Medical equipment stakeholders ranging from OEMs to ISOs, refurbishers and health technology management (HTM) professionals came together in 2016 to voice a range of opinions with regard to the FDA’s renewed interest in the terms — and the definitions of the terms — which third-party providers attribute to their services.

For the first time in 20 years, the FDA was taking a microscope to third-party involvement with medical equipment and the industry is still waiting to see what kind of changes could result from what it found.

The administration’s interest in the topic was sparked, according to a docket opened on the FDA’s website, in response to safety concerns that had been brought to its attention.

“We hope that this current effort provides additional clarity on how these activities are defined, and what are some key considerations on the benefits and risks associated with these activities,” Deborah Kotz, press officer of media affairs and external affairs for the FDA, told HealthCare Business News.

Headlines in recent years — issues with duodenoscope reprocessing or patients being overexposed to radiation, for example — have stirred the public interest, but most third-party organizations contend that their safety records speak for themselves and are only hampered by a manufacturing industry that does not always communicate effectively with them.

OEMs, meanwhile, are calling for increased oversight of these third-party organizations, citing the high level of scrutiny their own organizations are subjected to and the comparatively limited data supporting the safety of third parties. From their perspective, neglecting to scrutinize these groups is a disservice to patients receiving care on their equipment.

These two (very generalized) views took shape in the 176 comments that organizations and individuals submitted before the docket’s June 3 deadline.

A few months later, the FDA invited stakeholders to attend a workshop at its Silver Spring, Md., headquarters, where individuals took the floor to further articulate their position and the position of their peers.

Some progress took place at the workshop, including a common interest emerging among virtually all stakeholders, who agreed on the importance of establishing a better record of repairs and service history on a given device. 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.

So what happens next?

Some third-party stakeholders view the docket as an omen that increased regulations may be arriving soon to disrupt their business. If the FDA does choose to go in that direction, it will have to be careful not to inadvertently promote manufacturer monopolies.

As Katie Ambrogi, attorney advisor in the Federal Trade Commission’s Office of Policy Planning, pointed out on behalf of the FTC at the workshop, competition is at the core of America’s economy.

“Greater competition gives consumers lower prices and increased innovation,” she said, before calling the health care market a “focus of FTC advocacy” for increased competition and the elimination of unwarranted regulations.

Others have expressed hope that the FDA’s investigation will usher in an era of greater transparency across the board — with more validated options for end-users and improved cooperation between OEMs and reputable third-party entities.

For hospitals, and the patients they serve, having more options is a concept in line with value-based care. If a third party can somehow provide hard evidence of its success record, be it through standards or certifications or anything else, then its value should increase. Conversely, if it isn’t as safe as the OEM, then that information should be available to hospitals, too, and reduce the value of its service.

Perhaps the most frequently cited statistic surrounding the FDA’s docket has been ECRI’s finding that 96 adverse incidents had taken place out of 2.1 million equipment service records issued over a 10-year period. That staggeringly not-alarming rate of incidents — which includes equipment serviced by OEMs — points to another issue that may require the FDA’s attention.

The sparse data on adverse events relating to medical equipment is a problem — and finding ways to encourage hospitals to publicly report them is a challenge. 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 the Regulatory Affairs Professionals Society website.

It’s possible that, in the course of its investigation, the FDA has discovered that incident reporting is more at the crux of its concerns than third-party providers, but only time will tell.

There are some stakeholders who think the whole thing will more or less blow over, as it did the last time the FDA opened this can of worms 20 years ago. Whatever happens, all parties involved (OEMs, third parties, end-users and the FDA) share a common top priority: patient safety.