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Seeking clarity on medical device instructions for use

by Lauren Dubinsky, Senior Reporter | May 04, 2021
From the May 2021 issue of HealthCare Business News magazine

Also, when manufacturers create and validate IFUs, they work in silos. This leads to a situation where devices of similar construction and design can vary quite a bit in the specific steps called out in the IFU, explained Basile.

To make things worse, sterile processing managers and device manufacturers have been working to solve this problem from different directions. In an effort to streamline, the managers have developed their own ways of categorizing medical devices so that the devices in each category undergo the same reprocessing steps.

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“Coincidentally, at about the same time, many of the largest medical device manufacturers, in reviewing their vast portfolio of instruments, sought to categorize their devices by the required steps of cleaning in an effort to standardize and streamline their IFUs,” said Basile.

The AAMI ST/WG12 Instructions for Reusable Device Reprocessing Working Group managed to bring together all industry stakeholders to achieve much-needed standardization.

The new and improved TIR12
In 2015, the FDA published an update to its guidelines for medical device reprocessing, which included much more attention and detail related to cleaning.

“This document, which tells manufacturers the information they need to supply to healthcare facilities, and what testing they need to do to validate those instructions, was significantly ‘beefed up’ from the document it replaced,” said Basile.

The FDA made another revision to the document in 2017 to identify specific device designs that are especially challenging to clean, that would require more testing to validate cleaning instructions.

A separate document, ANSI/AAMI/ISO 17664, was also published in 2017 to establish requirements for reprocessing instructions. It outlines what information needs to be provided to healthcare facilities in terms of instructions for pre-treatment, cleaning, disinfection, drying, inspection, maintenance and functionality testing, and packaging.

It also described that validation testing that is required to ensure that each of the processes are suitable for the devices.

“With updates to these two documents, TIR12 was recast from being a quasi-standard, with much in the way of recommendations related to cleaning, to acting as a guidance document for [manufacturers] as to how to comply with 17664 and the FDA document,” said Basile.

This TIR12 was a major update to a 2010 version of the document. It now tells manufacturers what information needs to be in IFUs as well as how to properly provide that information.

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