Congressmen Ryan Costello, R-Pennsylvania, and Scott Peters, D-California, were commended by the Medical Imaging & Technology Alliance (MITA) for introducing bipartisan legislation to ensure consistency in regulation for the proper servicing of medical devices. The bill is H.R. 2118, “ Ensuring Patient Safety through Accountable Medical Device Servicing.”
“We appreciate the strong bipartisan leadership of Congressmen Costello and Peters and applaud their commitment to patients through their support of medical device servicing requirements for both original equipment manufacturers and third-party vendors,” said Joe Robinson, chairman of MITA board of directors and senior vice president of health systems solutions at Philips Healthcare in a statement. “Patients count on the safe, effective, and reliable operation of medical devices and are the most important stakeholders in device servicing. MITA is committed to working with Congress and the U.S. Food and Drug Administration (FDA) to protect the safety of patients through implementation of consistent oversight and minimum quality and safety requirements for all medical device service providers.“
Currently, only medical device service activities performed by a manufacturer are regulated by the FDA. If a device does not perform in a safe and effective manner as a result of improper service by an unregulated, third-party organization, it is possible that a patient could be at risk for serious physical injury or result in low image quality.
The majority of Americans believe proper servicing and maintenance of all medical and radiation-emitting devices are important to protecting patients. They agree that the FDA should extend regulatory oversight, including minimum quality, safety and regulatory requirements, to all entities servicing medical devices, according to a survey conducted by KRC Research.