In a report released on May 15, the FDA said it would promote the adoption of quality management principles for servicers of medical devices and clarify the difference between servicing and remanufacturing. It would also pursue the strengthening of cybersecurity practices associated with servicing medical device, as well as foster the development of evidence to assess the quality, safety, and effectiveness of medical device servicing, MITA said.
The FDA currently only regulates service activities when they are performed by the medical device's OEM; service activities performed by non-OEM parties are not held to the same quality, safety, and regulatory requirements, including FDA oversight, according to MITA. The organization believes that Congress must now implement basic patient protection measures by requiring third-party servicers to register with the FDA and report adverse events.
"We agree the evidence available to the FDA is not sufficient to conclude whether or not a public health concern is warranted," said Patrick Hope, MITA's executive director, in a statement.
MITA noted that Reps. Ryan Costello (R-PA) and Scott Peters (D-CA) recently introduced the Medical Device Servicing, Safety, and Accountability Act, a bill that would require third-party servicers to register with the FDA, report deaths and serious injuries, and maintain complaint handling systems. The bipartisan bill would be an important first step and a common-sense approach, Hope said.
The alliance also pointed out that it has recently expanded its National Standard for Servicing of Medical Imaging Devices to cover all medical devices, not just medical imaging technologies.
"We are encouraged by the FDA's decision to promote the adoption of quality management principles and believe our proposed servicing standard provides the agency with a suitable framework in which to work," Hope said. "We look forward to working with the FDA, Congress, manufacturers, and third-party servicers to ensure and advance patient safety."
Patients should not have to take a leap of faith regarding the upkeep of medical devices, according to Hope.
"While many third-party servicers perform high-quality work, waiting for adverse events to occur before quality controls are put in place to receive and track adverse events is not in the best interests of patients," he said. "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."
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