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

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


The value proposition
In an industry that prioritizes “value” over virtually everything else, refurbishers, ISOs, OEMs and in-house HTMs offer unique benefits that make them desirable to different types of providers. While they all have a common interest in medical equipment, there is much they do differently.

An HTM has a broader focus, while OEMs tend to focus only on equipment maintenance, says Samantha Jacques, director of clinical engineering at Penn State Milton S. Hershey Medical Center in Hershey, Pennsylvania. “We aid the organization in vendor management, contract management, alarm management, and we also help our organizations support equipment planning across departments,” she says.



That means technical assistance is always on site. Steve Vanderzee, director of clinical engineering at Advocate Healthcare in Downers Grove, Illinois, says downtime may be greater for a piece of equipment serviced by the OEM if they have to travel long distances to repair it.

An in-house team, provided they have the capabilities to fix the problem, can start correcting it immediately. In cases where they must defer to the OEM, an HTM can articulate the problem more precisely and knowledgably than, say, a radiologist. There is value in that, too.

Although they won’t be at the hospital with the regularity of an in-house HTM, ISOs provide their own value. According to Francoeur, they provide a broad and unbiased intelligence to asset management because their focus is on the needs of the hospital rather than brand-specific equipment.

A good ISO evaluates products from an array of manufacturers and determines what equipment, or combination of equipment, would best suit a particular facility. In contrast, an OEM may have a financial interest in encouraging hospitals to invest in its own products.

“We know based on our data that OEM service, whether it be transactional or contracted, is often the most expensive service option,” says Vanderzee.

But to some extent, all third-party stakeholders are dependent on manufacturers. Vanderzee says 75 percent of Advocate’s HTM technical training is provided by the OEMs, and Jacques says her Penn State crew attends OEM training classes.

Although Sodexo offers on-the-job training for most devices, Francoeur says it sometimes partners with OEMs for servicing certain equipment.

Besides the larger footprint and intimate knowledge of the systems they’ve built, OEMs provide a level of security that third parties currently cannot. That’s because of the high level of accountability the FDA puts on them.
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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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