Reprocessing Reusable Medical Devices: Standards, Recommendations, and Guidelines, part 2
This second 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.
In the first article, 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 discussed 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 how adherence to reprocessing best practices ensures patient safety as one of our greatest threats is healthcare-associated infections (HAIs).1 While improperly reprocessed medical devices are not the leading cause of HAIs, it has been documented by the CDC and reported in the national media as one of the causes. For this reason, compliance with best practices as detailed in national standards, recommendations, and guidelines is critical for patient safety, for maintaining your healthcare facility’s accreditation, and to keep your facility out of the national news. Compliance not just some of the time, not most of the time, but all of the time.
Unfortunately, breaches do occur 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 9/11/2015 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 This CDC Health Alert raised a number of issues regarding sterilization and/or high-level disinfection (HLD), such as:
- Are all reprocessing personnel properly trained?
- Do you provide regular audits of personnel and processes?
- Are policies and procedures consistent with current standards?
- Do you have all your device manufacturers’ IFUs?
- What is your policy regarding conflicting IFUs?
- Do you have the necessary resources to comply with all IFUs?
In the past, many healthcare facilities struggled to secure IFUs and keep them up to date. Fortunately, most medical device manufacturers now provide them with each purchase, or post them on their websites and make them available upon request. Another popular option is to hire a company to do the search for you and keep the IFUs up to date. For an annual fee, the company provides you with an internet based library with electronic copies that can be printed out. Special note: According to the FDA, “reprocessing instructions for some older, legally marketed, reusable devices may not be consistent with state-of-the-art science and therefore may not ensure that device is clean, disinfected, or sterile. It is incumbent upon the device manufacturer to provide sufficient instructions on how to prepare devices for use on the next patient.”4
Now let’s highlight best practices for reprocessing reusable medical devices from the referenced AAMI Standards5, AORN Recommendations6 and CDC Guidelines7 stated in the first article. Starting at point of use (POI), reusable medical devices should be kept free of gross soil during the surgical procedures as blood, body fluids, and saline can damage instruments and if allowed to dry, become difficult to remove during the decontamination process. All instruments opened during the surgical procedure should be considered contaminated and properly contained for transport to prevent damage, as well as exposure or injury to personnel and patients. Decontamination should occur immediately after the surgical procedure to prevent soil from drying and the formation of biofilms. The instrument manufacturer’s IFU should be available and followed.
On the clean side, it is important to carefully inspect and assemble surgical instruments prior to packaging. A dirty or nonfunctioning instrument is a patient safety issue and should never be used. Packaging systems must be validated for the intended sterilization process and used according to the manufacturer’s IFU. Steam sterilization is considered the process of choice over all other sterilization processes. The instrument manufacturer’s validated IFU must be followed when selecting the method of steam sterilization and cycle parameters. Always load steam sterilizers with lighter items on top and heavier items below. Peel pouches, basins, and instrument trays with solid bottoms should be placed on edge facing the same direction on the sterilizer shelf or cart. Rigid containers and wrapped trays using perforated bottoms should be placed flat on the sterilizer shelf or cart. Never place items directly on or against the sterilizer chamber. Steam sterilized items should not be touched until they have cooled to 78oF/26oC, as this is the maximum recommended storage temperature. Special note: A handheld temperature laser sensor can be used to verify pack temperature.
For heat- and moisture-sensitive devices, a variety of low-temperature sterilization processes is available. The instrument manufacturer’s validated IFU must be followed when selecting the method and cycle parameters. Open shelving may be used for storage of sterilized items and should be 2″ from outside walls, 8–10″ from the floor and 18″ from ceiling fixture. Packaged sterile items should not be crunched, bent, compressed, punctured or near any location that could become wet. Special note: Wrapped trays should not be stacked, as this causes compression, whereas rigid containers are designed to be stacked.
Sterilization quality assurance must be documented through the use of physical, chemical, and biological indicators. Sterilization records should be maintained in compliance with local, state and federal regulations. Sterilizers that fail any of the quality assurance tests should be reported immediately to a supervisor and all test results reviewed. The load should be reprocessed and the sterilizer retested.
In the next article, we will discuss these highlighted best practices in more detail, along with some common errors in the reprocessing of reusable medical devices. Until then, please remember that while accreditation organizations are looking for strict compliance with standards, recommendations, and guidelines during your survey, your goal must be 100% compliance each and every day because behind every instrument is a patient!
- 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
- CDC Health Advisory, issued September 11, 2015. Accessed July 7, 2020. https://emergency.cdc.gov/han/han00382.asp
- FDA Alert, issued 4/23/2018
- AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities. 2017.
- AORN Guidelines for Perioperative Practice. 2019.
- CDC Disinfection and Sterilization in Healthcare. 2008.
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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