ELIMINATING STERILE OUTDATES

(EVENT-RELATED STERILITY ASSURANCE)

Presented by SPSmedical

• Largest sterilizer testing Lab in North America with over 50 sterilizers

• Develop and market sterility assurance products that offer advanced technologies

• Provide full day sterilization Seminars and on-site Facility audits for compliance with best practices

• Corporate member: CSA and AAMI, serving on numerous sterilization working groups

Association for the Advancement of Medical Instrumentation

Meets in Washington, DC throughout each year and establishes guidelines for sterility assurance which become our American National Standards.

Membership includes: • Healthcare facilities• Healthcare organizations• Government agencies• Medical device manufacturers• Testing Labs and Consultants

Association of periOperative Registered Nurses

Recommended Practices are developed by the AORNRecommended Practices Committee and approved by the AORN Board of Directors.

The Joint Commission inspects facilities for compliance with

best practices.

Objectives

At the end of this program, participants will be able to…

• understand the difference between time and event-related sterility assurance,

• explain why sterility is event-related and not time related

• identify the steps to an event-related sterility assurance policy within their facility.

Time vs Event-Related

Time – When a healthcare facility puts an arbitrary “Expires” date on every item they sterilize. These shelf-life dates are typically 6 – 12 months from date of processing.

Event-Related – When a healthcare facility puts the date of processing on items they sterilize and marks it “sterile unless damaged or opened”.

Shelf Life

“The shelf life of packaged sterile item is event related”. AORN Standards, Recommended

Practices and Guidelines

“The shelf-life of a packaged sterile item is event-related and depends on the quality of the packaging material, the storage conditions during transport, andthe amount of handling.” AAMI

Standards

In 1683, Louis Pasteur sterilized flasks of fermentable liquids

Today some of these flasks are on display in the Smithsonian – STILLSTERILE AFTER MORE THAN 300 YEARS!

Recommended Practices

• “Sterility is an event related function, not time related, and that if sterilized items are protected properly by wrap and storage procedures, (and the sterilizers’ function is monitored) items can be given an indefinite shelf life” - Carole H. Patterson, Associate Director for

Interpretation, Dept. of Standards JCAHO

• “Shelf life of a packaged sterile item is event related” – AORN Recommended Practices

Benefits of Event-Related Sterility Assurance

TIME SAVER – No longer will staff need to:

• Pull expired packs from sterile storage.

• Reprocess the packs clean, package, sterilize…and return them!

Benefits of Event-Related Sterility Assurance

MONEY SAVER –

Reduces consumable usage:

•Pouches•Wrap & Tape•Filters•CI’s & BI’s•Labels•Record Cards•Envelopes

AAMI Standards State:

• “The shelf life of a packaged sterile item is event-related and depends on the quality of the packaging material, the storage conditions the conditions during transport, and the amount of handling.”

-AAMI ST:79 2006

Regardless of when, where or how processed…

Sterile packs are subject to contamination in many ways at any time!

• Plastic dust covers may be used to protect and extend the shelf life of properly sterilized items.

• Or, use peel pouches as a method of protecting items.

To Eliminate Sterile Outdates

• Select approved packaging,• Monitor the sterilization process,• Control the events surrounding the handling

and storage of sterile items until they are used.

** The only instance in which event-related sterility is not advisable is when using medication or materials within the package that can deteriorate with time, such as balloon catheters.

Packaging Selection

Obtain a copy of each Mfg.’s Lab Report and choosethe most appropriate one.

AORN Standards State That Packaging System Should…

1. Permit sterilization to take place

2. Maintain sterility until opened

3. Provide aseptic delivery

Sterilization Monitoring

1) Physical

2) Chemical

3) Biological

Sterile Storage

Open shelving may be used,

but should be:

• 2” from outside walls • 8 to 10” from floor• 18” from ceiling fixture• not crunched, bent, compressed, punctured or near

any location that could become wet. Doors closed, proper ceiling tiles, etc…

Sterile Storage

Sterile items should not be stored under sinks, near

windows or doors, on the floor, near exposed pipes or

vents and/or in high traffic areas.

Heavy trays should be stored on middle shelves for ease

of handling by staff. Rigid containers are designed to

allow stacking; however, heavy “wrapped” trays should

not be stacked as this can compromise sterility.

How To Start

1. Establish a written policy

2. Do a cost/benefit study

3. Present the new policy to the IC committee

4. Write & distribute a memo to staff and begin training

5. Implement policy

Establish a Written Policy and be Sure to Include:

SUBJECT OBJECTIVE POLICY STATEMENT PROCEDURES

Do a Cost/Benefit Study

Consider each of the following:

Labor

Materials Sterilizer costs

This study helps to educate those involved in the

procedure about the immediate payback if they

incorporate change.

Present to Infection Control Committee

Offer monitoring suggestions:

First In, First Out (FIFO) inventory rotation,

Periodic lab culturing to verify sterility,

Ongoing review of infection rates within the facility.

After Approval

• Write & distribute MEMO to staff and all related depts.

• Describe new event-related sterility assurance policy and provide rational...

• Offer to meet with depts. that have questions or concerns regarding new policy!

Event

Related

Sterility

Assurance

Policy

Implement New Policy

But only after in-servicing all personnel who handle sterile packs!

Emphasize that everyone is responsible to inspect sterile packs prior to use!

Remember to Reject Packages that are:

•DAMAGED

•OPENED

•or WET, regardless

of what the label says!

Cooperation and Teamwork

are required between all departments to make it work!

So When You’re Asked…

• How long do sterile packs remain sterile?

• Answer truthfully: Until they become contaminated!

Conclusion

Event-related sterility assurance can and will work for your facility, providing there is a total Quality commitment to practice establishedstandards for proper packaging, sterilization, storage, handling and inspection of all sterile packs!

THANK YOU!!

SPSmedical Supply Corp.

Sterilization Products & Services6789 W. Henrietta RoadRush, NY 14543 USAFax: (585) 359-0167Ph: (800) 722-1529

Website: www.spsmedical.com

© SPSmedical Supply Corp.

Certificate is available after viewing by calling SPSmedical

or e-mailing education@spsmedical.com

Eliminating Sterile Outdates

Purchasing AAMI Standards

If your organization is not a member of AAMI, you may purchase the Standards directly from SPSmedical at our member discount. The member discount saves you 40-50% depending on the document.

For example:

ORDER CODE: AAMI ST:79List Price: $220 Member Price: $110

References & Resources

Association for the Advancement of Medical Instrumentation 1110 North Glebe Road, Suite 220, Arlington, VA 22201-4795703-525-4890 Fax: 703-276-0793 www.aami.org

Association of periOperative Registered Nurses 2170 South Parker Road, Suite 300 Denver, CO 80231-5711800-755-2676 www.aorn.org

Canadian Standards Association5060 Spectrum Way Mississauga, Ontario L4W 5N6 CANADA800-463-6727 Fax: (416) 747-2510 www.csa.ca

Certification Board for Sterile Processing & Distribution2 Industrial Park, Suite 3 Alpha, NJ 08865 908-454-9555 www.sterileprocessing.org

International Assoc. of Healthcare Central Service Materiel Management 213 W. Institute Place, Suite 307 Chicago, IL 60610312-440-0078 Fax: 312-440-9474 www.iahcsmm.org