rigid sterilization containers 101 –the...

3M Sterile U Webinar 8.18.11 8/18/2011

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3M™ Sterile U Network3M™ Sterile U Web Meeting – August 18, 2011

© 3M 2011. All Rights Reserved.1

Rigid Sterilization Containers 101– The Basics

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

Welcome!Topic: Rigid Sterilization Containers 101 – The Basics

Facilitators: Dorothy Larson, 3MDianne Koch, 3M

Speaker: Martha Young


Housekeeping• Questions

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

• “Chat” feature

• Technical difficulties

• Post session follow-up

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

How do I get a CE Certificate?

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.


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Disclosure Statement

Martha Young, MS, BS, CSPDT

Martha L. Young, LLC

Retired from 3M

Consultant for 3M

marthalyoung1@aol com


[email protected]

Learning Objectives

Describe the best practices for cleaning, packaging, preparation, loading, and storage of medical devices using rigid sterilization containers.

Explain AAMI guidance on prepurchase evaluation of rigid


p g p p gsterilization containers.

Discuss AORN guidelines on the use of rigid containers for immediate-use steam sterilization (IUSS).

Reusable Rigid Sterilization Containers

• Box-like structures with sealable and removable lids

• Inner basket to hold instruments

• Outer container is protective barrier

• Uses valves and filters to allow sterilant to enter but not microorganisms


• Inner basket and outer container have handles to make them easy to carry

• Available in many sizes and designs

• Constructed of anodized aluminum, stainless steel, high-temperature plastics, fiber glass, or a combination of these

• Baskets have instrument posts and dividers to organize instruments

Rigid Container Systems (Part I), IAHCSMM Communique: July/August 2010


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• Training required• Cleaning method• Sterilization method• Packaging manufacturer’s test data and IFUs • Base packaging procedure and policy on the manufacturer’s written

Reusable Rigid Sterilization Containers

© 3M 2011. All Rights Reserved.7 ANSI/AAMI ST79:2010 Section 8.2

p g g p p yIFU

• Competency testing

Medical Device Manufacturer

• “The written instructions of the device manufacturer should always be followed.”

• “The reusable medical device manufacturer is responsible for ensuring that the device can be effectively cleaned and


g ysterilized.”

• “The device labeling should identify specific methods of cleaning and sterilization that have been validated by the manufacturer.”

ANSI/AAMI ST79:2010 Section 7.2.2

Cleaning and Inspection


g p

• ANSI/AAMI ST79:2010

• Section 8.1 to 8.4.5


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Cleaning of Reusable Rigid Sterilization Containers

• Remove lid

• Remove all disposable filters and discard

• Remove filter protector/holder or retention plate from both ends

• Valve type closures (reusable filters) must be cleaned


• Valve-type closures (reusable filters) must be cleaned according to IFU• Usually remove and disassemble for cleaning

• Remove interior baskets

• Remove CIs, disposable labels, locks

• Remove posts/dividers if interfere with cleaningRigid Container Systems (Part II), IAHCSMM Communique: September/October 2010

Cleaning of Reusable Rigid Sterilization Containers

• Follow manufacturer’s IFUs for cleaning agents, tools, methods, and rinsing• Cleaning agent

• Some cannot be exposed to certain chemicals such as high alkaline solutions


• Follow instructions for loading containers into mechanical cleaning equipment• TJC wants these taken apart for cleaning*

Rigid Container Systems (Part II), IAHCSMM Communique: September/October 2010,*Joint Commission Perspectives®, July 2009, Vol. 29, Issue 7. Copyright 2009 Joint Commission on Accreditation of Healthcare Organizations, and personal communications with hospitals that have had surveys

• Check latching mechanism or closure to make sure it is functioning properly and remains secure

• The sealing or mating surfaces should not be dented or chipped

• Screws and rivets on filter retention mechanisms and

Inspection of Reusable Rigid Sterilization Containers


Screws and rivets on filter retention mechanisms and fasteners should be secure, not distorted or burred orpenetrate the surface of the lid

• The reusable filter media should be examined for integrity• Discard if damaged or if recorded removal date is near

• Gasket should be pliable, securely fastened, no breaks or cutsANSI/AAMI ST79:2010 Section 8.4.3 and Section 8.4.4


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What is wrong with this picture?

Poor loading technique in mechanical washing equipment - need to disassemble reusable rigid containers (remove disposable filter

retentions plates) so all surfaces are exposed to the cleaning process.

Packaging and Preparation


Packaging and Preparation


• Section 8.1 to 8.4.5

• Follow the reusable rigid sterilizer container manufacturer’s instructions for set preparation and assembly

• Place instruments in a basket of adequate size that has been validated by the manufacturer

• Do not exceed more than 25 pounds of weight (contents plus

Loading Instruments Into Reusable Rigid Sterilization Containers


container weight)

• Employee safety

• Effect on sterilization and drying

• Use only non-woven filters validated for this use and visually inspect for holes before use

ANSI/AAMI ST79:2010 Section 8.4.1, 8.4.2, 8.4.4 Rigid Container Systems (Part II) IAHCSMM Communique: September/October 2010


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• Remove excess moisture from cleaning and rinsing of instruments using filtered, medical-grade, compressed air

• Jointed instruments should be open or unlocked with ratchets not engaged

• Racks, pins, stringers and other devices can be used to hold



instruments in the open position

• Multipart instruments should be disassembled

• Position to allow sterilant to come into contact with all surfaces and water to drain from concave surfaces

• Do not hold instruments together with rubber bands

• Heavy instruments placed so do not damage delicate items


Contain all items in the basket or tray within the container system “Small, basket-type accessory containers with covers or lids

(e.g., nail or bone-screw holders), protective organizing baskets, trays, or cases, (e.g., microsurgery instrument cases,



baskets, trays, or cases, (e.g., microsurgery instrument cases, air-powered equipment sets, orthopedic instrument organizing sets) should be placed into rigid sterilization container systems onlyif the container systems have been specifically designed and tested for this purpose.”


• “Paper-plastic pouches are not appropriate for use within wrapped sets or containment devices.”


© 3M 2011. All Rights Reserved.18 ANSI/AAMI ST79:2010 Section 8.3.4


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Chemical Indicator Placement

•Rigid container• Place two CIs inside rigid

containers

• Place one in each of two opposite corners


• Or follow manufacturer’s IFUs

AORN Recommended Practices for Selection and Use of Packaging Systems for Sterilization, Recommendation IX


Multi-layer rigid container• Place two CIs in each

level of multi-level rigid container


• Place one in each of two opposite corners on each level

AORN RP for Selection and Use of Packaging Systems for Sterilization (2011) Recommendation IX


Multi-layer rigid container• Place two CIs in each level

of multi-level rigid container





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Multi-layer rigid container• Place two CIs in each level

of multi-level rigid container




Sterilizer Loading, Sterilization Parameters Sterilizer Unloading


Parameters, Sterilizer Unloading


• Section 8.5

Correct or Incorrect Loading?


Incorrect: Reusable rigid sterilization containers and instrument set on edge, packed too tightly.


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• Place on shelf below absorbent items to prevent wetting of absorbent items by condensate

• Do not stack unless validated and recommended by MDM

Correct Sterilizer Loading for Reusable Rigid Containers


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• Do not stack containers from different MDM because the configurations might not be compatible which could effect air removal and steam penetration

• Place instrument sets (including containers) flat on shelf

ANSI/AAMI ST79:2010 Section 8.5.3 and 8.5.6

Incorrect loading of sterilizer• “Stacking of containment devices if not recommended by manufacturer

• Stacking of perforated instrument trays

• Incorrect placement of instrument trays (i.e., not laying instrument

Table 8 Checklist for Identifying Reasons for Steam Sterilization Process Failures


trays flat or parallel to the shelf)

• Incorrect placement of paper-plastic pouches (e.g., placing pouches flat instead of on edge; not allowing sufficient space between pouches; not placing pouches with plastic sides facing one direction)”


• Choose based on the written IFUs from the• Medical device manufacturer

• Packaging manufacturer

• Sterilizer manufacture

Sterilization Parameters


• Investigate and resolve if the parameters do not agree

“NOTE─Care should be taken to ensure that all devices in a load have the same exposure time, as specified in the device manufacturers’ written instructions.”

ANSI/AAMI ST79:2010 Section 8.6

3M Sterile U Webinar 8.18.11

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• Maintain items on sterilizer cart until adequately cooled

• Do not touch during the cooling process

• Could wick bacteria from hands into packaging

• Place sterilizer cart in a low traffic area, no air-conditioning or cold-air-t

Unloading


vents

• Do not transfer warm items to a cool cart which could result in condensate forming and contamination

• May open door slightly at end of cycle to reduce the potential for condensation formation

“Flash-sterilized items are to be used immediately, not stored for later use.”


Sterile Storage


g


• Section 8.9

Store sterilized items in a separate area until distributed for patient care use. Environmental conditions for sterile storage include:• Controlled temperature 24°C (75°F)• ≥ four air exchanges/hour

Quality in the Sterile Storage Area

© 3M 2011. All Rights Reserved.30 ANSI/AAMI ST79:2010 Sections 3.3.7.4 and 8.9.2

• ≥ four air exchanges/hour• Relative humidity not to exceed 70%• Controlled traffic • Positive air flow (out)


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Inventory is protected from contamination• Store at least 8–10” from the floor, 18” below ceilings and 2” from

outside walls

• Storage on carts or shelves

• Cleanliness standards

Quality in the Sterile Storage Area

© 3M 2011. All Rights Reserved.31 ANSI/AAMI ST79:2010 Section 8.9.2

• Solid bottom shelf

• Store so not crushed, bent, compressed

• Stack containers if recommended by MDM

• Store heavy instrument trays in middle shelves for ease of handling and do not stack

Correct or Incorrect Storage of Reusable Rigid Sterilization Containers?


Incorrect: Containers may be stacked if recommended by the manufacturer, but they cannot be placed on edge.

Prepurchase Evaluation



• Section 10.10.3.2


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• Conduct a pre-purchase evaluation to determine if in your sterilizer chamber

• Air can be removed from the container

Prepurchase Evaluation of Reusable Rigid Container Systems


• Adequate steam can penetrate the container

• The sterilizer and container design system will achieve sterilization

• The sterilizer and container design will permit adequate drying and promote sterility maintenance

ANSI/AAMI ST79:2010 Section 10.10.3.2

Prepurchase Evaluation of Reusable Rigid Container Systems• Test system should contain largest instrument set

(including optional absorbent material)

• Containers should represent the sizes that will be used routinely

• Filter, if required, must be in place


• Consult container manufacturer for recommended BI and CI placement

• Maximum-load and small-load test are run in representative sterilizers (dynamic-air-removal and gravity)• Number of trays/load and placement will depend on type of

sterilizer and size of chamber

ANSI/AAMI ST79:2010 Section 10.10.3.2

Evaluation of New Packaging



• Section 10.10.3.2


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“Product testing should always be performed when major changes are made in packaging, wraps, or load configuration, such as dimensional changes, weight changes, or changes in the type or material of packaging or wrapper.”*

• This would include small, basket-type accessory containers with covers or lids, protective organizing baskets, trays, or cases, foam,

Evaluation of New Packaging


AORN Recommended Practices for Selection and Use of Packaging Systems for Sterilization:2011 Recommendation X 1. *ANSI/AAMI ST79:2010 Section 11.2.2

, p g g , y , , ,paper/paper pouches, etc.

• 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)• Inside accessory containers

• Test results

• Results determine routine placement of BI and CI

• Examine for evidence of excess moisture

Product Testing


• Inside accessory containers

• Label as product testing• Place in full load• Run the appropriate cycle• Document

• Date testing performed• Name of set, tray or item• Placement of all BIs and CIs (photo)

AAMI ST79:2010 Section 10.9

Product Testing Performed and All Monitors Stated the Sterilization Process was Effective

Can You Make this Packaging Change?


No, Unless the manufacturer(s) provides validated, written instructions for this packaging technique. This change cannot be done based on the results of

product testing.


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• Is there a risk of a patient acquiring an infection if the manufacturer’s instructions for use are not followed?• Cleaning, packaging, and sterilization

• Have you done a risk analysis for sterilization process

Risk Analysis


y y pfailures?

Standard IC.01.03.01

“The hospital identifies risks for acquiring and transmitting infections.”

Element of Performance # 4

The Joint Commission (TJC)


Element of Performance # 4

“The hospital reviews and identifies its risks at least annually and whenever significant changes occur with input from, at a minimum, infection control personnel, medical staff, nursing, and leadership.”

41The Joint Commission: 2011 Hospital Accreditation Standards (HAS)

Validation vs. Verification


They Are Not The Same


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“Documented procedure for obtaining, recording, and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications.”

Validation


• Covers three activities: installation qualification, operational qualification, and performance qualification

• Performed by device manufacturer

• Users cannot conduct validation testing


• Sterilization efficacy testing is expensive and time-consuming

• Manufacturer selects most challenging product (master product) in product family to test

• Biological testing is done in half cycle, fractional cycles, or

Manufacturer Validation


incremental critical process parameter cycles using BI spore strips, inoculated threads, or direct inoculation


• Internal temperature mapping is done inside containers or other packaging using multiple calibrated temperature sensors (Section 5.6)

• Sterilant residual removal (Section 5.8)

Manufacturer Validation


( )

• Perform sterility maintenance testing, microbial challenge testing, and physical integrity tests to determine if sterility is maintained until the device is opened for use (Section 5.9)

• Repeat validation testing when design changes are made on device

ANSI/AAMI ST77:2006


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“Documented procedures, performed in the user environment, for obtaining, recording, and interpreting the results required to establish that predetermined specifications have been met.”

• AAMI product testing verifies the validated instructions provided b th d i f t

User Verification


by the device manufacturer

• Product testing does not allow a user to validate a change in the product instructions for use as received from the device manufacturer

• Packaging, sterilization time, etc.

ANSI/AAMI ST79:2010 Section 2.128, Section 10.9

“The reusable medical device manufacturer is responsible for ensuring that the device can be effectively cleaned and sterilized.”

“The written instructions of the device manufacturer should

Reduce Risk


always be followed.”


Can You Make this Packaging Change?


No, Unless the manufacturer(s) provides validated, written instructions for this packaging technique. This change cannot be done based on the results of

product testing.


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Reusable Rigid Containers for Immediate-Use Steam Sterilization (IUSS)


( )

• AORN Recommended Practices for Sterilization in the Perioperative Practice Setting:2011

• Section IV.d. and IV.e.

• AORN recommends the use of rigid sterilization containers designed and intended for IUSS

• Reduce risk of contamination during transport to point of use

Implementation of ReusableRigid Containers for IUSS


transport to point of use

• Ease of presentation to sterile field

• Container should be opened, used immediately, and not stored for later use

• Containers should be differentiated from other types of containers

AORN RP for Sterilization in the Perioperative Practice Setting, RP IV.e

Immediate-Use Steam Sterilization

•Aseptic transfer from the sterilizer to the point of use is critical to protect items from contamination.

•Minimize exposure to air and other environmental contaminates

•Use single wrappers or containers for transport

•Not to be stored for future use


•Not held from one case to another

•Follow the device manufacturer’s IFU

•If they are not compatible with the packaging manufacturer's IFU (rigid container) then contact the device manufacturer to resolve the issue

http://www.aami.org/publications/standards/ST79_Immediate_Use_Statement.pdf


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Immediate-Use Steam Sterilization

Use critical thinking skills

Be knowledgeable about evidence-based recommended practices and standards (AAMI, AORN, CDC)

Appropriate training and education

Certification


Certification

Do not process implants by immediate-use steam sterilization

http://www.aami.org/publications/standards/ST79_Immediate_Use_Statement.pdf

The Joint CommissionUpdated Position on Steam Sterilization

• Storage and return to the sterile field• Are instruments protected from recontamination

when returned to sterile field?


The Joint Commission Perspectives®, July 2009, Volume 29, Issue 7http://www.jcrinc.com/common/PDFs/fpdfs/pubs/pdfs/JCReqs/JCP-07-09-S8.pdf

Any Questions or Comments?



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Next 3M™ Sterile U Web Meeting:

• September 15, 2011

• Biological Indicators – Do

Thank you!


Biological Indicators Do they make your life easier or harder?

Register at www.3m.com/SterileU/WebMeetings

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 (C lid t d T t)

Evidence-Based Guidelines


ANSI/AAMI ST79:2010 & A1:2010 (Consolidated Text)

How to Purchase AAMI Standards for Your Reference Library

AAMI documents can be purchased through AAMI by credit card using the following four options:

• Internet: http://marketplace.aami.org • Call: 1-877-249-8226• Fax: 301 206 9789


• Fax: 301-206-9789• Mail: AAMI Publications, P.O. Box 0211, Annapolis Junction, MD

20701-0211A free PDF of future amendment(s) may be downloaded by visiting http://www.aami.org/publications/standards/st79.html, which also includes information on how to update your copy of ST79.Print and save to your hard drive.


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Association of periOperative Registered Nurses (AORN) Perioperative Standards and Recommended Practices (2011)

• Recommended Practices for Practices for Sterilization in the Perioperative Practice Setting

Evidence-Based Guidelines


• Recommended Practices for Selection and Use of Packaging Systems for Sterilization

How to Purchase AORN Standards for Your Reference Library

AORN Standards can be purchased through AORN using the following options:

• Internet: www.aorn.org/bookstore/ordering.htm

• Call: 1-800-755-2676 x 1 or 303-755-6304 x 1 (Monday-Friday, 8AM


to 4:30PM mountain standard time)

• Fax: 303-750-3212

• By mail: AORN, Inc., Customer Service/Book Orders, 2170 South Parker Road, Suite 300, Denver, CO 80231-5711, USA

References

• Rigid Container Systems (Part I), IAHCSMM Communique: July/August 2010, accessed 8/3/2011 at http://iahcsmm.org/Recertification/LessonPlans/CIS_lessonPlans/CIS_Lessons/CIS_220.html

• Rigid Container Systems (Part II) IAHCSMM Communique:


Rigid Container Systems (Part II), IAHCSMM Communique: September/October 2010, accessed 8/3/2011 at

http://iahcsmm.org/Recertification/LessonPlans/CIS_lessonPlans/CIS_Lessons/CIS_221.html

• IAHCSMM Central Service Technical Manual, 7th Edition.

• Sterile Processing University, LLC. The Basics of Sterile Processing, 3rd Edition, 2009.


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• Joint Commission Perspectives®, July 2009, Vol. 29, Issue 7. Copyright 2009 Joint commission on Accreditation of Healthcare Organizations accessed 8/3/2011 athttp://www.jcrinc.com/common/PDFs/fpdfs/pubs/pdfs/JCReqs/JCP-07-09-S8.pdf

References


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• Joint Commission. 2011 Hospital Accreditation Standards (HAS)

• AAMI and Multi-society Immediate-Use Sterilization Position Statemen, accessed 8/3/2011 at http://www.aami.org/publications/standards/st79.html

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