No IFUs?

What About Loaner Instruments and Items That Do Not Have IFU? In 2018 the FDA approved more 510(k) submissions for new medical devices than in any previous year.¹ A significant number of those new approvals were for surgical instruments that are designed for use in complex surgical procedures. The good news is that all of those new devices had their cleaning instructions for use (IFUs) validated by independent laboratory testing prior to approval by the FDA. The problem that CS/SPD departments face almost daily is what to do about all of those items and instruments, especially loaner instruments and sets, that do not have IFU, much less a validated IFU. Prior to 2015, the FDA did not require manufacturers to provide validated cleaning IFUs with their new product approval submissions. The recurring problem of devices with no IFUs prompted a question recently on AAMI’s Members Discussion Group. Eddie in the discussion group had a question about using Sterrad® to sterilize an instrument even if the device manufacturer does not list that as an option in the IFU for that product.  He was wondering if he could use the new product evaluation AAMI 15.1 (multi-functional team) and then verification testing procedure AAMI 13.94 to test and document his idea to Sterrad® the item. He also asked about being able to do this in a similar situation if the item does not have an IFU at all.² Donna, an AAMI member responded to the question with some insightful comments, noting that ANSI/AAMI ST79 13.9.4 (verification testing procedure) is for product quality assurance (PQA) testing where a facility is verifying that the manufacturer's IFU work at a specific facility. But that requires that the IFU exist in the first place. She suggested that validation testing is what is needed in the case that the IFU don't exist, but that is a more involved process that is typically not done in the hospital but rather an independent testing lab. Also, even if able to be validated through a lab, since the manufacturer is not endorsing those IFU, the item warranty may be voided. Most hospitals would not undertake this testing anyways due to the risk and cost. She ultimately suggested that the best way to proceed in cases where no IFU is available is to ask the manufacturer. If the manufacturer can't provide adequate IFU, there are options to notify the FDA about the problem through the Medical Device Reporting (MDR) procedure.³ Thanks go out to Donna for very thorough, informative response to Eddie’s questions. All CS/SPD departments routinely face the challenge presented by an item or device that does not have an IFU, much less an IFU that has been validated by an independent testing laboratory. As Donna’s conclusion points out, it is impractical, if not impossible, for a hospital to perform its own product validations (time, labor, liability, risk, etc.). 1. www.fda.gov 2. “AAMI Members Discussion Group” January 22, 2019. 3. Op. Cite.