Medical Dealer, a magazine published by MD Publishing, quickly gathered industry experts to discuss the recent FDA docket, “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments.”
Medical device experts from a range of backgrounds joined Medical Dealer on a conference call to discuss the docket on March 16.
MD Publishing President and Founder John Krieg described the teleconference as “a preliminary call to discuss key points and gain input.” MD Publishing also plans to host a special free webinar on this important topic on March 31.
The teleconference included AAMI President and CEO Mary Logan, ECRI Institute staff members and a several representatives from third-party and independent service organizations.
Dave Francour from Sodexo served as co-moderator along with Krieg. Industry veterans joining the call to share their insights included Manny Roman; Ira Lapides from RPI; Matt Tomory and Mark Conrad from Conquest Imaging; Wanda Legate from Tri-Imaging Solutions; and Rick Staab from The InterMed Group. Representatives from hospitals and health care systems were also on the call including Chris Nowak and Doug Dreps.
The goal of the teleconference was to gather information and encourage industry professionals to submit comments prior to the May 3 deadline. Experts also shared their thoughts regarding what they believe to be the reasons for FDA’s decision to open this docket as well as the FDA’s perceived goals and how it could effect the different segments of the health care community.
A FDA press release announcing the opening of the docket stated patient safety as the reason for seeking comments.
“The FDA is taking this action, in part, because various stakeholders have expressed concerns about the quality, safety, and continued effectiveness of medical devices that have been subject to one or more of these activities when performed by both original equipment manufacturers and third parties, including health care establishments,” according to the FDA press release.
The special webinar on the FDA docket is set for March 31. For more information or to register for the free webinar, visit https://1technation.com/registration-special-fda-webinar-medical-equipment-sales-service-industry/.
In addition, MD Expo Dallas will feature a special panel discussion on the FDA docket.
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