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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


“Under current regulation, 21 CFR 820 must be adhered to by OEMs and registered remanufacturers,” writes Douglas J. Thistlethwaite, manager of regulatory affairs at Hitachi Medical Systems America, in his docket comment. “Since third-party servicers are not required to follow these regulations, the risk of incorrectly servicing medical equipment increases.”

“OEMs are more confident in the rigor of their quality system and risk management processes, which are highly regulated, documented, validated and audited,” says AAMI’s Logan. In addition, she says their parts have gone through a strong purchasing control process and their technicians have documented qualifications from controlled training programs.

All about data
Wherever one’s interests lie, it is generally agreed that more data about third-party service can’t hurt. They are “a growing and significant portion of the industry about which the FDA, health care providers, patients and OEMs know very little due to the lack of regulatory oversight, registration, or reporting,” writes MITA’s Hope.

But that isn’t to say there isn’t any data. ECRI Institute studied the MAUDE (Manufacturer and User Facility Device Experience) database and found that the number of technology- related adverse incidents caused by poor maintenance or repairs is “very low,” according to AAMI.

In addition, a search of the FDA’s official records for fiscal years 2007-2008 revealed “no pattern of adverse event reports or incidents indicating that refurbished and remarketed devices had been associated with or contributed to a death, serious injury or malfunction,” says IAMERS’ Upton. Without that pattern, Upton suggests there is no reason to assume third-party service or refurbishment puts patients in any more danger than if they are treated with OEM-serviced devices.

“We view it as a due diligence initiative by the FDA with the potential for increased regulations if the FDA isn’t satisfied with the status quo on all the information it gathers during this due diligence process,” says AAMI’s Logan. “It wants to do the right thing, and doing the right thing means gathering as much data as possible before deciding whether something further is needed.”

Collecting data is something AAMI knows about. In 2012, it hosted a survey from the Joint Commission to find out about the rate of patient injuries or deaths that had occurred due to modifying the preventive maintenance procedures assigned by manufacturers.

Of the 1,526 respondents, according to Kathryn E. Spates, director of federal relations for the Joint Commission’s own docket comment, only 12 reported any adverse outcomes. She goes on to state, “there seems to be very little, if any, evidence of differences in the risks associated with the various maintenance activities performed by the different owners, users, and maintainers.”
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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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