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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


Will new regulations hurt the health system?
Faced with the FDA’s concerns, third-party providers and their representative associations have vigorously defended their safety record, their value proposition, and the importance of a competitive market.

“Much like automobiles, aircraft or other complex machinery, the OEM isn’t the only one that is capable to repair the equipment,” writes Jeffrey Little, who describes himself as a 25-year veteran of health care operations, in his docket comment.

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“At the end of the day, items like this definitely have a place for debate, however they are typically spawned from OEM vendors feeling a decline in dollars coming in from repairs, and finding fault with someone else’s work,” he writes.

In 1998, the FDA decided to exclude refurbishers and servicers from the requirement to comply with the 1997 Quality System Regulation under part 820, according to Diana Upton, president of the International Association of Medical Equipment Remarketers and Servicers, Inc. (IAMERS). Since the issues being raised in the current docket are the same, she argues, the agency would need compelling reasons to reverse its prior position.

For the FDA to make a judgment in the best interest of the entire health system, David Francoeur, senior director of brand and quality at Sodexo, says it needs to stick to the data. “Whatever the outcome, it has to be based on the impact of safety and not anything else – if it isn’t broken, why fix it?” he asks.

But, according to MITA's Hope, there may not be sufficient evidence either way. “It is impossible to provide a statistically valid analysis of the extent of problems that have occurred when there has been no prior scrutiny or any regulatory oversight of non-OEM service providers and other third parties, which would require reporting of problems,” he writes.

Although wary of lobbyists and the private interests of big business, many third-party stakeholders agree that some degree of increased oversight might not be such a bad idea, as long as it is implemented in a way that doesn’t unfairly undermine the value they bring to a health system that is already strapped for cash.

For Francoeur, that means new standards to ensure levels of technical competency, oversight and management. “I’m not necessarily advocating certification or registration,” he says, “but I do think it’s reasonable for the FDA to require some form of assurance that technicians possess the skill sets needed to work on medical equipment.”

Little also acknowledges the need for some kind of common requirements. “Not all third-party repair vendors are created equal, so standards must be established so that [everyone is] on the same level playing field,” he writes.
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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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