By Keri Forsythe-Stephens

Suffice it to say that it’s been an eventful few months in the healthcare technology management (HTM) sector. To start, some sad news. 24×7’s editorial board member­—and a true legend in the HTM community—Patrick Lynch passed away on March 1 after a lengthy battle with pancreatic cancer.

Pat was larger than life, certainly larger than the cancer that he grappled with for years, and his absence leaves a gaping hole in the industry. HTM’s self-professed “Chief Do-Gooder,” who dedicated his life to serving others via his nonprofit organization Biomeds Without Borders, as well as his various biomed posts, Pat always advocated for others. And his passion for the field was unmatched, in my opinion.

Keri Forsythe-Stephens, Chief Editor

“I’ve done a lot of things in my career, and I’m very outspoken and I’ve probably made every single mistake that could possibly be made in this profession,” Lynch told 24×7 in 2019. “And my job as Chief Do-Gooder is to share those mistakes that I’ve made with others so that they don’t have to make them.”

Pat also wrote an article for 24×7 several years ago—“The Great Wait: Will the FDA Increase Service Regulations?”—that couldn’t be timelier. 

While Pat didn’t live to see it, the FDA recently issued final guidance on medical device remanufacturing, clearing up industry ambiguities. This guidance expands on the June 2021 draft, “Remanufacturing of Medical Devices Draft Guidance,” and includes feedback from the public commentary period. 

Specifically, the FDA clarified that “remanufacturing” involves activities that significantly alter a reusable device’s performance, safety, or intended use, while “servicing” covers routine maintenance.

Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, believes these clarifications have big implications for the medical device sector. “Today’s action represents an important step forward in our mission to assure continued patient access to high-quality, safe and effective medical devices,” Shuren says. “This guidance provides important clarity on defining remanufacturing and helps to remove perceived barriers to obtaining repair or maintenance of a device if it does not alter the safety, performance or intended use.”

I wonder what Pat would think—and I wonder what you all think too. Please e-mail me your reactions to the FDA’s final guidance at [email protected].

Keri Forsythe-Stephens is chief editor of 24×7.