If you can remember back as far as October 2016, you will recall that the FDA held hearings on “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers”…

The purpose of the hearings to determine “are independent service organizations and inhouse biomedical personnel qualified to work on OEM equipment”?

Some people considered this “round 2” of the war between ISO’s and OEM’s for the right to service OEM equipment.

Well the FDA has now issued their report.  Basically, they don’t feel there is much reason to change the staus quo.

…but you be the judge and click below to read more.

According to a summary by Diana Upton and Robert Kerwin of IAMERS, the FDA’s key conclusions were:

  • The currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern relating to servicing of medical devices, including by third-party servicers, that would justify imposing additional/different burdensome regulatory requirements at this time.
  • The FDA does not believe that additional formal regulatory action is warranted, based on available information and findings.
  • The FDA nonetheless intends to pursue the adoption of quality management principles and clarify the difference between servicing and remanufacturing.
  • The FDA intends to strengthen cybersecurity practices associated with servicing of medical devices; and
  • The FDA intends to foster evidence development to assess the quality, safety and effectiveness of medical device servicing.

Seems the score is OEM’s – 0 and ISO’s 2.   I’d argue that in the end everyone: ISO’s, dealers, equipment owners, patients and even the FDA, wins.

Here’s a link to the DOTMED article – click here

Here’s a link to the FDA report – click here