Presentation on theme: "Steam Sterilization: The Process of Choice!. Presented by SPSmedical Largest sterilizer testing Lab in North America with over 50 sterilizers Develop."— Presentation transcript:
Steam Sterilization: The Process of Choice!
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: Health care facilities Health care organizations Government agencies Medical device manufacturers Testing Labs and Consultants AAMI standards are available in text and on CD-ROM. ANSI/AAMI ST:79
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 for the Advancement of Medical Instrumentation NEWS…2008 update available. ST79 is the first AAMI standard to be part of the American National Standards Institute’s “continuous maintenance” classification. Normally, AAMI standards undergo “periodic maintenance,” which calls for review (and subsequent revision, reaffirmation, or withdrawal) of a standard every five years. With continuous maintenance, AAMI will consider requests for change at any time.
Objectives At the end of this program, participants will be able to… Understand the history of steam sterilization Recognize the minimum recommended cycle times for steam sterilization, including gravity displacement, dynamic air removal and flash sterilization Understand that some instrumentation requires extended steam sterilization cycles to achieve sterilization Proper loading, unloading and storage of sterilized items Discuss quality control measures to ensure proper efficacy of each sterilizer Identify special quality control measures for implant loads
Steam Sterilization Steam 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
Steam Sterilization Sterilization standards worldwide recommend steam sterilization as the PROCESS of CHOICE, because it’s: 1. fast, 2. efficient, and 3. relatively inexpensive.
Steam Sterilization Steam sterilizers (small and large) are Class II medical devices subject to FDA approval. They are available in a wide variety shapes and sizes.
Steam Sterilization Steam sterilization can be used to process a wide variety of items that can withstand moist heat under pressure at high temperatures.
Steam Sterilization Of 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.
Steam Sterilization There are two (2) types of steam sterilizers: 1.Gravity displacement 2.Dynamic 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.
Gravity Displacement (AAMI - Minimum cycle parameters) Wrapped instruments 250°F/121°C temperature, 30 mins exposure, 30 mins dry time 270°F/132°C temperature, 15 mins exposure, 30 mins dry time 275°F/135°C temperature, 10 mins exposure, 30 mins dry time
Dynamic Air Removal (AAMI - Minimum cycle parameters) Wrapped instruments 270°F/132°C temperature, 4 mins exposure, 30 mins dry time 275°F/135°C temperature, 3 mins exposure, 16 mins dry time
FLASH Sterilization (AAMI - Minimum cycle parameters) Gravity-displacement sterilizer - unwrapped 270°F/132°C, 3 min exposure (nonporous items) 270°F/132°C, 10 min exposure (nonporous & porous) Dynamic air removal - unwrapped 270°F/132°C, 3 min exposure (nonporous items) 270°F/132°C, 3 min exposure (nonporous & porous) Dry times are usually minute.
SYNTHES: Sterilization Parameters Power Drive / Small Battery Drive Systems Wrapped Temperature Minimum Exposure Time Pre-vacuum ° C/ ° F 24 minutes Gravity Displacement – Not recommended Unwrapped (Flash) is same as wrapped parameters.
URGENT: 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 literature Discard all Power Drive/Small Battery Drive Sterilization Guides and replace with new literature Distribute this information to all departments Complete verification section of letter and return to SYNTHES
DePuy a Johnson & Johnson Company Instruments – 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 º C 8 mins / 20 min dry time for metal w/ 4 or metal/poly trays and 45 minutes pulses for all poly trays º C 5 mins/ 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.
Other Examples Mfg/DeviceMethodParameters Hand Innovations (all)Gravity 132°C for 20 mins Pre-vacuum132°C for 10 mins Medtronic Midas RexGravity132°C for 25 mins Pre-vacuum132°C for 4 mins Baxter Prosthetic RingGravity132°C for 20 mins Stryker Spine SetsPre-vacuum132°F for 15 mins Abbott Spine SetsPre-vacuum132°F for 15 mins Scientix SACP SystemPre-vacuum134°F for 18 mins
Loading Steam Sterilizers Steam sterilizers should be loaded with light items on top, heavy items on bottom. Linen packs, basins and solid trays should be placed on their sides. Mesh bottom instrument trays should be placed flat. Note: Lead/Latex Free Steam Indicator Tape is now available for wrapped items!
Loading 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
Loading 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.
Steam Sterilization Paper/plastic pouches are not recommended to be placed inside wrapped sets or rigid containers. Rationale: “Placing pouches along with heavy metal instruments can result in inadequate air removal, steam contact and/or drying.”
Steam Sterilization According 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.”
Steam Sterilization Count sheets – you have two choices: 1.Tape them on the outside of wrapped trays/ containers, 2.Cytotoxicity test them to confirm they are safe.
Unloading 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.
Confirm 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. Inspection
Wet 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 lines improper drying time condensate dripping from carriage shelves metal items on an upper shelf dripping condensate onto items below
Wet Packs? Staff can cause wet packs by: overloading the sterilizer improper loading too many instruments in the set fabrics wrapped to tight Mechanical problems that can cause wet packs: obstructed drains improper steam pressure
Sterile Storage Open shelving can be used, but should be: 2” from outside walls 8 to 10” from floor with covered bottom 18” from ceiling fixtures maintained clean and dry Care should be taken to avoid crushing, bending, compressing, or puncturing the packaging or otherwise compromising the sterility of the contents.
Sterile Storage Heavy trays should be stored on middle shelves for ease of handling by staff. Rigid sterile containers may be stacked; however, wrapped trays should not be stacked as this can compromise sterility!
Sterile Storage 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. Temperature should not exceed 75°F and humidity should not exceed 70%
Quality Control Physical monitors must be recorded and maintained for each sterilizer cycle: - time - temperature - pressure Sterilizer chart or printout, should be reviewed and initialed after each cycle.
Quality Control Pre-vacuum sterilizers should be tested daily with a Bowie-Dick test pack to confirm proper air removal. Gravity displacement type sterilizers do not require this test.
Quality 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.
Quality Control Chemical 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.
Quality Control AAMI standards define CI’s by six classes: Class 1 – Process Indicators Class 2 – Specific Test Indicators Class 3 – Single parameter Indicators Class 4 – Multi-parameter Indicators Class 5 – Integrating Indicators Class 6 – Emulating Indicators
Quality Control The 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.
What 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.
Quality Control Biological 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.
Quality Control A 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.
Quality Control For routine release of loads with an implant, a PCD with a BI and a Class 5 integrating indicator should be used. Whenever possible, the implant should be quarantined until the results of the BI are known.
Quality Control Flash sterilizers are different in that the BI and CI are not placed inside a test pack or a load, but loose in an empty tray or rigid container nearest the drain. AORN recommends each flash cycle be monitored with a Class 5 integrator.
Special Note: Controls 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. Are you testing each incubator?
Special Note: RRBI Periodic verification of the early readout 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 ST79:2006 VA Directive 7176 requires hospitals to grow out the RRBI for 48 hours
Critical 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.
BI 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!
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 Fax: Association of periOperative Registered Nurses 2170 South Parker Road, Suite 300 Denver, CO Canadian Standards Association 5060 Spectrum Way Mississauga, Ontario L4W 5N6 CANADA Fax: (416) Certification Board for Sterile Processing & Distribution 2 Industrial Park, Suite 3 Alpha, NJ International Assoc. of Healthcare Central Service Materiel Management 213 W. Institute Place, Suite 307 Chicago, IL Fax: