The FDA announced on March 4, 2016 that they are seeking input about, among other things, people and companies who service medical equipment other than the original manufacturers. They cite anonymous sources that have expressed concern about the quality of the work performed. The FDA is accepting comments until May 3 on this topic.
I strongly suspect that the “ANONYMOUS” concerned sources are the ones who have lots of money to gain from putting in-house biomeds, third party repairers, national ISOs and anybody else who is repairing medical equipment our of business. I know for a fact that there are no safety issues surrounding the servicing of medical equipment by in-house,m ISO, third party, or anyone else. The motivation for this has got to be financial.
MD Publishing (TechNation) is assembling a group is industry leaders (I will be there) to discuss this issue and make suggestions to the biomedical community. There will be a Webinar hosted by TechNation on March 31, which all will be open to all biomedical associations and interested individuals.
In the meantime, the original FDA memorandum is reproduced below for your perusal. I encourage you to begin thinking about drafting a letter to the FDA explaining why this limiting medical equipment service to manufacturers-only would not be a good idea for the hospital, the patient, the nation, the cost of healthcare, or anyone else but the manufacturers themselves. We need to explain that there are currently no safety issues with third parties or in-house service, and that faster response time and lower cost and increased uptime actually improves patient care.
Also, very important, begin thinking about how to bring political pressure into this fight. We need people other than biomeds and ISOs telling the story of how this rule, if it passes, can cripple healthcare, raise costs, and hurt patient care.
CLICK HEREto go to the Federal Register to download the original document
Patrick Lynch, CHTM, CBET, CCE