AAMI guidance aims to revamp medical device IFUs

March 16, 2021

Medical device manufacturers, regulators, and healthcare technology management (HTM) experts recently helped develop the updated technical information report, TIR12:2020, Designing, testing, and labeling medical devices intended for processing by healthcare facilities: A guide for device manufacturers, standardizes manufacturer instructions for use (IFU) for the processing of clinically used medical devices and helps manufacturers understand how well the end users comprehend a device’s instructions and labeling.

“Regulators have been pushing the message that end users need to follow manufacturer instructions, saying ‘Don’t make it up yourself.’ But when users look at an IFU, it can be confusing or incomplete,” explained Damien Berg, a regional manager of sterile processing at University of Colorado Health and past president of IAHCSMM.

Berg co-chaired the AAMI working group that completely revamped TIR12, creating its new 2020 version. The working group determined early on that even though manufacturers and test labs have been validating IFUs all along, the conditions and terminology that they have used were not always an “apples-to-apples" comparison to the rapidly changing environment that is the clinical setting.

“It's a much cleaner and easier to read reference document for the manufacturers,” Berg said. “In turn, the hope is that this will allow them to get their product through the FDA easier and quicker. Then I as an end user get to use their product with clear instructions. It all comes down to proactively reducing confusion for my staff.”

Initially, sterile processing managers and device manufacturers worked at this problem from different directions, added AAMI working group co-chair Ralph Basile, vice president of marketing and regulatory affairs for Healthmark Industries Company, Inc.

“A number of manufacturers were going through the process of rewriting their IFUs alone. They were saying, ‘If we can't figure this out, how are customers supposed to do it?’ Around that time, the working group had turned its attention towards standardizing IFUs, so the manufacturers shared what they had,” Basile said. “We got end-users, testing labs, and even the FDA involved and that really got this whole effort going.”

In 2017, there was an update of the standard ANSI/AAMI/ISO 17664, Processing of healthcare products—Information to be provided by the medical device manufacturer for the processing of medical devices, which details what information must be provided to healthcare facilities (including instructions for pre-treatment, cleaning, disinfection, drying, inspection, maintenance and functionality testing, and packaging). It also describes the validation testing that needs to be conducted to ensure each of these processes is suitable for the device.

Three years after ISO 17664 was published, TIR12 now ensures that manufacturers not only know what information they need to provide, but also how to provide it.

AAMI has the release.