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

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

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


HCB News: What do you think the next few months will hold in relation to these matters?
Rob Kerwin: Sadly, we understand there will be renewed legislative and regulatory efforts on the part of manufacturers’ trade associates such as MITA. They are also reaching out to the medical device community and seeking to establish a standard for the servicing of all medical equipment. We are wondering how they can effectively pursue these dual objectives and permit, during the standards development process, an unfettered discussion of all the ‘elephants in the room’ such as access to service keys by independent and in-house servicers.

Scot Mackeil: Yes, I agree with Rob. HTM/ISO absolutely should not underestimate the trade association lobbyists and their determination to shape the regulatory landscape to suit their client’s global business objectives. I believe HTM has heard the FDA loud and clear and that we will not only meet but exceed the expectations set forth in the report. There has recently been a lot of constructive dialogue between HTM ISO, OEM and FDA, and that level of communication is exactly what this situation calls for.

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HCB News: What advice do you have for biomeds and third-party servicers who want their voices heard in this ongoing conversation?
Rob Kerwin: Outreach really should be occurring with your state and federal representatives. Get your colleagues to write!

Scot Mackeil: Yes! All segments of the HTM community, from regional associations, individual BMETs, the ISO employees and others need to become politically active and contact their legislators in support of right to repair laws and against HR 2118. Reach out and let your C-suites, coworkers and caregivers know what is going on, and ask for their support as well.

HCB News: What does this whole conversation boil down to? Is there a bottom line that gets lost in the discussion?
Rob Kerwin: Let’s seriously consider adopting the FDA’s suggestion of “collaborative communities”, where important dialogues could take place between and among all stakeholders. IAMERS would welcome the opportunity to participate. If it’s truly about patient safety then there should be more collaboration and less finger pointing. It shouldn’t be “days” before a servicer is able simply to receive a manual or obtain an IP address.

Scot Mackeil: Again, I would say the key takeaway is to look at the big picture and not cherry-pick things that are “good” for specific segments of the industry. The voices of HTM, ISO and OEM have all been heard loud and clear by our FDA. The cards are clearly laid out on the table. With the right perspective, one can see the report is a historical turning point for the medical equipment industry and builds a foundation for a better future for all stakeholders and industry segments.

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