No IFUs? Pt. 2

What About Loaner Instruments & Items That Do Not Have An IFU?(Part II)

In Part I of this blog post we began looking into the problems and issues that occur when trying to reprocess items that do not have IFU. The challenge 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 an IFU, much less a validated IFU?

The recurring problem of devices with no IFUs prompted a question by a member recently on AAMI’s Members Discussion Group regarding the ability to test and document reprocessing using product evaluation AAMI 15.1 (multi-functional team) and verification testing procedure AAMI 13.94 for devices that don't have IFUs.1

An AAMI member responded to the question with a suggestion to contact the FDA through the MDR procedure or file a complaint with the manufacturer regarding the lack of manufacturer-provided IFU for the items as a better route than trying to conduct internal testing.2

The original poster clarified that he was wanting a standard to validate work instructions for the process (work flow, etc.) and not to validate the IFUs themselves - i.e. process validation and not product (IFU) validation.

The responder then suggested that it could be done using validation principles that require three repeated tests. The purpose of this would be to confirm that already-validated IFUs by the manufacturer work in a particular facility setting. She suggested some standards to consider including ANSI/AAMI ISO 17665, 11135 and 11137 series standards as well as to consult with experts knowledgeable in those standards.

To summarize, process validation is something that can and should be done by a facility but product validation should be done by the device manufacturer.

Thanks go out to the posters Donna and Eddie for some excellent points and recommendations. 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.

The best was to minimize problems and protect your patients from unnecessary risk is to always demand validated IFUs from your suppliers.

1. “AAMI Members Discussion Group” January 22, 2019 by Eddie

2. “AAMI Members Discussion Group” January 22, 2019 by Donna

3. “AAMI Members Discussion Group” February 7, 2019

4. Op. Cite.