Cleaning, Packaging and Sterilization of Instruments

1. Cleaning, Packaging and Sterilization of Instruments Provided by: McKesson Corporation McKesson Medical-Surgical Richmond, VA

2. Continuing Education Program Following established protocols for instrument processing is an important aspect of modern health care as it helps to minimize the patient’s risk for infection of the surgical site. This program reviews the most current recommended practices for instrument processing and is approved through two national sterile processing organizations. IAHCSMM and CBSPD offer certification programs for sterile processing personnel

3. SPECIAL UPDATE The Centers for Medicare & Medicaid Services (CMS) has recently revised their Survey and Certification document to include more stringent audits in the areas of infection control and sterilization. Areas of emphasis include: • Compliance with nationally recognized standards documents. • Formal training in areas of infection control and sterilization. • Compliant cleaning, sterilization and monitoring procedures. • Established criteria for flash sterilization. Reference: CMS Infection Control Surveyor Worksheet, Exhibit 351, 2009

4. SPECIAL UPDATE The Accreditation Association for Ambulatory Healthcare (AAAHC) added an infection control chapter to their standards handbook. Infection control highlights included: “Adhering to standards, guidelines, and manufacturer’s instructions for cleaning, disinfection, and sterilization of instruments, equipment, supplies, and implants.” Reference: OR Manager Magazine, Volume 26, Number 2, 2010.

5. INSTRUMENT PROCESSING There are six (6) recommended steps for Instrument Processing: Cleaning Inspection Packaging Sterilization Storage & Delivery 6. Quality Assurance

6. STEP 1 - CLEANING Cleaning of instruments should be performed in a designated area, immediately after the surgical procedure. Quick cleaning removes blood or debris much easier, and can minimize corrosion, pitting or instrument staining.

7. STEP 1 - CLEANING Whenever possible, it is best to mechanically clean instruments with an ultrasonic or washer using a neutral pH detergent. Mechanical cleaning has been proven to be up to 16 times more effective over manual cleaning.

8. STEP 1 - CLEANING Ultrasonic cleaners use high frequency sound waves to create microscopic bubbles that collapse. This “cavitation” process is very effective in getting into the serrations, box locks and crevices of instruments.

9. STEP 1 - CLEANING After cleaning, thoroughly rinse instruments with tap water to ensure loosened debris and detergents are removed. If the tap water is of poor quality, consider using treated water as a final rinse to avoid instrument staining.

10. STEP 2 - INSPECTION Each instrument must be critically inspected after each cleaning for residual debris or damage. Replace instruments as needed and never sterilize a “dirty” instrument.

11. STEP 2 - INSPECTION In addition, check each instrument for proper function and lubricate those that have “metal to metal” action. Instruments with stiff joints could be a sign of inadequate cleaning.

12. STEP 3 - PACKAGING Instrument packaging should be done in a clean, low contamination area using only FDA approved materials, such as: • Sterilization pouches • Sterilization wrappers • Sterilization containers

13. STEP 3 - PACKAGING Sterilization pouches are for packaging single instruments and small, light weight items. Paper/plastic pouches allow the user to see the packaged instruments and are available in multiple sizes for use with Steam or EO gas sterilization processes.

14. STEP 3 - PACKAGING When packaging instruments, be sure to select an appropriate size pouch and to place hinged instruments in an open position to allow sterilant contact. For quality control, be sure to include a chemical indicator inside and a lot label outside.

15. STEP 3 - PACKAGING To assist sterilization and aid drying, always place pouches facing each other and on edge using a pouch divider. Inexpensive pouch dividers are available for small and large sterilizers.

16. STEP 3 - PACKAGING Sterilization wrap is used for packaging instrument cassettes and/or trays. To allow sterilant to reach the instruments and to not trap air inside the package, cassettes and trays should be perforated. Wrap should be snug to prevent low spots that could collect condensate, but not too tight to cause strike through.

17. STEP 3 - PACKAGING Instrument trays should be double wrapped to maintain sterility per the wrap mfg’s instructions for use. Instrument trays should be wrapped in a way that allows for sterile presentation of the processed items.

18. STEP 3 - PACKAGING Wrapped packs should be sealed with 1”, 3/4” or ½” sterilization indicator tape. For quality control, be sure to include a chemical indicator inside and a lot label outside. Class 5 Class 4

19. STEP 3 - PACKAGING Wrapped packs (being heavier) should be placed on the lower shelf of the sterilizer. Loading heavier items on the bottom shelf and lighter items on the top, enables condensate to drain out without wetting other items in the load. To maintain sterility, packages need to be visibly dry before transporting to a sterile storage area

20. STEP 3 - PACKAGING Sterilization containers can be used to process instruments or sets. Containers offer excellent protection during storage and transport to the sterile field. As with wrapped trays, loading containers on the bottom shelf and lighter items on the top, enables condensate to drain away from lighter packages. Some rigid containers can be stacked during sterilization; however, all can be stacked during storage to save space

21. STEP 4 - STERILIZATION Steam sterilization is CDC recommended as the process of choice whenever possible. Steam under pressure is considered safe, fast and the most cost effective sterilization method for health care facilities. Gravity displacement and pre-vacuum are the two common types of steam sterilizers

22. STEP 4 - STERILIZATION Steam sterilizers are Class II medical devices subject to FDA approval per a 510(k) clearance letter. They are available in a wide variety of shapes and sizes for sterilization of heat-stable instruments.

23. STEP 4 - STERILIZATION Always process according to the sterilizer or instrument manufacturer’s validated Instructions For Use (IFU). Some common steam cycle parameters are: • 250°F/121°C for 30 minutes • 270°F/132°C for 10 minutes • 273°F/135°C for 4 minutes

24. STEP 4 - STERILIZATION Not all instruments can be processed at these common steam cycles. Therefore, it is critical that you have each device mfg’s IFU that details the cycle parameters (exposure time and temperature), along with the mode (gravity, prevacuum, steam flush pressure-pulse).

25. STEP 5 – Storage & Delivery Sterile items should be stored in a manner that reduces the potential for contamination. The shelf-life of sterile packages is event related and depends on the quality of the packaging material, storage conditions and amount of handling.

26. STEP 5 – Storage & Delivery Sterile packages should always be handled with care. Avoid dragging, crushing, bending, compressing or puncturing, as this will compromise the sterility of the contents. Be sure to inspect sterile packages before distributing. Do not use any package that is damaged, wet or opened.

27. STEP 5 – Storage & Delivery Sterility maintenance bags (dust covers) may be used to protect items that could be subjected to environmental challenges or multiple handling before use. Should be 2-3 mils thick and applied ASAP after sterilization and after the item has cooled.

28. STEP 6 – Quality Assurance Chemical indicators should be located on the outside/inside of each package to visibly show they have been processed. Biological indicators should be run at least weekly to verify sterilization and recorded as part of your formal Infection Control – QA program.

29. STEP 6 – Quality Assurance Chemical Indicators are available in tape, card and strip formats for use with all processes. These devices change color as indicated, for the process they are monitoring.

30. STEP 6 – Quality Assurance Most large steam sterilizers are prevacuum and require an air removal check before using. This daily test is done with a Bowie-Dick test pack. Most table top sterilizers are gravity displacement and do not require this special test; however, prevacuum table top sterilizers are now available.

31. STEP 6 – Quality Assurance Test Procedure: Place a Bowie-Dick test pack on the lowest shelf, over the drain in an empty chamber at 273°F for 3.5 or 4 minutes. After processing, the indicator sheet inside the test pack must show a uniform color change to pass. A shortened cycle omitting dry time should be run first to properly heat up the sterilizer.

32. STEP 6 – Quality Assurance Biological Indicators are processed along with a load for sterilizer verification. For steam sterilizers, users purchase a 55-60°C incubator and biological indicator vials. Sterilizer failure is noted if the BI grows during incubation. Growth is observed by a color change in the media from purple to yellow.

33. STEP 6 – Quality Assurance Biological Indicators can also be sent to an outside Lab for 3rd party documentation. Mail-in systems use BI strips and pre-paid mailer envelopes. Users simply run the BI strip and then mail. A Lab Report is returned and placed on a “password protected” website: www.checkyourtest.com

34. STEP 6 – Quality Assurance While sterilizers can and do mechanically fail, human error is the leading cause of sterilizer failure. • Cold start • Wrong cycle • Overloading • Improper packaging After processing, the BI strip is mailed to an outside Laboratory for incubation. After 24 hrs, a formal Lab Report is returned to verify steam sterilization

35. McKesson thanks you for taking the time to review… The six (6) recommended steps for Instrument processing: Cleaning Inspection Packaging Sterilization Storage & Delivery 6. Quality Assurance

36. CE Certificate Available This continuing education program was developed and produced by SPSmedical Supply Corp. for the McKesson Corporation. Customers who view this program may request a complimentary CE Certificate from SPSmedical.

37. SPSmedical Supply Corp. The largest sterilizer testing laboratory in North America with over 60 sterilizers SPSmedical serves on multiple AAMI sterilization standards committees and provides Seminar speakers to health care organizations. For technical questions and CE Certificates, please call: 800-722-1529 or E-mail: education@spsmedical.com

38. 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 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

39. McKesson Brand Sterility Assurance Products

40. McKesson Brand Sterility Assurance Products To assist users in meeting their sterility assurance needs, contact your local McKesson Representative for the following McKesson brand quality products: PACKAGING MONITORING • Self-Seal Sterilization Pouches • Chemical Indicators • Sterilization Indicator Tape • Biological Indicators • Record Keeping Systems • Bowie Dick Test Packs • • Incubators/Record Books

41. Self-Seal Pouches 73-SSP381 3.5” x 9” 73-SSP382 5.25” x 10” 73-SSP383 7.5” x 13” 73-SSP387 8” x 16” 73-SSP391 12” x 18” McKesson Brand Sterile Packaging Products

42. Sterilization Tape 73-ST048 3/4” x 60 yds 73-ST036 1” x 60 yds 73-BT048 3/4” x 60 yds 73-BT036 1” x 60 yds 73-GT036 1” x 60 yds McKesson Brand Sterile Packaging Products Label Applicator 73-MDG001 Load Record Label 73-URL012 Load Record Card 73-DLC250 Records Envelope 73-LEB100

43. Chemical Indicators 73-SIS250 4” Steam Strip 73-SIL250 8” Steam Strip 73-GIL250 8” EO Strip 73-DMS250 8” Dual Strip Chemical Integrators 73-SSI100 Steam (100 pk) 73-SSI1000 Steam (1,000 pk) 73-STP025 Steam Test Pack McKesson Brand Sterilization Monitoring Products Daily Air Removal Test 73-SBD030 Bowie-Dick Test Pack

44. Biological Indicators 73-SCS025 Steam vial (25 bx) 73-SCS100 Steam vial (100 bx) 73-SBT025 Steam Test Pack w/25 controls 73-SBT255 Steam Test Pack w/5 controls 73-NDB060 55-60°C Dry Block Incubator, 11 mm 73-PP012 Mail-In System (12 bx) 73-PP052 Mail-In System (52 bx) McKesson Brand Sterilization Monitoring Products