Who is repairing your medical devices? FDA should extend its regulatory oversight to the entities that service medical devices.
Who fixes your local CT scanner or MRI machine? This probably isn't a question that keeps you up at night, but maybe it should. You might be shocked to learn that in many cases there are essentially no regulations on who services medical devices.
Currently, FDA only exercises oversight over service activities performed by manufacturers. However, devices are often serviced by many other entities, including in-hospital engineers and third party repair shops which vary in size and sophistication. These non-manufacturer groups are not currently held to any minimum quality, safety, or regulatory requirements.
Although many of these third party service organizations regularly perform quality work, the lack of oversight and regulation presents serious concerns for patient safety.
Basically, anyone could one day decide to start repairing PET scanners or ultrasound devices and there would be no regulatory requirements that this person be trained, use the right parts, know anything about the device, or follow appropriate procedures.
Patients and their caregivers count on medical devices to perform safely and effectively and it is the patient who has the most at stake if the device fails to perform appropriately due to improper servicing. Patients should be able to assume an equivalent level of safety and efficacy regardless of the service provider. Performance of these activities within a quality management system by properly trained personnel using qualified, properly sourced parts greatly reduces the risk of harm to the patient.
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. If an X-Ray is fuzzy due to poor calibration, a fracture could be missed. If a CT scanner is out of operation, a car accident victim might have to wait hours to get scanned. If an MRI machine has the wrong parts, it could explode or suffocate the patient. If any electrical device is improperly sealed, the patient or healthcare provider could get a severe electric shock.
It is exactly these kinds of problems we want to avoid.
FDA last looked at this issue in 1998, but unfortunately decided not to take action. The medical device servicing industry has changed significantly since then. The number of unregulated and unregistered organizations and persons servicing medical devices has increased over the last twenty years without any comparable adjustment in the regulatory framework governing these activities. Unregulated and unregistered service providers are a growing and significant portion of the industry about which FDA, healthcare providers, and patients know very little due to the lack of regulatory oversight, registration, or reporting.
MITA has been pushing FDA to finally take action to address this problem. It is unacceptable that FDA would continue to allow so many people and companies to process medical devices without any oversight. But that may be about to change.
Recently, FDA has called for comments on this issue and held a public workshop, seeking to better understand the device servicing industry. It is unclear, though, what the FDA will do next, if anything.
We believe that the most efficient method for ensuring that devices are properly serviced would be for the FDA to extend regulatory oversight, including minimum quality, safety, and regulatory requirements, to all entities which service medical devices. Manufacturers are held to these requirements, shouldn't everyone else?
Patrick Hope is the executive director of the Medical Imaging & Technology Alliance (MITA).
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