From the May 2017 issue of HealthCare Business News magazine


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.

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