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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


A liability imbalance
As OEMs have had to share business with a growing and increasingly sophisticated third-party sector, they are interested in sharing more of their burden of responsibility, too. For them, the docket is an opportunity to gain clarification as to where their obligations end and liability for patient safety and device maintenance transfers to “the other guy” servicing the machine.

As it stands, regardless of how many times a piece of equipment changes hands, and how far removed the manufacturer is from maintaining the device, many OEMs make the case that they are forever accountable.



“OEMs have a role as legal manufacturer of the device and are therefore subject to all FDA regulations, including 21 CFR Part 820 Quality System Regulation (QSR),” writes Tracey Fox, regulatory affairs director – global services at GE Healthcare, in her comment. Because of this, she says OEMs are held to a higher standard.

Although OEMs would most likely benefit from any new action taken by the FDA, several of them commented specifically that limiting competition would be bad for health care.

“We believe that many third parties, including hospital service teams, independent service organizations and others, are currently performing excellent service,” Matt Nichols, senior product manager of multivendor services at Philips Healthcare, told HealthCare Business News.

Both Siemens Healthineers (in a comment written by Hans Beinke, vice president, U.S. country head of quality and technology) and MITA point out that unregulated and unregistered third parties in the device industry have increased over the last 20 years without any comparable adjustment in the regulatory framework governing their activities.

Fox says that although some evidence does exist regarding actual problems with the safety of devices serviced by third parties, (like the situation MITA’s Hope described with the MR panel) the information provided to OEMs when service is performed by a third party is “sporadic and anecdotal.”

That sporadic and anecdotal body of evidence gets to the root of the OEMs’ complaint: third-party providers lack oversight. If third parties improperly service their equipment, the damage comes down on them as the manufacturer.

“Without labeling to indicate that servicing or refurbishing has been performed by a third-party entity, it is typically wrongly believed that the OEM maintains full knowledge of and responsibility for the state of the device,” writes MITA’s Hope. He believes the best method for ensuring safe and effective medical devices is to extend minimum requirements and regulatory oversight to all entities engaging in the activities the FDA has brought up.
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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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