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 ANSI/AAMI ST79 consolidates five (5) other standards into one comprehensive guide, which was published in October, These other standards are: ST46 Steam sterilization and sterility assurance ST42 Steam sterilization using table-top sterilizers ST37 Flash sterilization ST35 Decontamination of medical devices ST33 Selection and use of packaging systems
Association of periOperative Registered Nurses Standards, Recommended Practices, and Guidelines are also developed by the AORN Recommended Practices Committee and approved by the AORN Board of Directors. The 2008 edition is now available and comes in text and CD-ROM. JCAHO inspects facilities for compliance with best practices.
Objectives At the end of this program, participants will be able to… discuss the different types of steam sterilizers, list issues related to processing heavy trays and/or instruments that require extended cycles, identify examples of extended cycles required by leading orthopedic instrument manufacturers, review the recommended parameters for when Flash sterilization is considered acceptable, and explain minimum cycle times for flashing loads with porous versus nonporous items.
How important is it to comply with best practices? According to CDC statistics, more than 5,000 patients each day come down with a nosocomial (hospital acquired) infection and over 360 per day* die. These statistics are expected to get worse, as many of these preventable infections can no longer be treated with traditional antibiotics. While the delivery of non-sterile instruments certainly is not a leading cause of surgical site infections, this has been documented by the CDC as one of the problems. * Statistics based on 250 business days per year
How important is your work? “A major responsibility of the perioperative registered nurse is to minimize patient risk for surgical wound infection…One of the measures for preventing surgical wound infections is to provide surgical items that are free of contamination at the time of use. This can be accomplished by subjecting them to a sterilization process”. -2008 AORN Recommended Practices and Guidelines
Sterilization is a patient safety issue and requires a “systems approach” Surgery Prepares soiled items for decontamination Sterile Processing & Distribution (SPD) Clean & disinfect soiled items in decontamination area Inspect and assemble items in prep & pack area Process items in sterilization area Maintain sterility of items in sterile storage area Distribute items sterile, complete and on time. Infection Control Audit Surgery/SPD for compliance with best practices
Steam Sterilization Saturated steam under pressure is one of the oldest methods used to sterilize items. AAMI, AORN and the CDC recommend steam sterilization as the PROCESS of CHOICE, because it’s fast, efficient and relatively inexpensive. Chamberland autoclave built in 1880
Steam Sterilizers All Class II medical devices are subject to FDA clearance per a 510(k) approval. Sterilization Parameters: Time Temperature Saturated Steam
Steam Sterilization There are two (2) different types of steam sterilizers: 1.Gravity displacement 2.Dynamic air removal a)Pre-vacuum b)Steam-flush-pressure-pulse Note: Flash sterilization is typically a “shortened cycle” that can usually be run on any type of steam sterilizer.
Steam Sterilization Steam sterilizers usually have the following standard cycle parameters: gravity displacement (250°F/121°C for 30 min. exposure, or 270°F/132°C for 15 min. exposure, plus drying) dynamic air removal (270°F/132°C for 4 min. exposure, or 275°F/135°C for 3 min. exposure, plus drying)
Tray Weight AAMI standards (for users) recommend… The weight of an instrument set should be based on: proper body mechanics the design and density of the individual instruments comprising the set, the recommendations of the medical device and sterilizer manufacturers the distribution of mass (the density) in the set and sterilizer load.
Covers minimum labeling and performance requirements for rigid sterilization container systems and for instrument cases, cassettes, and organizing trays. Among other things, ST77 limits total tray weight to 25 pounds. This will assist users in two important ways: 1)Ergonomics = safer to lift and transport, 2)Sterilization = use standard exposure & dry times. AAMI ST 77 passed November, 2005 (for Mfg’s)
Sterilization Parameters The FDA requires manufacturer’s to validate sterilization parameters for all Containment devices (rigid containers, instrument cases, organizing trays and cassettes). AAMI standards state that medical devices purchased by healthcare facilities should include written, validated processing instructions from the manufacturer.
Extended Cycles? Did you know some heavy and/or complex instrument sets (i.e. orthopedic trays) have been validated with extended cycles in their instructions for use?
SYNTHES: Sterilization Parameters Power Drive PN 530.100 Wrapped Temperature Minimum Exposure Time Pre-vacuum 132-135 ° C/270-275 ° F 24 minutes Gravity Displacement – Not recommended Unwrapped (Flash) is same as wrapped parameters.
a Johnson & Johnson Company DePuy a Johnson & Johnson Company Instruments – 0902-00-721 Rev. D, Page 2. Large Bone (Total Hips, Knees, Shoulders, Ankles, Elbows, Wrist) Sterilization Instructions Cycle Type Minimum Temperature Minimum Exposure Time / Dry Time Pre-vacuum 132 - 134º C 8 min. / 20 min. dry time for metal with 4 pulses or metal/poly trays and 45 minutes for all poly trays. 134 - 137º C 5 min./ 20 min. dry time for metal or metal/poly trays and 45 minutes for all poly trays. Note: DePuy Moreland Revision Instruments are recommended at 132°C for 18 mins pre-vacuum.
Zimmer Recommendations for Care, Cleaning, Maintenance and Sterilization for Zimmer Manual Orthopaedic Surgical Instruments Cycle TypeTemperature Sterilization Time Pre-vacuum270 ° F/132 ° C 4 min. 8 min. for wrapped Universal Instrument Cases without defined load configurations. 18 min. for Acetabular reamer system. Gravity displacement sterilization cycles are not recommended because cycle times are too long to be practical.
Issues with Extended Cycles Extended cycles can have a detrimental effect on efficiency and sterility assurance for healthcare facilities. For example… 1) Extended cycles tie up the sterilizer and can backlog sterilizer loads needing to be processed. Does your facility have enough resources for these delays?
Issues with Extended Cycles 2) Devices validated for standard cycles may be damaged in extended cycles. Have you contacted each device mfg. if extended cycles are used? 3) Barrier characteristics of sterile packaging (disposable wrap and rigid container filters) may be adversely affected. What testing has been done by mfg’s to validate their packaging’s barrier effectiveness in extended cycles?
Issues with Extended Cycles 4) ANSI/AAMI/ISO 12161 states: “Users should not over process the culture medium, as extended sterilization may induce changes that can affect its growth-promoting properties. The ability of the culturing medium to promote the growth of low numbers of microorganisms should be demonstrated.” What testing has your BI mfg done to validate their media’s growth promotion ability in extended cycles?
AAMI Recommendations “Because of the increased complexity of instrumentation, consideration may be given to the installation of a separate steam sterilizer designated for use on medical devices requiring nonroutine cycles” How many of you are aware that your facility is running extended cycles?
FLASH Sterilization Surgery may need to decontaminate and flash sterilize an instrument or instrument set for quick turnaround. AORN recommended practices cautions facilities that flashing should only be used when there is insufficient time to process by the preferred wrap or container method.
FLASH Sterilization Flash sterilization should not be used as a substitute for sufficient instrument inventory.
FLASH Sterilization (Examples of typical cycle parameters) Gravity-displacement sterilizer 270°F/132°C, 3-4 min. exposure for nonporous items 270°F/132°C, 10 min. exposure for porous items Pre-vacuum sterilizer 270°F/132°C, 3 - 4 min. exposure for porous or nonporous items
FLASH Sterilization Flash sterilization should be used only in selected clinical situations and in a controlled manner. Flash sterilization should only be considered if all of the following conditions are met:
Sterilization & Infection Control Flash Sterilization Conditions 1)The device manufacturer ’ s written instructions are available and followed. Many device manufacturers only provide terminal sterilization parameters and not flash. It is important that users verify the items can be flashed and how.
Sterilization & Infection Control Flash Sterilization Conditions 2)Items are disassembled and thoroughly cleaned with detergent and water to remove soil, body fats and other substances. This requires an appropriate cleaning area with an approved detergent, cleaning brushes and personal protective equipment (PPE) worn properly by staff.
Sterilization & Infection Control Flash Sterilization Conditions 3.Lumens are flushed with the cleaning solution and rinsed thoroughly. Lumens are particularly difficult to clean and sterilize. It is important to consult with the device manufacturer for cleaning information.
Sterilization & Infection Control Flash Sterilization Conditions 4.Items are placed in an instrument tray or container in a manner that allows proper steam contact. Specialized flash containers are available and can be used according to their label claim. Flash containers should be cleaned between uses.
Sterilization & Infection Control Flash Sterilization Conditions 5.Measures are taken to prevent contamination during transfer to the sterile field. Personnel may use sterile towels as “ potholders ” or sterile gloves when removing trays from the sterilizer. The flashed items may then be removed from the tray by the scrub person and taken to the sterile field.
Sterilization & Infection Control Flash Sterilization Conditions 6.Documentation of cycle information and monitoring results is maintained to provide for tracking to the individual patient. Physical parameters, chemical indicators and biological indicators should be monitored/used to test the efficacy of the sterilizer. Records should be kept for each sterilization cycle.
Caution: Increased Risk Pressure on personnel could eliminate one or more steps in the cleaning and sterilization process. ALL Steps in the sterilization process must be performed properly!
FLASH Sterilization Decontamination process is essential for removing bioborden. Cleaning- remove debris from all parts of instrument, disassemble (if possible). Instruments should be dry before sterilization
FLASH Sterilization Packaging & wrapping should not be used in flash cycles (unless specifically approved) Special handling of items during transport Sterile gloves Avoidance of contact with unsterile surfaces Note: Specialized flash sterilization containers are commercially available and may reduce the risk of contamination during transport.
FLASH Sterilization Each sterilization cycle should be monitored to verify that parameters required for sterilization have been met. 1) Physical indicators: Time Temperature Pressure
Quality Control Is the sterilizer chart or printout reviewed and initialed after each cycle, before opening the door? Physical indicators should be recorded and maintained for each sterilizer cycle.
FLASH Sterilization 2) Chemical Indicators: It is recommended that one or more CI’s be used because CI’s give immediate information regarding sterilization process efficacy.
Chemical Indicators Pre-vacuum type Steam sterilizers should be tested daily with a Bowie-Dick type test. This is usually done in the morning, before the first processed load.
Chemical Indicators The Bowie-Dick test is placed over the drain in empty chamber and run at 273°F for 3.5 minutes. The indicator inside the test pack should show a uniform color change to pass. 9/05/06 2 CAH Pass Test Sheet
FLASH Sterilization 3) Biological Indicators: Should be used daily and with every load that contains an implant. Each sterilization MODE needs to be tested with a biological indicator (gravity and pre-vac). A control should be run each day from the same lot as the test BI.
FLASH Sterilization Both the BI and CI are placed loose in an empty tray or rigid container (in the area most difficult to sterilize) This if often the area nearest the drain.
Why an Empty Chamber? This configuration is a more rigorous biological challenge to sterilizer performance than is a filled chamber. Minimizes heat-up time (because there is little metal to absorb the heat) which minimizes the lethality of the process making it harder to kill the BI
FLASH Sterilization An unprocessed control BI (from the same lot) should be incubated each day the sterilizer is tested to confirm spore viability and proper function of the incubator.
FLASH Sterilization A lot number should be assigned to each flash sterilization load and a load record should be generated for each sterilization cycle: assigned lot number, including sterilizer identification and cycle number general contents of the load duration and temperature of the exposure phase of cycle signature or other identification of the operator date and time of the cycle
Implantable Devices Flash sterilization should NOT be used for implantable devices. Implants are foreign bodies, and they increase the risk of surgical site infection. Careful planning, appropriate packaging, and inventory management in cooperation with suppliers can minimize the need to flash implantable medical devices.
Smith & Nephew Important Sterilization Note: Smith & Nephew, the Association of Operating Room Nurses (AORN), and the Center for Disease Control (CDC) in Atlanta (USA), do not recommend the use of flash steam sterilization on implants. Due to the increased risk of contamination, Smith & Nephew encourages the return of all opened porous coated implants for recleaning and sterilization.
Implantable Devices If flash sterilization is unavoidable, full traceability of the item to the patient should be maintained. Both a BI and Class 5 integrator are recommended with implants.
Wrap up Questions Are sterilizers being monitored by physical, chemical and biological indicators? Are you requesting written sterilization parameters from your medical device manufacturers? Are you running extended cycles? If flash sterilization is being used, is it being done only in selected clinical situations and in a controlled manner? If implants are being flashed, are you using a BI and a Class 5 integrator every time? Are the items traceable to the patient?
Conclusion Infection Control, Surgery and Sterile Processing should work together to comply with sterilization best practices. 1)Flash only in selected clinical situations, 2)Avoid flashing implantable devices, and 3)Follow medical device mfg’s validated instructions for sterilization parameters (time & temperature). Remember to follow validated instructions for use as provided by the medical device manufacturer.
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:79 List Price: $220 Member Price: $110
References & Resources Association for the Advancement of Medical Instrumentation 1110 North Glebe Road, Suite 220, Arlington, VA 22201-4795 703-525-4890 Fax: 703-276-0793 www.aami.org Association of periOperative Registered Nurses 2170 South Parker Road, Suite 300 Denver, CO 80231-5711 800-755-2676 www.aorn.org Canadian Standards Association 5060 Spectrum Way Mississauga, Ontario L4W 5N6 CANADA 800-463-6727 Fax: (416) 747-2510 www.csa.ca Certification Board for Sterile Processing & Distribution 2 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 60610 312-440-0078 Fax: 312-440-9474 www.iahcsmm.org