At the opening day of the FDA’s docket workshop in Silver Spring, Maryland, a few hundred stakeholders came together on the FDA campus to discuss what happens next with the definitions of third-party terms.

Considering the event had a wait list, the room was only sparsely occupied and, while there was rain on the forecast, the reason for those vacancies is anybody's guess.

The day opened with Rob Sauer, FDA policy analyst, providing a brief history of the FDA’s background in investigating the issues of third-party service. In 1998 they looked into the issue and the docket received less than half of the responses it got this time. Perhaps, if anything indicates the industry is growing and changing, that does.
The FDA also shared working definitions with the crowd, phrases had been adjusted slightly from their previous incarnations, but he emphasized that these were only working definitions and not finalized.

Indeed, the attendees were there to help arrive at final definitions — and also to settle the larger issue of how third-party oversight requirements might be adjusted in the wake of this investigation.

Most of the morning was spent with various stakeholders taking the podium to share their perspectives on the issues in question and how they might be addressed, or, why they are best left alone.

Multiple stakeholders (particularly on the manufacturer side or neutral) referred to Quality Service Regulations (QSRs) as being a viable solution to the lack of scrutiny over third-party providers.

“We believe many third-parties already meet the demands of QSR for the value these practices bring to their business and patients,” said Tara Federici, AdvaMed's vice president of technology and regulatory affairs, arguing that, therefore, key elements of QSR could be applied to third-parties in a scalable way without disrupting the third-party value proposition.

Even without the requirement of reporting, Federici said AdvaMed was made aware of 107 Medical Device Reporting (MDR) situations in three device categories over three years. She said these MDRs should be things that people are aware of, and that it's not unreasonable for these situations to inform the decisions providers make on behalf of their patients and businesses — leaving them out may qualify as a patient safety risk.

Still, little evidence exists to suggest that third-party service is putting patients at any significant risk. The rate of avoidable events, according to research by ECRI, has been low, and the potentially costly prospect of regulations has left many ISOs and HTMs taking the position that "if it isn't broken why fix it?"

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