Comments to FDA Highlight Fault Lines in Third-Party Service Debate


Posted June 12, 2017

Is third-party servicing of medical devices a patient safety problem? Should everyone who services medical devices be subject to the same oversight by the Food and Drug Administration (FDA)?

These questions have been swirling around the healthcare technology community since the FDA published a call for comments on the "refurbishing, reconditioning, rebuilding, remarketing, remanufacturing, and servicing of medical devices” in March 2016.

In an attempt to inject some insight, Michael Capuano, manager of biomedical technology at Hamilton Health Sciences, and Binseng Wang, director of quality and regulatory affairs at WRP32 Management, Inc. and Greenwood Marketing LLC, analyzed the comments sent in response to the FDA’s notice and the available data on service-related adverse events. They presented their results to attendees of the AAMI 2017 Conference & Expo during a presentation on Sunday.

Overall, the comments were predictable, with each camp asserting its ability to effectively and safely service medical devices. Independent of those comments, the most interesting aspect about the often-heated debate is a lack of clear data to support the claim that service by third parties poses a greater risk, according to Wang.

To better understand the response to the FDA’s docket, Capuano read and classified the 171 comments that were available online at the time of the analysis. (The final number of comments was 176.) He found that 54 comments (43%) had been submitted by independent service organizations (ISOs), while healthcare technology management (HTM) professionals submitted 38 (22%), and original equipment manufacturers (OEMs) submitted 34 (20%).

Not surprisingly, the tone of the comments was divided along party lines. Comments from HTM professionals were overwhelmingly positive toward in-house HTM departments, neutral toward ISOs, and negative toward OEMs. ISOs were positive toward ISOs, neutral toward in-house HTM departments, and negative toward OEMs. OEMs tended to be negative toward in-house HTM departments and ISOs, articulating the position that “only they are able to provide quality service.”

In general, Capuano said the comments themselves did little to advance the cause for any one position.

“This particular call for comments was an opportunity for HTM, ISOs, and the OEMs to really put their foot to the floor and really provide that stake in the heart, if you want to call it that, for what they’re lobbying for. It didn’t quite happen that way,” Capuano said.

Out of a total of 24 incidents described in the submitted comments, there were only two examples of what Capuano defined as “critical,” one of which was reported outside the United States. And surprisingly, only a little more than half of OEMs (53%) explicitly stated a desired for increased regulation of third parties.

“This was OEMs' chance to really sock it to everybody, and they didn’t do it. A lot of it was subjective, anecdotal … and there was nothing specifically critical that resulted in patient injury or death,” Capuano said.

A focus on data, Wang suggested, might prove more illuminating.

One of the FDA’s main questions in the docket was: “What evidence exists regarding actual problems with the safety and/or performance of devices that result from these activities?” So, Wang focused his research on analyzing data compiled from analyses of the FDA’s MAUDE database that ECRI Institute completed in 1998 and 2016, an AAMI–Joint Commission study from 2011, an Aramark analysis completed in 2014, and unpublished results from a 2016 AAMI survey.

Wang calculated that the U.S. average of service-related events was 0.0634%. When he applied Six Sigma principles, Wang found that the medical device service industry was “at par with most commercial airlines.”

For their part, manufacturers have said that empirical data on the servicing of medical devices is so spotty (and often submitted only on a voluntary basis) that the problem is likely more significant than might be suggested by the data that’s currently available.

After accounting for the “valid concern” of underreporting patient safety events, the sigma level went down. “It’s not really bad, but it’s not as good as it seemed at first glance when you just used the raw data,” Wang said.

Based on his analysis, Wang concluded: “In terms of patient safety, in my opinion, it’s going to be a wash … I’m not sure additional regulations will improve the situation a whole lot more … I just don’t see any scientific justification for additional, redundant regulation.”

Most of those in the audience agreed with Wang’s position. In an informal poll conducted at the beginning of the session, 35 out of 53 respondents (67.27%) did not think third parties, including in-house HTM teams, should be required to register with and be regulated by the FDA.

The results come as Congress is considering an amendment added to the FDA Reauthorization Act of 2017 (H.R. 2430) that would require the FDA to submit a report to the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions on how the agency “intends to ensure the quality, safety, and continued effectiveness of devices” with respect to service "performed by any entity engaging in such servicing.”

If passed, the FDA would have 180 days to complete the report, which is required to include findings based on the comments received in response to last year’s docket.