Manufacturer lobby group the Medical Imaging & Technology Alliance (MITA) has released a video featuring a service engineer who has worked on medical devices for more than 20 years at both independent service organizations (ISOs) and original equipment manufacturers (OEMs).
Wes Bonebright, district vice president for service at Philips Healthcare, says the video sheds light on the differences between current OEM and ISO training requirements. He says it also calls for the U.S. FDA to hold all servicing of FDA-regulated medical devices to the same standards to enhance patient safety, transparency, and accountability.
Bonebright adds that he brings a unique perspective to the contentious right-to-repair debate as a service engineer with both ISO and OEM experience. In the film, Bonebright discusses safety training requirements, as well as the different approaches to sourcing and installing medical device parts in imaging systems.
“We appreciate Wes sharing his service engineering story, which showcases the immense training and experience requirements as well as the time and resource investment OEMs place in their service engineers early and often to ensure patients can depend on the repair and maintenance of FDA-regulated medical devices,” says MITA’s excecutive director Patrick Hope.
“MITA has long advocated for regulatory parity of service, and Wes’s unique perspective underscores why this work is critical to enhance patient safety and medical device service quality,” Hope adds.
Please share your thoughts of the full video, available here, in the comments section.
Clearly another example of FUD (fear uncertainty and doubt) disseminated by someone who works for an OEM that is a member of MITA. Indeed, FDA is currently not regulating medical device servicing companies and professionals (collectively called servicers). It has the authority to do so and has elected not to exercise its authority after reviewing the evidence of servicing problems and their root causes. The OEMs have pushed repeatedly the FDA to regulate servicers since 1996 and FDA informed the Congress most recently in 2018 that “We believe the currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing of medical devices, including by third party servicers, that would justify imposing additional/different burdensome regulatory requirements at this time.” Furthermore, servicers are under contract with hospitals to follow regulations issued by the FDA’s sister agency, Centers for Medicare & Medicaid (CMS), that has strict requirements on competency and service quality. Finally, all are subject to legal risks if a patient harm is caused by their service. BTW, if OEM representatives cannot get to the hospitals promptly like what happened during the pandemic, who should be responsible for patient care delay or even denial? Isn’t it also a patient safety issue?