Additive Manufacturing Strategies

3D Printing COVID-19: First Do No Harm

ST Medical Devices

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We must be mindful that just because we can make a design that this design is not necessarily the right one. While I’m buoyed by the 3D printing industry’s efforts to come up with solutions to COVID-19 I’m also skeptical and feel that we must be more careful.

Just because we can make a shape it does not mean that this shape will solve for the problem in question. Just because we may make a part does not mean that this part is functional. 3D printing unsterilized respiratory and ventilation devices could create more problems than it solves. Many materials I see being used are not skin contact approved or have unknown additives in them. Many of the printers used could perhaps create sterile parts but I see little to no work being done on serialization, testing and finding out if parts can be cleaned. Also, some of you should ask yourselves “Why use 3D printing?” It is a technology well suited to many applications but perhaps not when sewing will provide a less expensive, safer, faster solution.

We are solving for the obvious and not the necessary. Most projects show an idiocy that indicates that no possible effort could ever make this a working efficient safe solution for anyone. Newsflash: your marketing department should not be in the driving seat here. Porosity in 3D Printed parts, as well as issues in cleaning or sterilizing them because of their layers, is a real issue. Many materials are not autoclavable which takes place at 121 C. You should, therefore, be working on newer methods to sterilize these parts, through hydrogen peroxide and the like, funnily enough, that doesn’t seem to be happening. Nor are people looking at the effects that sterilization will have on parts or indeed if FDM has “intrinsic sterilization” or not. Particles entering printers or embedding themselves in prints is also a potential issue. Testing or verifying if the part in question can be cleaned is also essential. Some 3D printing materials are carcinogenic or can cause contact allergies and some additives and materials exhibit cytotoxicity. What happens if we use a material or shape that causes viral particles to embed deep within a mask for days? Somewhere where it can not be cleaned? We can take a thing that is meant to keep particles out and turn it into something that infects the user or even others near the user at times when there would otherwise not be virus exposure. More simply put, we could be making things that increase the spread op the virus rather than contain it. Rather than be a solution for someone who has no mask, we could infect their entire family.

There is a reason why medical devices and parts are expensive and have lengthy approval processes. We may be able to do some things faster, but we should be careful when compromising safety. You may also be exposing yourself to liability in making things that are nonfunctional or indeed could be detrimental to health. And saying that it is a quick and temporary solution or only to be used in emergencies will not help you, legally or ethically. Yes, just in case 3D prints could be pushed into service in times of extreme deprivation, but we have a duty of care as well.

It used to be that speed was of the utmost essence in surgeries involving amputations, as this would improve outcomes. In the 1800’s, surgeon Robert Liston was known as one of the fastest surgeons of his time. Once he amputated a leg in record time, while cutting off his assistant’s fingers. The patient died, as did his assistant and a third man, a spectator, died as well, reportedly of fright. The fastest leg amputation ever, with an unanticipated 300% mortality rate. Not something you may have considered a worst-case scenario until now. If we want to introduce things into ICUs and hospitals we must adhere to the precautionary principle. First, do no harm, has as a concept, been around for millennia. This concept’s longevity is not because it sounds cool, but because of its efficacy. We need to keep to it to protect ourselves and those who we claim to want to help. Yes, we are in exigent circumstances, no the legal system is not on holiday. No, not any and all effort will help. Some efforts will be like throwing water on an oil fire or gasoline on any fire. Don’t be that person.

Also giving people hope may endanger and cheat them out of a better outcome. That lovely diving mask thing is apparently not a solution to the ventilator issue as many seem to think. It is a high-pressure oxygen device that, if it works, could be used prior to putting patients into the medically induced coma that is the only option open to hundreds of people each day now. By misinterpreting that news we may have caused people to direct their efforts towards less pressing problems. Hope can be toxic too, and more importantly, hope is not a strategy.

We must not end up making ventilators that breed and ventilate bacteria throughout a hospital or silently kill patients in the night. We must realize that a malfunction there could have people aspirate their vomit into their lungs and die. We also can not make devices that give people the illusion of safety causing them to perhaps become infected because they thought that the ineffectual 3D printed device would save them. You can not as a company or individual be cavalier with other people’s lives. For some of you, your ill-chosen projects and processes are doing just that.

Please refocus your efforts on things with fewer unanticipated consequences and significantly lower risks. You could severely impede your ability to ever feel happiness again and it will also be a career-limiting move for you if your super awesome “we’re helping guys” 3D Printing project ends up killing people. You won’t ever get a CMO job anywhere if your cool “3D printing save the world thing” kills hundreds of people and gives your company a headshot. This is not a Yoda head, we’re making parts for hospitals and sick people. Please, I beg of you, be careful. First, do no harm.

Featured image is by Brett Jordan.

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