The Medical Imaging and Technology Alliance (MITA) announced its support of the FDA's recent decision to promote the adoption of quality management principles in medical equipment servicing, according to a statement released May 15.
“Today’s release of the FDA report on medical device servicing clearly demonstrates why Congress needs to step in and implement basic patient protection measures by requiring third-party servicers to register with the FDA and report adverse events,” said Patrick Hope, executive director of MITA, in a prepared statement.
Currently, service activities are regulated only by the FDA when performed by the medical device's original equipment manufacturer (OEM), however non-OEM parties are not held to the same FDA safety and quality standards, MITA explained.
In April 2017, Reps. Ryan Costello, R-Pennsylvania, and Scott Peters, D-California, introduced the Medical Device Servicing, Safety, and Accountability Act, requiring third-party medical device servicers to register with the FDA, report adverse events such as deaths and injuries and maintain complaints systems accordingly. Hope noted the legislation as "an important first step" and a "common-sense approach", in a prepared statement.
Released May 15, the FDA report states that available evidence regarding medical device servicing is "not sufficient to conclude whether or not there is a widespread public health concern related to servicing, including by third party servicers, of medical devices that would justify imposing additional/different, burdensome regulatory requirements.”
"We agree the evidence available to the FDA is not sufficient to conclude whether or not a public health concern is warranted," Hope said.
The FDA explained it would pursue the following:
- Promote the adoption of quality management principles.
- Clarify the difference between servicing and remanufacturing.
- Strengthen cybersecurity practices associated with servicing of medical devices.
- Foster evidence development to assess the quality, safety and effectiveness of medical device servicing.
Hope explained that patients should need to "take a leap of faith" in ensuring their medical devices quality and safety, according to the MITA statement.
“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," Hope 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."
Recently, MITA expanded the scope of the NEMA American National Standard for Servicing of Medical Imaging Devices to cover all medical devices, not just those related to imaging.
"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."