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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


Vanderzee, with Advocate, would like to see more recertification and better competency assessments after initial training, although he says some OEMs already do require recertification on a periodic basis.

GE, in its online comment to the FDA, writes, “We believe the most efficient way to ensure patient safety is through a consistent set of minimum requirements for all parties involved in these activities on complex medical devices.”

The most important stakeholder
So what happens next? According to the FDA’s Kotz, the Administration plans to share a summary of the submitted comments once it finishes reviewing them.

“We cannot comment on what actions we will take until after we finish our review and engage stakeholders further on this topic,” she says. “FDA intends to hold a public meeting later in 2016 to discuss activity definitions, benefits and risks, and appropriate next steps.”

Will manufacturers have to provide more detailed manuals ensuring third parties can adequately service their systems? Will those third parties, as Siemens’ requests in its comment, have to let manufacturers know that devices continue to meet design specifications?

“It’s important to remember that it’s not about where the paycheck or training comes from,” says Sodexo’s Francoeur. “It’s about the individual service providers — their skill sets, capabilities and talents. When someone is motivated by a passion for helping others, and they have the right training and tools to do the job, you’ll see that carry through in the integrity of the work they perform.”

AAMI’s Logan thinks that no matter what, one outcome of all this will be industry wide definitions to the key terms listed in the docket. She hopes the FDA will let those definitions arise through a “consensus-based process” with stakeholders working together.

She also points out that there are limits to what the FDA can do. It does not regulate component parts or hospital practices. It regulates medical device companies and the manufacturing of medical devices, she says.

The third-party industry has certainly grown since the last time the FDA looked into these issues. If it decides to take a greater interest in the work these organizations do, perhaps that is a testament to their significance.

For hospitals, and the patients they serve, having more options is a concept in line with value-based care. If a third party can somehow provide hard evidence of its success record, be it through standards or certifications or anything else, then its value should increase. If it isn’t as safe as the OEM, then that should be known, too.
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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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