Right-to-Repair Groups Fire Shots at Medical Device Manufacturers

iFixit and Right-to-Repair Groups Fire Shots at Medical Device Manufacturers

A robust resource for DIY smartphone repairs is focusing next on ventilators and other critical medical equipment.

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. That’s 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 today it’s 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, Calpirg’s 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 they’re 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: They’re 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 isn’t fixed, you’re 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 don’t 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 Frank’s Hospital Workshop. But that site was created to support his colleagues in developing countries, Weithoner said in an email to WIRED. It hosts about 4,5000 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 they’ve collected over the years,” Wiens says. “And they’re 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 isn’t 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 hospital’s basement to replace a part. It requires navigating each device’s 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.

“It’s not that it could mean life or death—it’s 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. We’ve 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 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.

Read the original article courtesy of Wired.com.