3M™ Attest™ Sterile U Web Meeting March 19, 2009

© 3M 2009. All Rights Reserved.

3M™ Attest™ Sterile U Web MeetingMarch 19, 2009

How Long Did They Go? Healthcare Facilities Share Flash Reduction Best Practices


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Welcome!

Facilitator: Tammy Torbert, 3M Sterilization Assurance

Speaker: Dorothy Larson, 3M Technical Service

Panelist: Francis Zieman, 3M Technical Service

Housekeeping: Questions;

-Mute feature (*7=unmute; *6=mute)-“Chat” feature

Technical difficulties CE Credits Post session follow-up

For more information: www.3M.com/AttestSterileUOnline


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Discussion Topics

1. Define flash sterilization

2. Discuss the Association of periOperative Registered Nurses (AORN) and the Association for the Advancement of Medical Instrumentation’s (AAMI’s) recommended practice on flash sterilization

3. Discuss issues associated with flash sterilization

4. Describe an effective quality assurance program for flash sterilization

5. Discuss Flash Reduction Best Practices


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Quality Control Recommended Practices

ANSI/AAMI Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ST79:2006/A1:2008

AORN– Recommended Practices for Sterilization in

Perioperative Practice Setting, 2009– Recommended Practices for Selection and Use of

Packaging Systems for Sterilization, 2009– Recommended Practices for Surgical Instruments

and Powered Equipment, 2009


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AAMI and AORN

AAMIGuidelines for the use, care and/or processing of medical device or system to ensure a device is used safely and effectively and its performance will be maintained

AORN Standards and recommended practices serve as the basis for policies and procedures

Promote safety and optimal outcomes for patients


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Flash Sterilization

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

AAMI ST79


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Flash Sterilization - History

Reprocessing of dropped instruments mid-procedure

Unwrapped, 270 deg. F. Gravity cycle only-No dry time

High Temperature Sterilization

AAMI ST79


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Flash Sterilization - Today

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

No dry time/ No storage

Sterilization Process:- Gravity- Dynamic-air-removal

Packaging expanded beyond mesh-bottom surgical tray

AAMI ST79

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


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Flash Sterilization - Packaging

Perforated, mesh bottom, open surgical tray Rigid sterilization container system Protective organizing case Single-wrapped surgical tray

AAMI ST79


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AORN recommends the use of rigid sterilization containers Reduce risk of contamination

during transport to point of use Ease of presentation to sterile

field

AORN

Flash Sterilization - Packaging


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Types of Steam Sterilization Processes

Gravity Displacement

Dynamic-Air-Removal by Prevaccuum Steam-flush pressure-pulse (SFPP)

AAMI ST79


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Minimum Flash Cycle Times for Gravity Steam Sterilization Cycles

Flash Sterilization

Load Contents Temp Time(Min)

Unwrapped nonporous items 270°F/132°C 275°F/135°C

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Unwrapped nonporous & porous items in mixed load

270°F/132°C275°F/135°C

1010

AAMI ST79


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Minimum Flash Cycle Times for Dynamic-Air-Removal Steam Sterilization Cycles

Flash Sterilization

Load Contents Temp Time(Min)

Unwrapped nonporous items 270°F/132°C 275°F/135°C

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Unwrapped nonporous & porous items in mixed load

270°F/132°C275°F/135°C

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AAMI ST79


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QUESTION: Review information in following table – is this a flash cycle?

Sterilization Temperature 270 deg. F.

Sterilization Time 4-minute exposure

Sterilization Method Prevacuum

Packaging Type Rigid Container

Dry Time None


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QUESTION: Review information in following table – is this a flash cycle?

Sterilization Temperature 270 deg. F.

Sterilization Time 4-minute exposure

Sterilization Method Prevacuum

Packaging Type Rigid Container

Dry Time None

ANSWER: YES!

Remember, flash sterilization is the steam sterilization of patient care items for immediate use!


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ANSI/AAMI ST79 Section 10 Quality Control

Four levels of testing

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

Routine sterilizer efficacy monitoring

Establishing 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


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Routine Load Release Nonimplants

Physical monitors External process indicator (Class 1) on every package Internal CI (Class 3, 4 or 5) inside every package Optional monitoring of load with a PCD containing a

– BI– BI and a Class 5 CI – Class 5 integrating indicator

Evaluation of all data by an experienced, knowledgeable person

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

AAMI ST79


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Routine Load Release Implants

Physical monitors External process indicator (Class 1) on

every package Internal CI (Class 3, 4 or 5) inside every package A PCD containing a BI and a Class 5 integrating indicator Evaluation of all data by an experienced, knowledgeable

person Do not distribute load if any data suggests

a sterilization process failure

AAMI ST79


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Sterilization Process Monitoring Tools

Physical Monitors

Chemical Indicators

Biological Indicators


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Physical Monitors

Verify that parameters of sterilization cycle are met Recording charts Gauges Tape Printouts Digital displays

AORN & AAMI


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

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


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Chemical Indicators

Class 1: Process Indicators Use with individual units to indicate

that the unit has been directly exposed to the sterilization process – Exposure Control (e.g., indicator

tapes)– Distinguish between processed and

unprocessed units

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

AAMI ST79


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Chemical Indicators

Class 2: Indicators for Specific TestsEquipment Control

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)

AAMI ST79


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Chemical Indicators

Internal CIs – Class 3, 4, 5 Tests conditions inside individual packs

Internal chemical indicator inside each package Use inside each pack, wrapped tray, flash tray or container in

area least accessible to sterilant – identifies sterilant penetrated

AORN & AAMI


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AORN

Placement of internal chemical indicators

AORN


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Chemical Indicator Placement

Rigid container Place two CIs inside rigid containers Place one in each of two opposite

corners

AORN


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Multi-layer container Place two CIs in each level of

multi-level rigid container Place one in each of two

opposite corners on each level

AORN


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Multi-level container

Supplied by the manufacturer,holes in tray, has to be wrapped

Place a CI in center on each level

AORN


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Wrapped instrument trays

Place CI in geometric center, not on the top

AORN


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Routine Load Release Nonimplants – Flash Sterilization

Class 5 Integrating Indicator PCD for releasing flash loads PCD must be representative of load

– Open surgical tray– Rigid sterilization container– Protective organization case– Single-wrapped surgical tray

Class 5 Integrating Indicator also serves as internal CI

AAMI ST79


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

AAMI ST79


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3M™ Attest™ Rapid Readout Biological Indicators - Flash Cycles

1291, Blue Cap BI

270°F/132°C, gravity

1292, Brown Cap BI270°F/132°C, dynamic-air-removal


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Biological Indicators AAMI ST79

AAMI and AORN - Weekly, preferably daily and implants

AAMI ST79 & AORN


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Routine Load Release Implant Loads

“Emergency situations should be defined”

AAMI ST79


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Implant Loads – Flash Cycles

“In an emergency, when flash sterilization of an implant is unavoidable, a rapid-action BI and a Class 5 chemical integrating indicator (or enzyme-only indicator) should be run with the load. The implant should be quarantined on the back table and should not be released until the rapid-action BI provides a negative result.”

AORN


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“Rationale: The use of BIs provides evidence of efficacy by challenging the sterilizer with a large number of highly resistant bacterial spores. Biological monitoring provides the only direct measure of the lethality of a sterilization cycle. Sterilizer manufacturers validate their sterilization cycles using BIs; therefore, routine sterilizer efficacy monitoring in health care facilities should also be conducted using BIs.” (section 10.5.3.2)

AAMI ST79


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Record Keeping

“Documentation establishes accountability.”AORN Sterilization Recommended Practice

AORN


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Implant Loads - Flash Cycles

“Flash sterilization should not be used for implantable devices except in cases of emergency when no other option is available.”

AORN

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


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Flash Sterilization - AORN Documentation

Log or data base to trace sterilized items used on patients should include:Information on each load Item(s) processed Patient receiving the item(s) Cycle parameters used (e.g., temperature, duration of cycle) Day and time cycle is run Operator information Reason for flash sterilization

AORN


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Routine Sterilizer Efficacy MonitoringSterilizer Qualification Testing

Routine Efficacy Testing

Establishing a regular pattern of testing the efficacy of the sterilization process

Qualification TestingTesting 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

AAMI ST79


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Flash sterilization cycles

Routine Efficacy Testing: Qualification Testing:Representative BI PCD using one or more BIs and one or more CIs

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

Perforated, mesh bottom, open surgical tray

Rigid sterilization container system

Protective organizing case

Single-wrapped surgical tray

Perforated, mesh bottom, open surgical tray

Rigid sterilization container system

Protective organizing case

Single-wrapped surgical tray

Test each type of tray configuration – Must always test the open surgical tray configuration

Select one representative tray

Place on bottom shelf over the drain in otherwise empty chamber

Place on bottom shelf over the drain in otherwise empty chamber

Weekly, preferably daily Three consecutive cycles

After Bowie-Dick test if dynamic air-removal Before Bowie-Dick test if dynamic air-removal


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Process Challenge Device (PCD) Definition

“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 Placed in most difficult area in sterilizer for the sterilant

to penetrate

AAMI ST79


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Process Challenge Device (PCD)

User assembledChallenge test pack or tray (e.g., flash tray)

*Note there are no commercially available – FDA Cleared PCDs available for flash sterilization

AAMI ST79


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Quality Assurance ProgramSterilization Process Monitoring

Monitoring Tools Physical monitors Chemical indicators Biological indicators Process challenge devices (PCDs)

Test or challenge pack

Results – Integrate results of all monitoring controls; determine if an effective sterilization process

AAMI ST79


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If a biological indicator (BI) is positive, do you only recall that load?

QUESTION:


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QUESTION: If a BI is positive, do you only recall that load?

ANSWER:

If determined to be an operator error e.g.,.. using incorrect sterilization

cycle No recall, don’t use load

If not operator error or don’t know reason Recall all items processed since last

negative BI Reprocess all retrieved items


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Biological Indicator Monitoring Frequency

Why monitor every load? Universal standard of patient care Reduces variability and chance for errors To be certain all implants, including those in loaners sets, are

appropriately monitored To ensure all cycle types used are tested with a BI

To ensure all types of packaging used in flash sterilization are tested with a BI To reduce the risk, cost, and impact of a recall To reduce the risk/cost of healthcare-associated infections (HIAs)


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The Joint Commission

Organizational policies/procedures should be based on most stringent: Laws and regulations Accepted practice guidelines Current scientific knowledge And, are consistent throughout facility


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Issues Associated with Flash Sterilization

Time Pressures– skipped steps in cleaning/decontamination

Flashing large and/or multiple trays– increases cycle and cooling time

Loaner Instrumentation

AAMI ST79


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Loaner Instrumentation Issues

Patient Safety Timelines (flashing is not recommended) Communication (OR, SPD, Vendor) Quality

– MDM Reprocessing Guidelines– Adequate time– Implants

Potential for lost items


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Toxic Anterior Segment Syndrome - TASS

The Issue: serious damage to a patient’s intraocular tissue and vision loss as a result of contaminants in the eye during ophthalmic surgeryCauses: contaminated irrigating fluids; antiseptics; antibiotic ointments; powder from surgical gloves “Most cases of TASS appear to result from inadequate instrument cleaning and sterilization”

Nick Mamalis, MD, Toxic Anterior Segment Syndrome Journal of Cataract and Refractive Surgery 2006; 32:324-333.


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Toxic Anterior Segment Syndrome - TASS

Inadequate or inappropriate instrument cleaning “Detergents Heat stable endotoxin from overgrowth of gram-negative bacilli in water baths or ultrasonic cleaners Degradation of brass containing surgical instruments from plasma gas sterilization Impurities of autoclave steam”

Recommended practices for cleaning and sterilizing intraocular surgical instruments, J Cataract Refract Surg, Vol 33, June 2007


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AAMI ST79 2008 Amendments - Annex N (informative)Toxic anterior segment syndrome (TASS) and the processing of surgical instruments

Follow Mfr’s. cleaning and sterilization instructions Adequate inventory-time for processing Designated cleaning area and dedicated equipment Precleaned immediately Transport in closed containers PPE Appropriate cleaning agent & water of appropriate quality as specified

by the Mfr. Sterilization according the Mfr’s. instructions Maintenance of cleaning and sterilization equipment, boilers and water

filtration systems Training


Thank You!


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SHARING FLASH REDUCTION “BEST PRACTICES”

Documents

3M™ Attest™ Sterile U Web Meeting March 19, 2009