47
Immediate-Use-Steam Sterilization (IUSS) Are Your Instruments Sterile or Did They Just Get Hot?
Immediate-Use-Steam Sterilization (IUSS)
Are Your Instruments Sterile or Did They Just Get Hot?
Presented by SPSmedical
• Largest sterilizer testing Lab in North America and now a part of Crosstex International, a Cantel Medical Company
• Develop and market sterility assurance products that offer advanced technologies
• Provide full day sterilization Seminars and on-site Facility sterilization audits
• Corporate member: CSA and AAMI, serving on numerous sterilization working groups
2
Cantel Medical Corp.
3
Program Objectives
After viewing this program, participants will be able to…
• define IUSS according to AAMI,
• explain AAMI’s recommended criteria for IUSS,
• describe the two most common reasons for IUSS,
• identify 10 ways to reduce IUSS.
4
Immediate-Use Steam Sterilization (IUSS)
IUSS of surgical instruments raises many concerns if not done properly, as stated in AAMI Standards and AORN Recommended Practices.
Today’s program will discuss AAMI Standards and AORN Recommended Practices for IUSS, along with ways to reduce IUSS.
5
“Flash” Sterilization changes to “Immediate-Use”
AAMI, AORN and other organizations have agreed that “flash” is an antiquated term that does not fully describe the various steam sterilization cycles now used to onitems not intended to be stored for later use.
“Immediate-Use” is broadly defined as the shortest possible time between a sterilized item’s removal from thesterilizer and its aseptic transfer to the sterile field.
6
Immediate-Use Steam Sterilization (IUSS)
is defined by AAMI as…
“process designed for the steam sterilization of patient
care items for immediate use”
7
AAMI ST79 A4:2013 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
Considered the bible of sterilization,
this comprehensive guide to steam
sterilization in healthcare facilities
covers all aspects of facility design,
personnel and instrument reprocess-
ing procedures.
Including IUSS!
8
AAMI ST79 A4:2013 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
Sterilization for immediate use should meet the following criteria:a)The item or items have been through a cleaning process consistent with all devices processed within the facility. Once clean, they are placed within a container or package intended for immediate use. Sterilizing unwrapped is not recommended.
b)Cycle time (i.e. gravity-displacement, dynamic air removal, etc.) and parameters should be selected according to the sterilizer manufacturer’s written instructions for use (IFU) and compliant with specific IFU for the device or devices.
9
AAMI ST79 A4:2013 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
Sterilization for immediate use should meet the following criteria:
c) Since IUSS cycles usually have little or no dry time, the items processed are assumed to be wet at the conclusion of the cycle.
d) The processed item(s) must be transferred immediately, using aseptic technique, from the sterilizer to the actual point of use, usually the sterile field in an ongoing surgical procedure.
10
Immediate-Use Steam Sterilization
The same critical reprocessing steps must be followed as a safe process does not include short-cuts. A sterilized item intended for immediate use is not stored for future use, nor held from one case to another.
Cleaning, decontamination and rinsing are critical and users must follow and complete all required processing steps regardless of the sterilizer exposure parameters being used. The device MFG’s written instructions for use (IFU) must be followed.
11
EXAMPLE - MFG’s Cleaning IFU SYMMETRY Orthopedic Instruments
1. Submerge in enzymatic detergent.
2. Flush port with 50 ml enzymatic detergent.
3. Soak for 10 min in protein soluble detergent.
4. Scrub with soft bristled brush (agitate instrument while scrubbing).
5. Rinse with warm tap water (38-49°C)
6. Flush port with 50 ml warm tap water.
7. Place in bath of warm water (agitate by hand for at least 1 min). Repeat this process 2 additional times.
12
8. Ultrasonic for 10 min with neutral pH detergent (flush port with 50 ml prepared detergent before sonication).
9. Flush port with clean tap water (3 times).
10. Rinse for at least 1 min with tap water.
11. Dry with clean, lint free cloth.
12. Inspect.
13. Lubricate tip mechanism and finger slot (do not lubricate flush port).
EXAMPLE - MFG’s Cleaning IFU SYMMETRY Orthopedic Instruments
13
EXAMPLE MFG’s Cleaning IFU Zimmer Orthopedic Surgical Instruments
1. Completely submerge instruments in enzyme solution and allow to soak for 20 min.
2. Rinse in tap water for minimum of 3 min.
3. Ultrasonic clean for 10 min.
4. Rinse in purified water for at least 3 min.
5. Repeat sonication and rinse steps.
6. Remove excess moisture from the instrument with
a clean, absorbent and non-shedding wipe.
14
EXAMPLE - MFG’s Cleaning IFU BAUSCH + LOMB Storz Ophthalmic Instruments Bausch + Lomb is pleased to announce the availability of new cleaning instructions for our surgical instruments marketed under the Storz Ophthalmic Instrument and Bausch + Lomb Instrument brands.
Manual Cleaning
1. Disassemble the instrument as applicable and inspect the instrument for damage or corrosion.
2. Pre-rinse the instrument by holding it under cold running water for at least 30 seconds, rotating the instrument to expose all surfaces and cavities to flowing water. Additional rinsing may be necessary depending on the size and extent of soiling of the instrument.
3. Place the instrument into a suitable clean basin filled with fresh neutral pH cleaning solution prepared according to the directions of the solution manufacturer. Use only cleaning solutions that are labeled for use with medical devices or surgical instruments.
15
Ensure that the instrument is fully immersed in the cleaning solution. The following conditions were validated using a neutral pH detergent (Steris ProKlenz NpH) and a severe organic soil challenge (Biomedical Instrumentation and Technology 2007;41(4):324-331).
4. Using a soft cleaning brush gently scrub all surfaces of the instrument while keeping the instrument submerged in the cleaning solution for at least 5 minutes. Clean the instrument until all visible soil has been removed.
5. Rinse the instrument by holding it under cold running water for at least 30 seconds, rotating the instrument to expose all surfaces and cavities to flowing water. Additional rinsing may be necessary depending on the size of the instrument and the amount of soil.
EXAMPLE - MFG’s Cleaning IFU BAUSCH + LOMB Storz Ophthalmic Instruments
16
6. Place the instrument in an ultrasonic bath filled with fresh neutral pH cleaning solution and sonicate for 5 minutes. Use only cleaning solutions that are labeled for use with medical devices or surgical instruments. Ensure that the instrument is fully immersed in the cleaning solution. Do not overload the ultrasonic bath or allow instruments to contact one another during cleaning. Do not process dissimilar metals in the same ultrasonic cleaning cycle.
7. WARNING: Do not process powered instruments in an ultrasonic cleaner.
8. The cleaning solution should be changed before it becomes visibly soiled. The ultrasonic bath should be drained and cleaned each day it is in use or more frequently if visible soiling is evident.
EXAMPLE - MFG’s Cleaning IFU BAUSCH + LOMB Storz Ophthalmic Instruments
17
Follow the instructions of the manufacturer for the cleaning and draining of the ultrasonic bath.
9. Repeat steps 4-6 as necessary if visible soil remains on the instrument.
10. Rinse the instrument by holding it under warm (27˚C – 44˚C; 80˚F – 100˚F) running water for at least 30 seconds, rotating the instrument to expose all surfaces and cavities to flowing water. Additional rinsing may be necessary depending on the size of the instrument.
11. If the instrument has lumens the lumens should be flushed using a syringe filled with 50cc of warm distilled or deionized water using a stopcock as follows:
EXAMPLE - MFG’s Cleaning IFU BAUSCH + LOMB Storz Ophthalmic Instruments
18
EXAMPLE - MFG’s Cleaning IFU BAUSCH + LOMB Storz Ophthalmic Instruments
a. Place syringe tip into a beaker of warm (30˚C – 40˚C/85˚F – 105˚F) distilled or deionized water and fill to the 50cc mark.
b. Connect the end of the syringe to the center stopcock fitting.
c. Rotate the stopcock lever to the male Luer fitting (irrigation) or to the female Luer fitting (aspiration) to allow fluid flow to the
appropriate Luer fitting.
d. Connect the stopcock to the appropriate Luer connector on the instrument.
e. Push on the syringe plunger to force fluid through the lumen into another beaker for proper disposal. Do not draw flushing fluid back through the lumen. Disconnect the syringe. Disconnect the syringe/stopcock from the instrument.
19
f. Repeat steps A-E at least three times, for each lumen.
g. Fill the syringe with 50cc of air, reattach the stopcock, and push on the plunger to force air through each lumen. Disconnect the syringe/stopcock from the instrument.NOTE: The CX7120 Universal Maintenance Kit contains a syringe and stopcock suitable for cleaning instrument lumens.
12. Immerse the instrument in clean basin containing fresh deionized or distilled water and soak for at least three minutes.
13. Immerse the instrument in second clean basin containing fresh deionized or distilled water and soak for at least 3 minutes.
14. Perform a final rinse of the instrument with sterile distilled or deionized water for at least 30 seconds, rotating the instrument to expose all surfaces and cavities to flowing water.
20
AAMI ST79 A4:2013 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
IUSS should only be considered if all the following conditions are met:
a)Work practices ensure proper cleaning and decontamination, inspection, and arrangement of instruments into the recommended sterilizing tray or other containment devices before sterilization.
b)The physical layout of the department or work area ensures direct delivery of sterilized items to the point of use (e.g. the sterilizer door opens into an area either within or directly adjacent to the procedure room).
21
AAMI ST79 A4:2013 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
IUSS should only be considered if all the following conditions are met:
c) Procedures are developed, followed and audited to ensure aseptic handling and personnel safety during transfer of the sterilized items from the sterilizer to the point of use.
d) The item is needed for use immediately following IUSS.
Implantables should not be sterilized for immediate use (CDC 2008).
22
FDA definition of an implant:
A device that is placed into a surgically-or naturally-formed body cavity with the intention of remaining there for a period of 30 days or more.
23
Immediate-Use Steam Sterilization
Traditionally, flash was recommended for emergency use only (e.g. a dropped instrument) using an unwrapped tray or pan and processing at 270°F/132°C for 3 or 10 min in a gravity displacement steam sterilizer.
Today, IUSS has been expanded for use in gravity and dynamic air removal cycles; and a variety of packaging systems, including: protective organizing cases, single layer wrap, and sealed sterilization containers.
24
Traditional Flash Sterilization
Gravity Displacement (270-275°F/132-135°C)
3 min. exposure – unwrapped nonporous item10 min. exposure – unwrapped mixed nonporous
and porous items
The above “shortened” flash cycles were recommended for a single instrument or a few at a time. A full gravity displacement cycle is 15 minutes exposure at this temperature. Drying time was 0 or 1 min; therefore, instruments came out of the sterilizer hot and wet.
25
IUSS
Gravity Displacement (270-275°F/132-135°C) 3 min. exposure - per device manufacturer’s IFU10 min. exposure - per device manufacturer’s IFU
? min exposure – per device manufacturer’s IFU
Dynamic air removal (270-275°F/132-135°C) 3 min. exposure - per device manufacturer’s IFU 4 min. exposure - per device manufacturer’s IFU ? min exposure – per device manufacturer’s IFU
Note: There are devices that require “extended” cycles as well as those that cannot be processed in gravity displacement cycles.
26
MFG’s Instructions
SYNTHES Power Drive 530.100
Wrapped Temperature Minimum Exposure TimePrevacuum 132-135°C/270-275°F 24 minutes
Gravity Displacement – Not recommended
Unwrapped (Flash) is same as wrapped parameters
27
Zimmer
MFG’s Instructions
►
28
DePuy Large Bone
MFG’s Instructions
29
MFG’s Instructions
Device Method ParametersDePuy Hand Innovation Gravity 270°F for 20 min
Prevacuum 270°F for 10 min
Medtronic Midas Rex Gravity 270°F for 25 minPrevacuum 270°F for 4 min
Aesculap 4S Spine Set Prevacuum 270°F for 10 minStryker Spine Set Prevacuum 270°F for 15 minAbbott Spine Set Prevacuum 270°F for 15 minScientix SACP System Prevacuum 273°F for 18 min
30
Sterile or Just Hot?
IUSS of an instrument or instrument setsin the wrong sterilizer mode or the wrongexposure time, will certainly get hot, but they will not be sterile.
IUSS has unique challenges; and therefore, is not recommended by AAMI, AORN or The Joint Commission for routine use or implants.
31
Question:What are the
common reasons for IUSS?
32
Immediate-Use Steam Sterilization
The two most common reasons for IUSS are:
1. Lack of inventory:• Case volume requiring same instruments• Scheduling back to back blocks that require the
same instruments• Vendors not delivering instruments in time• CSSD/SPD not reprocessing instruments in time• Surgeon’s personal instruments being used
33
Immediate-Use Steam Sterilization
2. Lack of communication:• Surgeons not contacting vendors with enough time
to deliver instruments• OR not contacting CSSD/SPD with enough time to
reprocess instruments• Staff and Vendors limited knowledge regarding
best practices, e.g. not knowing how long it takes to properly reprocess instruments
34
Immediate-Use Steam Sterilization
CSSD/SPD needs to educate the hospital/vendors:• time it takes to decontaminate soiled instruments
using best practices;• time it takes to inspect, assemble, package and
sterilize instruments using best practices;• quickest possible turnaround time (staff & equipment);• and, average turnaround time
Improved communication it the quickest and most cost effective way to reduce IUSS!
35
Question:How can healthcare
facilities reduce IUSS?
36
10 Ways To Reduce IUSS
1. Update Policy & Procedures to reflect national standards.
2. Clearly define what your facility considers “emergency” situations and in-service personnel.
3. Educate personnel as to risks associated with IUSS and how to terminally sterilize instruments.
4. Review all logs of all IUSS cycles to document what instruments are being processed using IUSS.
5. Review each instrument manufacturer’s written instructions for use (IFU) to understand terminal sterilization cycle(s) validated for these devices.
37
10 Ways To Reduce IUSS
6. Based on manufacturer’s IFUs, determine parameters needed to terminally sterilize these devices.
7. Use this information to allow enough time when scheduling cases involving these instruments.
8. Purchase additional instruments if case scheduling conflicts with terminal sterilization.
9. Adjust all steam sterilizer IUSS cycles to terminal cycles – including appropriate dry times.
10. Hold all personnel (staff and vendors) accountable to comply with all Policies & Procedures.
38
Association of periOperative Registered Nurses
Perioperative Standards and Recommended Practices
For Inpatient and Ambulatory Settings
IUSS should be kept to a minimum and should be used only in selectedclinical situations and in a controlledmanner.
39
Association of periOperative Registered Nurses
Perioperative Standards and Recommended Practices
For Inpatient and Ambulatory Settings
IUSS may be associated with increased risk of infection to patients. Time constraints may result in pressure to personnel to eliminate or modify one or more steps in the cleaning and sterilization process.
40
http://www.mc.vanderbilt.edu/documents/infectioncontrol/files/Zuckerman%20Flash%20Sterilization%20AJIC%202012.pdf
IUSS Sterility AssuranceA class 5 chemical integrating indicator or a class 6 indicator should be used within each sterilization container or tray used for IUSS.
Class 5
Class 6
41
Association of periOperative Registered Nurses
Perioperative Standards and Recommended Practices
For Inpatient and Ambulatory Settings
IUSS should not be used for implantable devices except in cases of defined emergency when no other option is available. Implants are foreign bodies and they increase the risk of in surgical site infection.
42
IUSS Sterility AssuranceWhen IUSS of an implant is unavoidable, cycle selection should be determined by the manufacturer’s written instructions for use, and a biological indicator and a class 5 chemical integrating indicator should be run with the load.
43
IUSS Record keeping
Documentation of cycle information and monitoring
results should be maintained in a log (electronic or
Manual).
These records should include the items processed,
patient items were used on, type of cycle, cycle
parameters, monitoring results, date and time, operator
information and reason for IUSS.
44
Conclusion
Because there are increased risks associated with IUSS, it should be kept to a minimum and only used in selectclinical situations. While the delivery of non-sterile instruments certainly is not a leading cause of SSIs, it has been documented by the CDC as one of the causes.
I hope the information we have shared with you today regarding IUSS, helps you to provide
the best patient care!
45
Chuck Hughes VP, Infection Prevention Consulting Services Cantel Medical c/o SPSmedical Supply Corp. 6789 W. Henrietta Road · Rush, NY 14543 USA (800) 722-1529 · E-mail: [email protected]
Certified as a Health Education teacher, Chuck has worked for over 25 years in the manufacturing industry in areas of Regulatory Affairs, R&D, Marketing, Microbiology and Sterilization Training. He is a corporate member AORN, AST, IAHCSMM, SGNA and numerous other organizations, including AAMI and CSA where he contributes to sterilization standards. A popular speaker at regional, national and international healthcare conferences, Chuck has visited thousands of healthcare facilities during his career providing sterilization consulting services that include fee based and complementary audits of instrument reprocessing areas.
Thank You!
46
REFERENCES:Association for the Advancement of Medical Instrumentation (AAMI). (2013). ANSI/AAMI ST 79:A2013 Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities, Amendment 2. Arlington, VA: AAMI.
Association of periOperative Nurses (AORN). (2014). Perioperative Standards and Recommended Practices. Denver: AORN, Inc.
Centers for Disease Control and Prevention (CDC). (2008). Guideline for Disinfection and Sterilization in Healthcare Facilities, Atlanta, GA.
U.S. Food and Drug Administration (FDA). Silver Spring, MD 20993. www.fda.gov
47
