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 and repair of medical devices. Last week, 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 at the FDA’s headquarters in Silver Spring, Md.—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. During the workshop, OEM representatives showed pictures and cited examples of improper service ranging from a woodscrew used to repair an angiographic power injector to the now infamous report of an endoscope repaired with chewing gum.
ISOs and hospital-based HTM professionals, however, criticized such 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 percent 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.
In her role as a representative of the American College of Clinical Engineering, Maguire also pointed out that the “vast majority of services” are already regulated by the Centers for Medicare & Medicaid Services, through state agencies, or through accreditation agencies like the Joint Commission. “Additional regulation would be redundant,” she contended.
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.”
Over the course of the two days, presenters and audience members also sparred over the availability of replacement parts and service manuals, as well as the training of service technicians. And 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.
When it comes to finding solutions, several presenters urged all stakeholders to focus on their common ground—and build on that.
“There is so much mistrust from all sides,” said AAMI President Mary Logan. “We need to find middle ground in the areas where we are not so far apart and start building trust there. Once that trust is built, then we can start to find middle ground on the bigger issues.”
As for the FDA, it does not have any “pre-conceived solutions to this problem,” said Capt. Sean Boyd, deputy director for regulatory affairs in the FDA Center for Devices and Radiological Health’s Office of Compliance. The agency is still in the process of gathering information and will likely include patients and physicians in further discussions.
“FDA alone is not going to solve and resolve this problem,” Boyd said. “We together are going to solve and resolve these issues moving forward … This workshop is a starting point.”
“Following the public workshop and upon completion of review of input received, the FDA will prepare a white paper to summarize recommendations and identify next steps it will pursue,” Valerie Flournoy, deputy director in the Office of Compliance’s Division of Manufacturing and Quality at the FDA, wrote in the September/October 2016 issue of BI&T. “The FDA will wait until after the public workshop to determine what additional action, if any, should be conducted.”