May 3MSterileU Webinar Steam Sterilization Process...

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© 3M 2013. All Rights Reserved.1

Refresher Course!

Steam Sterilization Process Monitoring

Today’s meeting times: 9:00 a.m., 11:00 a.m. and 1:00 p.m. CST

To hear audio, call 800-937-0042 and enter access code 7333633

Phone lines are muted. Audio will commence when the webinar begins.

3M™ Sterile U Network3M™ Sterile U Web Meeting – May 16, 2013


Introducing the 3M Learning Connection:

New Name, Same Great Courses

• It’s an educational resource bringing you 3M™ Sterile U and other Infection Prevention courses.

• Improved features:• “Add to my Calendar” feature• Other 3M courses will be more accessible as we expand our offerings.

• What do you need to do? • Nothing. Your current registrations remain and our Sterile U offerings have not changed.


Welcome!Topic: Refresher Course! Steam Sterilization Process Monitoring

Speaker: Martha Young BS, MS, CSPDT

Facilitators: Diane Koch, 3M Susan Flynn, 3M

Housekeeping

• Questions

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

• “Chat” feature

• Technical difficulties

• Post session follow-up

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

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Next week, all of today’s meeting participants will be sent

an email containing instructions for obtaining a CE

Certificate for today’s meeting.

The email will be sent to the email address you provided

when you logged-in to today’s meeting. If there are others

listening with you today who did not log-on, you may

forward the CE certificate email to them.

How do I get a CE Certificate?


Disclosures

Martha Young BS, MS, CSPDT

President of Martha L. Young, LLC

Providing SAVVY Sterilization Solutions

for Healthcare

Educational Consultant to 3M


Learning Objectives

Define the different types of sterilization monitoring

devices and discuss their recommended use

Describe the recommended practices for routine

load release of implants and non-implants

Describe the recommended practices for routine

sterilizer efficacy testing

Describe the recommended practices for sterilizer

qualification testing

1

2

3

4

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Refresher Course! Steam Sterilization Process

Monitoring

Risks Being Taken in Reprocessing Medical Devices

• Not following monitoring products instructions for use (IFU)

• Not following recommended practices and standards for monitoring

the steam sterilization process


Evidence-Based Guidelines

� Association for the Advancement of Medical Instrumentation (AAMI)• Comprehensive guide to steam sterilization and sterility

assurance in health care facilities ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 (Consolidated Text)

�Association of Perioperative Registered Nurses (AORN)• Perioperative Standards and Recommended Practices

(2013 Edition)

�Centers for Disease Control and Prevention (CDC) • Guideline for Disinfection and Sterilization in

Healthcare Facilities, 2008


Regulations & Recommended

Practices Establish

State-of-the-Art

for Sterile Processing

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The Joint Commission

National Patient Safety Goals

•NPSG.07.05.01

•“Implement evidence-based practices for preventing

surgical site infections.”

�Element of Performance 3

•“Implements policies and practices aimed at reducing the risk of

surgical site infections. These policies and practices meet regulatory

requirements and are aligned with evidence-based guidelines (for

example, the Center for Disease Control and Prevention [CDC]

and/or professional organization guidelines).”

The Joint Commission. 2013 Hospital Accreditation Standards (HAS)


Every Facility that Utilizes a

Steam Sterilization Process

Should Follow Recommended Practices for

Monitoring the Steam Sterilization Process

Hospitals

ASCs

Clinics

Doctor’s Offices

Dental Facilities


Sterilization Process Monitoring

• Goal of sterilization process:

• Kill microorganisms

• You cannot see sterility

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Sterilization Process Monitoring

•Monitoring Tools

• Physical monitors

• Chemical indicators

• Biological indicators

• Process challenge

devices (PCDs)

Test or challenge pack


Objective One

14 © 3M 2013. All rights reserved.

DEFINE THE DIFFERENT TYPES OF STERILIZATION

MONITORING DEVICES AND DISCUSS THEIR

RECOMMENDED USE


Biological Indicators

• Challenges the sterilizer with a large number of highly

resistant bacterial spores

• Provide the only direct measure of the lethality of a

sterilizer cycle

• Cannot be replaced by the use of Class 5 integrating

indicators or Class 6 emulating indicators

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.5.3.2

Spore Strip

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• Use for

• Release of non-implant and implant loads

• Routine monitoring of the sterilization process

• Qualification testing of the sterilization process

• Product testing (will not be discussed during this webinar)




Observations

Biological indicators (BIs) and BI process challenge devices

(PCDs) not appropriate for cycle being tested

Information on appropriate BI PCDs to use is covered in

ANSI/AAMI ST79 Section 10

and

BI and BI PCD manufacturer’s IFU

This slide was prepared based on what the author learned from a Joint Commission presentation

at the annual IAHCSMM meeting in May 2012


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

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Definition 2.103

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BI PCD Immediate-Use Steam Sterilization (IUSS)

270ºF/132ºC Dynamic-air-removal Steam Sterilization

Process

BI PCD Used Daily Packaging Used Routinely

Is this the correct BI PCD for the packaging routinely used?


BI PCD Immediate-Use Steam Sterilization (IUSS)


Process


Is this the correct BI PCD for the packaging routinely used?

Answer: Incorrect The BI PCD does not represent the packaging

routinely used which means you may miss a sterilization process failure


BI PCD IUSS Sterilization


Process


Correct BI PCD. Represents packaging routinely used

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Question asked of TJC at IAHCSMM May 2012

Question:

We use a 1 hour and a 3 hour BI in our implant loads so we can release

the implant in 1 hour. Is that correct?

Answer:

• No because each of those BIs are designed and FDA cleared for

different cycles

• This is an example

• Operator error

• Not using critical thinking

• Not following the monitoring product manufacturer’s IFU



• 3M™ Attest™ 1291 Rapid

Readout Biological Indicator

(Blue Cap)

• Use for 270°F/132°C gravity steam sterilization cycles

• Healthcare facility prepared

PCD that is representative

of the load

• 1 hour readout

• 3M™ Attest™ 1292 Rapid

Readout Biological Indicator

(Brown Cap)

• Use for 270°F/132°C vacuum-

assisted or 250°F/121°C gravity steam sterilization

cycles

• Healthcare facility prepared

PCD that is representative

of the load

• 3 hour readout


Is this the Correct Placement of a BI PCD in a Full Load?

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Is this the Correct Placement of a BI PCD in a Full Load?

Incorrect placement: The BI PCD is placed under a pack which creates

too great of a challenge for air removal and steam penetration.


Process Challenge Device (PCD)

3M™ Attest™ 41382 Rapid 5

Steam-Plus Pack

“Place an Attest Rapid 5 Steam-Plus

Test Pack flat with the label side up,

in a full load in the most challenging area for the sterilant to

reach. This is generally on the bottom shelf, over the drain.

Do not place objects (i.e. another pack) on top of the Attest

Rapid 5 Steam-plus Test Pack. This will create too great of a

challenge for air removal and steam penetration.”


Correct Placement of a BI PCD in a Full Load

According to AAMI ST79 andthe BI PCD manufacturer’s IFU

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The Joint Commission Observations

• BI test and control results not being recorded

• Need BI test and control from same lot

These slides were prepared based on what the author learned from a Joint Commission

presentation at annual IAHCSMM meeting in May 2012


Biological Indicators Positive BI Control

• Incubate a positive BI control each day a test vial is

incubated in each incubator

•Positive control BI should be from same lot number as

test BI

• Good Science

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Sections 10.7.2.3, 10.7.3.3, 10.7.4.3



• Purpose is to verify the test system

is working and ensure

• Proper incubation temperature

• Placed into correct incubator• Incubator is functioning

• Presterilization viability of test spores• Capability of medium to promote growth of test spores

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Sections 10.7.2.3, 10.7.3.3, 10.7.4.3

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• Read and record test and control results upon completion of

incubation time

• If control test BI from lot fails:

-Test spores are nonviable or dead

-Improper incubation

•Test results are invalid•Determine why and rerun BI and load

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 A3:2012 Sections 10.7.2.3, 10.7.3.3, 10.7.4.3


Chemical Indicator (CI)

• Use a Class 1 CI on the outside of each package unless

the internal CI is visible

• Read CI result before issue package or open in OR

• Do not use package if “CI suggests inadequate steam

processing”

AORN Sterilization 2013 Recommendation XX.g., XX.g.1.

AORN Sterile Technique 2013 VI.f.2.

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.5.2.2.1



• Use a Class 3, 4, 5, or 6 CI inside each package.

• “Class 6 emulating indicators are cycle-specific; that is, they

should be used only in the specific cycles for which they are

labeled.”

• Place in “area of package, tray, or containment device (rigid

sterilization container system, instrument case, cassette, or

organizing tray) considered least accessible to steam

penetration”

• Follow container manufacturer’s IFU for placement

AORN Sterilization 2013 Recommendation VII.c.3., XX.g.


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• Use a Class 3, 4, 5, or 6 CI inside each package.

• Read CI before package is placed on sterile field

• Do not use package if “CI suggests inadequate steam

processing”

• Supervisor “should then initiate appropriate follow-up measures”

AORN Sterile Technique 2013 Recommendation VI.a.2., VI.f.4.

AORN Sterilization 2013 Recommendation XX.g.2.



Placement of Internal CIs

•Incorrect placement of CI•Not inside of tray •Not in a location to detect inadequate air removal or steam penetration

•Same tray with correct placement of CI inside of tray•In location to detect inadequate air removal or steam penetration


AORN Recommendation

Chemical Indicator (CI) for IUSS

• Use a Class 5 or Class 6 CI within each sterilization

container

• “Class 6 indicators are cycle-specific and should be used only in

the specific cycles for which they are labeled.”

AORN Sterilization 2013 Recommendation VII.c.3.

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Physical Monitors

• Mark with correct date and

sterilizer identification at

beginning of each cycle

• Read & verify by initialing at end

of each cycle

• If not correct, do not release load

• Remove sterilizer from service

• Investigate

AORN Sterilization 2013 Recommendation VII.c.1., XX.d.1., XX.f., XX.f.1., XX.f.2.

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.5.1


Bowie-Dick Test

• Testing sterilizer performance

• Bowie-Dick Test monitors efficacy of air removal and steam

penetration in

• 132-135°C/270-275°F dynamic-air-removal

sterilizers (i.e., prevacuum sterilizers)

ANSI/AAMI ST79 :2010 & A1:2010 & A2:2011 & A3:2012 Section 10.7.6


Bowie-Dick Test

• Detects:

• Air leaks

• Inadequate air removal

• Inadequate steam penetration

• Presence of non-condensable gases

• Air or gases from boiler additives

AORN Sterilization 2013 Recommendation XX.h.2.


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Bowie-Dick Test

• Used for routine daily testing and qualification testing

• Test pack should be either

• AAMI towel pack (100% cotton towels), or

• Equivalent commercially available

BD test pack




Bowie-Dick Test

• Follow the sterilizer and Bowie-Dick test

pack instructions for use

• Run a warm up cycle

• Place one pack on bottom shelf of

sterilizer over drain

• Run not more than 3.5 to 4 min,

132-133°C/270-273ºF, no dry time, immediately remove

from sterilizer


ANSI/AAMI ST79 :2010 & A1:2010 & A2:2012 & A3:2012 Section 10.7.6


Incorrect Placement of Bowie-Dick Test Packs

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Incorrect Placement of Bowie-Dick Test Packs


ANSI/AAMI ST79 :2010 & A1:2010 & A2:2011 & A3:2012 Sections 10.7.6.5

• Uniform color change – Use

• If not uniform, shut down and report to

supervisor

• Remain in use

• Retest

• Call for repair

• Re-qualify if major repair

Bowie-Dick Test


Objective Two


DESCRIBE THE RECOMMENDED PRACTICES FOR ROUTINE

LOAD RELEASE OF IMPLANTS AND NON-IMPLANTS

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Routine Load Release of Implant Loads


• Read and initial

• External process indicator (Class 1) on outside of every

package unless internal CI is available• Read before package is issued or opened in OR

• Internal CI(s) (Class 3, 4, 5, 6) inside each package• Read before package is placed on sterile field

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

• Quarantine implant(s) until BI results available

AORN Sterilization 2013 Recommendation VII.c.1., XX.d.1., XX.f.2., XX.h.1.

AORN Sterile Technique 2013 Recommendation VI.a.2., VI.f.2., VI.f.4.

ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 Section 10.5.1,10.5.2,10.5.4,

10.6.1, 10.6.3



• Evaluation of all data by an experienced, knowledgeable

person

• Do not distribute load if any data suggests a sterilization

process failure

ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 Section 10.6.3



• “Each load should be monitored if it contains implantable

objects. If feasible, implantable items should not be used

until the results of spore tests are known to be negative.”

(CDC)

• “Releasing implants before the BI results are known is

unacceptable and should be the exception, not the rule.”

(AAMI)

CDC, 2008 Guideline for Disinfection & Sterilization

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.5.3.2., 10.6.3

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• Class 5 integrating indicator used to

release implant in emergency situations

• “Emergency situations should be defined.”

• Class 6 emulating indicators cannot be

used to release implants early or as a

replacement for a BI*

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.3.2, 10.6.1,10.6.3


Early Release of Implant Loads

• Exception form for premature release of implantable device/tray in

defined emergency situations

• Name of implant

• Name of patient

• Name of surgeon

• Reason for premature release

• What could have prevented the premature

release

• Critical that this documentation

be fully traceable to the patient

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.6.3, Annex L



New Emphasis for 2011

•Exception form (AAMI ST79 10.6.3 and Annex L)•Early release of implant is unacceptable; an exception form must be completed

• Exceptions guided by policy: multidisciplinary input


presentation at IAHCSMM in May 2011

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New Emphasis for 2011

•Exception form (AAMI ST79 10.6.3 and Annex L)

•WHO can authorize early release of implants?

•Signature not required

•Should be a department of surgery policy

•Suggest it be a surgeon




Routine Load Release of Non-implants


• Read and initial

• External process indicator (Class 1) on outside of every

package unless internal CI is available• Read before package is issued or opened in OR

• Internal CI(s) (Class 3, 4, 5, 6) inside each package• Read before package is placed on sterile field

AORN Sterilization 2013 Recommendation VII.c.1., XX.d.1., XX.f.2., XX.h.1.

AORN Sterile Technique 2013 Recommendation VI.a.2, VI.f.2, VI.f.4

ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 Section 10.5.1, 10.5


Key Considerations for Use of Class 6 CIs

• “Class 6 emulating indicators are cycle-specific; that is, they should be used only in the specific cycles for which they are labeled.” (Section 10.5.2.2)


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Routine Load Release of Non-implants

• 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

ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 Section 10.5.4


Objectives Three and Four


- DESCRIBE THE RECOMMENDED PRACTICES FOR

ROUTINE STERILIZER EFFICACY TESTING

- DESCRIBE THE RECOMMENDED PRACTICES FOR

STERILIZER QUALIFICATION TESTING


Routine Sterilizer Efficacy Monitoring

Sterilizer Qualification Testing

•Divided into sections

• Sterilizers larger than 2 cubic

feet

• Table-top sterilizers

• IUSS sterilization cycles

Photo courtesy of Rose Seavey,

The Children's Hospital - Denver

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Routine Efficacy Testing

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

• At least weekly, preferably every day that the sterilizer is in use

Every load monitoring with a BI PCD covers routine sterilizer efficacy testing

AORN Sterilization 2013

Recommendation XX.h.1.

ANSI/AAMI ST79:2010 & A1:2010 &

A:2011 & A3:2012 Section 10.7.2, 10.7.3,

10.7.4





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

• At least weekly, preferably every day that the sterilizer is in use

Every load monitoring with a BI PCD covers routine sterilizer efficacy testing

Qualification Testing

Testing of sterilizer after eventsoccur that affect the ability of the sterilizer to perform

• Sterilizer installation

• Relocation

• Malfunction

• Major repairs of sterilizer or utilities

• Sterilization process failuresAORN Sterilization 2013

Recommendation XX.h.1.

ANSI/AAMI ST79:2010 & A1:2010 &

A:2011 & A3:2012 Section 10.7.2, 10.7.3,

10.7.4

AORN Sterilization 2013 Recommendation

XX.h.1.

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 &

A3:2012 Section 10.8.2, 10.8.3, 10.8.4


Bowie-Dick Test Pack for 270-275°F Dynamic-Air-

Removal Steam Sterilizers


•Run Bowie-Dick Test Pack:

• Daily in an empty cycle

• Before BI PCD

• One pack


•Run Bowie-Dick Test Pack:

• After BI PCDs

• One pack in three

consecutive cycles



Uniform color change – Use

If not uniform, shut down and call repair person

Re-qualify if major repair

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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

IUSS 132°C to 135°C 270°F to 275°F

IUSSSingle wrapper or other

packaging



•AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.7.1

•“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.”


Joint Commission Observations

• BI PCDs should be used for testing at least weekly and

according to policy and procedure

• Need to test both gravity and vacuum-assisted cycles

• If use an “odd cycle” still need to test at same frequency as more

common cycles

• Be prepared to use that odd cycle

• If do not use gravity cycle then turn it off



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Weekly, preferably daily

BI PCD in full cycle


BI PCD in 3 consecutive empty

cycles

Sterilizers Larger than 2 Cubic Feet


Sterilizers Larger than 2 Cubic Feet


•BI PCD: AAMI 16 towel pack or

commercially available

disposable, FDA cleared BI PCD

•Full load on bottom shelf over

drain

•Weekly, preferably daily


•BI PCD: AAMI 16 towel pack or

commercially available disposable,

FDA cleared BI PCD

•Empty load on bottom shelf over

drain

•Three consecutive cycles

•Follow with BD testing (empty load)

•Three consecutive cycles


ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3: 2013 Section 10.7.2 and 10.8.2


Table-Top Sterilizers



BI PCD in full cycle


After major events

BI PCD in 3 consecutive full

cycles

Quarantine the loads until the BI

results are known

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Examples of BI PCDs for Table-Top Sterilizers


Immediate-Use Steam Sterilization Cycles (IUSS)



BI PCD in empty cycle

After Bowie-Dick test if dynamic

air-removal sterilizer


BI PCD in 3 consecutive empty

cycles

Before Bowie-Dick tests if

dynamic air-removal sterilizer


Immediate-Use Steam Sterilization Cycles (IUSS)


Representative BI PCD* using

one or more BIs and one or

more CIs in the empty tray

configuration

• 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 tested


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

•Select one representative tray configuration

• Placed on bottom shelf over the drain

• Otherwise empty chamber


ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Sections 10.7.4, 10.8.4

* No commercial BI PCDs

are available for IUSS

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Running a BI PCD in Every Load and Quarantining

• Standardization of BI monitoring policy

• Less chance of operator error (human factors issue)

• Ensure meeting recommended practices requirements related to

monitoring of cycles and packaging used

• Ensure monitoring all loads with implants

• Quicker detection of IUSS container failures resulting from poor

functioning mechanical filters or leaks due to damaged gaskets

• Quicker detection and correction of process failures

• Eliminates recalls

• Reduce patient risk because less patients involved

• Save money

• Peace of mind


Documentation

“Documentation demonstrates compliance with regulatory and

accrediting agency requirements and identifies trends and

quality improvement opportunities.”

AORN Recommended Practices for Sterilization 2013, Recommendation XVIII


Importance of Traceability of Instruments and Implants

to the Patient

“Sterilization quality control relies heavily on historical data, especially

when quality assurance measures yield conflicting evidence. Record-

keeping is needed for both epidemiological tracking and ongoing

assessment of the reliability of the sterilization process. Accountability

to the patient and surgeon for the sterility of a reprocessed device

requires documentation that can be directly traced to the patient.

Traceability of implants is especially important because the

consequences of implant-related infections are particularly severe and

result in increased morbidity and mortality.”


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Summary

• Don’t take risks in reprocessing medical devices

• Follow the monitoring products IFU

• Follow AAMI, AORN, and CDC recommended practices

Because Patients Are Depending On You To Do The

Right Things


QUESTIONS?


Next 3M™ Sterile U Web Meeting:

When: Thursday, June 20, 2013

Topic: At the Helm: IAHCSMM 2013 Highlights

Register at www.3m.com/SterileU

Thank you!

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References




• Association for the Advancement of Medical

Instrumentation (AAMI)

• Comprehensive guide to steam sterilization and sterility

assurance in health care facilities,

ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012

(Consolidated Text)



• AORN Perioperative Standards and

Recommended Practices (2013)

-Recommended Practices for Sterilization

-Recommended Practices for Sterile Technique

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•Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare

Facilities, 2008

Available at:http://www.cdc.gov/hicpac/Disinfection_Sterilization/13_0Sterilization.html


References for The Joint Commission

• The Joint Commission, Hospital Accreditation Standards 2013


Thank you


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