The coronavirus COVID19 outbreak has left hospitals and health systems across the world scrabbling for equipment to fight the virus: masks, gowns, respirators are all in short supply. In some areas, there’s simply not enough equipment to go around; in others, equipment is just not getting to the places it’s needed. Could 3D printing offer an alternative way to get vital equipment into the hands of the doctors and patients?
The drive to use 3D printing to manufacture vital medical materiel was driven largely by makers and hobbyists, who quickly grasped that their home and business machines could be repurposed to generate a range of healthcare equipment. An Italian 3D-printing startup, Isinnova, recently began printing much-needed Venturi valves for hospitals after hearing about a shortage. Venturi valves are used to change the oxygen and air flow on the respiratory masks used by patients with breathing difficulties; people with coronavirus are often short of breath due to the body’s immune response to the virus. The startup’s founder Cristian Fracassi was able to deliver 100 of the valves to his local hospital, and the company is now working on converting snorkel masks to CPAP masks, which use positive air pressure to keep a patient’s airways open.
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Across the Atlantic, US startups are working on addressing other medical equipment shortages. The New York-based couple behind 3D-printing company Budmen Industries have been working on producing hundreds of face shields — worn by medical staff to prevent virus-laden sneezes or coughs landing on their faces — for their local coronavirus testing centre. Isaac Budmen and Stephanie Keefe began working on a prototype last week after hearing about equipment shortages and after six iterations, they developed a functional, comfortable face shield that could be 3D printed.
“We set our printers working Sunday night, and then Monday we spent all day just running around as fast as we could, cutting material, cutting foam, gluing things together and packaging everything up. Then we reached out to the county executive’s office and said, ‘Hey, we have 50 of these. We don’t know if you need them or if you want them just yet, but we’re willing to donate them.’ We got a phone call back that said ‘You have 50? Can you make 300 more?’. We said sure and we jumped on that. It’s just been a whirlwind,” Budmen told ZDNet.
Budmen Industries has been inundated with requests for kit and offers of support since then. Now, thanks to volunteers and assistance from local businesses, the company is printing 24/7 and hopes to make 1,000 shields a day. Presently, it’s focusing on shields only, but hasn’t ruled out making other medical materiel. “We’re trying to keep the door open because the beautiful thing about 3D printing is you can make just about anything,” Budmen added.
And there are other community-led efforts to print medical equipment springing up across the US. In Baltimore, nonprofit maker-space Open Work has been coordinating efforts by local 3D printer owners to build and distribute face shields. The organisation has nearly 300 volunteers and over 600 printers. “Open Works will receive the 3D-printed straps, which will have unique serial numbers so they can track inventory, and has a team assembling them with the bulk plastic they purchased for the shield (those are laser cut at Open Works). They will sterilize them by UV light and package in batches of 10 for distribution,” the organisation told ZDNet.
So far, efforts to 3D print medical supplies have been bottom up, with individual makers and small companies creating materials on an ad-hoc basis. That might be about to change, as pressure mounts to create more widespread initiatives, with hospitals asking specifically for 3D-printed kit: the president of Massachusetts General Hospital reported severe shortages of key equipment, asking companies with 3D printers to step up production.
Back in Europe, the European Commission has been asking the 3D-printing industry to collate information on who, what and how much gear can be 3D printed. The EC has asked Cecimo, the pan-European trade organisation for the additive manufacturing industry, to survey its members and the wider industry for any companies that could help out in creating in-need medical goods. Cecimo is “urging everybody who has the possibility to do so, to assist the needs of hospitals all over Europe,” the organisation said. Cecimo’s website will be collating a list of companies that are able to 3D print medical supplies, which the European Commission will then distribute to buyers of medical equipment such as national authorities and healthcare groups.
As well as facilitating communication between creators and those in need of equipment, the European Commission has also worked to smooth regulation in order to allow printers to make designs without infringing any intellectual property rules.
3D-printing companies that had hoped to offer their products to buyers at short notice had concerns about breaching EC regulations, said Filip Geerts, CEO of Cecimo. “Our companies are complaining that there was a request to some companies to provide 3D-printed equipment, like the valves, but they have problems with the medical device directive… and therefore they contacted us to solve it, [asking] that, for the time being, these requirements should be waived by national authorities for specific products that are really needed, for a temporary period at least,” he said. The organisation welcomed a statement by Thierry Breton, European Commissioner for the Internal Marks, that the EC will aim to facilitate companies helping with the outbreak and protect them from potential legal issues.
3D-printing companies’ concerns about legislation appear to be well-placed. It was initially reported that the Italian valve printers had been accused of patent infringement by the medical device manufacturer whose valves they were emulating. The reports turned out to be wrong, but do highlight the difficulties that could lie ahead for citizen medical device makers.
“Although the engineers printed lots of valves for local use, they declined to share the file with others out of fear of patent liability. Their fear was not misplaced. A person can be liable for indirect patent infringement for helping or inducing others to commit direct patent infringement. And the person can be potentially liable in any and all countries where the direct infringement occurred or was facilitated, Lucas Osborn, professor of law at the Campbell University School of Law, wrote.
In order to make certain medical equipment, 3D-printing companies and makers may need to reverse engineer patented designs, and therefore put themselves at risk of being sued by patent owners, or gain temporary access to patented designs, which patent-holders may see as a risk to their business.
3D-printed kit might be something of a novelty in hospitals pre-COVID19, but there are niches where additive manufacturing has already taken hold. One of the advantages that 3D printing offers compared to traditional manufacturing is the ability to create kit that can be custom-fitted to the individual that will use it, such as hearing aids and prosthetics. While for now the bespoke prints have been made of plastic, in future they could be made of tissues like cartilage or bone.
The coronavirus outbreak may set the stage for greater use of 3D-printed kit in future. As hospitals and healthcare authorities take delivery of equipment printed locally and on-demand, 3D printing could help to cut down delivery times and quickly scale-up production in times of need.
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