergent
Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer
Assists in the loosening of soils to facilitate cleaning
Do NOT soak in fluids for prolonged periods of time - biofilms can form
Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems
use enzymatic gels or foam
Biofiolms
Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates
Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow
Cleaning
Need to take special precautions with eye instruments due to
Delicate nature of the design
Sensitivity of eye tissue
Cleaning becomes a challenge
Manual cleaning may be only validated method
Manual cleaning is not as controlled (standardized) as mechanical cleaning
Dilemma
Some eye instrument manufacturer’s do not recommend ANY detergent
Source of confusion for end user
Need to challenge manufacturers
Enzymatic Cleaners
Organic substances which assist in the breakdown of soils
Facilitate the removal of blood and protein soils
Excellent for devices with lumens
Effectiveness dependent upon concentration, use temperature and contact time
Enzymatic Cleaners
Sold as liquid concentrates or powder
Generally more effective in warm water (110-140oF)
Enzyme activity can be inactivated above certain maximum temperatures (140oF)
Follow manufacturer’s directions
Use a thermometer – monitor water temperature
Principles of Cleaning
Must have manufacturer’s written instructions for cleaning of all devices processed
Follow all recommended steps using equipment recommended
Must wear PPE
Impervious gown, head cover, shoe covers, cuffed gloves, face shield
Manual Cleaning Process
May be the only cleaning process available
Items should be submerged, disassembled
Preferable to use 3-sink method; wash, rinse, rinse
Can also be used to remove deposits which were not removed during the pre-soak
Brush all serrations, crevices, tips, handles, and hinges.
Brushing should be done under the surface of the water to prevent aerosolization of contaminants.
Manual Cleaning – General Instructions
Handle instruments one at a time or in small numbers to avoid damage
Open hinged instruments
Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning
Brush and flush all lumened devices
Clean all surfaces
Specialty Items
Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.
Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface
Manual Cleaning Detergents
Usually used for manual cleaning and as a pre-soak
Range from low foam to high foam products
Generally have neutral pH of 7 to 9
Sold as concentrates
Free rinsing
Always measure and dilute the detergent as specified by the detergent manufacturer
Water used to clean instruments should be discarded after each use
Manual Cleaning Implements
Soft bristle brushes, various sizes and lengths (no metal brushes)
Soft cloths
No abrasive items
No sponges
No materials which are permeable; i.e.. Wood
Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use
Mechanical Cleaners
Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.
Can result in damage to instruments
Specialty Cleaner
Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces
Effectively cleans and rinses lumens
Must disinfect according to IFUs and document
Diamond Knives
The diamond knife is designed to make precision atraumatic cuts
The diamond knife has the sharpest cutting edge possible
Cost can range from $800 - $2,500 or more
Diamond Blade Knives
Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.
Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.
The blade should not touch any other instruments or the sides of the cleaner.
Diamond Blade Knives
Never completely submerge a diamond knife in an ultrasonic cleaner.
At all time, (except cleaning) the blade should be in the retracted position to prevent damage.
Inspect with microscope.
Ultrasonic Cleaning
Uses sound waves transmitted through a solution
Sound waves produce tiny bubbles which implode - results in scouring action that cleans
Mechanical process = cavitation
Ultrasonic Cleaning
Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)
Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming
Water temperatures usually 100 - 140 o F.
Can be used after manual cleaning
Ultrasonic Cleaning
Solution should be changed at least daily preferably after each use
Outbreaks of TASS have been associated with contaminated sonic baths
Unit should have a cover to contain aerosols
Items should not be stacked
Need to “de-gas” water
Ultrasonic Cleaning
Containers/baskets should have perforations; should be all metal mesh; no plastic
Should be located in Decontamination Area
cleaning process
more efficient than manual cleaning
Test the sonic for efficacy (daily???)
Testing Sonic
Rinsing
The most important part of the cleaning process
Essential to remove loosened debris
Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)
Water used to rinse instruments should be discarded after each use
Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS
Lubrication
The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.
However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.
Principles of Inspection/Assembly
All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)
All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.
Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.
Inspection
Best method is to use a microscope
Principles of Inspection/Assembly
All parts are present and functional
Use perforated or mesh bottom trays
All scissors should be tested for sharpness each time they are processed
Test that ratchets hold on clamps
Inspect hand held forceps that tips approximate
Test needle holders; ratchets hold and tips hold suture needle
Principles of Inspection/Assembly
Inspect that joints are not stiff
Use a lighted magnifying lamp or microscope to inspect
Inspect for rust, pitting, cracked box lock, etc.
Demagnetization of eye instruments may be needed
Separate delicate, sharp items
Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material
Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water
Ophthalmic Instruments
Look for defects:
Rusting common (especially if IUSS frequently used
Corrosion
Damage to tips/ teeth
Cords
Lumens (e.g. Phaco handpieces)
Stiffness
Sharpness
Spotting – Staining - Rust
Delicate Tips Require Protection
Can use small containers with silicone mat for individual instruments to provide protection.
General Guidelines for Packaging
Instrument Sets
Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.
The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers
The basket or container of the correct size to prevent instrument damage
Handling Eye Instruments
Place instruments in the tray so that they do not touch each other.
Locate each instrument in the tray to prevent movement and possible damage during handling.
Always keep delicate tips protected with a tip guard when the instrument is not in use.
Protective Container - Cataract Set
Finger Mats May Not Provide Adequate Protection
Paper Plastic Pouches
Widely used because of the visibility of the contents.
However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.
If packaging instruments separately, select the correct size pouch.
Allow approximately 1” distance from the device and the pouch edges.
Must ensure instruments packaged to protect from damage
General Guidelines for Packaging
Individual Instruments/Small Items
Use correct size packaging
Do not use rubber bands to secure instruments
Paper Plastic Pouches
Double pouching is not required (AORN, AAMI)
May be used for small items which would be difficult to keep together
If double pouching, do not fold over the edges of inside pouch
Inside pouch must lay flat
Tip Protectors
Obtain the manufacturer’s instructions for use.
Some can “catch” onto the instruments – can result in damage
You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.
Make sure device can be held open with protector on (e.g. scissors, clamps).
Must have manufacturer’s data that sterilant will penetrate through the tip protector.
Chemical Indicators (Types)
External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not
Internal chemical indicators (Type 3-4-5)
Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.
Type 3 – responds to one parameter
Type 4 – responds to 2 or more parameters
Should use at least a Type 4 CI
Chemical Indicators
Type 5 – integrating indicators – correlate to the action of a biological test
Cannot substitute for a BI test
Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time
Labeling Packages
Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).
Need documentation that marker is non-toxic.
Packages - label on the indicator tape used to close the package, never on the wrapping material itself.
Paper–plastic pouches - label only on the plastic side or on sterilization tape.
If a package is labeled directly on the packaging material, the
marker could damage the packaging material.
Exception is the plastic side of paper plastic pouches.
Table Top Sterilizers
Many ASCs use table top sterilizers
A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).
Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.
Also found in doctors’ and dental offices.
Cycles
The device manufacturer’s sterilization instructions should always be followed
If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.
Conventional Steam Sterilizers
Read the IFUs for exposure time, temperature and cycle time
Many have CJD cycles ONLY
Many have European temperatures only (e.g. 273oF)
Must reconcile IFU information
May have to separate sets to meet IFUs
E.g. some instruments require 10 minutes exposure
Water Quality
Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.
Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.
Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.
Maintenance
Perform all the recommended maintenance of the tabletop sterilizer
Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.
Documentation
All cycles run should be documented
All items processed must be documented
Specific name of device/tray
Quantity
All items must be identified with a lot control number (to facilitate recall)
Must include date sterilized, sterilizer #, load number
Expiration date or event related statement
Traceability to the patient if posterior eye tissue surgery (CJD)
Summary
Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS
Manufacturers IFUs
Effective cleaning
Correct packaging methods and materials
Effective sterilization –
Processing equipment in good condition
Proper handling after sterilization
Monitoring of staff compliance with all stated policies and manufacturers’ instructions
Training and competencies for staff
Conclusion - The End
Successful patient outcomes require we develop effective policies, train staff and monitor for compliance
Careful handling of ophthalmic instruments will keep patients safe and reduce costs.
References
AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.
AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.
Centers for Disease Control (Hospital Infection Control Guidelines) 2008
American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).
The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.
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3/13/2019
6
Keeping Ophthalmic Instruments Safe
Nancy Chobin, RN, AAS, ACSP, CSPM, CFER
CEO Sterile Processing University
Lebanon, NJ
Copyright 2019
Objectives
Identify AAMI recommended cleaning protocols to prevent TASS
Review the AAMI preparation recommendations for instruments and sets
Review care and handling of ophthalmic instruments
Background
Time to perform a cataract procedure has decreased15-20 minutes.
The cost for a set of instruments can range from $6,000 to $8,000 or more
Urgency to turn the instruments around for the next case.
Instruments come in contact with the eye and thus body fluids.
They are considered contaminated and must receive the entire cleaning and sterilization process between patients.
Manufacturer’s Instructions
Instrument manufacturer should:
specify the pH of detergent (e.g. neutral pH)
may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)
specify if any special cleaning implements are needed (e.g. to clean out lumens).
Specify water quality for cleaning and rinsing
However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.
Manufacturer’s Instructions
Also known as Instructions for Use (IFUs)
Keep on file - readily available to processing personnel.
Ensure IFUs followed each and every time the instrument is processed.
Employee training should complement the AAMI guidelines as well as manufacturers’ instructions
Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.
Example of Steam Sterilization IFU
Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.
NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.
Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.
High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.
Training and Competencies
Employee competencies should be verified in the processing protocols for processing ophthalmic instruments
Competencies should be verified initially and annually
Utilize resources such as ophthalmic instrument company's educational materials
Reconcile with national standards
Cleaning
Removal of contamination from an item to the extent necessary for further processing or for the intended use.
Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.
Due to their design, eye instrument challenging to clean
Very small lumens, very delicate tips, can easily break/damage
Pre-Cleaning in Room
Treat with demineralized water to prevent drying of bioburden.
Saline, disinfectants, and chlorinated solutions can cause pitting
and corrosion and should never be used for soaking instruments
Instruments should not remain in water for lengthy periods of time.
–– Biofilms may form, particularly within lumens.
Decontamination
According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]
NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood
First and most critical step in breaking the chain of disease transmission
Why Is Cleaning Important?
Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item
Protein left on items can be “baked on” in the sterilizer
Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?
TASS – Focus
Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN
TASS - an acute inflammatory response of the anterior chamber of the eye.
May lead to severe visual impairment if it is not recognized and treated in a timely manner.
Many causes including detergents, water quality, steam quality, instruments, etc.
Major concern is when endotoxins form
Causes of TASS (ASCRS)*
Detergent residues (in general)
Endotoxins
Preservatives
Residues from sterilization processing
Residues of detergents inside a reusable cannula or instrument
Cement sealant on bags of irrigating solution which has leached out
All can induce TASS and cause severe damage to ocular tissue
* American Society of Cataract and Refractive Surgeons
TASS
Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.
TASS
Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer
Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).
Also in AAMI ST-79 as an Annex
ASCRS Recommendations
An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.
Major issue in surgery centers
Insufficient inventory of instruments leads to short cuts in cleaning
ASCRS Recommendations
Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.
ASCRS Recommendations
A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.
Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments
ASCRS Recommendations
Instruments should be pre-cleaned immediately following use.
Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure
ASCRS Recommendations
Only cleaning agents that have been recommended by the manufacturer should be used.
Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.
ASCRS Recommendations
Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.
The water used to clean or rinse instruments should be discarded after each use.
ASCRS Recommendations
If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.
Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.
ASCRS Recommendations
Cleaning and sterilization equipment should be properly maintained.
Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS
Water Quality
Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed
devices.
Can lead to pyrogenic reactions (i.e., fever) in patients.
Adequate cleaning and rinsing should result in low bioburden
Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.
Physical Area
Separate area – dedicated to cleaning of ophthalmic instruments
Away from any other type of surgical instruments
Temp 60-65oF
Humidity 30-60%
Air exchanges 10/hour negative
Monitor temperature and humidity daily and document
FIRST STEP
Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended
Steps in the Cleaning Process
Pre-Cleaning in room
Contain contaminated items at the point of use
Transport to Decontamination (confined and contained)
Sort
Soak
Wash
Rinse/Dry
Pre-Cleaning - Transport
Instruments should be pre-cleaned immediately following use
Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)
Keep instruments moist to avoid drying of soils
Many now recommend cleaning immediately or within 30 minutes of use
Transport in closed container (confine/contain)
Container should be labeled as biohazard (OSHA)
Soaking
Can pre-soak with a detergent
Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer
Assists in the loosening of soils to facilitate cleaning
Do NOT soak in fluids for prolonged periods of time - biofilms can form
Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems
use enzymatic gels or foam
Biofiolms
Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates
Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow
Cleaning
Need to take special precautions with eye instruments due to
Delicate nature of the design
Sensitivity of eye tissue
Cleaning becomes a challenge
Manual cleaning may be only validated method
Manual cleaning is not as controlled (standardized) as mechanical cleaning
Dilemma
Some eye instrument manufacturer’s do not recommend ANY detergent
Source of confusion for end user
Need to challenge manufacturers
Enzymatic Cleaners
Organic substances which assist in the breakdown of soils
Facilitate the removal of blood and protein soils
Excellent for devices with lumens
Effectiveness dependent upon concentration, use temperature and contact time
Enzymatic Cleaners
Sold as liquid concentrates or powder
Generally more effective in warm water (110-140oF)
Enzyme activity can be inactivated above certain maximum temperatures (140oF)
Follow manufacturer’s directions
Use a thermometer – monitor water temperature
Principles of Cleaning
Must have manufacturer’s written instructions for cleaning of all devices processed
Follow all recommended steps using equipment recommended
Must wear PPE
Impervious gown, head cover, shoe covers, cuffed gloves, face shield
Manual Cleaning Process
May be the only cleaning process available
Items should be submerged, disassembled
Preferable to use 3-sink method; wash, rinse, rinse
Can also be used to remove deposits which were not removed during the pre-soak
Brush all serrations, crevices, tips, handles, and hinges.
Brushing should be done under the surface of the water to prevent aerosolization of contaminants.
Manual Cleaning – General Instructions
Handle instruments one at a time or in small numbers to avoid damage
Open hinged instruments
Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning
Brush and flush all lumened devices
Clean all surfaces
Specialty Items
Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.
Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface
Manual Cleaning Detergents
Usually used for manual cleaning and as a pre-soak
Range from low foam to high foam products
Generally have neutral pH of 7 to 9
Sold as concentrates
Free rinsing
Always measure and dilute the detergent as specified by the detergent manufacturer
Water used to clean instruments should be discarded after each use
Manual Cleaning Implements
Soft bristle brushes, various sizes and lengths (no metal brushes)
Soft cloths
No abrasive items
No sponges
No materials which are permeable; i.e.. Wood
Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use
Mechanical Cleaners
Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.
Can result in damage to instruments
Specialty Cleaner
Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces
Effectively cleans and rinses lumens
Must disinfect according to IFUs and document
Diamond Knives
The diamond knife is designed to make precision atraumatic cuts
The diamond knife has the sharpest cutting edge possible
Cost can range from $800 - $2,500 or more
Diamond Blade Knives
Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.
Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.
The blade should not touch any other instruments or the sides of the cleaner.
Diamond Blade Knives
Never completely submerge a diamond knife in an ultrasonic cleaner.
At all time, (except cleaning) the blade should be in the retracted position to prevent damage.
Inspect with microscope.
Ultrasonic Cleaning
Uses sound waves transmitted through a solution
Sound waves produce tiny bubbles which implode - results in scouring action that cleans
Mechanical process = cavitation
Ultrasonic Cleaning
Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)
Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming
Water temperatures usually 100 - 140 o F.
Can be used after manual cleaning
Ultrasonic Cleaning
Solution should be changed at least daily preferably after each use
Outbreaks of TASS have been associated with contaminated sonic baths
Unit should have a cover to contain aerosols
Items should not be stacked
Need to “de-gas” water
Ultrasonic Cleaning
Containers/baskets should have perforations; should be all metal mesh; no plastic
Should be located in Decontamination Area
cleaning process
more efficient than manual cleaning
Test the sonic for efficacy (daily???)
Testing Sonic
Rinsing
The most important part of the cleaning process
Essential to remove loosened debris
Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)
Water used to rinse instruments should be discarded after each use
Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS
Lubrication
The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.
However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.
Principles of Inspection/Assembly
All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)
All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.
Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.
Inspection
Best method is to use a microscope
Principles of Inspection/Assembly
All parts are present and functional
Use perforated or mesh bottom trays
All scissors should be tested for sharpness each time they are processed
Test that ratchets hold on clamps
Inspect hand held forceps that tips approximate
Test needle holders; ratchets hold and tips hold suture needle
Principles of Inspection/Assembly
Inspect that joints are not stiff
Use a lighted magnifying lamp or microscope to inspect
Inspect for rust, pitting, cracked box lock, etc.
Demagnetization of eye instruments may be needed
Separate delicate, sharp items
Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material
Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water
Ophthalmic Instruments
Look for defects:
Rusting common (especially if IUSS frequently used
Corrosion
Damage to tips/ teeth
Cords
Lumens (e.g. Phaco handpieces)
Stiffness
Sharpness
Spotting – Staining - Rust
Delicate Tips Require Protection
Can use small containers with silicone mat for individual instruments to provide protection.
General Guidelines for Packaging
Instrument Sets
Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.
The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers
The basket or container of the correct size to prevent instrument damage
Handling Eye Instruments
Place instruments in the tray so that they do not touch each other.
Locate each instrument in the tray to prevent movement and possible damage during handling.
Always keep delicate tips protected with a tip guard when the instrument is not in use.
Protective Container - Cataract Set
Finger Mats May Not Provide Adequate Protection
Paper Plastic Pouches
Widely used because of the visibility of the contents.
However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.
If packaging instruments separately, select the correct size pouch.
Allow approximately 1” distance from the device and the pouch edges.
Must ensure instruments packaged to protect from damage
General Guidelines for Packaging
Individual Instruments/Small Items
Use correct size packaging
Do not use rubber bands to secure instruments
Paper Plastic Pouches
Double pouching is not required (AORN, AAMI)
May be used for small items which would be difficult to keep together
If double pouching, do not fold over the edges of inside pouch
Inside pouch must lay flat
Tip Protectors
Obtain the manufacturer’s instructions for use.
Some can “catch” onto the instruments – can result in damage
You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.
Make sure device can be held open with protector on (e.g. scissors, clamps).
Must have manufacturer’s data that sterilant will penetrate through the tip protector.
Chemical Indicators (Types)
External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not
Internal chemical indicators (Type 3-4-5)
Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.
Type 3 – responds to one parameter
Type 4 – responds to 2 or more parameters
Should use at least a Type 4 CI
Chemical Indicators
Type 5 – integrating indicators – correlate to the action of a biological test
Cannot substitute for a BI test
Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time
Labeling Packages
Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).
Need documentation that marker is non-toxic.
Packages - label on the indicator tape used to close the package, never on the wrapping material itself.
Paper–plastic pouches - label only on the plastic side or on sterilization tape.
If a package is labeled directly on the packaging material, the
marker could damage the packaging material.
Exception is the plastic side of paper plastic pouches.
Table Top Sterilizers
Many ASCs use table top sterilizers
A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).
Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.
Also found in doctors’ and dental offices.
Cycles
The device manufacturer’s sterilization instructions should always be followed
If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.
Conventional Steam Sterilizers
Read the IFUs for exposure time, temperature and cycle time
Many have CJD cycles ONLY
Many have European temperatures only (e.g. 273oF)
Must reconcile IFU information
May have to separate sets to meet IFUs
E.g. some instruments require 10 minutes exposure
Water Quality
Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.
Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.
Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.
Maintenance
Perform all the recommended maintenance of the tabletop sterilizer
Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.
Documentation
All cycles run should be documented
All items processed must be documented
Specific name of device/tray
Quantity
All items must be identified with a lot control number (to facilitate recall)
Must include date sterilized, sterilizer #, load number
Expiration date or event related statement
Traceability to the patient if posterior eye tissue surgery (CJD)
Summary
Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS
Manufacturers IFUs
Effective cleaning
Correct packaging methods and materials
Effective sterilization –
Processing equipment in good condition
Proper handling after sterilization
Monitoring of staff compliance with all stated policies and manufacturers’ instructions
Training and competencies for staff
Conclusion - The End
Successful patient outcomes require we develop effective policies, train staff and monitor for compliance
Careful handling of ophthalmic instruments will keep patients safe and reduce costs.
References
AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.
AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.
Centers for Disease Control (Hospital Infection Control Guidelines) 2008
American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).
The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.
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3/13/2019
7
Keeping Ophthalmic Instruments Safe
Nancy Chobin, RN, AAS, ACSP, CSPM, CFER
CEO Sterile Processing University
Lebanon, NJ
Copyright 2019
Objectives
Identify AAMI recommended cleaning protocols to prevent TASS
Review the AAMI preparation recommendations for instruments and sets
Review care and handling of ophthalmic instruments
Background
Time to perform a cataract procedure has decreased15-20 minutes.
The cost for a set of instruments can range from $6,000 to $8,000 or more
Urgency to turn the instruments around for the next case.
Instruments come in contact with the eye and thus body fluids.
They are considered contaminated and must receive the entire cleaning and sterilization process between patients.
Manufacturer’s Instructions
Instrument manufacturer should:
specify the pH of detergent (e.g. neutral pH)
may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)
specify if any special cleaning implements are needed (e.g. to clean out lumens).
Specify water quality for cleaning and rinsing
However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.
Manufacturer’s Instructions
Also known as Instructions for Use (IFUs)
Keep on file - readily available to processing personnel.
Ensure IFUs followed each and every time the instrument is processed.
Employee training should complement the AAMI guidelines as well as manufacturers’ instructions
Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.
Example of Steam Sterilization IFU
Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.
NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.
Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.
High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.
Training and Competencies
Employee competencies should be verified in the processing protocols for processing ophthalmic instruments
Competencies should be verified initially and annually
Utilize resources such as ophthalmic instrument company's educational materials
Reconcile with national standards
Cleaning
Removal of contamination from an item to the extent necessary for further processing or for the intended use.
Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.
Due to their design, eye instrument challenging to clean
Very small lumens, very delicate tips, can easily break/damage
Pre-Cleaning in Room
Treat with demineralized water to prevent drying of bioburden.
Saline, disinfectants, and chlorinated solutions can cause pitting
and corrosion and should never be used for soaking instruments
Instruments should not remain in water for lengthy periods of time.
–– Biofilms may form, particularly within lumens.
Decontamination
According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]
NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood
First and most critical step in breaking the chain of disease transmission
Why Is Cleaning Important?
Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item
Protein left on items can be “baked on” in the sterilizer
Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?
TASS – Focus
Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN
TASS - an acute inflammatory response of the anterior chamber of the eye.
May lead to severe visual impairment if it is not recognized and treated in a timely manner.
Many causes including detergents, water quality, steam quality, instruments, etc.
Major concern is when endotoxins form
Causes of TASS (ASCRS)*
Detergent residues (in general)
Endotoxins
Preservatives
Residues from sterilization processing
Residues of detergents inside a reusable cannula or instrument
Cement sealant on bags of irrigating solution which has leached out
All can induce TASS and cause severe damage to ocular tissue
* American Society of Cataract and Refractive Surgeons
TASS
Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.
TASS
Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer
Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).
Also in AAMI ST-79 as an Annex
ASCRS Recommendations
An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.
Major issue in surgery centers
Insufficient inventory of instruments leads to short cuts in cleaning
ASCRS Recommendations
Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.
ASCRS Recommendations
A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.
Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments
ASCRS Recommendations
Instruments should be pre-cleaned immediately following use.
Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure
ASCRS Recommendations
Only cleaning agents that have been recommended by the manufacturer should be used.
Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.
ASCRS Recommendations
Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.
The water used to clean or rinse instruments should be discarded after each use.
ASCRS Recommendations
If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.
Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.
ASCRS Recommendations
Cleaning and sterilization equipment should be properly maintained.
Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS
Water Quality
Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed
devices.
Can lead to pyrogenic reactions (i.e., fever) in patients.
Adequate cleaning and rinsing should result in low bioburden
Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.
Physical Area
Separate area – dedicated to cleaning of ophthalmic instruments
Away from any other type of surgical instruments
Temp 60-65oF
Humidity 30-60%
Air exchanges 10/hour negative
Monitor temperature and humidity daily and document
FIRST STEP
Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended
Steps in the Cleaning Process
Pre-Cleaning in room
Contain contaminated items at the point of use
Transport to Decontamination (confined and contained)
Sort
Soak
Wash
Rinse/Dry
Pre-Cleaning - Transport
Instruments should be pre-cleaned immediately following use
Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)
Keep instruments moist to avoid drying of soils
Many now recommend cleaning immediately or within 30 minutes of use
Transport in closed container (confine/contain)
Container should be labeled as biohazard (OSHA)
Soaking
Can pre-soak with a detergent
Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer
Assists in the loosening of soils to facilitate cleaning
Do NOT soak in fluids for prolonged periods of time - biofilms can form
Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems
use enzymatic gels or foam
Biofiolms
Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates
Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow
Cleaning
Need to take special precautions with eye instruments due to
Delicate nature of the design
Sensitivity of eye tissue
Cleaning becomes a challenge
Manual cleaning may be only validated method
Manual cleaning is not as controlled (standardized) as mechanical cleaning
Dilemma
Some eye instrument manufacturer’s do not recommend ANY detergent
Source of confusion for end user
Need to challenge manufacturers
Enzymatic Cleaners
Organic substances which assist in the breakdown of soils
Facilitate the removal of blood and protein soils
Excellent for devices with lumens
Effectiveness dependent upon concentration, use temperature and contact time
Enzymatic Cleaners
Sold as liquid concentrates or powder
Generally more effective in warm water (110-140oF)
Enzyme activity can be inactivated above certain maximum temperatures (140oF)
Follow manufacturer’s directions
Use a thermometer – monitor water temperature
Principles of Cleaning
Must have manufacturer’s written instructions for cleaning of all devices processed
Follow all recommended steps using equipment recommended
Must wear PPE
Impervious gown, head cover, shoe covers, cuffed gloves, face shield
Manual Cleaning Process
May be the only cleaning process available
Items should be submerged, disassembled
Preferable to use 3-sink method; wash, rinse, rinse
Can also be used to remove deposits which were not removed during the pre-soak
Brush all serrations, crevices, tips, handles, and hinges.
Brushing should be done under the surface of the water to prevent aerosolization of contaminants.
Manual Cleaning – General Instructions
Handle instruments one at a time or in small numbers to avoid damage
Open hinged instruments
Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning
Brush and flush all lumened devices
Clean all surfaces
Specialty Items
Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.
Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface
Manual Cleaning Detergents
Usually used for manual cleaning and as a pre-soak
Range from low foam to high foam products
Generally have neutral pH of 7 to 9
Sold as concentrates
Free rinsing
Always measure and dilute the detergent as specified by the detergent manufacturer
Water used to clean instruments should be discarded after each use
Manual Cleaning Implements
Soft bristle brushes, various sizes and lengths (no metal brushes)
Soft cloths
No abrasive items
No sponges
No materials which are permeable; i.e.. Wood
Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use
Mechanical Cleaners
Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.
Can result in damage to instruments
Specialty Cleaner
Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces
Effectively cleans and rinses lumens
Must disinfect according to IFUs and document
Diamond Knives
The diamond knife is designed to make precision atraumatic cuts
The diamond knife has the sharpest cutting edge possible
Cost can range from $800 - $2,500 or more
Diamond Blade Knives
Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.
Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.
The blade should not touch any other instruments or the sides of the cleaner.
Diamond Blade Knives
Never completely submerge a diamond knife in an ultrasonic cleaner.
At all time, (except cleaning) the blade should be in the retracted position to prevent damage.
Inspect with microscope.
Ultrasonic Cleaning
Uses sound waves transmitted through a solution
Sound waves produce tiny bubbles which implode - results in scouring action that cleans
Mechanical process = cavitation
Ultrasonic Cleaning
Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)
Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming
Water temperatures usually 100 - 140 o F.
Can be used after manual cleaning
Ultrasonic Cleaning
Solution should be changed at least daily preferably after each use
Outbreaks of TASS have been associated with contaminated sonic baths
Unit should have a cover to contain aerosols
Items should not be stacked
Need to “de-gas” water
Ultrasonic Cleaning
Containers/baskets should have perforations; should be all metal mesh; no plastic
Should be located in Decontamination Area
cleaning process
more efficient than manual cleaning
Test the sonic for efficacy (daily???)
Testing Sonic
Rinsing
The most important part of the cleaning process
Essential to remove loosened debris
Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)
Water used to rinse instruments should be discarded after each use
Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS
Lubrication
The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.
However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.
Principles of Inspection/Assembly
All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)
All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.
Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.
Inspection
Best method is to use a microscope
Principles of Inspection/Assembly
All parts are present and functional
Use perforated or mesh bottom trays
All scissors should be tested for sharpness each time they are processed
Test that ratchets hold on clamps
Inspect hand held forceps that tips approximate
Test needle holders; ratchets hold and tips hold suture needle
Principles of Inspection/Assembly
Inspect that joints are not stiff
Use a lighted magnifying lamp or microscope to inspect
Inspect for rust, pitting, cracked box lock, etc.
Demagnetization of eye instruments may be needed
Separate delicate, sharp items
Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material
Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water
Ophthalmic Instruments
Look for defects:
Rusting common (especially if IUSS frequently used
Corrosion
Damage to tips/ teeth
Cords
Lumens (e.g. Phaco handpieces)
Stiffness
Sharpness
Spotting – Staining - Rust
Delicate Tips Require Protection
Can use small containers with silicone mat for individual instruments to provide protection.
General Guidelines for Packaging
Instrument Sets
Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.
The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers
The basket or container of the correct size to prevent instrument damage
Handling Eye Instruments
Place instruments in the tray so that they do not touch each other.
Locate each instrument in the tray to prevent movement and possible damage during handling.
Always keep delicate tips protected with a tip guard when the instrument is not in use.
Protective Container - Cataract Set
Finger Mats May Not Provide Adequate Protection
Paper Plastic Pouches
Widely used because of the visibility of the contents.
However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.
If packaging instruments separately, select the correct size pouch.
Allow approximately 1” distance from the device and the pouch edges.
Must ensure instruments packaged to protect from damage
General Guidelines for Packaging
Individual Instruments/Small Items
Use correct size packaging
Do not use rubber bands to secure instruments
Paper Plastic Pouches
Double pouching is not required (AORN, AAMI)
May be used for small items which would be difficult to keep together
If double pouching, do not fold over the edges of inside pouch
Inside pouch must lay flat
Tip Protectors
Obtain the manufacturer’s instructions for use.
Some can “catch” onto the instruments – can result in damage
You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.
Make sure device can be held open with protector on (e.g. scissors, clamps).
Must have manufacturer’s data that sterilant will penetrate through the tip protector.
Chemical Indicators (Types)
External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not
Internal chemical indicators (Type 3-4-5)
Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.
Type 3 – responds to one parameter
Type 4 – responds to 2 or more parameters
Should use at least a Type 4 CI
Chemical Indicators
Type 5 – integrating indicators – correlate to the action of a biological test
Cannot substitute for a BI test
Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time
Labeling Packages
Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).
Need documentation that marker is non-toxic.
Packages - label on the indicator tape used to close the package, never on the wrapping material itself.
Paper–plastic pouches - label only on the plastic side or on sterilization tape.
If a package is labeled directly on the packaging material, the
marker could damage the packaging material.
Exception is the plastic side of paper plastic pouches.
Table Top Sterilizers
Many ASCs use table top sterilizers
A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).
Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.
Also found in doctors’ and dental offices.
Cycles
The device manufacturer’s sterilization instructions should always be followed
If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.
Conventional Steam Sterilizers
Read the IFUs for exposure time, temperature and cycle time
Many have CJD cycles ONLY
Many have European temperatures only (e.g. 273oF)
Must reconcile IFU information
May have to separate sets to meet IFUs
E.g. some instruments require 10 minutes exposure
Water Quality
Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.
Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.
Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.
Maintenance
Perform all the recommended maintenance of the tabletop sterilizer
Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.
Documentation
All cycles run should be documented
All items processed must be documented
Specific name of device/tray
Quantity
All items must be identified with a lot control number (to facilitate recall)
Must include date sterilized, sterilizer #, load number
Expiration date or event related statement
Traceability to the patient if posterior eye tissue surgery (CJD)
Summary
Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS
Manufacturers IFUs
Effective cleaning
Correct packaging methods and materials
Effective sterilization –
Processing equipment in good condition
Proper handling after sterilization
Monitoring of staff compliance with all stated policies and manufacturers’ instructions
Training and competencies for staff
Conclusion - The End
Successful patient outcomes require we develop effective policies, train staff and monitor for compliance
Careful handling of ophthalmic instruments will keep patients safe and reduce costs.
References
AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.
AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.
Centers for Disease Control (Hospital Infection Control Guidelines) 2008
American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).
The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.
Questions??????
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3/13/2019
8
Keeping Ophthalmic Instruments Safe
Nancy Chobin, RN, AAS, ACSP, CSPM, CFER
CEO Sterile Processing University
Lebanon, NJ
Copyright 2019
Objectives
Identify AAMI recommended cleaning protocols to prevent TASS
Review the AAMI preparation recommendations for instruments and sets
Review care and handling of ophthalmic instruments
Background
Time to perform a cataract procedure has decreased15-20 minutes.
The cost for a set of instruments can range from $6,000 to $8,000 or more
Urgency to turn the instruments around for the next case.
Instruments come in contact with the eye and thus body fluids.
They are considered contaminated and must receive the entire cleaning and sterilization process between patients.
Manufacturer’s Instructions
Instrument manufacturer should:
specify the pH of detergent (e.g. neutral pH)
may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)
specify if any special cleaning implements are needed (e.g. to clean out lumens).
Specify water quality for cleaning and rinsing
However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.
Manufacturer’s Instructions
Also known as Instructions for Use (IFUs)
Keep on file - readily available to processing personnel.
Ensure IFUs followed each and every time the instrument is processed.
Employee training should complement the AAMI guidelines as well as manufacturers’ instructions
Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.
Example of Steam Sterilization IFU
Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.
NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.
Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.
High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.
Training and Competencies
Employee competencies should be verified in the processing protocols for processing ophthalmic instruments
Competencies should be verified initially and annually
Utilize resources such as ophthalmic instrument company's educational materials
Reconcile with national standards
Cleaning
Removal of contamination from an item to the extent necessary for further processing or for the intended use.
Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.
Due to their design, eye instrument challenging to clean
Very small lumens, very delicate tips, can easily break/damage
Pre-Cleaning in Room
Treat with demineralized water to prevent drying of bioburden.
Saline, disinfectants, and chlorinated solutions can cause pitting
and corrosion and should never be used for soaking instruments
Instruments should not remain in water for lengthy periods of time.
–– Biofilms may form, particularly within lumens.
Decontamination
According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]
NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood
First and most critical step in breaking the chain of disease transmission
Why Is Cleaning Important?
Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item
Protein left on items can be “baked on” in the sterilizer
Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?
TASS – Focus
Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN
TASS - an acute inflammatory response of the anterior chamber of the eye.
May lead to severe visual impairment if it is not recognized and treated in a timely manner.
Many causes including detergents, water quality, steam quality, instruments, etc.
Major concern is when endotoxins form
Causes of TASS (ASCRS)*
Detergent residues (in general)
Endotoxins
Preservatives
Residues from sterilization processing
Residues of detergents inside a reusable cannula or instrument
Cement sealant on bags of irrigating solution which has leached out
All can induce TASS and cause severe damage to ocular tissue
* American Society of Cataract and Refractive Surgeons
TASS
Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.
TASS
Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer
Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).
Also in AAMI ST-79 as an Annex
ASCRS Recommendations
An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.
Major issue in surgery centers
Insufficient inventory of instruments leads to short cuts in cleaning
ASCRS Recommendations
Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.
ASCRS Recommendations
A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.
Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments
ASCRS Recommendations
Instruments should be pre-cleaned immediately following use.
Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure
ASCRS Recommendations
Only cleaning agents that have been recommended by the manufacturer should be used.
Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.
ASCRS Recommendations
Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.
The water used to clean or rinse instruments should be discarded after each use.
ASCRS Recommendations
If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.
Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.
ASCRS Recommendations
Cleaning and sterilization equipment should be properly maintained.
Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS
Water Quality
Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed
devices.
Can lead to pyrogenic reactions (i.e., fever) in patients.
Adequate cleaning and rinsing should result in low bioburden
Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.
Physical Area
Separate area – dedicated to cleaning of ophthalmic instruments
Away from any other type of surgical instruments
Temp 60-65oF
Humidity 30-60%
Air exchanges 10/hour negative
Monitor temperature and humidity daily and document
FIRST STEP
Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended
Steps in the Cleaning Process
Pre-Cleaning in room
Contain contaminated items at the point of use
Transport to Decontamination (confined and contained)
Sort
Soak
Wash
Rinse/Dry
Pre-Cleaning - Transport
Instruments should be pre-cleaned immediately following use
Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)
Keep instruments moist to avoid drying of soils
Many now recommend cleaning immediately or within 30 minutes of use
Transport in closed container (confine/contain)
Container should be labeled as biohazard (OSHA)
Soaking
Can pre-soak with a detergent
Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer
Assists in the loosening of soils to facilitate cleaning
Do NOT soak in fluids for prolonged periods of time - biofilms can form
Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems
use enzymatic gels or foam
Biofiolms
Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates
Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow
Cleaning
Need to take special precautions with eye instruments due to
Delicate nature of the design
Sensitivity of eye tissue
Cleaning becomes a challenge
Manual cleaning may be only validated method
Manual cleaning is not as controlled (standardized) as mechanical cleaning
Dilemma
Some eye instrument manufacturer’s do not recommend ANY detergent
Source of confusion for end user
Need to challenge manufacturers
Enzymatic Cleaners
Organic substances which assist in the breakdown of soils
Facilitate the removal of blood and protein soils
Excellent for devices with lumens
Effectiveness dependent upon concentration, use temperature and contact time
Enzymatic Cleaners
Sold as liquid concentrates or powder
Generally more effective in warm water (110-140oF)
Enzyme activity can be inactivated above certain maximum temperatures (140oF)
Follow manufacturer’s directions
Use a thermometer – monitor water temperature
Principles of Cleaning
Must have manufacturer’s written instructions for cleaning of all devices processed
Follow all recommended steps using equipment recommended
Must wear PPE
Impervious gown, head cover, shoe covers, cuffed gloves, face shield
Manual Cleaning Process
May be the only cleaning process available
Items should be submerged, disassembled
Preferable to use 3-sink method; wash, rinse, rinse
Can also be used to remove deposits which were not removed during the pre-soak
Brush all serrations, crevices, tips, handles, and hinges.
Brushing should be done under the surface of the water to prevent aerosolization of contaminants.
Manual Cleaning – General Instructions
Handle instruments one at a time or in small numbers to avoid damage
Open hinged instruments
Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning
Brush and flush all lumened devices
Clean all surfaces
Specialty Items
Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.
Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface
Manual Cleaning Detergents
Usually used for manual cleaning and as a pre-soak
Range from low foam to high foam products
Generally have neutral pH of 7 to 9
Sold as concentrates
Free rinsing
Always measure and dilute the detergent as specified by the detergent manufacturer
Water used to clean instruments should be discarded after each use
Manual Cleaning Implements
Soft bristle brushes, various sizes and lengths (no metal brushes)
Soft cloths
No abrasive items
No sponges
No materials which are permeable; i.e.. Wood
Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use
Mechanical Cleaners
Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.
Can result in damage to instruments
Specialty Cleaner
Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces
Effectively cleans and rinses lumens
Must disinfect according to IFUs and document
Diamond Knives
The diamond knife is designed to make precision atraumatic cuts
The diamond knife has the sharpest cutting edge possible
Cost can range from $800 - $2,500 or more
Diamond Blade Knives
Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.
Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.
The blade should not touch any other instruments or the sides of the cleaner.
Diamond Blade Knives
Never completely submerge a diamond knife in an ultrasonic cleaner.
At all time, (except cleaning) the blade should be in the retracted position to prevent damage.
Inspect with microscope.
Ultrasonic Cleaning
Uses sound waves transmitted through a solution
Sound waves produce tiny bubbles which implode - results in scouring action that cleans
Mechanical process = cavitation
Ultrasonic Cleaning
Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)
Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming
Water temperatures usually 100 - 140 o F.
Can be used after manual cleaning
Ultrasonic Cleaning
Solution should be changed at least daily preferably after each use
Outbreaks of TASS have been associated with contaminated sonic baths
Unit should have a cover to contain aerosols
Items should not be stacked
Need to “de-gas” water
Ultrasonic Cleaning
Containers/baskets should have perforations; should be all metal mesh; no plastic
Should be located in Decontamination Area
cleaning process
more efficient than manual cleaning
Test the sonic for efficacy (daily???)
Testing Sonic
Rinsing
The most important part of the cleaning process
Essential to remove loosened debris
Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)
Water used to rinse instruments should be discarded after each use
Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS
Lubrication
The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.
However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.
Principles of Inspection/Assembly
All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)
All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.
Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.
Inspection
Best method is to use a microscope
Principles of Inspection/Assembly
All parts are present and functional
Use perforated or mesh bottom trays
All scissors should be tested for sharpness each time they are processed
Test that ratchets hold on clamps
Inspect hand held forceps that tips approximate
Test needle holders; ratchets hold and tips hold suture needle
Principles of Inspection/Assembly
Inspect that joints are not stiff
Use a lighted magnifying lamp or microscope to inspect
Inspect for rust, pitting, cracked box lock, etc.
Demagnetization of eye instruments may be needed
Separate delicate, sharp items
Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material
Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water
Ophthalmic Instruments
Look for defects:
Rusting common (especially if IUSS frequently used
Corrosion
Damage to tips/ teeth
Cords
Lumens (e.g. Phaco handpieces)
Stiffness
Sharpness
Spotting – Staining - Rust
Delicate Tips Require Protection
Can use small containers with silicone mat for individual instruments to provide protection.
General Guidelines for Packaging
Instrument Sets
Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.
The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers
The basket or container of the correct size to prevent instrument damage
Handling Eye Instruments
Place instruments in the tray so that they do not touch each other.
Locate each instrument in the tray to prevent movement and possible damage during handling.
Always keep delicate tips protected with a tip guard when the instrument is not in use.
Protective Container - Cataract Set
Finger Mats May Not Provide Adequate Protection
Paper Plastic Pouches
Widely used because of the visibility of the contents.
However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.
If packaging instruments separately, select the correct size pouch.
Allow approximately 1” distance from the device and the pouch edges.
Must ensure instruments packaged to protect from damage
General Guidelines for Packaging
Individual Instruments/Small Items
Use correct size packaging
Do not use rubber bands to secure instruments
Paper Plastic Pouches
Double pouching is not required (AORN, AAMI)
May be used for small items which would be difficult to keep together
If double pouching, do not fold over the edges of inside pouch
Inside pouch must lay flat
Tip Protectors
Obtain the manufacturer’s instructions for use.
Some can “catch” onto the instruments – can result in damage
You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.
Make sure device can be held open with protector on (e.g. scissors, clamps).
Must have manufacturer’s data that sterilant will penetrate through the tip protector.
Chemical Indicators (Types)
External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not
Internal chemical indicators (Type 3-4-5)
Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.
Type 3 – responds to one parameter
Type 4 – responds to 2 or more parameters
Should use at least a Type 4 CI
Chemical Indicators
Type 5 – integrating indicators – correlate to the action of a biological test
Cannot substitute for a BI test
Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time
Labeling Packages
Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).
Need documentation that marker is non-toxic.
Packages - label on the indicator tape used to close the package, never on the wrapping material itself.
Paper–plastic pouches - label only on the plastic side or on sterilization tape.
If a package is labeled directly on the packaging material, the
marker could damage the packaging material.
Exception is the plastic side of paper plastic pouches.
Table Top Sterilizers
Many ASCs use table top sterilizers
A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).
Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.
Also found in doctors’ and dental offices.
Cycles
The device manufacturer’s sterilization instructions should always be followed
If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.
Conventional Steam Sterilizers
Read the IFUs for exposure time, temperature and cycle time
Many have CJD cycles ONLY
Many have European temperatures only (e.g. 273oF)
Must reconcile IFU information
May have to separate sets to meet IFUs
E.g. some instruments require 10 minutes exposure
Water Quality
Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.
Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.
Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.
Maintenance
Perform all the recommended maintenance of the tabletop sterilizer
Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.
Documentation
All cycles run should be documented
All items processed must be documented
Specific name of device/tray
Quantity
All items must be identified with a lot control number (to facilitate recall)
Must include date sterilized, sterilizer #, load number
Expiration date or event related statement
Traceability to the patient if posterior eye tissue surgery (CJD)
Summary
Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS
Manufacturers IFUs
Effective cleaning
Correct packaging methods and materials
Effective sterilization –
Processing equipment in good condition
Proper handling after sterilization
Monitoring of staff compliance with all stated policies and manufacturers’ instructions
Training and competencies for staff
Conclusion - The End
Successful patient outcomes require we develop effective policies, train staff and monitor for compliance
Careful handling of ophthalmic instruments will keep patients safe and reduce costs.
References
AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.
AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.
Centers for Disease Control (Hospital Infection Control Guidelines) 2008
American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).
The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.
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3/13/2019
9
Keeping Ophthalmic Instruments Safe
Nancy Chobin, RN, AAS, ACSP, CSPM, CFER
CEO Sterile Processing University
Lebanon, NJ
Copyright 2019
Objectives
Identify AAMI recommended cleaning protocols to prevent TASS
Review the AAMI preparation recommendations for instruments and sets
Review care and handling of ophthalmic instruments
Background
Time to perform a cataract procedure has decreased15-20 minutes.
The cost for a set of instruments can range from $6,000 to $8,000 or more
Urgency to turn the instruments around for the next case.
Instruments come in contact with the eye and thus body fluids.
They are considered contaminated and must receive the entire cleaning and sterilization process between patients.
Manufacturer’s Instructions
Instrument manufacturer should:
specify the pH of detergent (e.g. neutral pH)
may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)
specify if any special cleaning implements are needed (e.g. to clean out lumens).
Specify water quality for cleaning and rinsing
However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.
Manufacturer’s Instructions
Also known as Instructions for Use (IFUs)
Keep on file - readily available to processing personnel.
Ensure IFUs followed each and every time the instrument is processed.
Employee training should complement the AAMI guidelines as well as manufacturers’ instructions
Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.
Example of Steam Sterilization IFU
Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.
NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.
Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.
High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.
Training and Competencies
Employee competencies should be verified in the processing protocols for processing ophthalmic instruments
Competencies should be verified initially and annually
Utilize resources such as ophthalmic instrument company's educational materials
Reconcile with national standards
Cleaning
Removal of contamination from an item to the extent necessary for further processing or for the intended use.
Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.
Due to their design, eye instrument challenging to clean
Very small lumens, very delicate tips, can easily break/damage
Pre-Cleaning in Room
Treat with demineralized water to prevent drying of bioburden.
Saline, disinfectants, and chlorinated solutions can cause pitting
and corrosion and should never be used for soaking instruments
Instruments should not remain in water for lengthy periods of time.
–– Biofilms may form, particularly within lumens.
Decontamination
According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]
NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood
First and most critical step in breaking the chain of disease transmission
Why Is Cleaning Important?
Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item
Protein left on items can be “baked on” in the sterilizer
Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?
TASS – Focus
Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN
TASS - an acute inflammatory response of the anterior chamber of the eye.
May lead to severe visual impairment if it is not recognized and treated in a timely manner.
Many causes including detergents, water quality, steam quality, instruments, etc.
Major concern is when endotoxins form
Causes of TASS (ASCRS)*
Detergent residues (in general)
Endotoxins
Preservatives
Residues from sterilization processing
Residues of detergents inside a reusable cannula or instrument
Cement sealant on bags of irrigating solution which has leached out
All can induce TASS and cause severe damage to ocular tissue
* American Society of Cataract and Refractive Surgeons
TASS
Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.
TASS
Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer
Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).
Also in AAMI ST-79 as an Annex
ASCRS Recommendations
An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.
Major issue in surgery centers
Insufficient inventory of instruments leads to short cuts in cleaning
ASCRS Recommendations
Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.
ASCRS Recommendations
A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.
Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments
ASCRS Recommendations
Instruments should be pre-cleaned immediately following use.
Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure
ASCRS Recommendations
Only cleaning agents that have been recommended by the manufacturer should be used.
Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.
ASCRS Recommendations
Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.
The water used to clean or rinse instruments should be discarded after each use.
ASCRS Recommendations
If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.
Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.
ASCRS Recommendations
Cleaning and sterilization equipment should be properly maintained.
Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS
Water Quality
Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed
devices.
Can lead to pyrogenic reactions (i.e., fever) in patients.
Adequate cleaning and rinsing should result in low bioburden
Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.
Physical Area
Separate area – dedicated to cleaning of ophthalmic instruments
Away from any other type of surgical instruments
Temp 60-65oF
Humidity 30-60%
Air exchanges 10/hour negative
Monitor temperature and humidity daily and document
FIRST STEP
Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended
Steps in the Cleaning Process
Pre-Cleaning in room
Contain contaminated items at the point of use
Transport to Decontamination (confined and contained)
Sort
Soak
Wash
Rinse/Dry
Pre-Cleaning - Transport
Instruments should be pre-cleaned immediately following use
Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)
Keep instruments moist to avoid drying of soils
Many now recommend cleaning immediately or within 30 minutes of use
Transport in closed container (confine/contain)
Container should be labeled as biohazard (OSHA)
Soaking
Can pre-soak with a detergent
Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer
Assists in the loosening of soils to facilitate cleaning
Do NOT soak in fluids for prolonged periods of time - biofilms can form
Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems
use enzymatic gels or foam
Biofiolms
Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates
Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow
Cleaning
Need to take special precautions with eye instruments due to
Delicate nature of the design
Sensitivity of eye tissue
Cleaning becomes a challenge
Manual cleaning may be only validated method
Manual cleaning is not as controlled (standardized) as mechanical cleaning
Dilemma
Some eye instrument manufacturer’s do not recommend ANY detergent
Source of confusion for end user
Need to challenge manufacturers
Enzymatic Cleaners
Organic substances which assist in the breakdown of soils
Facilitate the removal of blood and protein soils
Excellent for devices with lumens
Effectiveness dependent upon concentration, use temperature and contact time
Enzymatic Cleaners
Sold as liquid concentrates or powder
Generally more effective in warm water (110-140oF)
Enzyme activity can be inactivated above certain maximum temperatures (140oF)
Follow manufacturer’s directions
Use a thermometer – monitor water temperature
Principles of Cleaning
Must have manufacturer’s written instructions for cleaning of all devices processed
Follow all recommended steps using equipment recommended
Must wear PPE
Impervious gown, head cover, shoe covers, cuffed gloves, face shield
Manual Cleaning Process
May be the only cleaning process available
Items should be submerged, disassembled
Preferable to use 3-sink method; wash, rinse, rinse
Can also be used to remove deposits which were not removed during the pre-soak
Brush all serrations, crevices, tips, handles, and hinges.
Brushing should be done under the surface of the water to prevent aerosolization of contaminants.
Manual Cleaning – General Instructions
Handle instruments one at a time or in small numbers to avoid damage
Open hinged instruments
Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning
Brush and flush all lumened devices
Clean all surfaces
Specialty Items
Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.
Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface
Manual Cleaning Detergents
Usually used for manual cleaning and as a pre-soak
Range from low foam to high foam products
Generally have neutral pH of 7 to 9
Sold as concentrates
Free rinsing
Always measure and dilute the detergent as specified by the detergent manufacturer
Water used to clean instruments should be discarded after each use
Manual Cleaning Implements
Soft bristle brushes, various sizes and lengths (no metal brushes)
Soft cloths
No abrasive items
No sponges
No materials which are permeable; i.e.. Wood
Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use
Mechanical Cleaners
Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.
Can result in damage to instruments
Specialty Cleaner
Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces
Effectively cleans and rinses lumens
Must disinfect according to IFUs and document
Diamond Knives
The diamond knife is designed to make precision atraumatic cuts
The diamond knife has the sharpest cutting edge possible
Cost can range from $800 - $2,500 or more
Diamond Blade Knives
Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.
Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.
The blade should not touch any other instruments or the sides of the cleaner.
Diamond Blade Knives
Never completely submerge a diamond knife in an ultrasonic cleaner.
At all time, (except cleaning) the blade should be in the retracted position to prevent damage.
Inspect with microscope.
Ultrasonic Cleaning
Uses sound waves transmitted through a solution
Sound waves produce tiny bubbles which implode - results in scouring action that cleans
Mechanical process = cavitation
Ultrasonic Cleaning
Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)
Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming
Water temperatures usually 100 - 140 o F.
Can be used after manual cleaning
Ultrasonic Cleaning
Solution should be changed at least daily preferably after each use
Outbreaks of TASS have been associated with contaminated sonic baths
Unit should have a cover to contain aerosols
Items should not be stacked
Need to “de-gas” water
Ultrasonic Cleaning
Containers/baskets should have perforations; should be all metal mesh; no plastic
Should be located in Decontamination Area
cleaning process
more efficient than manual cleaning
Test the sonic for efficacy (daily???)
Testing Sonic
Rinsing
The most important part of the cleaning process
Essential to remove loosened debris
Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)
Water used to rinse instruments should be discarded after each use
Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS
Lubrication
The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.
However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.
Principles of Inspection/Assembly
All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)
All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.
Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.
Inspection
Best method is to use a microscope
Principles of Inspection/Assembly
All parts are present and functional
Use perforated or mesh bottom trays
All scissors should be tested for sharpness each time they are processed
Test that ratchets hold on clamps
Inspect hand held forceps that tips approximate
Test needle holders; ratchets hold and tips hold suture needle
Principles of Inspection/Assembly
Inspect that joints are not stiff
Use a lighted magnifying lamp or microscope to inspect
Inspect for rust, pitting, cracked box lock, etc.
Demagnetization of eye instruments may be needed
Separate delicate, sharp items
Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material
Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water
Ophthalmic Instruments
Look for defects:
Rusting common (especially if IUSS frequently used
Corrosion
Damage to tips/ teeth
Cords
Lumens (e.g. Phaco handpieces)
Stiffness
Sharpness
Spotting – Staining - Rust
Delicate Tips Require Protection
Can use small containers with silicone mat for individual instruments to provide protection.
General Guidelines for Packaging
Instrument Sets
Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.
The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers
The basket or container of the correct size to prevent instrument damage
Handling Eye Instruments
Place instruments in the tray so that they do not touch each other.
Locate each instrument in the tray to prevent movement and possible damage during handling.
Always keep delicate tips protected with a tip guard when the instrument is not in use.
Protective Container - Cataract Set
Finger Mats May Not Provide Adequate Protection
Paper Plastic Pouches
Widely used because of the visibility of the contents.
However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.
If packaging instruments separately, select the correct size pouch.
Allow approximately 1” distance from the device and the pouch edges.
Must ensure instruments packaged to protect from damage
General Guidelines for Packaging
Individual Instruments/Small Items
Use correct size packaging
Do not use rubber bands to secure instruments
Paper Plastic Pouches
Double pouching is not required (AORN, AAMI)
May be used for small items which would be difficult to keep together
If double pouching, do not fold over the edges of inside pouch
Inside pouch must lay flat
Tip Protectors
Obtain the manufacturer’s instructions for use.
Some can “catch” onto the instruments – can result in damage
You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.
Make sure device can be held open with protector on (e.g. scissors, clamps).
Must have manufacturer’s data that sterilant will penetrate through the tip protector.
Chemical Indicators (Types)
External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not
Internal chemical indicators (Type 3-4-5)
Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.
Type 3 – responds to one parameter
Type 4 – responds to 2 or more parameters
Should use at least a Type 4 CI
Chemical Indicators
Type 5 – integrating indicators – correlate to the action of a biological test
Cannot substitute for a BI test
Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time
Labeling Packages
Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).
Need documentation that marker is non-toxic.
Packages - label on the indicator tape used to close the package, never on the wrapping material itself.
Paper–plastic pouches - label only on the plastic side or on sterilization tape.
If a package is labeled directly on the packaging material, the
marker could damage the packaging material.
Exception is the plastic side of paper plastic pouches.
Table Top Sterilizers
Many ASCs use table top sterilizers
A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).
Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.
Also found in doctors’ and dental offices.
Cycles
The device manufacturer’s sterilization instructions should always be followed
If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.
Conventional Steam Sterilizers
Read the IFUs for exposure time, temperature and cycle time
Many have CJD cycles ONLY
Many have European temperatures only (e.g. 273oF)
Must reconcile IFU information
May have to separate sets to meet IFUs
E.g. some instruments require 10 minutes exposure
Water Quality
Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.
Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.
Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.
Maintenance
Perform all the recommended maintenance of the tabletop sterilizer
Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.
Documentation
All cycles run should be documented
All items processed must be documented
Specific name of device/tray
Quantity
All items must be identified with a lot control number (to facilitate recall)
Must include date sterilized, sterilizer #, load number
Expiration date or event related statement
Traceability to the patient if posterior eye tissue surgery (CJD)
Summary
Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS
Manufacturers IFUs
Effective cleaning
Correct packaging methods and materials
Effective sterilization –
Processing equipment in good condition
Proper handling after sterilization
Monitoring of staff compliance with all stated policies and manufacturers’ instructions
Training and competencies for staff
Conclusion - The End
Successful patient outcomes require we develop effective policies, train staff and monitor for compliance
Careful handling of ophthalmic instruments will keep patients safe and reduce costs.
References
AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.
AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.
Centers for Disease Control (Hospital Infection Control Guidelines) 2008
American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).
The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.
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3/13/2019
10
Keeping Ophthalmic Instruments Safe
Nancy Chobin, RN, AAS, ACSP, CSPM, CFER
CEO Sterile Processing University
Lebanon, NJ
Copyright 2019
Objectives
Identify AAMI recommended cleaning protocols to prevent TASS
Review the AAMI preparation recommendations for instruments and sets
Review care and handling of ophthalmic instruments
Background
Time to perform a cataract procedure has decreased15-20 minutes.
The cost for a set of instruments can range from $6,000 to $8,000 or more
Urgency to turn the instruments around for the next case.
Instruments come in contact with the eye and thus body fluids.
They are considered contaminated and must receive the entire cleaning and sterilization process between patients.
Manufacturer’s Instructions
Instrument manufacturer should:
specify the pH of detergent (e.g. neutral pH)
may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)
specify if any special cleaning implements are needed (e.g. to clean out lumens).
Specify water quality for cleaning and rinsing
However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.
Manufacturer’s Instructions
Also known as Instructions for Use (IFUs)
Keep on file - readily available to processing personnel.
Ensure IFUs followed each and every time the instrument is processed.
Employee training should complement the AAMI guidelines as well as manufacturers’ instructions
Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.
Example of Steam Sterilization IFU
Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.
NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.
Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.
High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.
Training and Competencies
Employee competencies should be verified in the processing protocols for processing ophthalmic instruments
Competencies should be verified initially and annually
Utilize resources such as ophthalmic instrument company's educational materials
Reconcile with national standards
Cleaning
Removal of contamination from an item to the extent necessary for further processing or for the intended use.
Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.
Due to their design, eye instrument challenging to clean
Very small lumens, very delicate tips, can easily break/damage
Pre-Cleaning in Room
Treat with demineralized water to prevent drying of bioburden.
Saline, disinfectants, and chlorinated solutions can cause pitting
and corrosion and should never be used for soaking instruments
Instruments should not remain in water for lengthy periods of time.
–– Biofilms may form, particularly within lumens.
Decontamination
According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]
NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood
First and most critical step in breaking the chain of disease transmission
Why Is Cleaning Important?
Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item
Protein left on items can be “baked on” in the sterilizer
Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?
TASS – Focus
Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN
TASS - an acute inflammatory response of the anterior chamber of the eye.
May lead to severe visual impairment if it is not recognized and treated in a timely manner.
Many causes including detergents, water quality, steam quality, instruments, etc.
Major concern is when endotoxins form
Causes of TASS (ASCRS)*
Detergent residues (in general)
Endotoxins
Preservatives
Residues from sterilization processing
Residues of detergents inside a reusable cannula or instrument
Cement sealant on bags of irrigating solution which has leached out
All can induce TASS and cause severe damage to ocular tissue
* American Society of Cataract and Refractive Surgeons
TASS
Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.
TASS
Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer
Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).
Also in AAMI ST-79 as an Annex
ASCRS Recommendations
An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.
Major issue in surgery centers
Insufficient inventory of instruments leads to short cuts in cleaning
ASCRS Recommendations
Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.
ASCRS Recommendations
A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.
Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments
ASCRS Recommendations
Instruments should be pre-cleaned immediately following use.
Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure
ASCRS Recommendations
Only cleaning agents that have been recommended by the manufacturer should be used.
Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.
ASCRS Recommendations
Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.
The water used to clean or rinse instruments should be discarded after each use.
ASCRS Recommendations
If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.
Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.
ASCRS Recommendations
Cleaning and sterilization equipment should be properly maintained.
Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS
Water Quality
Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed
devices.
Can lead to pyrogenic reactions (i.e., fever) in patients.
Adequate cleaning and rinsing should result in low bioburden
Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.
Physical Area
Separate area – dedicated to cleaning of ophthalmic instruments
Away from any other type of surgical instruments
Temp 60-65oF
Humidity 30-60%
Air exchanges 10/hour negative
Monitor temperature and humidity daily and document
FIRST STEP
Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended
Steps in the Cleaning Process
Pre-Cleaning in room
Contain contaminated items at the point of use
Transport to Decontamination (confined and contained)
Sort
Soak
Wash
Rinse/Dry
Pre-Cleaning - Transport
Instruments should be pre-cleaned immediately following use
Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)
Keep instruments moist to avoid drying of soils
Many now recommend cleaning immediately or within 30 minutes of use
Transport in closed container (confine/contain)
Container should be labeled as biohazard (OSHA)
Soaking
Can pre-soak with a detergent
Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer
Assists in the loosening of soils to facilitate cleaning
Do NOT soak in fluids for prolonged periods of time - biofilms can form
Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems
use enzymatic gels or foam
Biofiolms
Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates
Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow
Cleaning
Need to take special precautions with eye instruments due to
Delicate nature of the design
Sensitivity of eye tissue
Cleaning becomes a challenge
Manual cleaning may be only validated method
Manual cleaning is not as controlled (standardized) as mechanical cleaning
Dilemma
Some eye instrument manufacturer’s do not recommend ANY detergent
Source of confusion for end user
Need to challenge manufacturers
Enzymatic Cleaners
Organic substances which assist in the breakdown of soils
Facilitate the removal of blood and protein soils
Excellent for devices with lumens
Effectiveness dependent upon concentration, use temperature and contact time
Enzymatic Cleaners
Sold as liquid concentrates or powder
Generally more effective in warm water (110-140oF)
Enzyme activity can be inactivated above certain maximum temperatures (140oF)
Follow manufacturer’s directions
Use a thermometer – monitor water temperature
Principles of Cleaning
Must have manufacturer’s written instructions for cleaning of all devices processed
Follow all recommended steps using equipment recommended
Must wear PPE
Impervious gown, head cover, shoe covers, cuffed gloves, face shield
Manual Cleaning Process
May be the only cleaning process available
Items should be submerged, disassembled
Preferable to use 3-sink method; wash, rinse, rinse
Can also be used to remove deposits which were not removed during the pre-soak
Brush all serrations, crevices, tips, handles, and hinges.
Brushing should be done under the surface of the water to prevent aerosolization of contaminants.
Manual Cleaning – General Instructions
Handle instruments one at a time or in small numbers to avoid damage
Open hinged instruments
Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning
Brush and flush all lumened devices
Clean all surfaces
Specialty Items
Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.
Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface
Manual Cleaning Detergents
Usually used for manual cleaning and as a pre-soak
Range from low foam to high foam products
Generally have neutral pH of 7 to 9
Sold as concentrates
Free rinsing
Always measure and dilute the detergent as specified by the detergent manufacturer
Water used to clean instruments should be discarded after each use
Manual Cleaning Implements
Soft bristle brushes, various sizes and lengths (no metal brushes)
Soft cloths
No abrasive items
No sponges
No materials which are permeable; i.e.. Wood
Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use
Mechanical Cleaners
Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.
Can result in damage to instruments
Specialty Cleaner
Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces
Effectively cleans and rinses lumens
Must disinfect according to IFUs and document
Diamond Knives
The diamond knife is designed to make precision atraumatic cuts
The diamond knife has the sharpest cutting edge possible
Cost can range from $800 - $2,500 or more
Diamond Blade Knives
Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.
Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.
The blade should not touch any other instruments or the sides of the cleaner.
Diamond Blade Knives
Never completely submerge a diamond knife in an ultrasonic cleaner.
At all time, (except cleaning) the blade should be in the retracted position to prevent damage.
Inspect with microscope.
Ultrasonic Cleaning
Uses sound waves transmitted through a solution
Sound waves produce tiny bubbles which implode - results in scouring action that cleans
Mechanical process = cavitation
Ultrasonic Cleaning
Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)
Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming
Water temperatures usually 100 - 140 o F.
Can be used after manual cleaning
Ultrasonic Cleaning
Solution should be changed at least daily preferably after each use
Outbreaks of TASS have been associated with contaminated sonic baths
Unit should have a cover to contain aerosols
Items should not be stacked
Need to “de-gas” water
Ultrasonic Cleaning
Containers/baskets should have perforations; should be all metal mesh; no plastic
Should be located in Decontamination Area
cleaning process
more efficient than manual cleaning
Test the sonic for efficacy (daily???)
Testing Sonic
Rinsing
The most important part of the cleaning process
Essential to remove loosened debris
Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)
Water used to rinse instruments should be discarded after each use
Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS
Lubrication
The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.
However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.
Principles of Inspection/Assembly
All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)
All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.
Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.
Inspection
Best method is to use a microscope
Principles of Inspection/Assembly
All parts are present and functional
Use perforated or mesh bottom trays
All scissors should be tested for sharpness each time they are processed
Test that ratchets hold on clamps
Inspect hand held forceps that tips approximate
Test needle holders; ratchets hold and tips hold suture needle
Principles of Inspection/Assembly
Inspect that joints are not stiff
Use a lighted magnifying lamp or microscope to inspect
Inspect for rust, pitting, cracked box lock, etc.
Demagnetization of eye instruments may be needed
Separate delicate, sharp items
Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material
Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water
Ophthalmic Instruments
Look for defects:
Rusting common (especially if IUSS frequently used
Corrosion
Damage to tips/ teeth
Cords
Lumens (e.g. Phaco handpieces)
Stiffness
Sharpness
Spotting – Staining - Rust
Delicate Tips Require Protection
Can use small containers with silicone mat for individual instruments to provide protection.
General Guidelines for Packaging
Instrument Sets
Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.
The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers
The basket or container of the correct size to prevent instrument damage
Handling Eye Instruments
Place instruments in the tray so that they do not touch each other.
Locate each instrument in the tray to prevent movement and possible damage during handling.
Always keep delicate tips protected with a tip guard when the instrument is not in use.
Protective Container - Cataract Set
Finger Mats May Not Provide Adequate Protection
Paper Plastic Pouches
Widely used because of the visibility of the contents.
However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.
If packaging instruments separately, select the correct size pouch.
Allow approximately 1” distance from the device and the pouch edges.
Must ensure instruments packaged to protect from damage
General Guidelines for Packaging
Individual Instruments/Small Items
Use correct size packaging
Do not use rubber bands to secure instruments
Paper Plastic Pouches
Double pouching is not required (AORN, AAMI)
May be used for small items which would be difficult to keep together
If double pouching, do not fold over the edges of inside pouch
Inside pouch must lay flat
Tip Protectors
Obtain the manufacturer’s instructions for use.
Some can “catch” onto the instruments – can result in damage
You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.
Make sure device can be held open with protector on (e.g. scissors, clamps).
Must have manufacturer’s data that sterilant will penetrate through the tip protector.
Chemical Indicators (Types)
External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not
Internal chemical indicators (Type 3-4-5)
Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.
Type 3 – responds to one parameter
Type 4 – responds to 2 or more parameters
Should use at least a Type 4 CI
Chemical Indicators
Type 5 – integrating indicators – correlate to the action of a biological test
Cannot substitute for a BI test
Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time
Labeling Packages
Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).
Need documentation that marker is non-toxic.
Packages - label on the indicator tape used to close the package, never on the wrapping material itself.
Paper–plastic pouches - label only on the plastic side or on sterilization tape.
If a package is labeled directly on the packaging material, the
marker could damage the packaging material.
Exception is the plastic side of paper plastic pouches.
Table Top Sterilizers
Many ASCs use table top sterilizers
A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).
Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.
Also found in doctors’ and dental offices.
Cycles
The device manufacturer’s sterilization instructions should always be followed
If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.
Conventional Steam Sterilizers
Read the IFUs for exposure time, temperature and cycle time
Many have CJD cycles ONLY
Many have European temperatures only (e.g. 273oF)
Must reconcile IFU information
May have to separate sets to meet IFUs
E.g. some instruments require 10 minutes exposure
Water Quality
Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.
Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.
Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.
Maintenance
Perform all the recommended maintenance of the tabletop sterilizer
Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.
Documentation
All cycles run should be documented
All items processed must be documented
Specific name of device/tray
Quantity
All items must be identified with a lot control number (to facilitate recall)
Must include date sterilized, sterilizer #, load number
Expiration date or event related statement
Traceability to the patient if posterior eye tissue surgery (CJD)
Summary
Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS
Manufacturers IFUs
Effective cleaning
Correct packaging methods and materials
Effective sterilization –
Processing equipment in good condition
Proper handling after sterilization
Monitoring of staff compliance with all stated policies and manufacturers’ instructions
Training and competencies for staff
Conclusion - The End
Successful patient outcomes require we develop effective policies, train staff and monitor for compliance
Careful handling of ophthalmic instruments will keep patients safe and reduce costs.
References
AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.
AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.
Centers for Disease Control (Hospital Infection Control Guidelines) 2008
American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).
The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.
Questions??????
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74
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84
3/13/2019
11
Keeping Ophthalmic Instruments Safe
Nancy Chobin, RN, AAS, ACSP, CSPM, CFER
CEO Sterile Processing University
Lebanon, NJ
Copyright 2019
Objectives
Identify AAMI recommended cleaning protocols to prevent TASS
Review the AAMI preparation recommendations for instruments and sets
Review care and handling of ophthalmic instruments
Background
Time to perform a cataract procedure has decreased15-20 minutes.
The cost for a set of instruments can range from $6,000 to $8,000 or more
Urgency to turn the instruments around for the next case.
Instruments come in contact with the eye and thus body fluids.
They are considered contaminated and must receive the entire cleaning and sterilization process between patients.
Manufacturer’s Instructions
Instrument manufacturer should:
specify the pH of detergent (e.g. neutral pH)
may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)
specify if any special cleaning implements are needed (e.g. to clean out lumens).
Specify water quality for cleaning and rinsing
However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.
Manufacturer’s Instructions
Also known as Instructions for Use (IFUs)
Keep on file - readily available to processing personnel.
Ensure IFUs followed each and every time the instrument is processed.
Employee training should complement the AAMI guidelines as well as manufacturers’ instructions
Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.
Example of Steam Sterilization IFU
Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.
NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.
Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.
High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.
Training and Competencies
Employee competencies should be verified in the processing protocols for processing ophthalmic instruments
Competencies should be verified initially and annually
Utilize resources such as ophthalmic instrument company's educational materials
Reconcile with national standards
Cleaning
Removal of contamination from an item to the extent necessary for further processing or for the intended use.
Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.
Due to their design, eye instrument challenging to clean
Very small lumens, very delicate tips, can easily break/damage
Pre-Cleaning in Room
Treat with demineralized water to prevent drying of bioburden.
Saline, disinfectants, and chlorinated solutions can cause pitting
and corrosion and should never be used for soaking instruments
Instruments should not remain in water for lengthy periods of time.
–– Biofilms may form, particularly within lumens.
Decontamination
According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]
NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood
First and most critical step in breaking the chain of disease transmission
Why Is Cleaning Important?
Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item
Protein left on items can be “baked on” in the sterilizer
Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?
TASS – Focus
Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN
TASS - an acute inflammatory response of the anterior chamber of the eye.
May lead to severe visual impairment if it is not recognized and treated in a timely manner.
Many causes including detergents, water quality, steam quality, instruments, etc.
Major concern is when endotoxins form
Causes of TASS (ASCRS)*
Detergent residues (in general)
Endotoxins
Preservatives
Residues from sterilization processing
Residues of detergents inside a reusable cannula or instrument
Cement sealant on bags of irrigating solution which has leached out
All can induce TASS and cause severe damage to ocular tissue
* American Society of Cataract and Refractive Surgeons
TASS
Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.
TASS
Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer
Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).
Also in AAMI ST-79 as an Annex
ASCRS Recommendations
An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.
Major issue in surgery centers
Insufficient inventory of instruments leads to short cuts in cleaning
ASCRS Recommendations
Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.
ASCRS Recommendations
A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.
Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments
ASCRS Recommendations
Instruments should be pre-cleaned immediately following use.
Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure
ASCRS Recommendations
Only cleaning agents that have been recommended by the manufacturer should be used.
Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.
ASCRS Recommendations
Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.
The water used to clean or rinse instruments should be discarded after each use.
ASCRS Recommendations
If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.
Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.
ASCRS Recommendations
Cleaning and sterilization equipment should be properly maintained.
Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS
Water Quality
Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed
devices.
Can lead to pyrogenic reactions (i.e., fever) in patients.
Adequate cleaning and rinsing should result in low bioburden
Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.
Physical Area
Separate area – dedicated to cleaning of ophthalmic instruments
Away from any other type of surgical instruments
Temp 60-65oF
Humidity 30-60%
Air exchanges 10/hour negative
Monitor temperature and humidity daily and document
FIRST STEP
Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended
Steps in the Cleaning Process
Pre-Cleaning in room
Contain contaminated items at the point of use
Transport to Decontamination (confined and contained)
Sort
Soak
Wash
Rinse/Dry
Pre-Cleaning - Transport
Instruments should be pre-cleaned immediately following use
Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)
Keep instruments moist to avoid drying of soils
Many now recommend cleaning immediately or within 30 minutes of use
Transport in closed container (confine/contain)
Container should be labeled as biohazard (OSHA)
Soaking
Can pre-soak with a detergent
Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer
Assists in the loosening of soils to facilitate cleaning
Do NOT soak in fluids for prolonged periods of time - biofilms can form
Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems
use enzymatic gels or foam
Biofiolms
Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates
Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow
Cleaning
Need to take special precautions with eye instruments due to
Delicate nature of the design
Sensitivity of eye tissue
Cleaning becomes a challenge
Manual cleaning may be only validated method
Manual cleaning is not as controlled (standardized) as mechanical cleaning
Dilemma
Some eye instrument manufacturer’s do not recommend ANY detergent
Source of confusion for end user
Need to challenge manufacturers
Enzymatic Cleaners
Organic substances which assist in the breakdown of soils
Facilitate the removal of blood and protein soils
Excellent for devices with lumens
Effectiveness dependent upon concentration, use temperature and contact time
Enzymatic Cleaners
Sold as liquid concentrates or powder
Generally more effective in warm water (110-140oF)
Enzyme activity can be inactivated above certain maximum temperatures (140oF)
Follow manufacturer’s directions
Use a thermometer – monitor water temperature
Principles of Cleaning
Must have manufacturer’s written instructions for cleaning of all devices processed
Follow all recommended steps using equipment recommended
Must wear PPE
Impervious gown, head cover, shoe covers, cuffed gloves, face shield
Manual Cleaning Process
May be the only cleaning process available
Items should be submerged, disassembled
Preferable to use 3-sink method; wash, rinse, rinse
Can also be used to remove deposits which were not removed during the pre-soak
Brush all serrations, crevices, tips, handles, and hinges.
Brushing should be done under the surface of the water to prevent aerosolization of contaminants.
Manual Cleaning – General Instructions
Handle instruments one at a time or in small numbers to avoid damage
Open hinged instruments
Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning
Brush and flush all lumened devices
Clean all surfaces
Specialty Items
Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.
Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface
Manual Cleaning Detergents
Usually used for manual cleaning and as a pre-soak
Range from low foam to high foam products
Generally have neutral pH of 7 to 9
Sold as concentrates
Free rinsing
Always measure and dilute the detergent as specified by the detergent manufacturer
Water used to clean instruments should be discarded after each use
Manual Cleaning Implements
Soft bristle brushes, various sizes and lengths (no metal brushes)
Soft cloths
No abrasive items
No sponges
No materials which are permeable; i.e.. Wood
Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use
Mechanical Cleaners
Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.
Can result in damage to instruments
Specialty Cleaner
Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces
Effectively cleans and rinses lumens
Must disinfect according to IFUs and document
Diamond Knives
The diamond knife is designed to make precision atraumatic cuts
The diamond knife has the sharpest cutting edge possible
Cost can range from $800 - $2,500 or more
Diamond Blade Knives
Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.
Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.
The blade should not touch any other instruments or the sides of the cleaner.
Diamond Blade Knives
Never completely submerge a diamond knife in an ultrasonic cleaner.
At all time, (except cleaning) the blade should be in the retracted position to prevent damage.
Inspect with microscope.
Ultrasonic Cleaning
Uses sound waves transmitted through a solution
Sound waves produce tiny bubbles which implode - results in scouring action that cleans
Mechanical process = cavitation
Ultrasonic Cleaning
Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)
Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming
Water temperatures usually 100 - 140 o F.
Can be used after manual cleaning
Ultrasonic Cleaning
Solution should be changed at least daily preferably after each use
Outbreaks of TASS have been associated with contaminated sonic baths
Unit should have a cover to contain aerosols
Items should not be stacked
Need to “de-gas” water
Ultrasonic Cleaning
Containers/baskets should have perforations; should be all metal mesh; no plastic
Should be located in Decontamination Area
cleaning process
more efficient than manual cleaning
Test the sonic for efficacy (daily???)
Testing Sonic
Rinsing
The most important part of the cleaning process
Essential to remove loosened debris
Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)
Water used to rinse instruments should be discarded after each use
Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS
Lubrication
The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.
However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.
Principles of Inspection/Assembly
All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)
All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.
Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.
Inspection
Best method is to use a microscope
Principles of Inspection/Assembly
All parts are present and functional
Use perforated or mesh bottom trays
All scissors should be tested for sharpness each time they are processed
Test that ratchets hold on clamps
Inspect hand held forceps that tips approximate
Test needle holders; ratchets hold and tips hold suture needle
Principles of Inspection/Assembly
Inspect that joints are not stiff
Use a lighted magnifying lamp or microscope to inspect
Inspect for rust, pitting, cracked box lock, etc.
Demagnetization of eye instruments may be needed
Separate delicate, sharp items
Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material
Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water
Ophthalmic Instruments
Look for defects:
Rusting common (especially if IUSS frequently used
Corrosion
Damage to tips/ teeth
Cords
Lumens (e.g. Phaco handpieces)
Stiffness
Sharpness
Spotting – Staining - Rust
Delicate Tips Require Protection
Can use small containers with silicone mat for individual instruments to provide protection.
General Guidelines for Packaging
Instrument Sets
Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.
The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers
The basket or container of the correct size to prevent instrument damage
Handling Eye Instruments
Place instruments in the tray so that they do not touch each other.
Locate each instrument in the tray to prevent movement and possible damage during handling.
Always keep delicate tips protected with a tip guard when the instrument is not in use.
Protective Container - Cataract Set
Finger Mats May Not Provide Adequate Protection
Paper Plastic Pouches
Widely used because of the visibility of the contents.
However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.
If packaging instruments separately, select the correct size pouch.
Allow approximately 1” distance from the device and the pouch edges.
Must ensure instruments packaged to protect from damage
General Guidelines for Packaging
Individual Instruments/Small Items
Use correct size packaging
Do not use rubber bands to secure instruments
Paper Plastic Pouches
Double pouching is not required (AORN, AAMI)
May be used for small items which would be difficult to keep together
If double pouching, do not fold over the edges of inside pouch
Inside pouch must lay flat
Tip Protectors
Obtain the manufacturer’s instructions for use.
Some can “catch” onto the instruments – can result in damage
You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.
Make sure device can be held open with protector on (e.g. scissors, clamps).
Must have manufacturer’s data that sterilant will penetrate through the tip protector.
Chemical Indicators (Types)
External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not
Internal chemical indicators (Type 3-4-5)
Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.
Type 3 – responds to one parameter
Type 4 – responds to 2 or more parameters
Should use at least a Type 4 CI
Chemical Indicators
Type 5 – integrating indicators – correlate to the action of a biological test
Cannot substitute for a BI test
Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time
Labeling Packages
Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).
Need documentation that marker is non-toxic.
Packages - label on the indicator tape used to close the package, never on the wrapping material itself.
Paper–plastic pouches - label only on the plastic side or on sterilization tape.
If a package is labeled directly on the packaging material, the
marker could damage the packaging material.
Exception is the plastic side of paper plastic pouches.
Table Top Sterilizers
Many ASCs use table top sterilizers
A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).
Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.
Also found in doctors’ and dental offices.
Cycles
The device manufacturer’s sterilization instructions should always be followed
If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.
Conventional Steam Sterilizers
Read the IFUs for exposure time, temperature and cycle time
Many have CJD cycles ONLY
Many have European temperatures only (e.g. 273oF)
Must reconcile IFU information
May have to separate sets to meet IFUs
E.g. some instruments require 10 minutes exposure
Water Quality
Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.
Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.
Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.
Maintenance
Perform all the recommended maintenance of the tabletop sterilizer
Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.
Documentation
All cycles run should be documented
All items processed must be documented
Specific name of device/tray
Quantity
All items must be identified with a lot control number (to facilitate recall)
Must include date sterilized, sterilizer #, load number
Expiration date or event related statement
Traceability to the patient if posterior eye tissue surgery (CJD)
Summary
Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS
Manufacturers IFUs
Effective cleaning
Correct packaging methods and materials
Effective sterilization –
Processing equipment in good condition
Proper handling after sterilization
Monitoring of staff compliance with all stated policies and manufacturers’ instructions
Training and competencies for staff
Conclusion - The End
Successful patient outcomes require we develop effective policies, train staff and monitor for compliance
Careful handling of ophthalmic instruments will keep patients safe and reduce costs.
References
AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.
AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.
Centers for Disease Control (Hospital Infection Control Guidelines) 2008
American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).
The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.
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3/13/2019
12
Keeping Ophthalmic Instruments Safe
Nancy Chobin, RN, AAS, ACSP, CSPM, CFER
CEO Sterile Processing University
Lebanon, NJ
Copyright 2019
Objectives
Identify AAMI recommended cleaning protocols to prevent TASS
Review the AAMI preparation recommendations for instruments and sets
Review care and handling of ophthalmic instruments
Background
Time to perform a cataract procedure has decreased15-20 minutes.
The cost for a set of instruments can range from $6,000 to $8,000 or more
Urgency to turn the instruments around for the next case.
Instruments come in contact with the eye and thus body fluids.
They are considered contaminated and must receive the entire cleaning and sterilization process between patients.
Manufacturer’s Instructions
Instrument manufacturer should:
specify the pH of detergent (e.g. neutral pH)
may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)
specify if any special cleaning implements are needed (e.g. to clean out lumens).
Specify water quality for cleaning and rinsing
However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.
Manufacturer’s Instructions
Also known as Instructions for Use (IFUs)
Keep on file - readily available to processing personnel.
Ensure IFUs followed each and every time the instrument is processed.
Employee training should complement the AAMI guidelines as well as manufacturers’ instructions
Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.
Example of Steam Sterilization IFU
Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.
NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.
Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.
High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.
Training and Competencies
Employee competencies should be verified in the processing protocols for processing ophthalmic instruments
Competencies should be verified initially and annually
Utilize resources such as ophthalmic instrument company's educational materials
Reconcile with national standards
Cleaning
Removal of contamination from an item to the extent necessary for further processing or for the intended use.
Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.
Due to their design, eye instrument challenging to clean
Very small lumens, very delicate tips, can easily break/damage
Pre-Cleaning in Room
Treat with demineralized water to prevent drying of bioburden.
Saline, disinfectants, and chlorinated solutions can cause pitting
and corrosion and should never be used for soaking instruments
Instruments should not remain in water for lengthy periods of time.
–– Biofilms may form, particularly within lumens.
Decontamination
According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]
NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood
First and most critical step in breaking the chain of disease transmission
Why Is Cleaning Important?
Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item
Protein left on items can be “baked on” in the sterilizer
Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?
TASS – Focus
Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN
TASS - an acute inflammatory response of the anterior chamber of the eye.
May lead to severe visual impairment if it is not recognized and treated in a timely manner.
Many causes including detergents, water quality, steam quality, instruments, etc.
Major concern is when endotoxins form
Causes of TASS (ASCRS)*
Detergent residues (in general)
Endotoxins
Preservatives
Residues from sterilization processing
Residues of detergents inside a reusable cannula or instrument
Cement sealant on bags of irrigating solution which has leached out
All can induce TASS and cause severe damage to ocular tissue
* American Society of Cataract and Refractive Surgeons
TASS
Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.
TASS
Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer
Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).
Also in AAMI ST-79 as an Annex
ASCRS Recommendations
An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.
Major issue in surgery centers
Insufficient inventory of instruments leads to short cuts in cleaning
ASCRS Recommendations
Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.
ASCRS Recommendations
A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.
Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments
ASCRS Recommendations
Instruments should be pre-cleaned immediately following use.
Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure
ASCRS Recommendations
Only cleaning agents that have been recommended by the manufacturer should be used.
Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.
ASCRS Recommendations
Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.
The water used to clean or rinse instruments should be discarded after each use.
ASCRS Recommendations
If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.
Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.
ASCRS Recommendations
Cleaning and sterilization equipment should be properly maintained.
Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS
Water Quality
Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed
devices.
Can lead to pyrogenic reactions (i.e., fever) in patients.
Adequate cleaning and rinsing should result in low bioburden
Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.
Physical Area
Separate area – dedicated to cleaning of ophthalmic instruments
Away from any other type of surgical instruments
Temp 60-65oF
Humidity 30-60%
Air exchanges 10/hour negative
Monitor temperature and humidity daily and document
FIRST STEP
Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended
Steps in the Cleaning Process
Pre-Cleaning in room
Contain contaminated items at the point of use
Transport to Decontamination (confined and contained)
Sort
Soak
Wash
Rinse/Dry
Pre-Cleaning - Transport
Instruments should be pre-cleaned immediately following use
Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)
Keep instruments moist to avoid drying of soils
Many now recommend cleaning immediately or within 30 minutes of use
Transport in closed container (confine/contain)
Container should be labeled as biohazard (OSHA)
Soaking
Can pre-soak with a detergent
Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer
Assists in the loosening of soils to facilitate cleaning
Do NOT soak in fluids for prolonged periods of time - biofilms can form
Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems
use enzymatic gels or foam
Biofiolms
Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates
Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow
Cleaning
Need to take special precautions with eye instruments due to
Delicate nature of the design
Sensitivity of eye tissue
Cleaning becomes a challenge
Manual cleaning may be only validated method
Manual cleaning is not as controlled (standardized) as mechanical cleaning
Dilemma
Some eye instrument manufacturer’s do not recommend ANY detergent
Source of confusion for end user
Need to challenge manufacturers
Enzymatic Cleaners
Organic substances which assist in the breakdown of soils
Facilitate the removal of blood and protein soils
Excellent for devices with lumens
Effectiveness dependent upon concentration, use temperature and contact time
Enzymatic Cleaners
Sold as liquid concentrates or powder
Generally more effective in warm water (110-140oF)
Enzyme activity can be inactivated above certain maximum temperatures (140oF)
Follow manufacturer’s directions
Use a thermometer – monitor water temperature
Principles of Cleaning
Must have manufacturer’s written instructions for cleaning of all devices processed
Follow all recommended steps using equipment recommended
Must wear PPE
Impervious gown, head cover, shoe covers, cuffed gloves, face shield
Manual Cleaning Process
May be the only cleaning process available
Items should be submerged, disassembled
Preferable to use 3-sink method; wash, rinse, rinse
Can also be used to remove deposits which were not removed during the pre-soak
Brush all serrations, crevices, tips, handles, and hinges.
Brushing should be done under the surface of the water to prevent aerosolization of contaminants.
Manual Cleaning – General Instructions
Handle instruments one at a time or in small numbers to avoid damage
Open hinged instruments
Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning
Brush and flush all lumened devices
Clean all surfaces
Specialty Items
Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.
Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface
Manual Cleaning Detergents
Usually used for manual cleaning and as a pre-soak
Range from low foam to high foam products
Generally have neutral pH of 7 to 9
Sold as concentrates
Free rinsing
Always measure and dilute the detergent as specified by the detergent manufacturer
Water used to clean instruments should be discarded after each use
Manual Cleaning Implements
Soft bristle brushes, various sizes and lengths (no metal brushes)
Soft cloths
No abrasive items
No sponges
No materials which are permeable; i.e.. Wood
Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use
Mechanical Cleaners
Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.
Can result in damage to instruments
Specialty Cleaner
Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces
Effectively cleans and rinses lumens
Must disinfect according to IFUs and document
Diamond Knives
The diamond knife is designed to make precision atraumatic cuts
The diamond knife has the sharpest cutting edge possible
Cost can range from $800 - $2,500 or more
Diamond Blade Knives
Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.
Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.
The blade should not touch any other instruments or the sides of the cleaner.
Diamond Blade Knives
Never completely submerge a diamond knife in an ultrasonic cleaner.
At all time, (except cleaning) the blade should be in the retracted position to prevent damage.
Inspect with microscope.
Ultrasonic Cleaning
Uses sound waves transmitted through a solution
Sound waves produce tiny bubbles which implode - results in scouring action that cleans
Mechanical process = cavitation
Ultrasonic Cleaning
Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)
Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming
Water temperatures usually 100 - 140 o F.
Can be used after manual cleaning
Ultrasonic Cleaning
Solution should be changed at least daily preferably after each use
Outbreaks of TASS have been associated with contaminated sonic baths
Unit should have a cover to contain aerosols
Items should not be stacked
Need to “de-gas” water
Ultrasonic Cleaning
Containers/baskets should have perforations; should be all metal mesh; no plastic
Should be located in Decontamination Area
cleaning process
more efficient than manual cleaning
Test the sonic for efficacy (daily???)
Testing Sonic
Rinsing
The most important part of the cleaning process
Essential to remove loosened debris
Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)
Water used to rinse instruments should be discarded after each use
Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS
Lubrication
The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.
However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.
Principles of Inspection/Assembly
All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)
All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.
Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.
Inspection
Best method is to use a microscope
Principles of Inspection/Assembly
All parts are present and functional
Use perforated or mesh bottom trays
All scissors should be tested for sharpness each time they are processed
Test that ratchets hold on clamps
Inspect hand held forceps that tips approximate
Test needle holders; ratchets hold and tips hold suture needle
Principles of Inspection/Assembly
Inspect that joints are not stiff
Use a lighted magnifying lamp or microscope to inspect
Inspect for rust, pitting, cracked box lock, etc.
Demagnetization of eye instruments may be needed
Separate delicate, sharp items
Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material
Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water
Ophthalmic Instruments
Look for defects:
Rusting common (especially if IUSS frequently used
Corrosion
Damage to tips/ teeth
Cords
Lumens (e.g. Phaco handpieces)
Stiffness
Sharpness
Spotting – Staining - Rust
Delicate Tips Require Protection
Can use small containers with silicone mat for individual instruments to provide protection.
General Guidelines for Packaging
Instrument Sets
Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.
The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers
The basket or container of the correct size to prevent instrument damage
Handling Eye Instruments
Place instruments in the tray so that they do not touch each other.
Locate each instrument in the tray to prevent movement and possible damage during handling.
Always keep delicate tips protected with a tip guard when the instrument is not in use.
Protective Container - Cataract Set
Finger Mats May Not Provide Adequate Protection
Paper Plastic Pouches
Widely used because of the visibility of the contents.
However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.
If packaging instruments separately, select the correct size pouch.
Allow approximately 1” distance from the device and the pouch edges.
Must ensure instruments packaged to protect from damage
General Guidelines for Packaging
Individual Instruments/Small Items
Use correct size packaging
Do not use rubber bands to secure instruments
Paper Plastic Pouches
Double pouching is not required (AORN, AAMI)
May be used for small items which would be difficult to keep together
If double pouching, do not fold over the edges of inside pouch
Inside pouch must lay flat
Tip Protectors
Obtain the manufacturer’s instructions for use.
Some can “catch” onto the instruments – can result in damage
You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.
Make sure device can be held open with protector on (e.g. scissors, clamps).
Must have manufacturer’s data that sterilant will penetrate through the tip protector.
Chemical Indicators (Types)
External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not
Internal chemical indicators (Type 3-4-5)
Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.
Type 3 – responds to one parameter
Type 4 – responds to 2 or more parameters
Should use at least a Type 4 CI
Chemical Indicators
Type 5 – integrating indicators – correlate to the action of a biological test
Cannot substitute for a BI test
Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time
Labeling Packages
Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).
Need documentation that marker is non-toxic.
Packages - label on the indicator tape used to close the package, never on the wrapping material itself.
Paper–plastic pouches - label only on the plastic side or on sterilization tape.
If a package is labeled directly on the packaging material, the
marker could damage the packaging material.
Exception is the plastic side of paper plastic pouches.
Table Top Sterilizers
Many ASCs use table top sterilizers
A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).
Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.
Also found in doctors’ and dental offices.
Cycles
The device manufacturer’s sterilization instructions should always be followed
If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.
Conventional Steam Sterilizers
Read the IFUs for exposure time, temperature and cycle time
Many have CJD cycles ONLY
Many have European temperatures only (e.g. 273oF)
Must reconcile IFU information
May have to separate sets to meet IFUs
E.g. some instruments require 10 minutes exposure
Water Quality
Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.
Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.
Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.
Maintenance
Perform all the recommended maintenance of the tabletop sterilizer
Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.
Documentation
All cycles run should be documented
All items processed must be documented
Specific name of device/tray
Quantity
All items must be identified with a lot control number (to facilitate recall)
Must include date sterilized, sterilizer #, load number
Expiration date or event related statement
Traceability to the patient if posterior eye tissue surgery (CJD)
Summary
Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS
Manufacturers IFUs
Effective cleaning
Correct packaging methods and materials
Effective sterilization –
Processing equipment in good condition
Proper handling after sterilization
Monitoring of staff compliance with all stated policies and manufacturers’ instructions
Training and competencies for staff
Conclusion - The End
Successful patient outcomes require we develop effective policies, train staff and monitor for compliance
Careful handling of ophthalmic instruments will keep patients safe and reduce costs.
References
AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.
AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.
Centers for Disease Control (Hospital Infection Control Guidelines) 2008
American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).
The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.
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3/13/2019
13
Keeping Ophthalmic Instruments Safe
Nancy Chobin, RN, AAS, ACSP, CSPM, CFER
CEO Sterile Processing University
Lebanon, NJ
Copyright 2019
Objectives
Identify AAMI recommended cleaning protocols to prevent TASS
Review the AAMI preparation recommendations for instruments and sets
Review care and handling of ophthalmic instruments
Background
Time to perform a cataract procedure has decreased15-20 minutes.
The cost for a set of instruments can range from $6,000 to $8,000 or more
Urgency to turn the instruments around for the next case.
Instruments come in contact with the eye and thus body fluids.
They are considered contaminated and must receive the entire cleaning and sterilization process between patients.
Manufacturer’s Instructions
Instrument manufacturer should:
specify the pH of detergent (e.g. neutral pH)
may recommend a pre-soak in an enzymatic cleaner to help remove protein soils (e.g. body fluids)
specify if any special cleaning implements are needed (e.g. to clean out lumens).
Specify water quality for cleaning and rinsing
However, need to reconcile this information with AAMI and ASORN, AORN, ASCRS and the CDC.
Manufacturer’s Instructions
Also known as Instructions for Use (IFUs)
Keep on file - readily available to processing personnel.
Ensure IFUs followed each and every time the instrument is processed.
Employee training should complement the AAMI guidelines as well as manufacturers’ instructions
Eye instrumentation is extremely delicate and as such requires very special handling and processing to prevent damage. All personnel handling eye instrumentation should ensure careful handling.
Example of Steam Sterilization IFU
Prevacuum High Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.
NOTE: As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F (135˚C) for 3 minutes are acceptable minimum cycle times for dynamic-air-removal steam sterilization cycles.
Standard Gravity Autoclave: 250˚F (121˚C) for 30 minutes; wrapped.
High Speed (Flash) Autoclave: 270˚F (132˚C) for 10 minutes; unwrapped.
Training and Competencies
Employee competencies should be verified in the processing protocols for processing ophthalmic instruments
Competencies should be verified initially and annually
Utilize resources such as ophthalmic instrument company's educational materials
Reconcile with national standards
Cleaning
Removal of contamination from an item to the extent necessary for further processing or for the intended use.
Involves the use of detergent and water, of adherent visible soil (i.e. blood, pus, protein) from the surfaces, crevices, serrations, jaws and lumens of instruments, devices and equipment, by a manual or mechanical process.
Due to their design, eye instrument challenging to clean
Very small lumens, very delicate tips, can easily break/damage
Pre-Cleaning in Room
Treat with demineralized water to prevent drying of bioburden.
Saline, disinfectants, and chlorinated solutions can cause pitting
and corrosion and should never be used for soaking instruments
Instruments should not remain in water for lengthy periods of time.
–– Biofilms may form, particularly within lumens.
Decontamination
According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030]
NOTE—Generally used in health care facilities to refer to all pathogenic organisms, not just those transmitted by blood
First and most critical step in breaking the chain of disease transmission
Why Is Cleaning Important?
Process of disinfection or sterilization dependent upon direct contact of the sterilant or disinfectant with the surface of the item
Protein left on items can be “baked on” in the sterilizer
Why are some facilities only “wiping off” the instruments? “Cleaning with water? Alcohol?
TASS – Focus
Toxic Anterior Segment Syndrome (TASS) – main focus by AAMI and AORN
TASS - an acute inflammatory response of the anterior chamber of the eye.
May lead to severe visual impairment if it is not recognized and treated in a timely manner.
Many causes including detergents, water quality, steam quality, instruments, etc.
Major concern is when endotoxins form
Causes of TASS (ASCRS)*
Detergent residues (in general)
Endotoxins
Preservatives
Residues from sterilization processing
Residues of detergents inside a reusable cannula or instrument
Cement sealant on bags of irrigating solution which has leached out
All can induce TASS and cause severe damage to ocular tissue
* American Society of Cataract and Refractive Surgeons
TASS
Particular care must be taken in the processing of intraocular surgical instruments to help ensure that foreign substances or materials associated with the instruments will not be introduced into the anterior chamber of the eye during surgery.
TASS
Outbreaks of TASS have often been linked to the failure to follow the processing procedures recommended by the instrument manufacturer
Specific instrument cleaning and sterilization recommendations intended to diminish the risk of TASS associated with intraocular surgical instruments have been published by the American Society for Cataract and Refractive Surgery (ASCRS, 2006).
Also in AAMI ST-79 as an Annex
ASCRS Recommendations
An adequate inventory of the necessary intraocular surgical instruments should be maintained in order to allow for the timely processing of instruments between cases.
Major issue in surgery centers
Insufficient inventory of instruments leads to short cuts in cleaning
ASCRS Recommendations
Adequate time must be allowed for processing instruments according to the manufacturer’s instructions; otherwise, the cleaning and sterilization of the instruments will be ineffective.
ASCRS Recommendations
A designated cleaning area and equipment specific to the cleaning of intraocular surgical instruments should be identified.
Whenever possible, intraocular surgical instruments should be processed separately from general surgical instruments and equipment in order to reduce the potential for cross-contamination by material or residue from the general surgical instruments
ASCRS Recommendations
Instruments should be pre-cleaned immediately following use.
Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water or another suitable agent as recommended in the room at the end of the procedure
ASCRS Recommendations
Only cleaning agents that have been recommended by the manufacturer should be used.
Particular attention should be paid to the specified concentration of cleaning agent and to the recommended water quality.
ASCRS Recommendations
Final rinsing of the instrument should be performed with sterile, distilled, or deionized water, unless otherwise specified by the manufacturer.
The water used to clean or rinse instruments should be discarded after each use.
ASCRS Recommendations
If an ultrasonic cleaner is used to process the instruments, it should be emptied, cleaned, rinsed, and dried at least daily or, preferably, after each use.
Brushes and other cleaning tools should be cleaned and sterilized as recommended by the manufacturer at least daily or, preferably, after each use.
ASCRS Recommendations
Cleaning and sterilization equipment should be properly maintained.
Foreign materials such as endotoxin or heavy metals may be deposited onto the instruments during processing and induce TASS
Water Quality
Water used to for the final rinse of the device should have a low endotoxin content to avoid pyrogens on processed
devices.
Can lead to pyrogenic reactions (i.e., fever) in patients.
Adequate cleaning and rinsing should result in low bioburden
Essential to the effectiveness of terminal sterilization and to the protection of patients from pyrogens.
Physical Area
Separate area – dedicated to cleaning of ophthalmic instruments
Away from any other type of surgical instruments
Temp 60-65oF
Humidity 30-60%
Air exchanges 10/hour negative
Monitor temperature and humidity daily and document
FIRST STEP
Must have manufacturer’s instructions for cleaning of all devices; method, implements and chemicals recommended
Steps in the Cleaning Process
Pre-Cleaning in room
Contain contaminated items at the point of use
Transport to Decontamination (confined and contained)
Sort
Soak
Wash
Rinse/Dry
Pre-Cleaning - Transport
Instruments should be pre-cleaned immediately following use
Remove gross debris and flush lumens with sterile distilled water (or other agent as recommended by the instrument manufacturer)
Keep instruments moist to avoid drying of soils
Many now recommend cleaning immediately or within 30 minutes of use
Transport in closed container (confine/contain)
Container should be labeled as biohazard (OSHA)
Soaking
Can pre-soak with a detergent
Use of enzyme detergents preferred – but only if recommended by the instrument manufacturer
Assists in the loosening of soils to facilitate cleaning
Do NOT soak in fluids for prolonged periods of time - biofilms can form
Generally form on any surface that is exposed to non-sterile water or other liquids and is consistently found in many environments including industrial and medical systems
use enzymatic gels or foam
Biofiolms
Are produced by microorganisms and consist of a sticky rigid structure of organic contaminates
Slime layer anchored firmly to a surface and provides a protective environment for microorganisms to grow
Cleaning
Need to take special precautions with eye instruments due to
Delicate nature of the design
Sensitivity of eye tissue
Cleaning becomes a challenge
Manual cleaning may be only validated method
Manual cleaning is not as controlled (standardized) as mechanical cleaning
Dilemma
Some eye instrument manufacturer’s do not recommend ANY detergent
Source of confusion for end user
Need to challenge manufacturers
Enzymatic Cleaners
Organic substances which assist in the breakdown of soils
Facilitate the removal of blood and protein soils
Excellent for devices with lumens
Effectiveness dependent upon concentration, use temperature and contact time
Enzymatic Cleaners
Sold as liquid concentrates or powder
Generally more effective in warm water (110-140oF)
Enzyme activity can be inactivated above certain maximum temperatures (140oF)
Follow manufacturer’s directions
Use a thermometer – monitor water temperature
Principles of Cleaning
Must have manufacturer’s written instructions for cleaning of all devices processed
Follow all recommended steps using equipment recommended
Must wear PPE
Impervious gown, head cover, shoe covers, cuffed gloves, face shield
Manual Cleaning Process
May be the only cleaning process available
Items should be submerged, disassembled
Preferable to use 3-sink method; wash, rinse, rinse
Can also be used to remove deposits which were not removed during the pre-soak
Brush all serrations, crevices, tips, handles, and hinges.
Brushing should be done under the surface of the water to prevent aerosolization of contaminants.
Manual Cleaning – General Instructions
Handle instruments one at a time or in small numbers to avoid damage
Open hinged instruments
Disassemble multi-part instruments – keep parts together for easy reassembly after cleaning
Brush and flush all lumened devices
Clean all surfaces
Specialty Items
Cannulas, irrigation cannulas,irrigation/aspiration (I/A) handpieces, suction tips, cystotomes.
Use a brush of the appropriate size to clean the lumen; hold instrument and brush below the water surface
Manual Cleaning Detergents
Usually used for manual cleaning and as a pre-soak
Range from low foam to high foam products
Generally have neutral pH of 7 to 9
Sold as concentrates
Free rinsing
Always measure and dilute the detergent as specified by the detergent manufacturer
Water used to clean instruments should be discarded after each use
Manual Cleaning Implements
Soft bristle brushes, various sizes and lengths (no metal brushes)
Soft cloths
No abrasive items
No sponges
No materials which are permeable; i.e.. Wood
Implements used to clean instruments should be cleaned according to the manufacturer or at least daily, preferably after each use
Mechanical Cleaners
Do not put microsurgical instruments into a washer decontaminator unless it has a delicate cycle.
Can result in damage to instruments
Specialty Cleaner
Specialty cleaning and rinsing system for lumened devices such as Phaco and OZIL handpieces
Effectively cleans and rinses lumens
Must disinfect according to IFUs and document
Diamond Knives
The diamond knife is designed to make precision atraumatic cuts
The diamond knife has the sharpest cutting edge possible
Cost can range from $800 - $2,500 or more
Diamond Blade Knives
Cleaning: Immediately after using a diamond knife, the blade must be rinsed with demineralized water, preventing cell particles or viscoelastic materials from sticking to the blade.
Generally. ultrasonically clean holding the knife and suspending only the blade into the fluid.
The blade should not touch any other instruments or the sides of the cleaner.
Diamond Blade Knives
Never completely submerge a diamond knife in an ultrasonic cleaner.
At all time, (except cleaning) the blade should be in the retracted position to prevent damage.
Inspect with microscope.
Ultrasonic Cleaning
Uses sound waves transmitted through a solution
Sound waves produce tiny bubbles which implode - results in scouring action that cleans
Mechanical process = cavitation
Ultrasonic Cleaning
Effective to remove soils in hard-to-reach areas (box locks, mouth teeth, etc..)
Generally can only use detergents specifically formulated for ultrasonic cleaners - low foaming
Water temperatures usually 100 - 140 o F.
Can be used after manual cleaning
Ultrasonic Cleaning
Solution should be changed at least daily preferably after each use
Outbreaks of TASS have been associated with contaminated sonic baths
Unit should have a cover to contain aerosols
Items should not be stacked
Need to “de-gas” water
Ultrasonic Cleaning
Containers/baskets should have perforations; should be all metal mesh; no plastic
Should be located in Decontamination Area
cleaning process
more efficient than manual cleaning
Test the sonic for efficacy (daily???)
Testing Sonic
Rinsing
The most important part of the cleaning process
Essential to remove loosened debris
Should be performed with the volume and quality (sterile, distilled, or deionized water (if manual cleaning)
Water used to rinse instruments should be discarded after each use
Sterile distilled water recommended for final rinse to prevent mineral deposits and TASS
Lubrication
The use of instrument milk is beneficial to instruments to prevent corrosion and to keep moving parts from getting stiff.
However, not all instruments should be lubricated. The instrument manufacturer will indicate if this process is recommended.
Principles of Inspection/Assembly
All items should be prepared according to the device manufacturer’s written instructions (i.e. must the device be disassembled for sterilization?)
All hinged instruments should be in the open position to permit the sterilant to contact all surfaces of the jaws, blades, etc.
Items must be checked for cleanliness – the use of a lighted magnifying lamp is recommended to visualize defects such as cracked box locks, soils or missing tips.
Inspection
Best method is to use a microscope
Principles of Inspection/Assembly
All parts are present and functional
Use perforated or mesh bottom trays
All scissors should be tested for sharpness each time they are processed
Test that ratchets hold on clamps
Inspect hand held forceps that tips approximate
Test needle holders; ratchets hold and tips hold suture needle
Principles of Inspection/Assembly
Inspect that joints are not stiff
Use a lighted magnifying lamp or microscope to inspect
Inspect for rust, pitting, cracked box lock, etc.
Demagnetization of eye instruments may be needed
Separate delicate, sharp items
Use non-linting surgical towels, or paper sterilization bags to separate items inside set; not peel pack material
Refer to manufacturer’s IFUs regarding flushing of all lumened devices (AAMI states only for gravity cycles). Use sterile, distilled water
Ophthalmic Instruments
Look for defects:
Rusting common (especially if IUSS frequently used
Corrosion
Damage to tips/ teeth
Cords
Lumens (e.g. Phaco handpieces)
Stiffness
Sharpness
Spotting – Staining - Rust
Delicate Tips Require Protection
Can use small containers with silicone mat for individual instruments to provide protection.
General Guidelines for Packaging
Instrument Sets
Use specialty containers to keep delicate instruments in place and prevent damage in transport and cleaning.
The single most effective means to prevent damage to eye instruments is to place them in specialty protective containers
The basket or container of the correct size to prevent instrument damage
Handling Eye Instruments
Place instruments in the tray so that they do not touch each other.
Locate each instrument in the tray to prevent movement and possible damage during handling.
Always keep delicate tips protected with a tip guard when the instrument is not in use.
Protective Container - Cataract Set
Finger Mats May Not Provide Adequate Protection
Paper Plastic Pouches
Widely used because of the visibility of the contents.
However, according to AAMI and AORN pouches should be used for 1-2, light weight instruments.
If packaging instruments separately, select the correct size pouch.
Allow approximately 1” distance from the device and the pouch edges.
Must ensure instruments packaged to protect from damage
General Guidelines for Packaging
Individual Instruments/Small Items
Use correct size packaging
Do not use rubber bands to secure instruments
Paper Plastic Pouches
Double pouching is not required (AORN, AAMI)
May be used for small items which would be difficult to keep together
If double pouching, do not fold over the edges of inside pouch
Inside pouch must lay flat
Tip Protectors
Obtain the manufacturer’s instructions for use.
Some can “catch” onto the instruments – can result in damage
You can use any tip protector that has been approved for use in a sterilization system; foam sleeves, plastic; paper/plastic.
Make sure device can be held open with protector on (e.g. scissors, clamps).
Must have manufacturer’s data that sterilant will penetrate through the tip protector.
Chemical Indicators (Types)
External (Type I) – used to distinguish an item that has been in a sterilizer from an item that has not
Internal chemical indicators (Type 3-4-5)
Should be used inside and outside each package. For wrapped sets, the internal chemical indicator should be located in the center of the pack, not the top.
Type 3 – responds to one parameter
Type 4 – responds to 2 or more parameters
Should use at least a Type 4 CI
Chemical Indicators
Type 5 – integrating indicators – correlate to the action of a biological test
Cannot substitute for a BI test
Type 6 – emulating indicators that respond to a specific cycle type, temperature and exposure time
Labeling Packages
Use a marking pen containing non-toxic, permanent ink and approved for the intended process (e.g., steam sterilization cycles).
Need documentation that marker is non-toxic.
Packages - label on the indicator tape used to close the package, never on the wrapping material itself.
Paper–plastic pouches - label only on the plastic side or on sterilization tape.
If a package is labeled directly on the packaging material, the
marker could damage the packaging material.
Exception is the plastic side of paper plastic pouches.
Table Top Sterilizers
Many ASCs use table top sterilizers
A table-top sterilizer is a ”compact steam sterilizer that has a chamber volume of not more than two cubic feet and that generates its own steam when distilled or deionized water is added by the user” (ANSI/AAMI ST79).
Table-top sterilizers -commonly found in smaller surgery centers where a high volume of sterilization processing does not take place.
Also found in doctors’ and dental offices.
Cycles
The device manufacturer’s sterilization instructions should always be followed
If the cycles provided by the sterilizer cannot be adjusted to conform to the device manufacturer’s instructions, the device should not be processed in that sterilizer.
Conventional Steam Sterilizers
Read the IFUs for exposure time, temperature and cycle time
Many have CJD cycles ONLY
Many have European temperatures only (e.g. 273oF)
Must reconcile IFU information
May have to separate sets to meet IFUs
E.g. some instruments require 10 minutes exposure
Water Quality
Water quality is just as important for table-top units as for sterilizers that use boiler-generated steam.
Distilled or deionized water is recommended to prevent the buildup of minerals in the reservoir and on processed devices.
Each day, before the sterilizer is used for the first time, the reservoir should be checked to ensure that there is enough water for the number of loads to be processed.
Maintenance
Perform all the recommended maintenance of the tabletop sterilizer
Document all maintenance (e.g. reservoir cleaned, gaskets cleaned, etc.
Documentation
All cycles run should be documented
All items processed must be documented
Specific name of device/tray
Quantity
All items must be identified with a lot control number (to facilitate recall)
Must include date sterilized, sterilizer #, load number
Expiration date or event related statement
Traceability to the patient if posterior eye tissue surgery (CJD)
Summary
Best practices for processing ophthalmic instruments requires knowledge of the standards and recommendations to prevent TASS
Manufacturers IFUs
Effective cleaning
Correct packaging methods and materials
Effective sterilization –
Processing equipment in good condition
Proper handling after sterilization
Monitoring of staff compliance with all stated policies and manufacturers’ instructions
Training and competencies for staff
Conclusion - The End
Successful patient outcomes require we develop effective policies, train staff and monitor for compliance
Careful handling of ophthalmic instruments will keep patients safe and reduce costs.
References
AAMI. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. ST-79, 2017.
AORN. Standards and Recommended Practices. “Selection and Use of Packaging Systems”, AORN.
Centers for Disease Control (Hospital Infection Control Guidelines) 2008
American Society of Cataract & Refractive Surgeons. White Paper on TASS (2006).
The Basics of Sterile Processing textbook, 6th edition, Sterile Processing University, 2016.
Questions??????
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