Third-party vendors, ISOs and health technology management professionals have expressed mixed feelings regarding a docket the FDA has opened seeking comments from anyone with insights on the refurbishing and servicing of medical equipment by non-OEMs.

Some stakeholders view the docket as a sign that increased regulations may be arriving soon to disrupt their business. Others have expressed hope that it will usher in an era of greater transparency across the board — with more validated options for end-users and improved cooperation between OEMs and reputable third-party entities.

The FDA's interest in the topic was sparked, according to the docket, in response to safety concerns that had been brought to its attention. While recent headlines — issues with duodenoscope reprocessing or patients being over-exposed to radiation, for example — have stirred the public interest, most third-party organizations contend that their safety records speak for themselves and are only hampered by a manufacturing industry that does not always communicate effectively with them.
Still, whatever position one takes, all parties involved (OEMs, third-parties, end users and the FDA) share an ultimate interest in patient safety. Therefore, some third-party stakeholders see this as an opportunity to educate the FDA and the OEMs on the value they bring to hospitals.

Currently there are 18 comments on the docket, 17 of which were issued publicly.

The docket took center stage in a webinar hosted by MD Publishing yesterday afternoon, in which a number of experts weighed in — not only on what the implications could be, but how stakeholders should frame their contributions.

The panel stressed that people should not read between the lines or reply defensively to the docket's questions. Mary Logan, president and CEO of AAMI, praised the FDA's point-of-contact for the docket, Valerie Flournoy, as a thoughtful and thorough person with a strong track record.

HCB News reached out to Flournoy for comment but did not receive an immediate response.

“We are urging everyone to provide responses,” said Logan, “Don’t say, ‘stay out of our business’ or ‘there’s no problem here,’ they want to read and listen and get the best information they can.”

AAMI has also issued talking points to help interested parties figure out which questions in the docket are applicable to them, as well as "food for thought" to help maximize the value of their answers.

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