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Reprocessing Reusable Medical Devices: Standards, Recommendations, and Guidelines, part 3

This third article is part of a series discussing the importance of proper medical device reprocessing with compliance to standards, recommendations, and guidelines (i.e., best practices).

Click here for the first article.
Click here for the second article.

This third article is the final part of a series discussing the importance of proper medical device reprocessing with compliance to standards, recommendations, and guidelines (i.e., best practices). Click here for the first and second articles. 

In the first two articles, we discussed how reusable medical devices continue to become more and more complex, and thus so does compliance with reprocessing best practices. Complex reusable medical devices often have detailed multistep instructions for use (IFUs) that require special resources healthcare facilities may not have anticipated when they purchase, borrow, or trial new devices. We explained how national survey organizations and many Department of Health (DOH) agencies now audit healthcare facilities for compliance with best practices as stated in our national standards, recommendations, and guidelines which we listed. And we reviewed how adherence to reprocessing best practices ensures patient safety as one of our greatest threats is healthcare-associated infections (HAIs).1

We discussed that breaches do occur unfortunately, and are regularly reported in the local and national news. The media describe thousands of patients being contacted by healthcare facilities and tested for possible hepatitis and HIV infections.2 In some cases, both patients and staff were reported to be infected. This prompted the CDC to issue a Health Alert on September 11, 2015, to all healthcare facilities that use reusable medical devices urging them to “immediately review current reprocessing practices at their facility to ensure they (1) are complying with all steps as directed by the device manufacturers, and (2) have in place appropriate policies and procedures that are consistent with current standards and guidelines.”3 

Lastly, we highlighted best practice steps for reprocessing reusable medical devices from the AAMI standards,4 AORN recommendations,5 and CDC guidelines6 referenced below. Starting at point of use (POI), the purpose of this final article is to discuss these best practice steps in more detail, along with describing some common errors with reprocessing reusable medical devices. 

Point of Use: All instruments should be kept free of gross soil during surgical procedures as blood, body fluids, and saline can damage instruments and, if allowed to dry, be difficult to remove during the decontamination process. Some common errors include failure to wipe off gross soil or flush lumens with sterile water during the procedure, and failure to use a presoak solution on soiled items prior to transport.

Transport: All instruments opened during a surgical procedure should be considered contaminated and properly contained for transport to prevent damage as well as exposure or injury to personnel and patients. Some common errors include transporting items in or on an open cart or in an open container, no biohazard symbols on transport cart or containers, and taking rigid containers to the clean area to be wiped versus decontamination for proper cleaning per their IFU.

Decontamination: Decontamination is the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and are rendered safe for handling, use, or disposal. Some common errors include not donning or doffing PPE properly, not having all the manufacturer’s IFUs or not following the manufacturer’s IFUs, testing some, but not all mechanical cleaners.

Prep & Pack: Careful inspection and assembly of all surgical instruments prior to packaging is important. A dirty or nonfunctioning instrument is a patient safety issue and should never be used. Some common errors include not inspecting 100% of instruments, cleaning instruments or rigid containers on the clean side, assembling hinged instruments in the closed position, using nonvalidated materials (i.e., marking pens, sterilization tape or wrap inside trays, count peel pouches or sheets inside wrapped trays), and trays exceeding 25 pounds.

Sterilization & Storage: Steam sterilization should be considered the process of choice over all other sterilization processes, where possible. For heat- and moisture-sensitive instruments, a variety of low temperature sterilization processes area available. The instrument manufacturer’s validated IFU must be followed when selecting the sterilization method and cycle parameters. Some common errors include improper loading of sterilizers, selecting incorrect sterilization mode or parameters, not enough dry time for type of load, not allowing steam sterilized items enough time to cool, dust or other contaminants in sterile storage area, and stacking heavy wrapped trays on top of each other.

Sterilization Quality Assurance: Sterilization quality assurance should be documented through the use of physical, chemical, and biological indicators. Sterilization records should be maintained in compliance with local, state and federal regulations. Some common errors include failure to review and initial sterilizer chart after each load, failure to test sterilizers with proper process challenge devices (PCDs), and forgetting to put one or more chemical indicators inside each pack.

Following these best practice steps not only protects patients and helps to maintain your accreditation, it also keeps your healthcare facility out of the local, regional, and national news regarding improper medical device reprocessing.

References:

  1. CDC.gov/hai/data
  2. TODAY Investigates: “Dirty surgical instruments a problem in the OR.” 2012. Accessed July 7, 2020. https://www.today.com/health/today-investigates-dirty-surgical-instruments-problem-or-1C9382187
  3. CDC Health Advisory, issued September 11, 2015. Accessed October 6, 2020. https://emergency.cdc.gov/han/han00382.asp
  4. ANSI/AAMI (American National Standards Institute/Association for the Advancement of Medical Instrumentation). 2017. ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Arlington, VA: AAMI.
  5. AORN (Association of periOperative Registered Nurses). 2019. Guidelines for Perioperative Practice. Denver, CO: AORN.
  6. CDC (Centers for Disease Control and Prevention). Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. Atlanta, GA: CDC.

Chuck Hughes is principal and lead educator for HIGHPOWER Validation Testing & Lab Services, Inc. based in Rochester, NY. He has been in the manufacturing industry for 25+ years in areas of regulatory affairs, R&D, marketing, microbiology, and sterilization training. He serves on numerous AAMI working groups and is a popular speaker at local, regional, national, and international conferences. To find out more about HIGHPOWER Labs, go to: www.HighpowerVTLS.com. Chuck can be contacted at NYchuckhughes@gmail.com.

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