Standards & Guidelines for Creating Presentations using

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

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

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

Discussion Topics

Define flash sterilization 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 Discuss issues associated with flash sterilization Describe an effective quality assurance program for flash sterilization Discuss Flash Reduction Best Practices

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

AAMI and AORN

AAMI

Guidelines 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

Flash Sterilization

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

Flash Sterilization - History

Reprocessing of dropped instruments mid-procedure Unwrapped, 270 deg. F. Gravity cycle only -No dry time High Temperature Sterilization

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

Flash Sterilization - Packaging

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

Flash Sterilization - Packaging

AORN recommends the use of rigid sterilization containers 

Reduce risk of contamination during transport to point of use



Ease of presentation to sterile field

Types of Steam Sterilization Processes

Gravity Displacement Dynamic-Air-Removal by 

Prevaccuum



Steam-flush pressure-pulse (SFPP)

Flash Sterilization

Minimum Flash Cycle Times for Gravity Steam Sterilization Cycles

Load Contents

Unwrapped nonporous items Unwrapped nonporous & porous items in mixed load

Temp

270 ° F/132 ° C 275 ° F/135 ° C 270 ° F/132 ° C 275 ° F/135 ° C

Time(Min)

3 3 10 10

Flash Sterilization

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

Load Contents

Unwrapped nonporous items Unwrapped nonporous & porous items in mixed load

Temp

270 ° F/132 ° C 275 ° F/135 ° C 270 ° F/132 ° C 275 ° F/135 ° C

Time(Min)

3 3 4 3

QUESTION

: Review information in following table –

is this a flash cycle?

Sterilization Temperature Sterilization Time Sterilization Method Packaging Type Dry Time 270 deg. F.

4-minute exposure Prevacuum Rigid Container None 14

QUESTION:

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

Sterilization Temperature 270 deg. F.

Sterilization Time Sterilization Method Packaging Type Dry Time 4-minute exposure Prevacuum Rigid Container None ANSWER: YES!

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

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

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

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

Sterilization Process Monitoring Tools

 Physical Monitors  Chemical Indicators  Biological Indicators

Physical Monitors

Verify that parameters of sterilization cycle are met 

Recording charts

 

Gauges Tape

 

Printouts Digital displays

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

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 the critical process variables of

Chemical Indicators

Class 2: Indicators for Specific Tests Equipment Control Testing sterilizer performance 

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

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

Placement of internal chemical indicators

Chemical Indicator Placement

Rigid container 

Place two CIs inside rigid containers



Place one in each of two opposite corners

Chemical Indicator Placement

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

Chemical Indicator Placement

Multi-level container

Supplied by the manufacturer, holes in tray, has to be wrapped Place a CI in center on each level

Chemical Indicator Placement

Wrapped instrument trays

Place CI in geometric center, not on the top

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

Biological Indicators

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

3M™ Attest™ Rapid Readout Biological Indicators - Flash Cycles 1291, Blue Cap BI

270 ° F/132 ° C, gravity

1292, Brown Cap BI

270 ° F/132 ° C, dynamic-air-removal

Biological Indicators AAMI ST79

AAMI and AORN - Weekly, preferably daily and implants

Routine Load Release Implant Loads

“Emergency situations should be defined”

Implant Loads – Flash Cycles

“In an emergency, when flash sterilization of an implant is unavoidable, a enzyme-only indicator) rapid-action BI and a Class 5 chemical integrating indicator (or 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.”

Biological Indicators

“Rationale: The use of BIs provides evidence of efficacy by challenging the sterilizer with a large number of highly resistant bacterial spores. cycle.

Biological monitoring provides the only direct measure of the lethality of a sterilization 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)

Record Keeping

“Documentation establishes accountability.”

AORN Sterilization Recommended Practice

Implant Loads - Flash Cycles

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

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

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

Routine Sterilizer Efficacy Monitoring Sterilizer Qualification Testing

Routine Efficacy Testing

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

Qualification 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

Flash sterilization cycles 41 Routine Efficacy Testing:

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 Test each type of tray configuration – Must always test the open surgical tray configuration Place on bottom shelf over the drain in otherwise empty chamber Weekly, preferably daily After Bowie-Dick test if dynamic air-removal

Qualification Testing:

otherwise empty chamber

Three consecutive cycles Before removal Bowie-Dick test if dynamic air-

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

Process Challenge Device (PCD)

User assembled Challenge test pack or tray (e.g., flash tray) *Note there are no commercially available – FDA Cleared PCDs available for flash sterilization

Quality Assurance Program

Sterilization 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

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

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

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)

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

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

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

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 surgery Causes: 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.

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”

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

53 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.

Thank You!

SHARING FLASH REDUCTION “BEST PRACTICES”

Standards & Guidelines for Creating Presentations using

Transcript Standards & Guidelines for Creating Presentations using

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

is this a flash cycle?

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

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

Sterilization Process Monitoring

SHARING FLASH REDUCTION “BEST PRACTICES”

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