Americans have high standards when it comes to our health care, and rightly so. We count on our trained physicians and nurses to make informed choices that better our health. We count on the purity of data, standards and testing to demonstrate the efficacy of medications we are prescribed. And we trust that the equipment and devices used to diagnose and treat us are built and maintained to operate as designed.
Trust and safety in health standards are cornerstones of American health care, and government agencies have been important partners toward ensuring patients have peace of mind. The U.S. Food and Drug Administration, for example, requires rigorous testing and review of drugs and medical products before they reach the market. Even afterward, the agency is deeply involved in making sure safety issues are revealed, reported and resolved.
Medical imaging devices – like MRI machines or CT scanners – are also tightly monitored for safety by federal regulators from production to servicing by their manufacturer. But what about when repairs or servicing are performed by someone else? Currently, those activities are unregulated and create an avoidable gap that jeopardizes the standard of care that Americans expect and trust.
Like any other complex technology, medical devices – including imaging equipment – require routine repairs and maintenance. But unlike most forms of technology, any malfunction, misdiagnosis or other mistake caused by incorrectly performed repairs or maintenance on imaging equipment can endanger those who depend on this technology.
Under current policy, service activities are only monitored by the FDA when they are performed by the medical device’s original equipment manufacturer. Any other repairs or maintenance performed by non-OEM entities are not held to the same quality, safety and regulatory requirements, including FDA oversight.
In a recent FDA report examining medical device servicing, the agency found that the number of firms performing medical device servicing is “between 16,520 and 20,830.” Not knowing the repair and maintenance track-record of potentially tens of thousands of servicers creates an astonishingly large blind spot for the FDA, practitioners and patients.
Medical device manufacturers take great pride in their products and the role they play in patients’ health. And we know that most third-party servicers share this commitment to patient safety.
While many of these servicers do, indeed, perform high-quality work, “many” is not enough. OEMs have uncovered instances where third-party service companies have used impromptu items such as aluminum foil, hand-secured wire nuts and tape to repair imaging equipment. In these cases, if an adverse event takes place, the FDA might not know about it since third-party servicers are not currently required to register with the FDA or even report an injury or death.
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. And waiting for adverse events to occur before enacting quality controls is not in the best interests of patients and fails to meet the high standard of care they expect.
That is why we support the FDA decision to promote the adoption of quality management principles in equipment servicing. The Medical Imaging and Technology Alliance has led the medical device community in advancing a proposed service standard and believes it provides the agency with a framework within which to advance its quality management principles. But while that will be a valuable addition, it is not sufficient to the need.
The agency declined to regulate all of the thousands of servicers maintaining and repairing medical devices today. It is time for Congress to step in and correct this blind spot in patient care. It is time to bring all medical imaging machine service up to par by having third-party servicers register with the FDA, report deaths and serious injuries, and maintain complaint handling systems. Regulating the standards for medical imaging machine servicing is a reasonable and common-sense approach to ensure safe, reliable and efficient patient care.
Our nation’s device manufacturers count on the FDA to put its regulatory muscle behind developing a better, safer system. We are also thankful that members of Congress have the issue on their radar. In fact, Congressmen Ryan Costello (R-Pa.) and Scott Peters (D-Calif.) introduced H.R. 2118 — the Medical Device Servicing Safety and Accountability Act — that would implement these very basic, common-sense requirements for independent servicers of medical devices.
Patients should be able to trust a consistently high level of safety and efficacy of a medical device – regardless of the service provider who last worked on it. It is time we set a 21st-century standard for these 21st-century devices. And the time to make it right is now.
Patrick Hope is executive director of the Medical Imaging & Technology Alliance.
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