The Medical Device Servicing Safety and Accountability Act would set regulations and standards for ALL who repair medical imaging devices
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.
Currently, third-party companies that service medical devices are not required to register with the FDA, and are not held to the same quality, safety, and regulatory requirements as servicers from the device’s original manufacturer. As a result, it is difficult to hold these servicers accountable for errors or improper servicing that could lead to misdiagnosis, injury, or in a worst-case scenario, death.
Regulating the standards for medical imaging machine servicing is a reasonable and common-sense approach to ensure safe, reliable and efficient patient care.
Thankfully, some members of Congress have the issue on their radar and have introduced H.R. 2118, The Medical Device Servicing Safety and Accountability Act, which 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.