US engineers require manufacturers to share manuals to repair respirators in hospitals

More than 300 clinical engineers and biomedical technicians in the United States have submitted a paper to the United States Congress requiring manufacturers to supply manuals and materials necessary to repair medical equipment such as respirators.

Saturated in recent months, these professionals explain that their work has been hampered by the usual practices carried out by some of these companies, which restrict permission to manuals or prevent access to repair the devices by independent experts.

In fact, the web iFixit, normally dedicated to facilitating the repair of household appliances or electronic devices, compiled more than a month ago a large database of medical device manuals to assist hospital technicians around the world. But some manufacturers have threatened them for not complying with what they consider to be part of intellectual property law.

“The pandemic has made this problem visible in the United States because in many hospitals there are respirators available that need to be repaired,” explains Ugo Vallauri, one of the founders of the right to repair association. Restart Proyect. “But we are beginning to see that this is a much more global problem that also affects Europe and, very urgently, developing countries.”

In addition to the difficulty in accessing the manuals, clinical engineers face problems such as a lack of spare parts, limitations in training and, above all, restrictions in the software.

“Just as it is happening in consumer products such as cars, the obstacles to accessing software is one of the big problems that technicians who repair medical equipment face,” Vallauri explains. “If you can’t update security or software, you’re too limited to extend the life of an appliance, leading to obsolescence and the perception that the product is no longer useful.”

However, some companies insist that this is simply a matter of security. As they explain, by requiring that only their technicians can repair their products, they ensure that the devices meet all the requirements and prevent mistakes from being made.

But the matter does not seem so simple. For John Sandham, President of the Association of Clinical and Electronic Engineers in the UK, if machines are repaired in a hospital, safety will always rest with the technician. “In the end, the technicians are alone and are solely responsible for making sure they have done their job well. We must do the safety tests, repair, replace the parts, and all other items.” In addition, he adds, except in some very special cases, most of the professionals who work directly in the health system have similar knowledge to that of the manufacturers of these products.

“Of course, when you think about repairing medical equipment, the first thing that comes to mind is security,” explains Nathan Proctor, director of the right to repair campaign of the United States Public Interest Research Group (US PIRG). “However,” he continues, “the data shows that using independent, accredited experts is as safe as calling the company’s technicians.” In fact, in 2018, the United States Government Food and Drug Organization (FDA) published a comprehensive study in which it concluded that the quality and safety of the repairs of these technicians was similar to that offered by the experts of the companies, albeit at a much lower cost.

“If hospitals depend on outside professionals, costs increase and efficiency is reduced,” says engineer Sandham, speaking of his experience in hospitals. “When a device stops working, it always takes longer to arrange a visit from someone outside than to be done by an internal engineer,” he concludes.

In certain cases, moreover, this may be the only option available, and therefore lack of sufficient information may put more lives at risk. “In some places, such as in poorer countries or isolated villages, having access to the manual is what can prevent mistakes from being made or allow it to be repaired quickly,” says Vallauri.

But the databases that some technicians from these places have tried to found have not escaped restrictions either. In the page Since it was created in Tanzania, companies such as the German Dräger or the American Tecme have demanded that their manuals be withdrawn for infringing intellectual property rights. Although, Vallauri points out, it is difficult to think that someone is going to copy such an apparatus looking at a manual.

John Sandham points out that a minority of manufacturers are actually opposed to offering workshops or replacement parts in order to profit from service and repair contracts. But, according to Nathan Proctor, of the 500 engineers involved in his organization, many have expressed concern about what seems like an increasingly common way to act. “Most comment that restrictions on repair have increased in the past decade, especially on certain especially expensive equipment, such as MRI, CT, or ultrasound imaging equipment.”

Proponents of the right to repair believe that what these companies are actually doing is creating monopolies by ending competition, as is the case with many of the products we consume. “What we see on medical equipment is similar to what happens, for example, when you buy a very cheap printer that you later discover only supports cartridges from its own brand that are much more expensive and wear out quickly,” explains Proctor. “For us this is a deceptive business model in which the doctrine of sale is not accepted. Companies must be honest and collect costs from the beginning but afterwards the buyer’s right must be respected to be able to repair their product as they wish. If not, it is selling something to continue collecting rent later. ” Something that in the case of medical equipment, and in circumstances such as a pandemic, damages, according to these advocates of reparations, the entire society.

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