The Medical Imaging and Technology Alliance (MITA) is applauding bipartisan legislation in the U.S. Congress that would extend oversight of medical device servicing to third-party vendors.
Currently, the U.S. Food and Drug Administration (FDA) regulates only medical device service performed by an OEM.
The bill (HR 2118), introduced by U.S. Reps. Ryan Costello (R-PA) and Scott Peters (D-CA), is titled "Ensuring Patient Safety through Accountable Medical Device Servicing." It proposes FDA oversight and minimum quality and safety requirements for service performed by both OEMs and third-party vendors.
MITA cited a survey conducted by KRC Research in 2016 that found the majority of Americans believe proper servicing and maintenance of all medical and radiation-emitting devices are crucial to protecting patients. Respondents also concurred that FDA should extend regulatory oversight, including minimum quality, safety, and regulatory requirements, to all entities servicing medical devices.
