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 Association for the Advancement of Medical InstrumentationMeets in Washington, DC throughouteach year and establishes guidelinesfor sterility assurance which becomeour American National standards.Membership includes:Health care facilitiesHealth care organizationsGovernment agenciesMedical device manufacturersTesting Labs and ConsultantsAAMI standards are available in text and on CD-ROM.ANSI/AAMI ST:79
4ANSI/AAMI ST79 consolidates five (5) other standards into Association for the Advancement of Medical InstrumentationANSI/AAMI ST79 consolidates five (5) other standards intoone comprehensive guide, which was published in October,These other standards are:ST46 Steam sterilization and sterility assuranceST42 Steam sterilization using table-top sterilizersST37 Flash sterilizationST35 Decontamination of medical devicesST33 Selection and use of packaging systems
5NEWS…2008 update available. Association for the Advancement of Medical InstrumentationNEWS…2008 update available.ST79 is the first AAMI standard to be part of the AmericanNational Standards Institute’s “continuous maintenance”classification. Normally, AAMI standards undergo “periodicmaintenance,” which calls for review (and subsequentrevision, reaffirmation, or withdrawal) of a standard everyfive years. With continuous maintenance, AAMI willconsider requests for change at any time.
6Objectives At the end of this program, participants will be able to… Understand the history of steam sterilizationRecognize the minimum recommended cycle times for steam sterilization, including gravity displacement, dynamic air removal and flash sterilizationUnderstand that some instrumentation requires extended steam sterilization cycles to achieve sterilizationProper loading, unloading and storage of sterilized itemsDiscuss quality control measures to ensure proper efficacy of each sterilizerIdentify special quality control measures for implant loads
7Chamberland autoclave built in 1880 Steam SterilizationSteam sterilization is one of the oldest methods used to sterilize items.Modeled after the steam pressure cooker which was developed in 1681, the first commercial sterilizer was introduced in the 1800s..Chamberland autoclave built in 1880
8Steam SterilizationSterilization standards worldwide recommend steam sterilization as the PROCESS of CHOICE, because it’s:fast,efficient, andrelatively inexpensive.
9Steam SterilizationSteam sterilizers (small and large) are Class II medical devices subject to FDA approval.They are available in a wide variety shapes and sizes.
10Steam Sterilization Steam sterilization can be used to process a wide variety of itemsthat can withstand moistheat under pressure athigh temperatures.
11Steam SterilizationOf course, not everything can be steam processed due to damage to the device or danger to people. For example, wood products are a problem because during sterilization lignocellulose resin (lignin) is driven out of wood by heat. Lignin is known to cause reactions if it gets into the tissues of a patient.Additionally, wood products can absorb moisture from the steam, causing superheating and decreasing it’s ability to sterilize other items in the load.
12Steam Sterilization There are two (2) types of steam sterilizers: Gravity displacementDynamic air removal (Pre-vacuum and Steam-flush-pressure-pulse)Note: Flash sterilization is a “shortened cycle” that can be ran on either type steam sterilizer.
13Gravity Displacement (AAMI - Minimum cycle parameters) Wrapped instruments250°F/121°C temperature, 30 mins exposure,30 mins dry time270°F/132°C temperature, 15 mins exposure,275°F/135°C temperature, 10 mins exposure,
14Dynamic Air Removal (AAMI - Minimum cycle parameters) Wrapped instruments270°F/132°C temperature, 4 mins exposure,30 mins dry time275°F/135°C temperature, 3 mins exposure,16 mins dry time
15FLASH Sterilization (AAMI - Minimum cycle parameters) Gravity-displacement sterilizer - unwrapped270°F/132°C, 3 min exposure (nonporous items)270°F/132°C, 10 min exposure (nonporous & porous)Dynamic air removal - unwrapped270°F/132°C, 3 min exposure (nonporous & porous)Dry times are usually minute.
16SYNTHES: Sterilization Parameters Power Drive / Small Battery Drive SystemsWrapped Temperature Minimum Exposure TimePre-vacuum °C/ °F minutesGravity Displacement – Not recommendedUnwrapped (Flash) is same as wrapped parameters.
17URGENT: Medical Device Correction Letter sent to customers in August, 2008 by SYNTHES®RE: Power Drive Unit/Discard all Power Drive User’s Manuals and replace with new literatureDiscard all Power Drive/Small Battery Drive Sterilization Guides and replace with new literatureDistribute this information to all departmentsComplete verification section of letter and return to SYNTHES
18DePuya Johnson & Johnson Company Instruments – Rev. D, Page 2.Large Bone (Total Hips, Knees, Shoulders, Ankles, Elbows, Wrist)Sterilization InstructionsCycle Type Minimum Temperature Minimum Exposure Time / Dry TimePre-vacuum º C mins / 20 min dry time for metal w/ or metal/poly trays and 45 minutes pulses for all poly trays.º C mins/ 20 min dry time for metal or metal/poly trays and minutes for all poly trays.Note: DePuy Moreland Revision Instruments are recommended at 132°C for 18 mins pre-vacuum.
19Other Examples Mfg/Device Method Parameters Hand Innovations (all) Gravity 132°C for 20 minsPre-vacuum 132°C for 10 minsMedtronic Midas Rex Gravity 132°C for 25 minsPre-vacuum 132°C for 4 minsBaxter Prosthetic Ring Gravity 132°C for 20 minsStryker Spine Sets Pre-vacuum 132°F for 15 minsAbbott Spine Sets Pre-vacuum 132°F for 15 minsScientix SACP System Pre-vacuum 134°F for 18 mins
20Loading Steam Sterilizers Steam sterilizers should beloaded with light items ontop, heavy items on bottom.Linen packs, basins andsolid trays should be placedon their sides.Mesh bottom instrument trays should be placed flat.Note: Lead/Latex Free Steam Indicator Tape is now available for wrapped items!
21Loading Steam Sterilizers Rigid containers should always be placed flat and not stacked unless the mfg. has validated to do so.Stacked containers are much more difficult to sterilize and may require extended cycle times.Before loading rigid containers, be sure all filters, data cards and locks are in place
22Loading Steam Sterilizers Pouches are designed for lightweight items, and should be placed on edge, facing the same direction.Inexpensive pouch dividers are available to separate and hold pouches in place.
23Steam Sterilization Paper/plastic pouches are not recommended to be placed inside wrappedsets or rigid containers.Rationale:“Placing pouches along with heavy metal instruments can result in inadequate air removal, steam contact and/or drying.”
24Steam SterilizationAccording to 2009 AORN Standards and Recommended Practices, count sheets should not be placed inside wrapped sets or rigid containers.“Although there are no known reports of adverse events related to sterilized count sheets, there is no available research regarding the safety of toners and/or various papers subjected to any sterilization method.”
25Steam Sterilization Count sheets – you have two choices: Tape them on the outside of wrapped trays/ containers,Cytotoxicity test them to confirm they are safe.
26Unloading Steam Sterilizers After drying, the sterilizer cart should be removed and placed in a low traffic area, where it should remain until the load is cool.Do not place carts near air vents as this can cause condensation to form inside the packs.Sterile items must not be touched while cooling.Freshly sterilized items should never be placed on metal or cold surfaces before they have cooled adequately.
27InspectionConfirm the Chemical Indicator on each package for proper color change verifying the item has been exposed to the sterilization process.Packages damaged, wet or opened should not be used.If you use sterility maintenance bags (dust covers) for added protection during storage, be sure all packs are completely cooled before being placed in the plastic bag.bag.
28Wet Packs?If packages are wet at the end of the cycle, the cause(s) must be identified and corrective actions initiated.Wet packs can be caused by:condensate collected in / blown out of steam linesimproper drying timecondensate dripping from carriage shelvesmetal items on an upper shelf dripping condensate onto items below
29Wet Packs? Staff can cause wet packs by: overloading the sterilizerimproper loadingtoo many instruments in the setfabrics wrapped to tightMechanical problems that can cause wet packs:obstructed drainsimproper steam pressure
30Sterile Storage Open shelving can be used, but should be: 2” from outside walls8 to 10” from floor with covered bottom18” from ceiling fixturesmaintained clean and dryCare should be taken to avoid crushing, bending, compressing, or puncturing the packaging or otherwise compromising the sterility of the contents.
31Sterile StorageHeavy trays should be stored on middle shelves for ease of handling by staff.Rigid sterile containers may bestacked; however, wrappedtrays should not be stacked asthis can compromise sterility!
32Temperature should not exceed 75°F and humidity should not exceed 70% Sterile StorageThe 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.Temperature should not exceed 75°F and humidity should not exceed 70%
33Quality Control Physical monitors must be recorded and maintained for each sterilizer cycle:- time- temperature- pressureSterilizer chart or printout,should be reviewed and initialed after each cycle.
34Quality Control Pre-vacuum sterilizers should be tested daily with a Bowie-Dick testpack to confirm properair removal.Gravity displacementtype sterilizers do notrequire this test.
35Quality Control Procedure: Place the test pack over the drain, on the lowest shelf in an empty chamber. Process at 273°F for minutes.After processing, the chemical indicator sheet inside the test pack must show a uniform color change to pass.
36Quality ControlChemical indicators should be used externally and internally for each item processed.Internal CIs should be Class 3, 4 or 5 depending upon the complexity of the pack and contents.
37Quality Control AAMI standards define CI’s by six classes: Class 1 – Process IndicatorsClass 2 – Specific Test IndicatorsClass 3 – Single parameter IndicatorsClass 4 – Multi-parameter IndicatorsClass 5 – Integrating IndicatorsClass 6 – Emulating Indicators
38Quality ControlThe results of Class 5 integrating indicators may serve as the basis for the release of processed items, excluding implants.For monitoring wrapped loads, these integrating indicators must be used within an appropriate challenge test pack.
39What about implants?Each load containing implantable devices should be monitored with a BI challenge test pack and, whenever possible, quarantined until the results of the BI testing is available.
40Quality ControlBiological indicators provide the highest level of sterility assurance and should be ran at least weekly, preferably daily and with any load that contains an implant.CSA = daily, and with implants.
41Quality ControlA BI inside a Test Pack is used to monitor gravity and dynamic air removal sterilizers processing full loads.Placement:The BI test pack should be placed flat on the bottom shelf, directly above the drain with a load.
42Quality ControlFor routine release of loads with an implant, a PCD with a BI anda Class 5 integrating indicatorshould be used.Whenever possible, the implantshould be quarantined until theresults of the BI are known.
43Quality Control Flash sterilizers are different in that the BI and CI are notplaced inside a test pack or aload, but loose in an emptytray or rigid container nearestthe drain.AORN recommends each flash cycle be monitored with a Class 5 integrator.
44Special Note: Controls An unprocessed control BI(from the same lot) shouldbe incubated each day thesterilizer is tested to confirmspore viability and properfunction of the incubator.Are you testing each incubator?
45VA Directive 7176 requires hospitals to grow out the RRBI for 48 hours Special Note: RRBIPeriodic verification of the earlyreadout with spore growth should be performed in accordance with the manufacturer’s instructions and facility policy and procedures.In the event of a sterilizer failure, the sterilizer mfg. may recommend additional and/or alternative BI testing to verify results.AAMI ST79:2006VA Directive 7176 requires hospitals to grow out the RRBI for 48 hours
46Critical Assessments?Biological indicator challenge test packs should be used during initial installation testing of steam sterilizers after relocation, after sterilizer malfunction, after sterilization process failures, after any major repairs of the sterilizer, and for periodic QA testing of representative samples of actual products being sterilized.NOTE. A major repair is a repair outside the scope of normal maintenance, such as weld repairs of the pressure vessel, replacement of the chamber door or a major piping assembly, or rebuilds or upgrades of controls.
47BI Failure?The Supervisor (and sterilizer Operator) should review proper procedures for sterilizer operation and all testing to determine if the failure was operator error or indeed sterilizer malfunction.Operator error is failure due to improper loading, wrong cycle selection, fluorescent spotting (RRBI), incorrect BI or BI test pack, etc... Operator error is cause to reprocess the load; whereas, sterilizer failure is cause to recall back to your last negative BI. This is an important distinction!
49Purchasing 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
50References & 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: