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Meeting third-party stakeholders halfway: Service after the FDA report

por Gus Iversen, Editor in Chief | August 07, 2018
HTM Parts And Service
From the August 2018 issue of HealthCare Business News magazine

Scot Mackeil and Rob Kerwin are two very different people with very different backgrounds. For 23 years, Kerwin has been general counsel to the ISO trade association IAMERS, and testified before Congress on ISO issues. Mackeil is a veteran biomedical engineer and current AAMI and GE Healthcare “BMET of the Year”.

Despite their differences, the FDA’s investigation (and subsequent report) on third-party service, and new initiatives to introduce service legislation like HR 2118, have given Kerwin and Mackeil a common cause: more efficient relationships with equipment manufacturers that will not compromise market competition or patient safety. Healthcare Business News sat down with the two of them to find out more.

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Rob Kerwin
HCB News: What would you say were the key findings in the FDA's recent report on third-party service?
Rob Kerwin: There were four top takeaways that the FDA highlighted in their report. The FDA does not recommend additional regulation of servicers of medical equipment. The FDA does not believe that additional regulatory action is warranted based on the available information and findings. The FDA found evidence of “high quality servicing.” The FDA noted that third part servicers are “critical” to the health care ecosystem.

Scot Mackeil: I think it’s important that I begin by saying my views on this matter are my own, and in no way represent the views of my employer. For me, the report indicates the FDA has heard, seen and recognizes the concerns of the HTM, ISO and OEM segments of the healthcare industry and the talking points that came up at the workshop in October 2016.

In the light of the report, equipment manufacturers lobbyists can no longer point to a “serious threat” to public safety in their efforts to stifle right to repair legislation or advocating for legislation like HR 2118.

HTM was also invited to "step up its game" in certain ways in the report, something I think should be done with alacrity and speed. Standards development is underway, but adoption and implementation are another matter. It is one thing to design and write tomorrow's standards and procedures, it’s another to get them into practice. I think the FDA's collaborative communities offer is outstanding and something all stakeholders should embrace. Based on what I saw at AAMI 2018, I have great expectations and a feeling that we will all be stronger together.

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