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Seeking clarity on medical device instructions for use

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

Medical device reprocessing instructions for use (IFUs) have historically been a point of confusion for the healthcare industry due to variability in how they are written. The root of this problem was a lack of standardization.

The FDA did provide information on what should be included in an IFU, such as cleaning and sterilizing instructions, but there was no rigor around how to format it. As a result, similar medical devices from different companies often came with very different IFUs.

Recently, AAMI had a group of medical device manufacturers, regulators and health technology management experts convene to solve this problem. The group’s solution is an updated technical information report (TIR) called TIR12 that standardizes the way to reference the tools, terminology and expectations of device users and regulators in IFUs.

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Damien Berg
“Following the IFU could be confusing because up until now, there was kind of a hodgepodge of different ways of writing them,” said Damien Berg, co-chair of this AAMI working group and manager of sterile processing at the University of Colorado Health.

Berg considers TIRs a “lite” version of a standard, which means that it offers guidance and recommendations, but it’s not a requirement.

His job is to “enlighten manufacturers who may have missed the mark on previous older editions of IFUs.” He’s had manufacturers revalidate their IFUs and resubmit them through the FDA after reviewing a TIR.

Why the confusion?
According to Ralph Basile, vice president of marketing and regulatory affairs for Healthmark Industries Company Inc., there are many reasons why IFUs have been confusing. However, all of the reasons boil down to one word: complexity.

Minimally invasive surgical instruments started to gain popularity in the 1980s. These devices are very beneficial to patients, but due to their small moving parts and lumens, it’s challenging to clean them.

“A related issue is the sheer diversity of devices, in many cases, requiring unique steps for cleaning,” said Basile. “It is a huge challenge, therefore, for sterile processing departments to train staff, to have the right equipment on hand, and to design a reprocessing system that is productive.”

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