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

by Gus Iversen , Editor in Chief
From the August 2016 issue of DOTmed HealthCare Business News magazine

A man was repairing an MR system’s service panel when a sudden explosion knocked him to the floor, leaving him with burns and causing a power outage throughout half of the hospital.

Although nobody knows what exactly triggered the explosion, they do know the servicer overlooked certain safety precautions and was not employed by the MR’s original equipment manufacturer (OEM).

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That real-life situation is one of several Patrick Hope, executive director of the Medical Imaging & Technology Alliance (MITA), recounts to the FDA in his response to a docket seeking comments from “the widest range of interested persons” on the possible safety issues that can arise from non-OEM medical equipment service.

MITA’s comment clocks in at 35 pages and, although more comprehensive than most, it is only one of 176 perspectives that organizations and individuals submitted before the docket’s June 3 deadline.

Third-party stakeholders – such as refurbishers, in-house health care technology managers (HTMs) and independent service organizations (ISOs) – generally view the docket as bad news.

“Smaller third-party vendors in particular fear they will be forced out of business with greater regulation,” writes Mary Logan, president and CEO of the Association for the Advancement of Medical Instrumentation (AAMI), in her comment.

Others, recognizing the exceedingly rare occurrence of events like the one described, are optimistic that the docket will usher in an era of more validated options for hospitals trying to save money. They see transparency on the horizon, and with it, better communication between OEMs and the reputable third-party organizations that can competitively service their equipment.

While just about everyone agrees that this docket has the potential to dramatically disrupt the balance of power in the device market, there are some stakeholders who think the whole thing will more or less blow over, as it did the last time the FDA opened this can of worms 20 years ago.

Why is this happening now? According to the docket itself, the FDA’s renewed interest in refurbishment came as a response to safety concerns brought to its attention. It’s also a chance to address ambiguities in the way certain terms associated with refurbishment and third-party service are defined.

“We hope that this current effort provides additional clarity on how these activities are defined, and what are some key considerations on the benefits and risks associated with these activities,” Deborah Kotz, press officer of media affairs and external affairs for the FDA, told HealthCare Business News.
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(34)
(1)

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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