Pop-Up Open Source Medical Hardware Projects Won’t Stop Coronavirus, but Might Be Useful Anyway. Here’s why

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Halfway to the moon and bleeding oxygen into space, the Apollo 13 spacecraft and its occupants seemed in dire straits. But the astronauts modified their CO2 scrubbers with a duct-tape-and-plastic-bag solution cooked up by NASA engineers and made famous in the 1995 movie. Now, in support of medical workers facing hardware shortages due to the coronavirus pandemic, several networks of volunteers are developing similarly MacGyver’d respiratory equipment using easy-to-find or printable parts.

Several such groups have taken on the open source mantle, and their stories illustrate some of the strengths and weaknesses of the wider open source movement.

One fast-moving team managed to use a 3D printer to produce 100 replacement valves for an Italian hospital’s intensive care unit, but was concerned that it might face legal threats from the original equipment manufacturer.

Another group is targeting a long list of supplies and devices, such as homemade hand sanitizer, 3D-printed face shields, nasal cannulas and ventilator machines. One company is prototyping an open-source oxygen concentrator. Some efforts are much lower-tech: One Indiana hospital asked volunteers to help sew facemasks following CDC guidelines.

The core idea is nothing new: anesthetist John Dingley and colleagues published free instructions for a low-cost emergency ventilator in 2010. But it may feel more urgent now that people are reading headlines about equipment shortages at hospitals in even the richest countries in the world.

One reason there often aren’t many manufacturers of a given medical device is the cost of getting the devices tested and approved for medical use. Even if the individual units don’t cost much, getting a medical device to market the usual way costs anywhere from $31 million to around $94 million, depending on the complexity and application, according to a 2010 estimate.

There are also issues with whether 3D-printed parts can be cleaned properly. Many ad hoc fixes won’t be as durable as products produced with an eye toward longer-term cost-effectiveness.

Still, moonshot-gone-wrong solutions may obtain expedited review from medical regulators for narrow uses, as is the case with the Open Source Ventilator Ireland group, which told Forbes it is getting a sped-up examination from Ireland’s regulator.

Michigan Technological University engineering professor Joshua M. Pearce, one of the editors of a forthcoming special issue of the journal HardwareX focusing on open source COVID-19 medical hardware, predicts that the U.S. Food and Drug Administration (FDA) will likely also waive some licensing requirements in the event of massive shortages.

“In the end I think it comes down to the Golden Rule: Do onto others as you would have them do onto you,” Pearce says. “I know I would be happy to have the option of even a partially tested open source ventilator if I had COVID19, needed it, and all the hospital systems were used.”

If volunteer medical device makers get past legal hurdles, they will also need to get in sync with patients and medical staff about what really works. 

The final users’ needs have often been “a minor part of the decision-making process” in commercial device development, wrote University of Pisa bioengineer Carmelo De Maria and colleagues in a chapter on open-source medical devices in the Clinical Engineering Handbook.

“Sometimes those people don’t have any competence in medical devices and they risk creating confusion,” De Maria says.

Already, some members of the Open Source COVID19 Medical Supplies group on Facebook have weighed in with that kind of criticism. One wrote: “None of the mask designs I’ve seen people printing here will do anything to stop the virus.” Another group member, a healthcare worker, pooh-poohed a thread devoted to an automatic bag valve, writing: “There is no real-life scenario an automated Ambubag would be useful. Everyone designing these can turn their skills elsewhere.”

That feedback, visible to any potential contributors, might help steer the group toward more viable solutions. One recent post, for example, suggested concentrating amateur efforts on lower-tech devices aimed at less critical patients, to free up first-line hardware for the most critical patients.

A different issue is coordinating all the digital Good Samaritans. One recently formed group, called Helpful Engineering, reported having over 3000 registered volunteers as of 19 March, and over 11,000 people on Slack, the messaging platform. (And you, newly remote worker, thought your office Slack was getting noisy.)

The speed with which people can talk about, and even design something online may be tantalizing, but it might not reflect how fast the output can spread in the real world. In the Clinical Engineering Handbook, De Maria and colleagues write that the growing ease with which people can make their own medical hardware makes it even more important to create accompanying rules and methods for validating do-it-yourself devices.

De Maria helped build Ubora, a platform where makers can document the work they have done to show their device’s efficacy.

“Open Source can create a reliable prototype but [when] you want to go to the next level you need another type of approach that has to take your brilliant idea, do an experiment together with experts before going to the patients,” De Maria says. 

Generating widely affordable, easily buildable devices that withstand rigorous testing and are legal to distribute, even with the speed of open source and goodwill and skills of thousands of volunteers, may not happen as quickly as we need it to in order to suppress this pandemic.

That doesn’t make the effort a waste. Think of all the engineers who were inspired by the story of Apollo 13’s improvised scrubbers, and the institutional knowledge NASA gained for future missions. If the lessons of the hardware push in response to today’s COVID-19 outbreak stay in the open, they will be useful in the longer term.

With that in mind, De Maria and colleagues are challenging open source hardware makers with a competition calling for European-compliant medical designs that will be well-documented using Ubora. The first deadline is 30 April and awards won’t be presented until June.

“We created the competition looking for a solution, but in perspective,” De Maria says. Creating and validating systematic solutions will take months, not weeks.

While some smaller open source components have already received government approval for so-called “compassionate use” and spare parts such as those valves are welcome, it may be too late for them to make much of a difference in places still on the wrong side of the COVID-19 growth curve.

The real reward is saving lives in future pandemics.

Says Pearce: “I am operating under the assumption that… anything we do now will help for the next pandemic.”

IEEE Spectrum updated this story with quotes from De Maria.

Source: IEEE-Spectrum – Fulltext

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