The FDA’s docket workshop last week in Silver Spring, Maryland, brought together hundreds of stakeholders to discuss ambiguities in the definitions of certain terms relating to third-party involvement in the medical equipment industry.
Here are the opposing perspectives in under 100 words:
OEMs want ISOs and HTMs to be regulated in some way — not because they feel all third-parties are bad, but because the limited data that exists includes evidence that some third-parties are not providing safe service.
ISOs and HTMs point to the available statistics that illustrate their high level of success, and say the cost of regulations would put an unnecessary burden on the value they bring to the care system, while simultaneously strengthening OEM control and limiting competition.
That very general overview sums up a lot of the presentations given at the FDA headquarters last week, but a few presenters brought valuable new details into focus. Here are some highlights:
Who says HTMs and ISOs aren't already being regulated?
Multiple stakeholders, including representatives from AdvaMed and MITA, referred to Quality Service Regulations (QSRs) as a viable solution to the lack of scrutiny over third-party providers, and suggested these oversight protocols are scalable and could be customized depending on the company.
But others, like Barbara Maguire, vice president, Quality and Geisinger Clinical Engineering, ISS Solutions, points to CMS and the Joint Commission as entities that already provide adequate quality control on third-party service.
And as for selecting the ISOs that HTMs choose to work with, Maguire said that reviewing qualifications is already part of the job and adding regulations to it would be "redundant."
Jim Nestel, manager of service projects & installations with Hitachi, made the case on behalf of OEMs that not all ISOs have the stringent guidelines described by attendees. He pointed specifically at outpatient clinics, which he said frequently do not incorporate the best practices described by many of the ISOs and HTMs present at the workshop.
This theme of "present company excluded" ran throughout the event when referring to the dangers associated with certain third-parties.
An OEM won't share necessary maintenance documents? There's a solution to that.
Repeatedly, ISOs and HTMs made the case that OEMs are uncooperative when it comes to sharing certain manuals and maintenance documents that may be essential for servicing their equipment. On the OEM side, this practice of withholding was sometimes justified as a necessity for keeping trade secrets out of the hands of their competitors.
Whatever the reason may be for withholding service instructions, Salvatore Tatta, director of clinical engineering services at James J. Peters VA Medical Center, offered a practical and straightforward solution. He said that at his facility they include the supply of these documents in the initial contract they sign with the OEM.
If an OEM refuses to share such information, they are in violation of the agreement. If they refuse to comply with the initial agreement, they lose a customer.
Where is that system now? I don't recall
Repeatedly, OEMs argued that they face a disproportionate degree of responsibility for the equipment they've designed, even after it has traded hands on the aftermarket. One of the clearest examples of this was offered by Hitachi's Nestel, who said that when a recall occurs, the OEM is responsible for notifying the entire install base.
When a third-party has bought or sold the system it becomes difficult — and in some cases impossible — to track down the current end user.
One area where HTMs, ISOs and OEMs all seemed to be on the same page was with establishing a better record of activity. Nobody wants to try to service or repair a piece of equipment without a complete record of all the previous work that has been done on it.
Nestel said that since third-parties are not required to label systems after servicing them, sometimes an OEM will be called on to fix something, but have to do a lot of detective work before discovering how previous maintenance has contributed to the system's failure.
Are further regulations on third-parties... un-American?
The FTC was represented at the workshop by Katie Ambrogi, attorney advisor in the commission's Office of Policy Planning. Although she didn't spend a lot of time addressing the crowd, the FTC's presence was felt throughout the event.
"Competition is at the core of America's economy," said Ambrogi, "greater competition gives consumers lower prices and increased innovation." She called the health care market a "focus of FTC advocacy" and referred to an executive order issued by President Obama in April 2016 calling for increased competition and the elimination of unwarranted regulations.
During one of the panels, Scot Mackeil, senior anesthesia biomedical engineer at Massachusetts General Hospital, connected the dots and asked the FDA if regulating ISOs and HTMs could possibly run contrary to those goals.
"On one side of this room we have Olympus, Hitachi and Pentax from Japan, Siemens, Karl Storz and Bayer from Germany, the Dutch company Philips, Agfa from Belgium, Medtronic from Ireland," said Mackeil. "On the other side we have professional associations representing America's clinical engineers, a number of our top-tier third-party servicers and remarketers."
Instead of creating regulations that would enhance the power of multinational corporations, Mackeil asked the FDA if it would consider a "180-degree turn-around" and instead, require these companies to provide parts and training as a provision to doing business in the U.S.
As attendees murmured their surprise, the FDA replied that the "venue and everyone participating has given us a lot to think about ... that this is not something that we are going to solve alone ... we're going somewhere and we need this community's help in order to get there."
About that limited evidence...
Perhaps the most frequently cited statistic at the workshop was ECRI's finding that 96 adverse incidents had taken place out of 2.1 million reports issued over a 10 year period. As Thomas G. Green, president of Paragon Services pointed out, those numbers also include equipment serviced by OEMs and at least one case in which an OEM mis-serviced a device.
Even if the rate of adverse incidents were twice as high, Maguire, with Geisinger, said it would not warrant FDA involvement.
But the limited data on adverse events is a problem bigger than third-party servicers. In fact, a recent FDA summary report cited multiple leading U.S. health centers for “their failure to keep written medical device reporting procedures and to report adverse events,” according to a report at the Regulatory Affairs Professionals Society website.
At the workshop, there was a lot of talk from both OEMs and third-parties about the ways in which event reporting could be improved. "The FDA should encourage collaboration between manufacturers and on-site teams for education and training, efforts to standardize maintenance documentation, and further voluntary reporting, so there is no longer a concern about missing evidence," said Maguire.