A mandated report released by the FDA concluded no additional or different, burdensome regulatory requirements are necessary at this time to ensure the quality, safety and efficacy of servicing of medical devices. This conclusion was based on the availability of no sufficient objective evidence, according to the report.
“Based on available information, the FDA believes the current available evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing of medical devices that would justify imposing burdensome regulatory requirements at this time,” according to an FDA release.
The FDA Reauthorization Act-mandated report, which was compiled of information presented at a public workshop, responses to a request for comments and evaluation of objective evidence related to the quality, safety and efficacy of medical device servicing, noted many original equipment manufacturers and third-party entities provide high quality, safe and effective servicing of medical devices. The FDA identified clinical adverse events and deaths believed to be caused by inadequate servicing pertained to remanufacturing and not servicing, and also noted that “the continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. health care system.”
Based on the available information and findings, the FDA intends to:
promote the adoption of quality management principles;
clarify the difference between servicing and remanufacturing;
strengthen cybersecurity practices associated with servicing of medical devices; and
foster evidence development to assess the quality, safety and efficacy of medical device servicing.
The FDA’s Center for Devices and Radiological Health has also committed to establishing collaborative communities as part of its 2018 to 2020 strategic priorities. According to the report, the goal of a collaborative community is to proactively solve shared problems between public and private sector members, as well as problems unique to other members in a safe and respected environment.
“We believe there may be value in the creation of a public-private forum, such as a collaborative community, to address the challenges associated with delivering high quality, safe and effective servicing of medical devices,” the FDA wrote in the report. “If there is sufficient interest and broad willingness to participate by stakeholder groups, we would facilitate the creation of such a community.” – by Casey Tingle