The upside
It’s Logan’s hope that this docket raises the awareness of hospitals that they should pay attention to the qualifications of people who do the work. She believes that they should care about that as much as they do about their nurses and physicians, because the serviced medical devices are ultimately going to diagnose, treat and keep patients alive. IAMERS’ Upton believes that one of the good things to come out of this is that it will better define what people do, whether they are a third-party servicer, remanufacturer, broker, etc. She is hoping that will solve a crucial problem.

“Part of the problem here — perhaps the definitions will help with the solution — is that the OEMs are not always forthcoming with service information, so that changes the dynamic,” says Upton. “If you want to be trained and you want to do in-house service, you’re denied access to software and things like that.”
Submit your comments
“My biggest fear is that people won’t submit detailed comments and the FDA won’t have a full picture,” says Logan. Some of the comments that have been made so far share a theme: ISOs and HTMs have done well in this business for many years and they don’t need more regulation. But Logan thinks those comments won’t help the FDA understand this business. To help with this, AAMI has issued a series of talking points that give advice on how to respond so the FDA can get the most useful information.

“I’m confident that the FDA has the right motives, wants to understand the business, and if they uncover serious problems, then they will search for the right solution to address those problems and be a part of the process that leads to whatever the final solutions are,” says Logan. If you would like to comment go to: dotmed.com/fdadocket.

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