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Hospitals Need to Repair Ventilators. Manufacturers Are Making That Impossible

We are seeing how the monopolistic repair and lobbying practices of medical device companies are making our response to the coronavirus pandemic harder.
March 18, 2020, 2:15pm

As hospitals face the prospect of a critical ventilator shortage caused by the worst public health crisis in a century, they face another problem: not being able to repair the ventilators that they do have.

This is because, like John Deere, Apple, and so many other electronics companies, the major device manufacturers have spent the last several years cementing a repair monopoly. They've done this by lobbying against legislation that would make it easier to repair machines, keeping access to repair guides out of the hands of independent repair professionals, and using software controls to limit who can perform repairs.

President Trump has said that states are more-or-less on their own when it comes to securing devices like ventilators, which are necessary to treat people with critical cases of Covid-19. “Try getting it yourselves,” Trump recently said. New York governor Andrew Cuomo, meanwhile, said that the state is struggling to create enough ICU beds for the expected number of people who will be sick: Getting enough ventilators “remains the challenge, and the numbers are daunting … you can't find a ventilator for sale. We're looking desperately,” he said.

Core to the fight against coronavirus, then, will be keeping the ventilators hospitals do have online. Many of them are not empowered to fix their own machines, however, due to the exact same issue that we’ve outlined before with John Deere tractors and other devices: medical devices, including ventilators, have gotten more complicated over the years. They are now controlled by microprocessors and software. That complexity hasn't made them inherently more difficult to repair, but manufacturers have artificially put “software locks” on them, meaning that only those who are authorized can make modifications.

Besides software, manufacturers also maintain control over the repair parts and diagnostic tools market and have attempted to keep service manuals out of the hands of independent repair professionals. Device manufacturers have also taken legal action against independent databases of repair manuals, such as those collected and hosted by a biomedical technician who works in the developing world known as “Frank.”

Frank has posted some ventilator service manuals, and gotten cease-and-desist letters from some manufacturers: “Download prohibited by Dräger. Support is not desired,” is a message he posted next to some previously-available repair manuals. In Italy, device manufacturers have threatened to sue makers who have 3D printed parts for medical devices used to treat Covid-19 patients.

To be clear, no one is suggesting that unqualified people try to repair complicated medical equipment that is going to be used on sick people. Most hospitals have their own service staff, and independent repair professionals are often certified to be doing the types of life-saving repairs that are needed.

“We have an issue where many of the independents work officially for the manufacturers on Monday and Tuesday, and then they’re doing work for themselves the rest of the week,” Rob Kerwin, general council for the International Association of Medical Remarketers and Servicers, said. “If earlier in the week they were safe and sound, why aren’t they allowed later in the week?”

"Even hospital employed biomedical technicians with the best training and qualifications aren't fixing things anymore, they're becoming shipping clerks packaging things to be sent away for repair," Gay Gordon-Byrne, the executive director of Repair.org, said. "In the context of ventilators, the on-site biomedical technicians can fix a ventilator in hours and return it to service more quickly than anyone else. If they can't get the info they need to fix and restore to use—a whole lot of very sick people won't have essential care."

In 2018, the Food and Drug Administration said that “the continued availability of third party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system.” The FDA’s report on repair found that third party repair is not dangerous and that both they and manufacturers “provide high quality, safe, and effective servicing of medical devices.”

And yet, manufacturers and their lobbyists have vehemently fought legislation that would make it easier for third parties to do repairs. This legislation would require manufacturers to release repair guides, sell repair parts, and prevent them from using software locks on their devices. AdvaMed, the medical device manufacturer trade group that represents more than 400 companies (including Siemens, GE Healthcare, and Philips, which are among the largest), wrote a letter to lawmakers in Massachusetts claiming that right to repair legislation “could result in maintenance and repairs of medical devices being performed by untrained personnel, and that inappropriate replacement parts may be used.”

“It is difficult to quantify the potential impact to patient safety from maintenance or repairs being done by improperly trained personnel or from the use of unapproved parts,” AdvaMed wrote. The organization also suggested, without evidence, that there would be cybersecurity concerns associated with the legislation.

Last year, GE Healthcare wrote a letter to lawmakers in New Hampshire saying that right to repair legislation would “require manufacturers of FDA Class I and II medical devices to provide proprietary diagnostic and repair information to unregulated service providers.”

“Requiring manufacturers to make available their proprietary tools, processes, and protocols is not the way to improve patient safety and equipment reliability,” it continued.

GE Healthcare, Siemens, AdvaMed, and Philips did not respond to a request for comment for this article.

In the wake of the coronavirus pandemic, independent repair professionals are calling on medical device manufacturers to release repair guides and loosen software locks that prevent repair, even if they only do so temporarily.

“Repair information ought to at least be provided to hospitals, which has a contractual relationship with these vendors,” Kerwin said. “It’s hard to anticipate what’s going to happen, but they should issue some temporary moratorium at a minimum so that hospitals can give this information to independent repair professionals and their in-house servicers.”