Medical device manufacturers, regulators and healthcare technology management (HTM) experts recently joined forces to solve a long-standing issue for medical device processing: confusing instructions for use (IFUs). These essential instructions explain how to properly clean, disinfect, sterilize and make the device ready for use on the next patient.
This updated technical information report, TIR12:2020, Designing, testing and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers, standardizes manufacturer IFUs 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.
To create more sensical instructions and labeling, manufacturers would need a way to reference the tools, terminology and expectations of device users and regulators alike. This is where the new report comes in.
“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.”
An important milestone was the 2017 update of the standard ANSI/AAMI/ISO 17664, Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices, which details what information must be provided to health care facilities (including instructions for pretreatment, 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.
“This was an amazing collaboration of end users, manufacturers and testing labs. At one point we were comparing hundreds of different IFUs, figuring out what the commonalities were and where the gaps were,” said Berg. “Now, we’re approaching a point where we all say, ‘follow the manufacturer’s instructions’ with confidence!”
The FDA’s Center for Devices and Radiological Health (CDRH) and its priorities were “overwhelmed” and “disrupted” by COVID-19 and the massive increase of work that resulted – but there is hope that the coming year will provide a “reset” for delayed work to begin while still managing the COVID-19 response. That’s according to a call between AAMI and Jeffrey Shuren, director of FDA’s Center for Devices and Radiologic Health (CDRH) and Alliance for a Stronger FDA.
COVID-19 “essentially disrupted the trajectory of the medical device program in 2020” delaying much of CDRH’s work while the agency dealt with emergency use authorizations (EUAs) and that the pandemic-related work likely cut down on the number of new technologies aiming for launch in 2020, Shuren said. The “reset” will give CDRH an opportunity to learn from its COVID-19 pandemic experience, as Shuren outlined his hopes, expectations and priorities for 2021 despite the “ripple effect” from COVID-19 related work. These include:
Shuren concluded by saying that they hoped to further manage the COVID-19 work but also move forward with projects unrelated to the pandemic that had to be placed on the “back burner.” However, he noted that 2021 will also be busy as developers seek full marketing approval for COVID-19 devices. He also emphasized addressing MDUFA V as a top priority because those fees that enable FDA to work faster on reviews and authorizations.
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