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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
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.
• 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
• 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
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.”
ANSI/AAMI ST79:2010 Section 8.4.4
• “Paper-plastic pouches are not appropriate for use within wrapped sets or containment devices.”
Loading Instruments Into Reusable Rigid Sterilization Containers
• 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)”
ANSI/AAMI ST79:2010 Section 10.7.5
• Choose based on the written IFUs from the• Medical device manufacturer
• 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
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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
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
• 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
“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,
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
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
“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.”
“Documented procedure for obtaining, recording, and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications.”
• 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
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)
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