2Presented by SPSmedical Largest sterilizer testing Lab in North America with over 50 sterilizersDevelop and market sterility assurance products that offer advanced technologiesProvide full day sterilization Seminars and on-site Facility audits for compliance with best practicesCorporate member: CSA and AAMI, serving on numerous sterilization working groups
3Meets in Washington, DC throughout each year and Association for the Advancement of Medical InstrumentationMeets in Washington, DC throughout each year andestablishes guidelines for sterility assurance whichbecome our American National Standards.Membership includes:Healthcare facilitiesHealthcare organizationsGovernment agenciesMedical device manufacturersTesting Labs and Consultants
4best practices. Recommended Practices are developed by the AORN Association of periOperative Registered NursesRecommended Practices are developed by the AORNRecommended Practices Committee and approved bythe AORN Board of Directors.The Joint Commission inspectsfacilities for compliance withbest practices.
5Objectives 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 relatedidentify the steps to an event-related sterility assurance policy within their facility.
6Time vs Event-RelatedTime – 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”.
7Shelf Life “The shelf life of packaged sterile item is event related”. AORN Standards, RecommendedPractices and Guidelines“The shelf-life of a packaged sterile item is event-related and depends on the quality of the packagingmaterial, the storage conditions during transport, andthe amount of handling.” AAMI Standards
8In 1683, Louis Pasteur sterilized flasks of fermentable liquids Today some of these flasksare on display in theSmithsonian – STILLSTERILE AFTER MORETHAN 300 YEARS!
9Recommended 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
10Benefits of Event-Related Sterility Assurance TIME SAVER –No longer will staff need to:Pull expired packs fromsterile storage.Reprocess the packs clean, package, sterilize…and return them!
12AAMI 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:
13Regardless of when, where or how processed… Sterile packs are subject tocontamination in manyways 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.
14To 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.
15Packaging Selection Obtain a copy of each Mfg.’s Lab Report and choose the mostappropriate one.
16AORN Standards State That Packaging System Should… 1. Permit sterilization to take place2. Maintain sterility until opened3. Provide aseptic delivery
18Sterile Storage Open shelving may be used, but should be: 2” from outside walls8 to 10” from floor18” from ceiling fixturenot crunched, bent, compressed, punctured or near any location that could become wet. Doors closed, proper ceiling tiles, etc…
19Sterile Storage Sterile items should not be stored under sinks, near windows or doors, on the floor, near exposed pipes orvents and/or in high traffic areas.Heavy trays should be stored on middle shelves for easeof handling by staff. Rigid containers are designed toallow stacking; however, heavy “wrapped” trays shouldnot be stacked as this can compromise sterility.
20How To Start 1. Establish a written policy 2. Do a cost/benefit study 3. Present the new policy to the IC committee4. Write & distribute a memo to staff and begin training5. Implement policy
21Establish a Written Policy and be Sure to Include: SUBJECTOBJECTIVEPOLICY STATEMENTPROCEDURES
22Do a Cost/Benefit Study Consider each of the following:LaborMaterialsSterilizer costsThis study helps to educate those involved in theprocedure about the immediate payback if theyincorporate change.
23Present to Infection Control Committee Offer monitoring suggestions:First In, First Out (FIFO)inventory rotation,Periodic lab culturing toverify sterility,Ongoing review of infectionrates within the facility.
24Event Related Sterility After ApprovalWrite & 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 SterilityAssurancePolicy
25Implement New Policy But only after in-servicing all personnel who handle sterilepacks!Emphasize that everyone isresponsible to inspect sterilepacks prior to use!
26Remember to Reject Packages that are: DAMAGEDOPENEDor WET, regardlessof what the label says!
27Cooperation and Teamwork are required between all departments to make itwork!
28So When You’re Asked… How long do sterile packs remain sterile? Answer truthfully: Until they become contaminated!
29Conclusion Event-related sterility assurance can and will work for your facility, providing there is a totalQuality commitment to practice establishedstandards for proper packaging, sterilization,storage, handling and inspection of all sterilepacks!
31Purchasing 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: $220Member Price: $110
32References & Resources Association for the Advancement of Medical Instrumentation1110 North Glebe Road, Suite 220, Arlington, VAFax:Association of periOperative Registered Nurses2170 South Parker Road, Suite 300 Denver, COCanadian Standards Association5060 Spectrum Way Mississauga, Ontario L4W 5N6 CANADAFax: (416)Certification Board for Sterile Processing & Distribution2 Industrial Park, Suite 3 Alpha, NJ 08865International Assoc. of Healthcare Central Service Materiel Management213 W. Institute Place, Suite Chicago, IL 60610Fax: