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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

That observation can be read in different ways. Either there is no evidence because there is no difference or there is no evidence because the data is insufficient. The Joint Commission does not comment on that ambiguity, but its findings do echo the other research supporting the safety of third-party service.

If more comprehensive data does reveal a higher rate of incidents from third-party devices, IAMERS’ Upton speculates it might be due to OEMs “failing to fulfill disclosure” of assembly, installation, adjustment and testing (AIAT) information – equipment instructions manufacturers are required to provide under federal regulation.

One of the most persistent complaints about service from HTMs is their difficulty in accessing a well-written service manual, according to the AAMI statement.

Fox, on behalf of GE, writes that medical devices in the imaging space – such as X-ray tubes, ultrasound probes and MR surface coils – do not typically have service manuals available, and cites the absence of those manuals as something putting patients at greater risk when those devices are serviced by third parties.

If ‘something further’ is needed
According to research by Markets and Markets, the global market for refurbished medical equipment is forecast to reach $9.37 billion by 2019. Currently, the U.S. medical device service aftermarket is estimated to be worth about $50 billion annually, according to AAMI.

The docket refers to a very broad array of specialties, including endoscopy, which might be the source of the safety concerns the FDA is responding to. Over the last year, infections resulting from insufficiently reprocessed duodenoscopes have been the subject of a number of major media headlines.

“As is often the case with complex issues that involve multiple disciplines, multiple service models, lack of standardization, paucity of reliable data about the industry, uneven lobbying capabilities across the sector, strong opinions, and stories galore, there is a huge risk of unintended consequences from a regulatory answer,” warns AAMI’s Logan.

While the FDA might define “remanufacturing” in such a way that “very significant” repairs fall under a regulatory scheme, Logan believes implementing standards will be the best overall solution to whatever concerns the docket may yield.

Certifications are the answer, says Sean Poellnitz, the director of contracting and resource utilization at Christus Health in Irving, Texas. They will help ensure that those who service equipment know the core principles of maintaining them, he says, and the FDA should create a “checkoff” list that ensures refurbished equipment has the ability to operate like new.

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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