FDA passes on setting new regulations for medical device servicing

Hybrid operating room
Instead of pursuing formal regulatory action, the agency will work to promote quality management principles, strengthen cybersecurity practices, and foster quality assessments. (The Innovation Institute)

The FDA said it could not find reason to impose new regulations on the servicing of medical devices, whether performed by original equipment manufacturers (OEMs), hospital systems or third-party providers.

Instead, the agency found that many OEMs and third parties provided high-quality, safe and effective servicing, such as refurbishing and reselling more durable equipment including imaging machines, automated external defibrillators, endoscopes and ventilators.

“We believe the currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing of medical devices, including by third party servicers, that would justify imposing additional/different burdensome regulatory requirements at this time,” the FDA said in its report.

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Instead of pursuing formal regulatory action, the agency will work to promote quality management principles, strengthen cybersecurity practices, foster quality assessments and clarify the difference between servicing and remanufacturing—that is, making changes to a device’s performance or specifications, instead of simply returning it to service.

The FDA also floated the idea of creating a public-private forum to address any challenges in the field.

Stakeholders, including manufacturers, have raised concerns about the quality of servicing and repairs, including the use of inferior replacement parts, inadequately trained personnel and poor documentation. Others have cited difficulty accessing servicing manuals, technical specifications and proper training.

“If there is sufficient interest and broad willingness to participate by all stakeholder groups, we would facilitate the creation of such a community,” the FDA said.

The 32-page report (PDF), required by the FDA user fee reauthorization law passed last August, was based on perspectives from a public workshop, submitted comments and a review of literature, medical device reports and other evidence, the agency said.

The Medical Imaging and Technology Alliance strongly supported the FDA’s decision to promote quality management principles but urged Congress to pass legislation that would require third-party services to register with the FDA and report adverse events.

“To ensure patient safety, the FDA needs to know who is servicing all medical devices so that if adverse events occur, the agency is alerted and can take appropriate action,” said Patrick Hope, MITA’s executive director.