Right-to-repair groups fire on medical device manufacturers

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The iFixit website has long been known for its electronic repair kits and for its very public stance that repair manuals should be accessible to everyone. That's one of the fundamental arguments of the broader right-to-repair movement, which pushes so that regular consumers can repair the products they have bought, from smartphones to washing machines and farm equipment, without violating a guarantee. Now, in the COVID-19 era, iFixit and a leading consumer interest group are addressing a more immediate concern: access to medical device repair manuals.

The company said this week that it will launch what it calls the "world's most comprehensive medical equipment services database." Collecting thousands of files is supposed to help biomedical engineering technicians, technicians updating or repairing medical equipment at healthcare facilities, to repair everything from imaging equipment to EKG monitors and ventilators. IFixit founder and CEO Kyle Wiens (who also contributes to the Ideas section of WIRED) called it an "absolutely massive,quot; company for iFixit, a project that took over two months to coordinate and required the help of 200 volunteers .

The launch of the iFixit database also comes immediately after a letter sent to state lawmakers by Calpirg, the California arm of the US Public Interest Research Group. USA, with more than 300 firms of experts in hospital repair. In the letter, the group calls for restrictions on the repair of medical equipment to be reduced and more cooperation from medical device manufacturers.

"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 problems have increased in devices like fans, he said, which are used 24 hours a day. "While some manufacturers provide service information, other manufacturers make it difficult to access manuals, read error logs, or perform diagnostic tests."

Many of the arguments presented by Calpirg and iFixit are similar to the right-to-repair arguments that have been made against giant tech companies like Apple and Microsoft, and are likely to upset both medical device manufacturers and product manufacturers. electronic. If you own an iPhone or Xbox, you should be able to repair it yourself or have a technician of your choice repair it, the right-to-repair group thinks; while lobbyists on behalf of the tech giants argue that allowing anyone and everyone to play with their electronic devices could raise serious security concerns.

But the debate over medical device repairs is different, as both right-to-repair advocates and trade groups advocating 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 they can repair life-saving medical equipment better and faster. Conversely, organizations like the Medical Imaging and Technology Alliance say they want to see more quality controls and regulatory requirements around the work that medical technicians do because that, they believe, will save lives.

"If the iPhone is not repaired, you will not have a phone," says Nader Hammoud, biomedical engineering manager 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 publish anything publicly about it, whether that meant issuing statements or posting a repair guide on iFixit.com. His thinking changed in mid-March, when scattered stories about the coronavirus suddenly transformed into a full-fledged global pandemic.

"It all crystallized for me when we saw fans fail in Italy, and one (starter group) was 3D printing valves for them," says Wiens. "And we started to think, OK, if ventilators are used more than normal, they could fail more than normal, and biomedical technicians will be on the front line along with everyone else."

On March 18, Wiens made a call to repairers, medical professionals, and biomedical technicians. He asked them to submit model numbers for critical equipment such as ventilators, BiPAP machines, and anesthesia machines, as well as fallibility estimates and ideas on what parts might need to be replaced. Essentially, I wanted to get one of the largest databases ever for medical device repair.

Wiens's efforts were unprecedented. For several years, 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 colleagues in developing countries, Weithoner said in an email to WIRED. It houses around 4,500 device manuals. In some cases, device manufacturers have banned downloading files. Frank is also just a boy. Wiens wanted to go bigger.

"There are these apocryphal hard drives floating around in the biomedical community, full of PDF files that they have collected over the years," says Wiens. "And they are as good at doing their job as that folder full of PDF files is."

Files started to flood in iFixit, with one folder in particular containing up to 50,000 files. Two weeks after the project, iFixit was overwhelmed. The company contacted researchers from the Maintainers and the American Library Association and asked for volunteers. After two months of work, and with the help of more than 200 archivists and librarians, iFixit launched its search collection. The database was deduplicated and consolidated, and contains more than 13,000 files: repair instruction manuals for everything from ventilators to ultrasound machines, X-ray equipment, and anesthesia systems. Wiens says that most of the files were shared with iFixit anonymously, but that he believes they were legitimately acquired and that hosting them is legal under the United States Copyright Law.

Of course, COVID-19 has exposed not only our biological vulnerabilities but also our structural, social and political deficiencies. Producing, acquiring, and distributing all kinds of medical equipment is a complicated maze outside of a pandemic; Within the context of a global pandemic, every move or maneuver has the potential for more serious consequences.

The US medical device industry The USA, the world's largest, is also a multi-billion dollar business and highly regulated industry, protecting its proprietary equipment. That means that repairing a medical device is not always a simple process of asking a biomedical technician to do a quick repair during surgery, or to take the device to the lab in the hospital basement to replace a part. It requires navigating the specific repair requirements of each device, a process that can take days.

Weins tends to position iFixit as a renegade team that distances itself from the broader device industry and its business groups, and has said that preventing access to this type of information is "particularly morally tense during a pandemic." Many biomedical technicians agree. And in April, five US state treasurers. USA They wrote a letter to fan manufacturers asking them to make their repair manuals more accessible.

"Is not that could it means life or death: it is definitely life or death, especially during a pandemic, "said John Muir Health's Hammoud during a virtual briefing on Monday." I had situations in the past, before COVID-19, that we had to get into to the hospital in the middle of the night and trying to extract parts from different devices, from different sources, because a patient was waiting for a device. We have had to do this several times throughout my career. " Hammoud recalled an instance where he searched for a replacement part that would generally cost around $ 80, only to have the original manufacturer of the device tell him that the manufacturer would have to come and fix the device at a cost of around $ 4,000.

Paul Kelley, director of biomedical engineering at Washington Hospital in Fremont, California, says that in the 40 years he has been in the field, he has seen a remarkable change. "It is becoming increasingly frustrating," he says. “We can work less and less in teams. We receive less and less documentation. Training is becoming more difficult and parts are becoming scarcer. ”

Hammoud, Kelley, and others in support of Calpirg's letter declined to name manufacturers of specific devices that they believe are the most restrictive when it comes to repairs. Hammoud said that is because he does not see his group as "fighting,quot; against device manufacturers, 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 for the Medical Imaging and Technology Alliance (MITA), made an observation that was eerily similar to Hammoud's: “With other products, if something like a cell phone is improperly repaired and then fails to perform The worst case scenario is that you have to replace the device. Whereas if a medical device is improperly repaired, there is a risk of injury to the patient or operator, or death. "But Weems is presenting 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 manufacture unique components or devices.

There are some key distinctions between other right to redress initiatives and this one, Weems noted. This includes the fact that in the US In the US, medical device manufacturers are regulated by the Food and Drug Administration and must report deaths, serious injuries or other major failures to a governing body. Third-party repair services are not necessarily subject to the same security or regulatory requirements.

"What we have been working with the FDA and Congress is to apply consistent requirements for all people serving a medical device, and these are common sense things like getting to know the FDA through registration," he says. Weems. Right now, the FDA estimates that there are between 16,000 and 20,000 biomedical engineers working in the United States. By gaining a firmer understanding of how many technicians there are, the agency can begin to implement a quality management system.

It's an effort that dates back to 2016, when MITA pressured Robert Califf, then the FDA commissioner, over tighter restrictions around third-party medical device repairs. He even sought to redefine terms such as "repair," "renovation," or "remanufacturing," as the terms allowed for a gray area in which repair technicians, those who did not work directly for device manufacturers, could operate. There is a risk of direct bodily harm to patients if a medical imaging device does not function properly, the alliance argued; But there is also a risk that device manufacturers face responsibilities or suffer from "diminished brand value." Follow-up reports issued by MITA in 2018 and 2019 highlighted that inadequate repair services, in some cases described as "remanufactured,quot;, could lead to "unsafe environments for patients and equipment users."

In other words, advocates of the right to repair continue to clamor for more flexible restrictions and fewer obstacles to the repair of personal devices, large appliances, and medical equipment; while representatives of the companies that manufacture these devices will continue to urge lawmakers to establish rules and regulations that protect their products. However, if there is one thing these groups seem to agree on, it is that what is at stake now is much higher.

This story originally appeared on wired.com.

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