Medical electronics reliability and safety

Right to repair is a valid area for consumer electronics, however medical devices need a more rigorous approach. This article may give some insights into what is involved with links to important topics - safety and reliability must equally apply to repairs of such equipment:

Right to repair policy must address these issues carefully.

Interesting article, thanks for sharing Roger.

I certainly agree that safety and reliability are particularly important when it comes to repairing medical equipment. This topic is obviously particularly pertinent at the moment, and one that we explored at Restart in some detail back in March-April. If you haven’t come across these already, you might be interested in the webinar we ran with ABI Electronics about Repairing ventilators and COVID19 medical equipment and the Restart Radio episode: Reuse and repair with two frontline medical professionals.

One of the points that came out of this work was that certain manufacturers of medical equipment often lock hospitals into strict service contracts and don’t make parts, service manuals or diagnostic tools available, even to the hospital’s own biomed engineers who would otherwise be well-qualified to perform the repair themselves. Consequently, hospitals often have to wait for the manufacturer to send their own technician to fix broken equipment, which can take time - not ideal, especially in a pandemic.

The reason these manufactures give for these restrictive contracts is generally related to the safety and reliability of the equipment - the argument goes that as company that produced the device, only they are qualified to perform high quality repairs. But back in 2018, the FDA produced a study into the ‘Quality, Safety, and Effectiveness of Servicing of Medical Devices’ [PDF], which concluded that:

the objective evidence indicates that many OEMs and third party entities provide high quality, safe, and effective servicing of medical devices

Added to this, it’s also worth noting that hospitals seem to bear full liability for repairs of their equipment, not manufacturers.

Rather than making the repair of medical equipment safer and more reliable, it seems to me that manufacturers’ efforts to control or obfuscate repair make it more difficult and less safe, even for trained professionals. On the other hand, making service manuals available would serve to make safe repairs more accessible, especially to biomeds in poorer areas where more lives hang in the balance.

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I was aware of some arguements however making service manuals available to “anyone” may lead to inexperienced individuals, all-be-it meaning well, dabbling with repairs. I have seen such “dabbles” at repair cafes.
Just having a service manual does not mean the repairer can proceed with a fix. It usually requires more specialised equipment, preferably calibrated correctly, to confirm a safe repair. It also requires a level of knowledge and skill to repair electronic equipment. So my point is simply yes it would be good to have service manuals available but there is a responsibility attached to the recipient/fixer. What could be a solution is to have some sort of system where specialist fixers are given such access. A specialist volunteer fixer would be peer assessed first to ensure they had correct and applicable repairs skills, for safe repair of such critical items. That means applicable practical experience, not necessarily paper qualifications.
I certainly do not believe in free unfettered access to service manuals for such critical equipment should be encouraged.
Neither do I believe manufacturers should use lame excuses! But if you know your specialism, you can easily see through and challenge such attempts.

I think we’re largely in agreement here :slight_smile:

The suggestion isn’t so much to start fixing ventilators or patient monitoring systems at community repair events, but rather to allow hospitals’ in-house electro-biomedical engineering teams (or 3rd-party specialists) access to the documentation, diagnostics and parts required to carry out repairs themselves.

This sounds pretty similar to the approach adopted by NHS England during the height of the pandemic in the UK. In March/April, they put out a call via RAENG for volunteer engineers to help maintain equipment under the supervision of in-house specialists:

^ This training and supervision process is something Dr Helen Meese covered in the webinar I mentioned above.

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