FDA’s Medical Device Service Report Brings Relief but Questions Remain
Posted June 1, 2018
The Food and Drug Administration's (FDA) recent decision not to impose additional regulation on third-party servicers of medical devices was met with a positive reception by attendees of the 34th Annual Conference on Clinical Engineering Productivity and Cost Effectiveness, held Friday in Long Beach, CA, in conjunction with the AAMI 2018 Conference & Expo.
Despite prompting feelings of relief from hospital-based healthcare technology management (HTM) departments and independent service organizations (ISOs), questions remain about the details going forward—as does the sense that the long-standing debate over the right to service and repair medical devices isn’t over.
“It would cost of tens of millions of dollars a year if original equipment manufacturers (OEMs) got their way and were the only ones who could service medical equipment,” said Dave Dickey, vice president of clinical engineering for McLaren Health Care, who moderated the meeting. “We’re all really thankful for the FDA’s decision. Without the third-party service market, I don’t know how any hospital would stay in business.”
During an afternoon session, Katelyn R. Bittleman, a consumer safety officer at the FDA’s Center for Devices and Radiological Health, presented her research, which underlies the FDA’s report. That research evaluated more than 4,300 medical device reports of events alleged to have involved third-party servicers, 68 complaints, and a literature review.
“We’re not on the sides of OEMs or ISOs. We’re trying to be fair and stay within the realms of our authority,” Bittleman said. “The FDA did not find evidence of a widespread 'systemic situation' surrounding the repair of medical devices. Therefore, the agency does not believe that imposing burdensome regulatory requirements is necessary.”
Instead, the FDA favors the promotion of quality management principles and is focusing on the need for more robust, systematic ways of collecting quantitative data, Bittleman explained. Ultimately, all of the relevant stakeholders need to focus on establishing a collaborative community for exchanging data.
Although they support the FDA’s conclusions, ISO representatives at the meeting expressed unease and sought clarification on concepts in the report that posed a gray area. For example, where the FDA draws the line between “repairing” a device (returning a component to original specifications) versus “remanufacturing” it (significantly changing the finished device's performance, safety specifications, or intended use). The FDA has promised future guidance to distinguish between the two.
Ultimately, while the FDA has settled much of the “right to repair” debate that has been simmering for years, the possibility of a legislative response that would override the agency’s regulatory authority remains on the table, said Robert Kerwin, general counsel for the International Association of Medical Equipment Remarketers and Servicers.
“This isn’t over—the Medical Device Servicing Safety and Accountability Act (requiring establishments servicing medical devices to register with the FDA) is still before Congress,” Kerwin said, adding that the work of HTM professionals was not part of committee discussions, but the field's perspective ought to be going forward.