You’ve heard the stories: engineers 3D printing face shields in their basements; do-it-yourself hobbyists sewing face masks; and fashion designers crafting personal protection gowns.
Globally, people are trying to help fill the medical supply gap caused by theCOVID-19pandemic throughopen-source medical hardware.It’s a heartwarming display of global ingenuity, innovation, and collaboration.In this post, we answer your questions about open-source medical hardware and provide some insight into what you can do to help.
Open-source hardware: the designs of physical objects that are openly licensed so they can be modified, created, and distributed without restrictions.
为什么开源医疗硬件如此重要?
随着此类活动的增多，人们很容易忘记，开源医疗硬件并不是什么新鲜事。In fact, ithas been instrumental in providing medical devices and equipment to under-resourced healthcare workers and facilities for years—a need that predates the COVID-19 pandemic. For example, following the H1N1 pandemic, medical professors at Swansea University published open-source instructions for alow-cost emergency ventilator.
In a 2010 report titled, “Managing the Mismatch,” the World Health Organization (WHO) stated, “Research is making rapid progress within the development of sophisticated medical technologies…Yet despite this progress, the majority of the world’s population has little or no access to many of these innovations.”In particular, the WHO detailed a significant “mismatch” in the availability of relevant, effective medical devices for localized public health needs, highlighting that “70–90% of all medical devices donated to the developing world never function as intended.” Four important components of correcting this “mismatch” are availability, accessibility, appropriate(ness), and affordability—this is where open-source medical hardware comes in, as Dr. Gerrit Niezen et. al.explainedin a 2016 research article:
“Making the hardware design available under an open source license allows anyone to improveand contribute to the device design, leading to very rapid innovation compared to traditional methods. It also enables the design to be modified for very specific uses, and makes the devices easy to repair…This has great potential for making medical devices more accessible in the developing world, where devices can also be designed as open-source and built for specific use cases, instead of having to depend on donated equipment.”
A clear example of a medical device “mismatch” is the cost of a stethoscope compared to its necessity. Although stethoscopes are one of the most important tools for healthcare workers, on the market, a reliable stethoscope costs between $90.00 – $200.00 USD and is almost impossible to come by in low-resource settings. After noticing this issue while working in Gaza,Dr. Tarek Loubani, an emergency room physician in Canada and recipient of the 2020 Bassel Khartabil Fellowship, created an open-source design for stethoscopes in 2018 that can be 3D printed for around $3.00 USD.Through his charity,The Glia Project,Dr. Loubani now creates and releases open-source designs for stethoscopes, tourniquets, and otoscopes so that they can be produced cheaply by anyone with a 3D printer. The charity not only creates these designs, they also train people in under-resourced and conflict-ridden areas to use 3D printers and deploy these medical devices in the field. “The Glia Project is first and foremost a project about independence,” explained Dr. Loubani in a 2019interview.
Just recently, in response to the pandemic, the organization turned to creating face masks for Canadian health workers. “That’s been my promise to my colleagues,” Dr. Loubani recentlytoldtheCBC不久，这将成为我对加拿大所有医疗工作者的承诺。”
Creating open-source medical hardware during the COVID-19 pandemic
Dr. Loubani is not alone in using open-source hardware to mitigate the medical supply and equipment shortage due to COVID-19. TheHelpful Engineering Groupon Slack is filled with thousands of engineers crowdsourcing ideas for medical devices and tools, and theOpen Source COVID-19 Medical Supplies(OSCMS) group on Facebook has over 50,000 members doing the same. Alongside these somewhat ad hoc and loosely organized efforts are initiatives by research institutions and labs, such as theMIT Emergency Ventilator(E-Vent) project and theJust One Giant Lab OpenCovid19 Initiative.
What’s the manufacturing process?
识别开源硬件设计并制造最终产品的过程因各种因素而不同，如设计复杂性、资源分配、安全要求、交付需求等。在某些情况下，一旦开源设计在内部创建，或在其他地方确定，制造过程可能会相对较快。“最重要的是测试设置，优化设计，根据当地资源调整设计，并与医院的专业人员进行测试。If it works, then you proceed,” saidAndré Rocha, assistant professor at the Escola Superior de Educação de Lisboa, co-coordinator ofFabLab Benfica, and an active member of CC Portugal.
“最重要的是测试设置，优化设计，根据当地资源调整设计，并与医院的专业人员进行测试。”
For example, a face shield—an important component ofpersonal protection equipment(PPE)—is very “fabricatable,” meaning it’s easy to design and manufacture with a 3D printer, taking around 20 minutes to an hour. Due to the global shortage of face shields, there are many people utilizing open-source designs to manufacture and deliver these to healthcare workers. This includes Darrell Currington, who runs theRapid Prototyping Centre at OCAD Universityin Toronto, Canada. “We’re currently working on the production of 3D printed visors which are used to make face shields for hospitals,” he explained over email, “With the university closed down, we weren’t able to run the facility as we normally would. So I decided the best thing we could do was to take what equipment we could, and distribute it among our staff, and faculty that would be most familiar with the technology.”
OCAD University producing 3-D printed protective face shields for hospitals such as@MGHTorontohttps://t.co/uAysgNQqOx#COVID19#covidontariopic.twitter.com/wdwAWyzPAb
— OCAD University (@OCAD)April 3, 2020
Although 3D printing is a low-cost and quick way to create PPE components like face shields, there are instances in which it’s better to use other technologies like laser cutting to manufacture more reliable and effective devices—this is especially true for more complex devices like apositive pressure helmet(PPH). A PPH supplies filtered and precise airflow to the wearer. “Imagine an inflatable bubble on your head,” André explained. These havebeen usedin hospitals where COVID-19 cases have overwhelmed the healthcare system, such as Italy. PPHs can relieve the pressure on ventilators and prevent sick people from contaminating the air in crowded hospitals.The process of designing and manufacturing a PPH is more complex than a face shield, requiring more collaboration with industrial companies and medical experts, more materials, and more tests to ensure the hardware is safe and reliable. Therefore, the pace of production and delivery is relatively slow.
André is currently tracking a PPH project launched bytheFab Foundation. The open project’s documentation can be trackedhereand the repository is locatedhere.
如何接收和交付请求?
Again, this varies widely depending on the specific context. In some cases, requests are formally channeled through government officials and/or hospital administrators and delivered by established organizations. In other cases, the requests are made informally by healthcare workers and hand-delivered through small volunteer groups or individuals, likeCoronavirus Makersin Madrid, Spain.André’sgroup in Lisbon, Portugal receives PPE supply requests directly from local healthcare workers. “All the help and requests are informal,” he explained, “We [the volunteers] meet remotely almost every day to prepare next day donations to hospitals, police squads, and next developments.”
Aquí una foto que nos hacen llegar unos héroes de un centro de salud de Madrid. Como siempre decimos, ¡¡gracias a vosotros!!#DeEstaSalimosJuntospic.twitter.com/pukPtWuFdD
— CoronavirusMakers.org (@CoronavirusMak3)April 10, 2020
Unfortunately, volunteer groups and individual efforts suffer from limited capacity and resources—thus, they’re unable to scale their efforts.André and his group are hoping to overcome these challenges by“developing cutting stamps for printing houses that can deliver a few thousand [face shields] in a couple of hours.” However, localized challenges, like a scarcity of the necessary materials to manufacture the supplies, are more difficult to solve. “The effort here is to create versions for different materials, thicknesses, and production processes based on available resources,” he explained.
Are these devices safe?
The landscape of open-source hardware feels a bit like the “wild wild west” due to the urgency and desperation of the current situation. However, ensuring that open-source hardware is safe and reliable is imperative. The devices developed by The Glia Project and their production site, for example, are approved by Health Canada. However, that approval process takes time and resources—neither of which are readily available during a crisis like the COVID-19 pandemic.
In many countries, safety information and regulations around medical devices are publicly available and should be followed.
Therefore, it’s important that manufacturers (even those do-it-yourself hobbyists sewing face masks) do their due diligence in ensuring their products are safe. But how? “I think the most basic level is to test solutions with local health professionals,” emphasized André, “Another is to be extremely careful during fabrication. Everything should be validated by professionals before usage…In projects that represent higher complexity, I believe that [public health] authorities should be involved and contacted.” Darrell’s group, for example, checked withMichael Garron Hospitalin Toronto for a tested and approved 3D printed face shield design before starting their efforts. “The hospital had worked with a designer named Shawn Lim, they tested his design, and found they could sanitize the visor and it would be safe for use in their hospital,” Darrell explained, “They then posted the design ontheir websiteand asked for anyone with a 3D printer to contribute…As of this evening [April 9] we should have just under 1000 units ready for drop off at the hospital on Tuesday.”
In many countries, safety information and regulations around medical devices are publicly available and should be followed. For example, the United States Federal Drug Administration (FDA) lists regulatory standards for a variety of devices on their website, and in response to COVID-19, they’vecurated specific information on ventilators and PPE.
Where can I find open-source initiatives and designs?
There are hundreds, if not thousands, of different open-source hardware initiatives that you can contribute to and designs that you can utilize. There are a few repositories that you can search through, includingAppropedia,Wikifactory, and Public Invention’s“Evaluation of Open Source Ventilators,” as well as loosely organized social media groups to join, including the aforementionedHelpful Engineering Groupon Slack andOpen Source COVID-19 Medical Supplies(OSCMS) on Facebook. Just One Giant Lab (JOGL) has also launched several projects under theirOpenCovid19 Initiative. There are also more country-specific initiatives and designs, such asBreath4Life(Belgium),Un Respiro(Argentina),Fast Jungle Face Shield(Panama),Make4Covid(USA),VentilAid(Poland),Open Source Ventilator(Ireland),OxyGen(Spain),Open Source Against COVID-19(Belgium).
According to André, it’s important to distinguish ‘pirate’ initiatives that “reverse-engineer medical equipment” from other initiatives developing new designs through more official collaborations and/or partnerships by universities, companies, and research centers. “Information about the latter is unclear because it is hard to distinguish the nature of the initiative,” he emphasized, “We don’t always know if patents will be filed later on or if they are universally available open-source designs.”
In order toavoid intellectual property (IP) issues, and make it clear the results of these collaborations are open source, Creative Commons is urging individuals, companies, and research institutions to clearly utilize an open-source license or sign theOpen COVID Pledge—which grants the public free, temporary access to IP rights in support of solving the COVID-19 crisis, removing obstacles to knowledge and inventions that could save lives and limit suffering.
P.s. You don’t need to know how to operate a 3D printer, laser cutter, or sewing machine to help out. You can donate materials, money, or your time to each initiative. Just take a look at their websites!
What’s next?
The current situation is not ideal. The explosive growth of open-source hardware over recent weeks is the direct result of devastating medical supply shortages across the world—and unfortunately, current efforts are relatively ad hoc, difficult to scale, and loosely organized. Therefore, it’s impossible to predict what will happen to all of the open-source hardware developed in reaction to COVID-19.Will these designs become legitimate alternatives to those found on the market once the pandemic is over? Will they be used to correct the “mismatch” of medical devices globally? Or will they simply be relegated to the digital archives of history? These are important questions that will need to be examined in the coming months.
For now, let’s get to work.
If you have a question regarding CC Licenses and how they apply to hardware designs or the Open COVID Pledge, please feel free to contact us atinfo@www.familygiver.com.
