The Medical Imaging & Technology Alliance (MITA) has commended Congressmen Ryan Costello (R-PA) and Scott Peters (D-CA) 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,” says Joe Robinson, chairman of MITA board of directors and senior vice president of health systems solutions at Philips Healthcare. “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 US Food and Drug Administration to protect the safety of patients through implementation of consistent oversight and minimum quality and safety requirements for all medical device service providers. “
“We are encouraged to see leaders in Congress champion consistency in the regulation of medical device servicing, which is critical to ensure patient safety and the effectiveness of life-saving medical technologies,” says Dennis Durmis, MITA board member and head of radiology commercial operations at Bayer Healthcare.
MITA Executive Director Patrick Hope adds, “Congressmen Costello and Peters have put forth a reasonable, common-sense solution that will not be costly or burdensome to third-party organizations, but will protect patients who rely on the safety, effectiveness and reliability of our technologies.”
Currently, only medical device service activities performed by a manufacturer are regulated by the FDA. If a device fails to perform in a safe and effective manner due to improper servicing by an unregulated, third-party organization, it could potentially put the patient at risk for serious physical injury or result in low image quality—which could lead to a delayed or missed diagnosis, according to MITA.
A survey conducted by KRC Research in 2016 found the majority of Americans believe proper servicing and maintenance of all medical and radiation-emitting devices is crucial to protecting patients, and agree that FDA should extend regulatory oversight, including minimum quality, safety, and regulatory requirements, to all entities servicing medical devices.
I suggest looking at the actual bill rather than relying on MITA’s interpretation. And, of course, bills aren’t laws and may never become law.
The bill would require registration and a complain handling process except for organizations exempted, the latter appearing to me to be almost everyone.