Part III –Review of key information from ST79,...

3M Medical Template v2 7.13.07

1

Infection Prevention Division

Attest™ Sterile U Network

© 3M 2011. All Rights Reserved.

Part III – Review of key information from ST79, Sections 10 - 12

July 14, 2011

Welcome!Topic: Part III – Review of key information from ST79,

Sections 10 - 12

Facilitator: Jamie Meilahn, 3M Marketing

Diane Koch, 3M Marketing

Speaker: Dorothy Larson, Technical Services

Housekeeping

� Questions

� Mute feature (*7 = unmute; *6 = mute)

� “Chat” feature

� Technical difficulties

� CE Credits

� Post session follow-up

For more information: www.3M.com/3MSterileU© 3M 2011. All Rights Reserved.

Dorothy Larson

Technical Service Representative

3M Infection Prevention Division

[email protected]

3M Sterilization Tech Line 1-800-441-1922 Option “2”

Disclosure Statement



2

Objectives

� Describe the various sterilization process monitoring

devices, including PCDs

� Describe how to put the monitoring tools into

practice


ST79, Section 10 – Quality control

� General rationale (10.1)

� Monitoring of mechanical cleaning equipment (10.2)

� Product identification and traceability (10.3)

� Overview of sterilization process monitoring (10.4)

� Sterilization process monitoring devices (10.5)

� Routine load release (10.6)

� Routine sterilizer efficacy monitoring (10.7)

� Qualification testing (10.8)

� Periodic product quality assurance testing of routinely processed items (10.9)

� Periodic quality assurance testing of rigid sterilization container systems (10.10)

� Product recalls (10.11)


Monitoring of mechanical cleaning equipment (10.2, Annex D)

� Verification methods include use of devices that � Directly test instruments for residual soils

� Challenge cleaning effectiveness with standardized test methods

� Measure specific key parameters to evaluate the functionality of the cleaning equipment (time, temperature)

� Key performance outcomes� Clean surfaces

� Adequate fluid flow in equipment that has adaptors for lumened devices



3


Monitoring of mechanical cleaning equipment (10.2)

Frequency of testing

� Upon installation

�Weekly (preferably daily) during routine use

� After major repairs


� “A major repair is a repair that is outside the scope of routine preventive maintenance and that significantly affect the performance of the equipment.”

� Examples include replacement of:

� Water pump(s)� Detergent delivery system � Heating system� Water delivery system� Water treatment system� Computer control � Upgrade of software



� Document monitoring

� Review and initial digital readouts for each cycle

printout and save

� “Ideally, cleaned medical devices should be

traceable to the patients on whom they are used.”



4


Product identification and traceability(10.3.1, 10.3.3)

�Labeling on product

Lot or load control number

• Date of processing

• Sterilizer number

• Cycle number

Expiration date or statement:

“Contents sterile unless package is open or damaged. Please check before using.”


Product identification and traceability(10.3.2)

�Record keeping documents

• Materials that have been processed

• Results of the sterilization process monitoring

�Includes;

• Load labels/package

• Paper log systems

• Electronic log systems

• Filed as individual document


� Sterilizer and load records- Load contents

- Date and time of cycle

- Exposure time and temperature

- Initials of operator

- Biological results

- Chemical indicator results

� Records of sterilizer repair, maintenance and calibration

� Maintain records for time determined by risk manager



5

For immediate-use sterilization (flash), a lot number

should be assigned to each load, incl. sterilizer ID and

cycle number

Information on each load

• Item(s) processed

• Cycle parameters used (e.g., temperature, duration of cycle)

• Day and time cycle is run

• Operator information

• Reason for immediate use (flash) sterilization



Steam Sterilization Cycles (8.6.1)

� Gravity DisplacementIncoming steam displaces air

� Dynamic-Air-RemovalPrevacuum - Series of pressure and

vacuum excursions

Steam-flush pressure-pulse (SFPP) A series of steam flushes and pressure pulses above atmospheric pressure


Immediate-Use Steam Sterilization (Flash)


“Process designed for the steam sterilization of patient care items for immediate use.”

-High temperature (270-275°F/ 132-135°C)

-Gravity or dynamic-air-removal

-No dry time; No storage

Packaging- Perforated, mesh bottom, open surgical tray

- Rigid sterilization container system

- Protective organizing case- Single-wrapped surgical tray

Photo courtesy of Rose Seavey, The Children's Hospital - Denver

Steam sterilization cycles(Introduction, 8.6.2)


6

Extended cycles

� Cycles whose time is extended beyond the minimum steam sterilization cycles

� Sterilization of specialty instruments and devices, i.e. drills, could require extended exposure times

- some manufacturers do not recommend immediate-use sterilization

� Device manufacturer’s written instructions should be followed!


Steam sterilization cycles (8.6.3)


�Four levels of testing

Routine load release Testing of each non-implant and implant load

Routine sterilizer efficacy

monitoringEstablishing a regular pattern of testing the efficacy of

the sterilization process

Sterilizer qualification testingTesting of the sterilizer after events occur which could

affect the ability of the sterilizer to perform

Periodic product testing

Testing of routinely processed items to ensure the

effectiveness of the sterilization process and to avoid

wet packs

Overview of sterilization process monitoring (10.4, Table 6, Table 7)


� Monitoring Tools

- Physical monitors

- Chemical indicators

- Biological indicators

- Process challenge devices

(PCDs) - also referred to as

test or challenge pack

Overview of sterilization process monitoring (10.4)


7

� Physical Monitors

Verify the parameters of sterilization cycle are met

- Provides real-time assessment of the sterilization cycle conditions, and a permanent record of recordings and printouts

• Recording charts / Gauges

• Tape / Printouts

• Digital displays

Sterilization process monitoring devices (10.5.1)


© 3M 2011 All Rights Reserved.

� Physical monitors

• Mark with correct date and sterilizer identification at beginning of cycle

• Read & verified by initialing at end of cycle

• If not correct, do not release load



�Physical monitors

Limitations

• Generally only monitor one location in the sterilizer

• Conditions not revealed in the temperature recording, such as:

Improper packaging

Improper loading procedures



8


Class 1 Process Indicators

Class 2 Indicators for use in Specific Tests

Class 3 Single Variable Indicators

Class 4 Multi-variable Indicators

Class 5 Integrating Indicators

Class 6 Emulating Indicators

ANSI/AAMI/ISO 11140-1, 2005 Sterilization of health care products-Chemical indicators - Part 1: General requirements

Chemical Indicators (10.5.2)



Class 1: Process Indicators (External CIs)

� Use with individual units to indicate that the unit has been directly exposed to the sterilization process

- (e.g., indicator tape, indicating label, indicating printed legend)

� Distinguishes between processed and unprocessed units

� Designed to react to one or more of the critical process variables


Class 2: Indicators for Specific Tests

Testing sterilizer performance

- Bowie-Dick Test monitors efficacy

of air removal and steam penetration in 270-275°F dynamic-air removal sterilizers (i.e., vacuum assisted sterilizers)



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Class 2: Indicators for Specific Tests

• Bowie-Dick tests can detect:

Air leaks

Inadequate air removal

Inadequate steam penetration

Presence of non-condensable gases: air or gases from

boiler additives

• Used for routine daily testing and qualification testing




Class 2: Bowie-Dick Test


Class 2: Bowie-Dick Test

• Uniform color change – Use

• If not uniform, shut down and call repair person

• Re-qualify if major repair



10


Presentation Title


Questions ?



Internal chemical indicators

Class 3, 4, 5, or 6

• Tests conditions inside individual packs

• Place inside each pack, wrapped tray, flash tray or container in area least accessible to sterilant:

- identifies sterilant penetrated



Key Definitions

�Critical Variables

- Parameters identified as being essential to the sterilization process (and required monitoring)

- For example, the critical variables for steam sterilization to be effective

ANSI/AAMI/ISO 11140-1, 2005 (Mfrs. Standard)

Time Temperature Steam


11


Key Definitions

Stated Value (SV) - “value or values of a critical variable at which the indicator is designed to reach its endpoint as defined by the manufacturer”

End Point - “point of the observed change as defined by the manufacturer occurring after the indicator has been exposed to specified stated values”

�Migration�Color change

ANSI/AAMI/ISO 11140-1, 2005 (Mfrs. Standard)

121°C 128°C 135°C

22.1 5.7 2.1

Lot 2012-09 JT


Class 3: Single-Variable Indicators

(Internal CIs)

� Designed to react to one of the critical variables

� Do not provide as much information as Class 4, 5, or 6



Class 4: Multi-variable Indicators (Internal CIs)

• Designed to react to two or more of the critical variables

• Indicates exposure to a sterilization cycle at stated values of the chosen variables



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Class 5: Integrating Indicators (Internal CIs)

• Designed to react to all critical variables

• Stated values equivalent to the performance requirements for BIs (ISO 11138 series: 2006)

- Response must correlate to a BI at three

time/temperature relationships : 250°F/121°C, 275°F/135°C , and at one or more temperatures in between

- Stated value at 250°F/121°C must be >16.5 min


Class 6: Emulating Indicators (Internal CIs)

• Designed to react to all critical variables

• Stated value generated from the critical variables of the specific sterilization process

• Cycle verification indicators




Internal chemical indicators

� The contents of a package with a non-responding chemical indicator should not be used

� Quarantine remainder of load until BI results are known

� If no BI, decide on recall based on physical monitors and other CI results



13

• Biological Indicators (BIs)

Test system containing viable microorganisms providing a defined resistance to a specified sterilization process

- BIs are intended to demonstrate whether the conditions were adequate to achieve sterilization

- BIs are the only sterilization process monitoring device that provides a direct measure of the lethality of the process.

Biological Indicators (10.5.3)



How they work . . .

�Spores are exposed to the sterilization process

�After processing, exposed spores immersed in optimized recovery media and incubated at optimal temperature

• Spore strips are transferred to medium using aseptic technique

• Self-contained designs allow immersion without transfer

• If spores are viable, process failure




�With enzyme-based early-readout (AAMI)

• Fluorescence in 1 to 3 hours

• Visual color change in 24 to 48 hours for steam

�Conventional

• Visual color change in 24-48 hours

�Manufacturer’s incubation instructions should be followed

�“Periodic verification of the early-readout with spore growth should be performed in accordance with the manufacturer’s instructions and facility policy and procedures.”

�The final incubation time is the time needed to ensure a negative

biological indicator.


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Control BI - Incubate a positive BI control each day a test vial

is incubated in each incubator or auto-reader

�From same lot number as test BI

Purpose is to validate the test system is working and ensure

� Correct incubation conditions

� Viability of spores

� Capability of medium to promote growth

� Proper functioning of auto-reader and incubator

Good Science

Biological Indicators (10.7.2.3, 10.7.3.3, 10.7.4.3)

� Process Challenge Device (PCD) –

Item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process.

� Representative of load and creates the greatest challenge

� Equal to or greater than the most difficult item to sterilize

Process Challenge Devices (10.5.4)



�User assembled

Challenge test pack or tray (e.g., AAMI 16-

towel pack, flash tray)

�Commercially available – FDA

Cleared PCD



15

� Depending on the application…

� a BI,

� a BI and a Class 5 integrating CI,

� a Class 5 integrating CI

� a Class 6 emulating indicator

• Place in most difficult area in sterilizer for the sterilant to

penetrate

43© 3M 2010. All Rights Reserved.




�Sterilizer Cycle Variation

Expertise of prep/pack personnel

Expertise of sterilizer operator

Condition of sterilizer equipment

Available Utilities

Usage

The less frequent the

sterilizer is used the

greater chance that an

unnoticed event could

affect sterilization


Presentation Title


Putting the monitoring tools into practice!



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Four levels of testing:

Routine load release Testing of each non-implant and implant load

Routine sterilizer efficacy

monitoringEstablishing a regular pattern of testing the efficacy of

the sterilization process

Sterilizer qualification

testing

Testing of the sterilizer after events occur which could

affect the ability of the sterilizer to perform

Periodic product testing

Testing of routinely processed items to ensure the

effectiveness of the sterilization process and to avoid

wet packs

Overview of sterilization process monitoring (10.4, Table 6, Table 7)


Routine Load Release Nonimplants - (Table 6)


� External process indicator (Class 1) on every package

� Internal CI (Class 3, 4, 5, 6) inside every package

� Optional monitoring of load with a PCD containing a

• BI

• BI and a Class 5 CI

• Class 5 integrating indicator

• Class 6 emulating indicator

� Evaluation of all data by an experienced, knowledgeable person

� Do not distribute load if any data suggests a sterilization process failure


Routine Load Release Implants – (10.6.3)


� External process indicator (Class 1) on every package

� Internal CI (Class 3, 4, 5, 6) inside every package

� A PCD containing a BI and a Class 5 integrating indicator

� Optional: Class 6 PCD (Note: Load release decision is still only based on BI, or Class 5 CI in an emergency)

� Evaluation of all data by an experienced,

knowledgeable person

� Do not distribute load if any data suggests

a sterilization process failure


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�“Releasing implants before the BI results are known is unacceptable and should be the exception, not the rule.”

Routine Load Release Implants – (10.6.3)


� BI PCD should contain a Class 5 integrating indicator

� Class 5 integrating indicator used to release implant in emergency situations

� “Emergency situations should be defined”

Routine Load Release Implants – (10.6.1, 10.6.3)


Early Release Implant Loads

�If documented medical exceptions dictate release of implant before BI result

• Use implant log and an exception form

�Critical that this documentation be fully traceable to the patient

Routine Load Release Implants – (10.6.3, Annex L)


18


� Exception Form for Premature

Release of Implantable Device/Tray

• Name of implant

• Name of patient

• Name of surgeon

• Reason for premature release

• What could have prevented the premature release

Routine Load Release Implants – (10.6.3, Annex L)

Immediate-Use Steam Sterilization (Flash Cycles)


Routine Load Release Implants – (Intro, 10.5.4, 10.6.2)

� Flash sterilization should not be used for implantable devices(AAMI Intro – Garner and Favero, 1985; CDC, 2003a, 2003b)

� The load should be quarantined until the results of the BI testing are available

(CDC, 2003a)

Emergency situations - Class 5 CI should be used to release implant

� Critical that all implants are traceable to the patient


Presentation Title


Questions ?



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Routine Sterilizer Efficacy Monitoring (10.7)

Monitoring recommendations

� Routine load release

Nonimplants; Implants

� Routine sterilizer efficacy monitoring

� Sterilizer qualification testing

� Periodic product QA testing


Routine Sterilizer Efficacy Monitoring &Sterilizer Qualification Testing (10.7)

Divided into sections

• Sterilizers larger than 2

cubic feet

• Table-top sterilizers

• Flash sterilization cycles

Photo courtesy of Rose Seavey, The Children's Hospital - Denver

Establishing a regular pattern of testing the efficacy of the

sterilization process

“Biological indicators should be used within PCDs for

routine sterilizer efficacy monitoring at least weekly, but

preferably every day that the sterilizer is in use.” (10.5.3.2)




20

Test each type of cycle with a BI PCD

Gravity-displacement 132°C to 135°C 270°F to 275°F

Gravity-displacement 121°C 250°F

Dynamic-air-removal 132°C to 135°C 270°F to 275°F



“NOTE - If a sterilizer will run the same type of cycle (e.g., dynamic-air-removal at 132°C to 135°C [270°F to 275°F] for different exposure times (e.g., 4 minutes and 10 minutes), then only the shortest cycle time needs to be tested.”

Sterilizers larger than 2 cubic feet

� Bowie-Dick Test Pack

Daily in an empty cycle

Before BI PCD

� BI PCD: Use a Commercially available disposable, FDA cleared BI PCD, or AAMI 16 towel pack

Full load on bottom shelf over drain

Weekly, preferably daily



Table-Top sterilizers

BI PCD

� Representative of package or tray routinely

processed and most difficult to sterilize

� Contain items normally present during routine

sterilization

Full load in cold point (check with sterilizer manufacturer)





21

Immediate-Use Steam Sterilization (Flash cycles)

� Run Bowie-Dick test, if dynamic-air-removal

� Run a representative BI PCD*, along with a CI, in the empty tray configuration (no instruments)

Perforated, mesh bottom, open surgical tray

Rigid sterilization container system

Protective organizing case

Single-wrapped surgical tray

� Each type of tray configuration used should be testedPlaced on bottom shelf over the drain in otherwise empty chamber


* No commercial BI PCDs are available for flash sterilization© 3M 2011. All Rights Reserved.



Routine Sterilizer Efficacy Monitoring Sterilizers > 2 cubic ft

�You’ve been hired as a consultant by a new surgery

center which will be doing daily BI PCD monitoring

�The surgery center will be running the cycles listed on

the next slide


CycleMonitor with BI PCD?

Gravity, 250°F, 40 min cycle


Prevacuum, 270°F, 4 min cycle

Prevacuum, 270°F, 10 min cycle


Which cycles do you recommend they routinely monitor?


22


CycleMonitor with BI PCD?



Dynamic-air-removal, 270°F, 4 min cycle

Dynamic-air-removal, 270°F, 10 min cycle



Air-Removal Method Temperature Monitor with BI PCD?

Gravity-Displacement

“Immediate-Use(Flash)”

270°F - 275°F


“Terminal”

250°F

Prevacuum “Immediate-

Use (Flash)”

270°F - 275°F

Prevacuum “Terminal” 270°F - 275°F


Which cycles do you recommend they routinely monitor?


Air-Removal Method Temperature Monitor with BI PCD?


“Immediate-Use(Flash)”

270°F - 275°F


“Terminal”

250°F

Prevacuum “Immediate-

Use (Flash)”

270°F - 275°F

Prevacuum “Terminal” 270°F - 275°F



23



Using the cycles listed on previous slide, routine testing is done,

as follows:

1) First, run an empty chamber warm-up cycle to preheat the sterilizer

2) Then, run the Bowie-Dick test pack in an otherwise empty chamber

3) Next, test the “Flash” cycles using a BI PCD - testing is done in an

empty chamber

4) And with the first terminal loads ran at 250 deg. F. Gravity and 270

deg. F. Prevacuum, run a BI PCD in with the load.


Tools:

�Figure 12— Decision tree for conducting investigations of steam sterilization process failures

�Table 8 -- Checklist for identifying reasons for steam sterilization process failures

Actions to take when biological indicators, chemical indicators, or physical monitors indicate failure (10.7.5)

Actions to take when biological indicators, chemical indicators, or physical monitors indicate failure (10.7.5)

If cause of failure not identified

� Quarantine load, recall all items processed since last negative BI

� Take sterilizer out of service

� Determine cause of failure

� Minor repair →return sterilizer to service

� Major repair → perform sterilization qualification testing

If cause of failure immediately identified and confined to one load or item (e.g., using incorrect sterilization cycle)

� No recall, correct problem and reprocess load



24

Major repairs of steam

sterilizer

Repairs outside the scope of normal maintenance

Examples:

• Weld repairs of pressure vessel

• Replacement of chamber door or piping assembly

• Rebuilds or upgrades of controls

Major repairs of utilities Changes to the utilities connected to the sterilizer

Examples:

Water-main break

•Annual boiler maintenance

•Additional equipment loads

•Installation of new boilers

Sterilizer Qualification Testing (10.8)






� Nonimplants, Implants



� Periodic product QA testing

Testing of sterilizer after events occur that affect

the ability of the sterilizer to perform

� Sterilizer installation

� Relocation

� Malfunction

� Major repairs of sterilizer or utilities

� Sterilization process failures




25

Sterilizers larger than 2 cubic feet

BI PCD: Commercially available disposable, FDA cleared BI PCD, or an AAMI 16 towel pack

•Empty load on bottom shelf over drain

- Run three consecutive cycles

•Follow with BD testing (empty load)

- Run three consecutive cycles



Table-Top Sterilizers

BI PCD

� Representative of package or tray routinely processed and

most difficult to sterilize

� Contain items normally present during routine sterilization

Full load in cold point (check with sterilizer manufacturer)

Three consecutive cycles

Quarantine the loads until the BI results are known



Immediate-Use Steam Sterilization (Flash cycles)

Representative BI PCD* using one or more BIs and one or more CIs

Select one representative tray configuration

�Place on bottom shelf over the drain in otherwise emptychamber

�Run three consecutive cycles

�If dynamic air-removal (e.g. prevacuum) , run a Bowie-Dick test pack in three consecutive cycles

* No commercial BI PCDs are available for flash sterilization




26




Nonimplants, Implants



� Periodic product quality assurance testing

Periodic product quality assurance testing of routinely processed items (10.9)


� The standardized BI PCD presents a known challenge

BUT…doesn’t necessarily reflect the same challenge as

routinely processed items

� Product testing is recommended for complete assurance:� Verify sterilization effectiveness

� Avoid wet packs



� Conduct periodic product QA testing of routinely processed items on the “master product” from each product family.

- Before using newly purchased or loaner sets

- After any changes: Product family or master product; Sterilization instructions; Packaging materials (wraps, containers, etc.); Load configuration

� Product Family

“Group or subgroup of product that is characterized by similar attributes, such

as mass, material, construction, set weight, shapes, lumens, and packaging system, and that presents a similar challenge to the sterilization process”.

�Master ProductThe most difficult-to-sterilize device in each group



27


� Place multiple BIs and CIs into

area of packages determined to

be the greatest challenge

� Corners

� Different layers

� Next to the heat sink (metal mass)



1. Label as product testing

2. Place in full load

3. Run the appropriate cycle

4. Document placement of all indicators and test results

5. Determines routine placement of BI and CI

6. Determine if sterilizer can effectively sterilize before putting into routine use


- Examine for evidence of excess moisture;

If moisture/wet packs are observed, take

steps to remedy the problem.

Periodic product quality assurance testing of rigid sterilization container systems (10.10)

� Conduct a pre-purchase evaluation of rigid sterilization

container system

� Consult container manufacturer for recommended BI and CI placement

� Test system should contain instruments

� Filters, if required, must be in place



28

Periodic product quality assurance testing of rigid sterilization container systems (10.10)

� Prepurchase evaluation test protocols

� Dynamic-air-removal steam sterilizers

� Gravity-displacement steam sterilizers

� To assess

� Air removal from the container system

� Steam penetration into the contents of the container system

� Sterilization cycle conditions

� Drying

� Sterility maintenance



Presentation Title


Questions ?


Product recalls (10.11)

� A recall procedure should be established

� Outlines when necessary to do a recall

� Expedites the retrieval of processed items suspected to be nonsterile

� Ensures patient safety and compliance

� Ensures follow-up actions: quarantine of the sterilizer, notification of physicians and affected clinical departments, and surveillance of patients

� Ensures proper documentation



29

ST79, Section 11

Quality process improvement


� Quality process (11.2)

General considerations

Risk analysis

Decontamination

Rigid sterilization container systems

Flash sterilization

� Functional areas for product and process improvements (11.3)

� Implementing product and process improvements (11.4)



Quality Process Improvement General considerations (11.2.1)

� Recalls

� BI Monitoring Frequency

� Managing Loaner Instrumentation

� Cleaning Verification

� TASS


Quality Process Improvement Risk Analysis (11.2.2)

Risk analysis =

Risk assessment + risk management + risk communication

� Perform at least annually

� Reevaluate whenever significant changes occur


30



�Risk assessment

• Identify sources of potential sterilization failures

• Estimate likelihood that each failure will occur

• Assess the consequences if that failure does occur



�Risk management • Determine which of the potential sterilization failures

identified require management

• Select and implement the plans or actions needed to ensure those failures are controlled

• AAMI ST79 describes the accepted means of managing these risks



�Risk communication (report actions taken to

eliminate identified risk)

� SPD, OR and ICP (recall procedures)


31


Quality Process Improvement Functional areas for product and process improvements (11.3)

� Evaluating and monitoring the effectiveness of a process should

be an ongoing effort

�Written procedures should be reviewed

� Current practices should be audited for compliance

Examples:

Training and continuing education, medical device processing protocols, maintenance of sterilizers, product identification and traceability, sterilizer physical monitoring records, sterilization process indicator records, sterilizer efficacy monitoring and qualification testing records, and product testing records

ST79, Section 12

New product evaluation


� Considerations (12.2)


“2.79 new product: A new product/technology that has been FDA

approved but for which AAMI does not offer guidance for application.”


Presentation Title


Questions ?



32

Reference:

Association for the Advancement of Medical Instrumentation (AAMI)

Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/ANSI/AAMI ST79: 2010 & A1:2010


ST79:2010 & A1:2010 Ordering Info

Contact AAMI to order ANSI/AAMI ST79:2010 & A1:2010,

Comprehensive guide to steam sterilization and sterility assurance in health care facilities (Consolidated Text)

� Order Code: ST79 or ST79-PDF by credit card

� Price/AAMI Member Price: $240/$120 (available at member price through AORN)

� Call 1- 877-249-8226

� Internet: http://marketplace.aami.org

� Fax: 301-206-9789

� Mail: AAMI Publications, P.O. Box 0211, Annapolis Junction, MD 20701-0211


Other Resources:

� 3M™ Sterile U

� www.3M.com/3MSterileU

� 3M Helpline: 1-800-228-3957

� 3M Sterilization Techline: 1-800-441-1922 option “2”

� AAMI: www.aami.org

� AORN: www.aorn.org



33


Presentation Title


Thank You


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