At least once in your Sterile Processing career, you will be asked to process items that do not have a manufacturer’s validation for surgical procedure usage. What, No “Manufacture Instructions for Use” (MIFU). We know this happens with Single-Use Devices (SUD’s), like toothpicks, baby blankets, and the unsterile 4×4’s. But this situation might pop up in other ways.In my past life as a surgical scrub nurse, I was asked to “flash” an instrument the surgeon made in his garage. We all know that we should not be sterilizing items that have no IFU, yet what if the item is on the count sheet and the surgical team NEEDS it? Thankfully, many of us use SUD’s that have been packaged and sterilized. But what options do we have with those “other” items? 

Although ANSI/AAMI ST 79 does not reference SUDs, they do refer to the FDA which states “Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals; Final Guidance for Industry”, with the definition: “A single-use device, also referred to as a disposable device, intended for use on one patient during a single procedure. It is not intended to be reprocessed (cleaned, disinfected/sterilized) and used on another patient…”

There are many best practices techniques that Sterile Processing professionals usually perform well, yet as Advantage Support educators teach to provide the rationales for techniques, we find the rationales for these techniques may not be as well known to technicians performing the tasks. As processing professionals, we can only assure our customers, usually the Operating Room staff and our patients, that the items delivered and used in a surgical procedure are processed, cleaned, decontaminated, and sterilized according to the MIFU because we have been versed in the science of sterilization.

For an item to be validated and marketed by a manufacturer, the FDA requires it contain information that can assure patient safety and effectiveness. The manufacturer must apply for premarket approval (PMA) and the item will be subject to an exhaustive scientific review (see section 515(a) of the Act, and a premarket notification submission 510(k)). The outcome of this process is a MIFU that assures users the item will meet necessary standards. 

But what about those rare occasions when you have an item without an IFU. You may not have time to find an alternate solution or may hesitate to tell the surgical team that your department cannot process an unvalidated item/instrument. The FDA provides a “heads up” warning about this situation: “The hospital is responsible for ensuring that the device complies with all applicable FDA labeling requirements, even if the device is exempt from the premarket requirements. If the hospital does not ensure the device complies with FDA labeling requirements, the device is misbranded, and the hospital may be considered responsible for causing the misbranding of the device in violation of section 301(k) of the Act.”

Although many departments are following the FDA guidelines, there are some solutions for reprocessing SUDs. Advantage Support Services suggests utilizing the services of a third-party reprocessing vendor. Another suggestion is utilizing services from a company that can develop an IFU for that “one-off” item. Ultimately, the most sustainable solution is to inventory those SUDs mentioned earlier and meet with your facility’s multidisciplinary team, further enhancing your best practices. 

Time spent evaluating inventory and creating protocols regarding SUDs is time well spent. Bioseal remains available to assist in determining the best option for your organization. As surgical service professionals and vendors, we all desire to serve our customers and patients well. 


ANSI/AAMI ST79: 2017: Comprehensive guide to steam sterilization and sterility assurance in health care facilities

Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals; Final Guidance for Industry


Written by: Angela Llewelyn LPN CRCST CHL

Director of Development & Research

Advantage Support Services, Inc. 

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