The Medical Imaging & Technology Alliance (MITA)—the trade association representing manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices—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.