By Keri Forsythe-Stephens
They say it’s about the journey, not the destination. Well, whoever “they” are, it’s unlikely that they’ve ever been stuck at the Atlanta airport for nearly 10 hours. But alas, that was the situation I found myself in as I tried to make my way to Cleveland for the AAMI Exchange conference earlier this month.
I had high hopes of flying in early in the morning—while most of Cleveland slept—and walking into the conference center after a leisurely breakfast. Instead, I waited at the terminal…and waited. And waited. The airline workers said it was a historic day at the airport, with unprecedented delays.
Although I finally made it to Cleveland, albeit after the show ended for the day, my memories of AAMI Exchange 2019 will forever be marred by my travel woes. (Let’s just say that AAMI Exchange 2019 will forever be known as “The Conference Where I Spent More Time in the Atlanta Airport Than the Exhibit Hall.”) But despite my personal disappointments—and they were numerous—AAMI Exchange 2019 was a success from an industry standpoint.
One of the biggest announcements to come out of AAMI Exchange 2019 was the revelation by the Center for Devices and Radiological Health’s Dr. Katelyn Bittleman that the FDA is planning to publish a draft guidance on medical device servicing by this fall.
Distinguishing between medical device servicing and remanufacturing has been a hot—and contentious—topic in the HTM sector, and the FDA draft guidance will cap off a debate that began in 2017. (In May 2018, the FDA said there was insufficient evidence to “justify imposing additional/different burdensome regulatory requirements” on third-party servicers of medical devices; five months later, the agency published a white paper titled, “Evaluating Whether Activities are Servicing or Remanufacturing.”)
So, what the draft guidance says is anybody’s guess, although it will likely reflect—at least in part—the discussion that took place at December’s public workshop regarding the issue.
In addition to Dr. Bittleman’s revelation about the FDA’s next moves, 24×7 Magazine also made a big “reveal” at AAMI Exchange 2019. We have a new publisher! Meet Randy Knotts, a veteran of the healthcare IT space who will no doubt make a great addition to the team. Please give him a big HTM welcome and feel free to reach out to him at firstname.lastname@example.org. And, Randy, I’m glad I finally made it to Cleveland to meet you in person.
Keri Forsythe-Stephens is chief editor of 24×7 Magazine. Questions and comments can be directed to email@example.com.