Up until now, so-called ‘right to repair’ legislation was a topic that touched on important questions, like whether or not farmers could repair their own tractors, or if end-users were allowed to repair their own electronics goods, but wasn’t viewed as a literal life-or-death issue. Now, however, the question of whether or not people and companies are allowed to fix hardware they’ve purchased has a real chance of becoming one.
The advocacy group US Public Interest Research Group has released a report detailing the results of interviews it conducted with 222 biomedical repair professionals. It writes: “Nearly half reported they had been denied access to ‘critical repair information, parts or service keys’ since March.”
Manufacturers claim these lockouts and other hoops are in place to protect patient safety, but such claims fly in the face of an FDA report, written in 2018, which found no evidence that third-party repair carries any risk whatsoever after reviewing 2.1 million medical device failure reports submitted over the past decade. Manufacturers are already supposed to provide “schematics, wiring diagrams, mechanical layouts, and other pertinent data for the appliance,” as well as, “preventative and corrective maintenance, inspection, and repair procedures.” According to US-PIRG, these standards are not being upheld.
According to multiple biomedical repair professionals, repairs in the time of coronavirus require a heavy reliance on online forums, because manufacturers will not distribute training and repair manuals adequately. In one case, the head of a biomedical college engineering program deliberately requires students to attempt to obtain repair manuals as part of their training in order to illustrate how difficult it is and how much begging they may have to do in order to get the documentation. US-PIRG also details how manufacturers have attempted to use copyright claims and legal threats to force websites to remove repair manuals. Steris, a company that manufacturers sterilizers, has requested iFixit remove manuals from its website.
Manufacturers, of course, want to handle these repairs themselves. The problem is, in some cases, quarantine protocol prevents hospitals from allowing random service technicians from entering the buildings. In others, manufacturers are no longer sending technicians out due to the pandemic. Both situations cause the same problem: Broken equipment no company-certified technician is going to be fixing any time soon.
In at least one case, a manufacturer booby-trapped an ultrasound machine to require software calibration if anyone removed the outside cover. This was not disclosed to the hospital, who attempted to troubleshoot the piece of equipment and found themselves locked out of it as a result. GE has only recently begun waiving the requirement that technicians complete an in-person, four-day training course to receive any documentation on its ventilators. Siemens refuses to allow already-trained colleagues to train co-workers under any circumstances.
According to one biomedical technician, an unnamed manufacturer charges $28,000 to train one technician in how to repair one device. The actual cost of the device? $35,000. Another manufacturer initially attempted to de-certify all of a hospital’s technicians due to their failure to complete a bi-annual recertification requirement during the pandemic, when the manufacturer was offering no recertification courses of any kind.
According to the survey results, 30.4 percent of technicians had equipment in their facilities they could not use, due to limited access to parts or training manuals, while 91.8 percent stated they had been denied service information for life-saving, critical equipment. 88.7 percent reported that manufacturers have refused to sell spare parts (4.5 percent “Most of the time,” 36.2 percent “Somewhat frequently,” and 48 percent reporting “Sometimes, but infrequently.”)
In the COVID-19 epidemic, you’d expect manufacturers to be prioritizing ventilator repairs above all else. You’d also be wrong. 69.5 percent of the 222 engineers and repair people surveyed are responsible for ventilator repair. Of that group, 29.2 percent report they have ventilators they cannot use due to a lack of either spare parts or servicing information. 24.2 percent of technicians have been denied access to information since March. 51.9 percent of technicians have ventilators on-site they cannot service or repair if they break.
A month ago, it might have been tempting to think such issues were receding behind us and would not need to be dealt with in the future. The current state of the pandemic in the United States belies such pleasant dreams. Technicians need permission to repair life-saving medical equipment the instant it breaks. They need to be able to purchase repair parts as soon as possible. If the pandemic continues to worsen, and America’s stockpiles of emergency medical equipment are stretched nationwide, these sorts of failures could start leading to deaths.
However much revenue device manufacturers might lose off repairs, we suspect they’ll lose more if people start dying because local, qualified technicians weren’t allowed to read a frickin’ manual.
DRM is a lot of things. It’s not supposed to be a death sentence. If it starts becoming one, device manufacturers will have bigger problems than just their profit margins to consider. iFixit has published a database of medical device repair information, if you are looking for manuals.
Feature image shows a NASA/JPL-designed ventilator, whose design is specifically intended to be easy to maintain, cheap, and repairable in the field.
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