AAMI News November 2016

Divergent Views on Display at FDA Service Workshop

A matter of life and death.For many in the healthcare industry, the most polarizing debate this fall has not been who should win the White House, but how far the Food and Drug Administration (FDA) ought to go in regulating the service of medical devices. These divergent views came to a head during the agency’s two-day workshop on the refurbishing, reconditioning, rebuilding, remarketing, remanufacturing, and servicing of medical devices by third-party entities and original equipment manufacturers (OEMs).

During the forum, held Oct. 27–28, OEMs, third-party vendors, and hospital-based healthcare technology management (HTM) professionals all voiced a commitment to patient safety but clashed over fundamental questions related to reporting requirements for device-related incidents, access to information and parts, competition in the marketplace, and even whether there is truly a service problem to debate. For every point offered by one presenter, there was a counterpoint, and the tension in the room was sometimes palpable.

OEMs called for the FDA to extend the regulations that cover the service and repair of medical devices by manufacturers, known as the Quality System Regulation, to anyone who performs these functions. Such a change would “level the playing field, drive accountability, and have a positive impact on patient care,” said Jeff Lersch, vice president of sales at Karl Storz Endoscopy.

According to OEMs, some third parties, such as independent service organizations (ISOs), have at times used unqualified personnel to service devices, installed parts that have not been validated, and inadequately documented their work, leading to patient safety concerns.

ISOs and hospital-based HTM professionals, however, criticized these examples as anecdotal, not evidence of a systemic problem. They cited the results of a study conducted by ECRI Institute, which found that servicing activities were related to just 0.005% of adverse events reported between 2006 and 2015.

“Even if the rate doubled, it would not be significant enough to warrant regulation by the FDA,” said Barbara Maguire, CCE, vice president of quality and Geisinger Clinical Engineering at ISS Solutions.

A number of ISO representatives—including David Anbari, vice president and general manager of Mobile Instrument Service and Repair Inc.—expressed concern that additional regulation would have the unintended effect of creating a “de facto OEM monopoly” in the service industry. However, OEMs maintained that the focus was ensuring quality patient care, not gaining a larger market share.

“Our goal is to ensure the performance of these activities always results in the safe and effective operation of medical devices,” said Peter Weems, director of policy and strategy for the Medical Imaging & Technology Alliance. “It is not our goal to limit competition or drive companies out of business.”

In a sign that business and cost considerations are very much a part of this debate, an attorney for the Federal Trade Commission (FTC) spoke at the workshop. Katie Ambrogi, attorney advisor with the FTC’s Office of Policy Planning, urged the FDA to keep in mind the “significant benefits of competition” and to “narrowly tailor” any future regulations.

According to the FDA, it does not have any “pre-conceived solutions to this problem” and sees this workshop as “a starting point.” An agency representative said in the September/October 2016 issue of BI&T that the FDA will prepare a white paper to summarize its recommendations and identify the next steps it will pursue.