Tech

Right-to-repair groups fire shots at medical device manufacturers

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The website iFixit has long been known for its electronics repair kits and for its very public stance that repair manuals should be accessible to everyone. Thats one of the foundational arguments of the broader right-to-repair movement, which lobbies that regular consumers should be able to repair the products they've purchased—everything from smartphones to washing machines to farming equipment—without violating a warranty. Now, in the time of COVID-19, iFixit and a prominent consumer interest group are tackling a more immediate concern: access to repair manuals for medical devices.

The company said this week its releasing what it calls the “most comprehensive medical equipment service database in the world.” The collection of thousands of files is supposed to help biomedical engineering technicians—the techs who update or fix medical equipment on site at health care facilities—repair everything from imaging equipment to EKG monitors to ventilators. iFixit founder and CEO Kyle Wiens (who also contributes to WIRED's Ideas section) called it an “absolutely massive” undertaking for iFixit, a project that took more than two months to coordinate and required help from 200 volunteers.

The rollout of the iFixit database is also coming on the heels of a letter sent to state legislators by Calpirg, the California arm of the US Public Interest Research Group, with more than 300 signatures from hospital repair experts. In the letter, the group calls for loosened restrictions on repairs of medical equipment and more cooperation from makers of medical devices.

“COVID-19 is putting incredible stress on our medical system, including the work of hospital biomedical repair technicians,” says Emily Rusch, Calpirgs executive director. Repair and maintenance issues have increased on devices like ventilators, she said, which are being used around the clock. “While some manufacturers provide service information, other manufacturers make it hard to access manuals, read error logs, or run diagnostics tests.”

Many of the arguments that Calpirg and iFixit make are similar to the right-to-repair arguments that have been made against giant tech companies like Apple and Microsoft—and theyre likely to rankle medical device makers as much as they have electronics makers. If you own an iPhone or an Xbox, you should be able to repair it yourself or get it repaired by a technician of your choice, goes the thinking of right-to-repair groups; while lobbyists on behalf of the tech giants maintain that allowing anyone and everyone to tinker with their electronics could pose serious safety and security concerns.

But the debate over medical device repairs is different in that both proponents of the right to repair and the trade groups that argue for stricter repair regulations are ultimately sounding the same alarm: Theyre concerned about patient safety. Biomedical engineers say they want easier access to repair manuals so that they can better and more quickly fix the medical equipment needed to save lives. Conversely, organizations like the Medical Imaging and Technology Alliance say they want to see more quality control and regulatory requirements put in place around the work medical technicians do because that, they believe, will save lives.

“If the iPhone isnt fixed, youre not going to have a phone,” says Nader Hammoud, manager of biomedical engineering at John Muir Health in Walnut Creek, California, and a supporter of the Calpirg initiative to reduce repair restrictions. “If you dont fix a vent, the patient is dead.”

Wiens said he had been aware of the needs of biomedical repair technicians for years but had decided not to post anything publicly about it, whether that meant issuing statements or publishing a repair guide on iFixit.com. His thinking changed in mid-March, when scattered stories about the coronavirus suddenly morphed into a full-fledged global pandemic.

“It all crystallized for me when we were seeing ventilators in Italy fail, and a [startup group] was 3D-printing valves for them,” Wiens says. “And we started thinking, OK, if ventilators are being used more than normal, they might fail more than normal, and the biomed technicians are going to be on the front lines alongside everyone else.”

On March 18, Wiens put out a call to fixers, medical professionals, and biomedical technicians. He asked them to submit model numbers for critical equipment like ventilators, BiPAP machines, and anesthesia machines, as well as fallibility estimates and ideas for what parts might need to be replaced. Essentially, he wanted to crowdsource one of the biggest databases ever for medical-device repair information.

Wiens' efforts were not unprecedented. For several years now, a biomedical engineer in Tanzania named Frank Weithoner has maintained a website for medical-device repair manuals, called Franks Hospital Workshop. But that site was created to support his colleagues in developing countries, Weithoner said in an email to WIRED. It hosts about 4,500 device manuals. In some cases, file downloads have been prohibited by device makers. Frank is also just one guy. Wiens wanted to go bigger.

“There are these apocryphal hard drives floating around the biomed community, filled with PDFs that theyve collected over the years,” Wiens says. “And theyre only as good at doing their job as that folder filled with PDFs is.”

Files started flooding into iFixit, with one particular folder containing as many as 50,000 files. Two weeks into the project, iFixit was overwhelmed. The company reached out to researchers at the Maintainers and the American Library Association and solicited volunteers. After two months of work, and with the help of more than 200 archivists and librarians, iFixit launched its searchable collection. The database was deduplicated and consolidated, and it contains more than 13,000 files—repair instruction manuals for everything from ventilators to ultrasound machines to X-ray equipment to anesthesia systems. Wiens says most of the files were shared with iFixit anonymously, but that he believes they were acquired legitimately and that hosting them is legal under the US Copyright Act.

Of course, COVID-19 has exposed not only our biological vulnerabilities but also our structural, society, and political shortcomings. Producing, procuring, and distributing all kinds of medical equipment is a complicated labyrinth outside of a pandemic; within the context of a global pandemic, every move or maneuver has the potential for more dire consequences.

The US medical device industry, the largest in the world, is also a multibillion-dollar business and a highly regulated industry, one that is protective of its proprietary equipment. That means repairing a medical device isnt always a simple process of asking a biomedical technician to do a quick fix during surgery, or to run the device down to the lab in the hospitals basement to replace a part. It requires navigating each devices specific requirements for repair, a process that can take days.

Weins tends to position iFixit as a renegade outfit that distances itself from the broader device industry and its trade groups, and has said that preventing access to this kind of information is “particularly morally fraught during a pandemic.” Many biomedical technicians agree. And in April, five US state treasurers penned a letter to ventilator manufacturers asking them to make their repair manuals more accessible.

“Its not that it could mean life or death—its definitely life or death, especially during a pandemic,” John Muir Health's Hammoud said during a virtual briefing on Monday. “I had situations in the past, before COVID-19, where we had to come into the hospital in the middle of the night and try to pull parts from different devices, different sources, because a patient was waiting on a device. Weve had to do this multiple times throughout my career.” Hammoud recalled an instance where he sought out a replacement part that would typically cost around $80, only to be told by the original device maker that the manufacturer would have to come in and fix the device at a cost of around $4,000.

Paul Kelley, the director of biomedical engineering at Washington Hospital in Fremont, California, says that in the 40 years hes been in the field, hes seen a notable change. “Its getting more and more frustrating,” he says. “We can do less and less work on equipment. Were getting less and less documentation. Training is getting harder, and pRead More – Source