Paul Kelley, the director of biomedical engineering at Washington Hospital in Fremont, California, says that in the 40 years he’s been in the field, he’s seen a notable change. “It’s getting more and more frustrating,” he says. “We can do less and less work on equipment. We’re getting less and less documentation. Training is getting harder, and parts are getting scarcer.”
Hammoud, Kelley, and others in support of the Calpirg letter declined to name the specific device manufacturers they believe are the most restrictive when it comes to repairs. Hammoud said that’s because he doesn’t see their group as “fighting” the device makers, but rather asking for cooperation. Wiens is more candid: He says giants like Medtronic and GE tend to be more restrictive, while other companies, like China-based Mindray, are doing a better job than others in terms of public availability of repair information.
Peter Weems, senior director of strategic operations and policy at the Medical Imaging and Technology Alliance (MITA), made a remark that was eerily similar to Hammoud’s: “With other goods, if something like a cell phone is improperly repaired and then it fails to perform, the worst-case scenario is that you have to replace the device. Whereas if a medical device is improperly repaired, there’s the risk of injury to the patient or the operator, or death.” But Weems is making this case on behalf of the medical device industry, particularly the medical imaging segment, and not the right-to-repair movement. MITA has around 50 member companies, ranging from large multinational companies such as GE, Siemens, and Philips, to smaller companies that make components or singular devices.
There are some key distinctions between other right-to-repair initiatives and this one, Weems pointed out. This includes the fact that in the US, manufacturers of medical devices are regulated by the Food and Drug Administration and have to report deaths, serious injuries, or other major malfunctions to a governing body. Third-party repair services aren’t necessarily held to the same safety or regulatory requirements.
“What we’ve been working on with the FDA and Congress is applying consistent requirements for everybody who services a medical device, and these are common sense things such as making yourself known to the FDA via registration,” Weems says. Right now the FDA estimates there’s anywhere from 16,000 to 20,000 biomedical engineers working in the US. By getting a firmer grasp on how many technicians there are, the agency can start to implement a quality-management system.
It’s an effort that goes back to 2016, when MITA lobbied Robert Califf, who was then the FDA’s commissioner, for tighter restrictions around third-party repairs of medical devices. It even sought to redefine terms like “repair,” “refurbish,” or “remanufacture,” as the terms were allowing for a gray area in which repair technicians—those who didn’t work directly for the device manufacturers—could operate. There’s the risk of direct bodily harm to patients if a medical imaging device isn’t functioning properly, the alliance argued; but also, there’s the risk that device makers would face liabilities or suffer “diminished brand value.” Follow-up reports issued by MITA in 2018 and 2019 underscored that inadequate repair services, in some cases described as “remanufacturing,” could result in “unsafe environments for patients and users of equipment.”
In other words, right-to-repair advocates continue to clamor for looser restrictions and fewer roadblocks around the repair of personal devices, large appliances, and medical equipment; while representatives for the businesses that make these devices will continue to urge lawmakers to put standards and regulations in place that would protect their products. If there’s one thing these groups seem to agree on though, it’s that the stakes are now suddenly much higher.
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