Cleaning, Packaging and Sterilization of

Instruments Provided by:

McKesson CorporationMcKesson Medical-Surgical

Richmond, VA

Continuing Education Program

Following established protocols for

instrument processing is an important

aspect of modern health care as it helps

to minimize the patient’s risk for

infection of the surgical site.

This program reviews the most current

recommended practices for instrument

processing and is approved through

two national sterile processing

organizations.

IAHCSMM and CBSPD offer certification programs for sterile

processing personnel

INSTRUMENT PROCESSING

There are six (6) recommended

steps for Instrument Processing:

1. Cleaning

2. Inspection

3. Packaging

4. Sterilization

5. Storage & Delivery

6. Quality Assurance

STEP 1 - CLEANING

Cleaning of instruments should be performed in a designated area, immediately after the surgical procedure.

Quick cleaning removes blood or debris much easier, and canminimize corrosion, pitting orinstrument staining.

STEP 1 - CLEANING

Whenever possible, it is best to mechanically clean instruments with an ultrasonic or washer

using a neutral pH detergent.

Mechanical cleaning has been proven to be up to 16 times more effective over manual cleaning.

STEP 1 - CLEANING

Ultrasonic cleaners use high frequency sound waves tocreate microscopic bubbles that collapse.

This “cavitation” process is very effective in getting into the serrations, box locks and crevices of instruments.

STEP 1 - CLEANING

After cleaning, thoroughly rinse instruments with tap water to ensure loosened debris and detergents are removed.

If the tap water is of poor quality, consider using treated water as a final rinse to avoid instrument staining.

STEP 2 - INSPECTION

Each instrument must be

critically inspected after

each cleaning for residual

debris or damage.

Replace instruments as

needed and never sterilize

a “dirty” instrument.

In addition, check eachinstrument for proper function and lubricate those that have “metal to metal” action.

Instruments with stiff joints could be a sign of inadequate cleaning.

STEP 2 - INSPECTION

STEP 3 - PACKAGING

Instrument packaging should be done in a clean, low contamination area using only FDA approved materials, such as:• Sterilization pouches• Sterilization wrappers• Sterilization containers

STEP 3 - PACKAGING

Sterilization pouches are for packaging single instruments and small, light weight items.

Paper/plastic pouches allowthe user to see the packaged instruments and are available in heat-seal & self-seal design for use with all sterilization processes.

STEP 3 - PACKAGING

When packaging instruments,

be sure to select an appropriate

size pouch and to place hinged

instruments in an open position

to allow sterilant contact.

For quality control, be sure to

include a chemical indicator

inside and a lot label outside.

STEP 3 - PACKAGING

To assist sterilization and aid drying, always place pouches facing each other and on edge using a pouch divider.

Inexpensive pouch dividers are available for small and large sterilizers.

STEP 3 - PACKAGING

Sterilization wrap is used forpackaging instrument cassettes and/or trays.

To allow sterilant to reach the instruments and to not trap air inside the package, cassettes and trays should be perforated.

Wrap should be snug to prevent low spots that could collect condensate, but not too tight to cause strike through.

STEP 3 - PACKAGING

Instrument trays should be

double wrapped to maintain

sterility per the wrap mfg’s

instructions for use.

Instrument trays should be

wrapped in a way that allows

for sterile presentation of the

processed items.

STEP 3 - PACKAGING

Wrapped packs should be sealed

with 1”, 3/4” or ½” sterilization

indicator tape.

For quality control, be sure to

include a chemical indicator

inside and a lot label outside.

Class 5

Class 4

STEP 3 - PACKAGING

Wrapped packs (being heavier)

should be placed on the lower

shelf of the sterilizer.

Loading heavier items on the

bottom shelf and lighter items

on the top, enables condensate

to drain out without wetting

other items in the load.To maintain sterility, packages need to be

visibly dry before transporting to a sterile storage area

STEP 3 - PACKAGING

Sterilization containers can be used to process instruments or sets. Containers offer excellent protection during storage and transport to the sterile field.

As with wrapped trays, loading containers on the bottom shelf and lighter items on the top, enables condensate to drain away from lighter packages.

Some rigid containers can be stacked during sterilization; however, all can be stacked

during storage to save space

STEP 4 - STERILIZATION

Steam sterilization is CDC

recommended as the process

of choice whenever possible.

Steam under pressure is

considered safe, fast and the

most cost effective sterilization

method for health care

facilities. Gravity displacement and pre-vacuum

are the two common types of steam sterilizers

STEP 4 - STERILIZATION

Steam sterilizers are Class II

medical devices subject to FDA

approval per a 510(k) clearance

letter.

They are available in a wide

variety of shapes and sizes for

sterilization of heat-stable

instruments.

STEP 4 - STERILIZATION

Always process according to the sterilizer or instrument manufacturer’s validated Instructions For Use.

Some common sterilizer cycle recommendations are:

• 250°F/121°C for 30 minutes• 270°F/132°C for 10 minutes• 273°F/135°C for 4 minutes

STEP 4 - STERILIZATION

Not all instruments can be processed

at common or “normal” cycle times.

For example, SYNTHES General

graphic cases:

• Gravity sterilizer:

132-135°C for 22 minutes

• Pre-vacuum sterilizer:

132-135°C for 8 minutes

STEP 5 – Storage & Delivery

Sterile items should be stored in a

manner that reduces the potential

for contamination.

The shelf-life of sterile packages

is event related and depends on

the quality of the packaging

material, storage conditions and

amount of handling.

STEP 5 – Storage & Delivery

Sterile packages should always be handled with care. Avoid dragging, crushing, bending, compressing or puncturing, as this will compromise the sterility of the contents.

Be sure to inspect sterile packages before distributing. Do not use any package that is damaged, wet or opened.

STEP 5 – Storage & Delivery

Sterility maintenance bags

(dust covers) may be used

to protect items that could

be subjected to

environmental challenges

or multiple handling

before use.Should be 2-3 mils thick and applied

ASAP after sterilization and after the item has cooled.

STEP 6 – Quality Assurance

Chemical indicators should be placed

on the outside/inside of each package

to visibly show they have been

processed.

Biological indicators should be run

at least weekly to verify sterilization

and recorded as part of your formal

Infection Control – QA program.

STEP 6 – Quality Assurance

Chemical Indicators are available

in tape, card and strip formats for

use with all processes.

These devices change color as

indicated, for the process they

are monitoring.

STEP 6 – Quality Assurance

Most large steam sterilizers are pre-vacuum and requirean air removal check before using. This daily test is donewith a Bowie-Dick test pack.

Most table top sterilizers are gravity displacement and do not require this special test.

STEP 6 – Quality Assurance

Test Procedure: Place a Bowie-Dick test pack on the lowest shelf, over the drain in an empty chamber at 273°F for 3.5 or 4 minutes.

After processing, the indicator sheet inside the test pack must show a uniform color change to pass.

A shortened cycle omitting dry time should be run first to properly heat

up the sterilizer.

STEP 6 – Quality Assurance

Biological Indicators are processed along with a load for sterilizer verification. For steam sterilizers, users purchase a 55-60°C incubator and biological indicator vials. Sterilizer failure is noted if the BI grows during incubation. Growth is observed bya color change in the media from purple to yellow.

STEP 6 – Quality Assurance

Biological Indicators can also be sent to an outside Lab for 3rd party documentation.

Mail-in systems use BI strips and pre-paid mailer envelopes. Users simply run the BI strip and then mail. A Lab Report is returned and placed on a “password protected” website: www.checkyourtest.com

STEP 6 – Quality Assurance

While sterilizers can and do mechanically fail, human error is the leading cause of sterilizerfailure.

• Cold start• Wrong cycle• Overloading• Improper packaging

After processing, the BI strip is mailed to an outside Laboratory for incubation. After 24 hrs, a formal Lab Report is returned

to verify steam sterilization

McKesson thanks you for taking the time to review…

The six (6) recommended steps

for Instrument processing:

1. Cleaning

2. Inspection

3. Packaging

4. Sterilization

5. Storage & Delivery

6. Quality Assurance

CE Certificate Available

This continuing education program

was developed and produced by

SPSmedical Supply Corp. for the

McKesson Corporation.

Customers who view this program

may request a complimentary CE

Certificate from SPSmedical.

SPSmedical Supply Corp.

The largest sterilizer testing Lab in North America with over 48 sterilizers, SPSmedical serves on10 AAMI sterilization standardscommittees & provides seminarSpeakers to health care organizations.

For technical questions andCE Certificates, please call: 1-800-722-1529 or E-mail: education@spsmedical.com

ANSI/AAMI ST35:2003

Safe handling and biological decontamination

of reusable medical devices in health care

facilities and in nonclinical settings

References

ANSI/AAMI ST33: 1996

Guidelines for the selection and use of

reusable rigid container systems for

EO & Steam sterilization in HC

facilities, 2ed

ANSI/AAMI ST37: 1996

Flash sterilization – Steam sterilization

of patient care items for immediate

care use

References

ANSI/AAMI ST46: 2002

Steam sterilization and sterility assurancein health care facilities

ANSI/AAMI ST 66: 1999

Sterilization of health care products-Chemical indicators- Part 2: Class

2 indicators for air removal test sheets and

packs

ANSI/AAMI ST 60: 1996

Sterilization of health care products-Chemical

indicators- Part 1: General requirements

References

McKesson Brand Sterility Assurance Products

McKesson Brand Sterility Assurance Products

To assist users in meeting their sterility assurance needs, contact

your local McKesson Representative and ask for the following

McKesson brand quality products:

PACKAGING MONITORING

• Self-Seal & Heat-Seal Pouches • Chemical Indicators

• Disposable Sterilization Wrap • Biological Indicators

• Sterilization Indicator Tape • B-D and BI Test Packs

• Record Keeping System • Incubators/Record Books

McKesson Brand Sterile Packaging Products

Self-Seal Pouches73-SSP381 3.5” x 9”

73-SSP382 5.25” x 10”

73-SSP383 7.5” x 13”

73-SSP387 8” x 16”

73-SSP391 12” x 18”

Heat-Seal Pouches73-HSP250 4” x 8”

73-HSP254 5.25” x 10”

73-HSP255 5.25” x 15”

73-HSP256 6” x 10”

73-HSP257 7.5” x 13”

McKesson Brand Sterile Packaging Products

Sterilization Wrap73-HDW1515 15” x 15”

73-HDW1818 18” x 18”

73-HDW2020 20” x 20”

73-HDW2424 24” x 24”

73-HDW3030 30” x 30”

Sterilization Tape73-ST048 3/4” x 60

yds

73-ST036 1” x 60 yds

73-BT048 3/4” x 60 yds

73-BT036 1” x 60 yds

73-GT036 1” x 60 ydsLabel Applicator 73-MDG001 Load Record Label 73-URL012 Load Record Card 73-DLC250 Records Envelope 73-LEB100

McKesson Brand Sterilization Monitoring Products

Chemical Indicators73-SIS250 4” Steam Strip

73-SIL250 8” Steam Strip

73-GIL250 8” EO Strip

73-DMS250 8” Dual Strip

Chemical Integrators73-SSI100 Steam (100 pk)

73-SSI1000 Steam (1,000 pk)

73-STP025 Steam Test Pack

Daily Air Removal Test 73-SBD030 Bowie-Dick Test Pack

McKesson Brand Sterilization Monitoring Products

Biological Indicators73-SCS025 Steam vial (25 bx)73-SCS100 Steam vial (100 bx)73-SBT025 Steam Test Pack w/25 controls

73-SBT255 Steam Test Pack w/5 controls

73-PCS025 Peracetic Acid Culture Set (for STERIS System 1)73-NDB055 60°C Dry Block Incubator, 16 mm73-NDB060 60°C Dry Block Incubator, 11 mm

73-PP012 Mail-In System (12 bx)73-PP052 Mail-In System (52 bx)