FDA Report on Medical Device Servicing Rightly Recognizes Need for Adoption of Quality Management Principles

05.15.18

Imaging manufacturers stress that congressional action still needed to protect patient safety

Rossyln, VA– The Medical Imaging & Technology Alliance (MITA) – the leading organization and collective voice of medical imaging equipment, radiopharmaceutical manufacturers, innovators, and product developers – said today that it strongly supports the FDA decision to promote the adoption of quality management principles in equipment servicing, but that Congress must still take quick action to ensure third-party servicers of medical devices register with the FDA and report adverse events.

“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.

“We agree the evidence available to the FDA is not sufficient to conclude whether or not a public health concern is warranted,” Hope continued.  “That is exactly why we believe Congressmen Costello’s and Peters’ bill requiring third-party servicers to register and report is an important first step and a common-sense approach.”

The Medical Device Servicing and Accountability Act, bipartisan legislation introduced by the two Congressmen, would require third-party servicers to register with the FDA, report deaths and serious injuries, and maintain complaint handling systems.

Released today, the FDA report, “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices,” stated that objective evidence is currently not sufficient to conclude whether or not there is a widespread public health concern related to servicing, including by medical device third-party servicers, that would justify imposing regulatory requirements. That said, the FDA indicated they wouldpursue the following:

    1. Promote the adoption of Quality Management Principles;
    2. Clarify the difference between servicing and remanufacturing;
    3. Strengthen cybersecurity practices associated with servicing of medical devices; and
    4. Foster evidence development to assess the quality, safety and effectiveness of medical device servicing.

MITA strongly supports the FDA decision to promote the adoption of quality management principles.  MITA has led the imaging and general device community in advancing a service standard.  In April, MITA expanded the scope of the NEMA American 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,” added Hope. “We look forward to working with the FDA, Congress, manufacturers, and third-party servicersto ensure and advance patient safety.”

Currently, service activities are only regulated by the FDA when they are performed by the medical device’s original equipment manufacturer (OEM). Service activities performed by non-OEM parties are not held to the same quality, safety, and regulatory requirements, including FDA oversight.

“Plain and simple, this is about patient safety. Patients should not have to risk taking a leap of faith regarding the upkeep of their medical device,” said Hope. “While many third-party servicers perform high-qualitywork, 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. 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.”

“If a medical imaging device malfunctions due to improper servicing, a diagnosis could be missed, care could be delayed, or the patient could be severely injured or even killed,” continued Hope. “It is exactly these kinds of problems we want to avoid. Fortunately, the bipartisan Medical Device Servicing and Accountability Act, if passed, would be a major first step toward solving this problem.”

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