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An in-depth look at the FDA’s refurb docket

by Gus Iversen, Editor in Chief | August 01, 2016
Business Affairs HTM Parts And Service
From the August 2016 issue of HealthCare Business News magazine


There won’t be any easy answers here, but as the dialogue started in Docket No. FDA-2016-N-0436 rolls on, the entire range of stakeholders agree that the goal has to be ensuring avoidable errors, like the one caused by that MR technician who knocked out electricity in half of the hospital he was working in, are mitigated and patient safety is improved.

“It is because of patient need that medical imaging equipment exists,” writes MITA’s Hope. “For this reason, the patient is the most important stakeholder.”

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Brian Tunell

A liability imbalance

August 04, 2016 12:20

As an HTM which receives OEM training on Imaging Equipment, and utilizes a "First Call" support contract with OEM's, the biggest challenge I see is the lack of OEM information after training.

As an OEM updates their documentation, publishes Field Service Notes, that information never seems to get to the HTM level. The only exception to that is Carestream, which allows access to it's online Service Database to prior training attendees.

The downside of Carestream's documentation is in it's information. The schematics provided on their equipment is more "block diagram" than schematic, which makes it difficult to troubleshoot below an assembly level. But, in many cases, that's where the parts support is, at the assembly level. Very few Imaging Devices can be troubleshot to the component level anymore, but there are exceptions.

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Gus Iversen

re: A liability imbalance

August 05, 2016 07:32

Interesting observation, Brian. In general, we've certainly heard a lot of frustration from HTMs regarding inadequate access to OEM information.

Maybe the Carestream approach, despite its limitations, is a step in the right direction?

One nice thing about this docket is that it allows those types of concerns and insights to be heard by a larger audience than just your peers. Nobody we've spoken to -- OEM or third-party -- seems totally satisfied with the current state of things.

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