A decentralized response to a central problem
We are in the midst of a supply chain crisis: Frontline Health Doers don’t have access to the equipment they need to do their jobs and protect themselves. Open-source advocates see an opportunity for open hardware and local production to contribute to the global response; everyone from manufacturers and engineers to designers and DIYers are eager to help. But their efforts have been hampered by a lack of coordination and guidance. In this particular crisis, authority is unclear, and without a central command to establish standards and protocols, the supply chain is stuck in disequilibrium.
Cottage industry solutions won’t be enough to address a large-scale, global problem. The maker community and distributed manufacturers will need to find ways to scale solutions that work. We’ll need to help the market find equilibrium so those with resources and expertise can effectively meet overwhelming demand. To make it work, we need to look at the entire supply chain — from design, production, and validation to distribution and logistics.
Rapid responders are asking: What are the best designs for PPE, ventilators, and other medical supplies? How do we test these designs and get them approved? And how do we get supplies to those who need them?
Planning
- Identifying market demand: The FDA published FAQs on shortages of surgical masks and gowns, and the CDC published strategies for optimizing the supply of N95 masks.
- Identifying customers: States and large healthcare systems have emerged as primary customers for PPE and equipment makers. New York State is helping companies find suppliers and sourcing COVID-19 supplies; the state is paying a premium for products and offering incentives to manufacturers transitioning their factories to produce medical supplies and equipment.
Designs, specifications, and standards
- Ventilators: Some are sharing designs for new ventilators — such as Medtronics’ open-source design and permissive license. Others are focused on optimizing existing equipment: Northwell Health shared a design for a 3D-printed T-connector adapter, which enables hospitals to convert BiPAP machines into ventilators; and Prisma Health said it will share printing specifications for VESper, a tool that enables a single ventilator to treat four patients.
- Masks and shields for Health Doers: HP released vetted specifications for 3D-printed PPE; the NIH 3D Print Exchange includes models for face visors, shields, and masks; Rowan University published instructions on assembling, using, and cleaning N95 masks; and Prakash Lab developed a prototype for a hacked snorkeling mask.
- Masks for the public: Following updated guidance from the CDC on face coverings, the internet has been flooded with patterns and tips for homemade masks. MakerMask has several evidence-based mask designs; Providence St. Joseph Health shared a mask pattern and video tutorial; and the Emergency Design Collective published downloadable instructions.
- Other products and equipment: Open Source COVID19 Medical Supplies, a group of experts that evaluates and approves designs, also created guides for additional supplies, including hand sanitizer, gowns, nasal cannulas, oxygen masks, and infusion pumps.
Manufacturing, production, and validation
- Production and testing standards: The FDA issued an Emergency Use Authorization — which allows for the emergency use of ventilators, anesthesia gas machines, and positive pressure breathing devices modified for use as ventilators — as well as guidance for making modifications to ventilators. The agency also published FAQs on printing medical devices, accessories, and components during the COVID-19 pandemic. New York State published medical supply guidelines for manufacturers, which includes requirements for PPE and test kits. And ASTM International published standards used in the production and testing of masks, gowns, and respirators.
- Distributed manufacturing: GetUsPPE published a list of suppliers of raw materials, such as 3D filament, sheet plastic, and Tyvek; Ultimaker’s map enables makers and manufacturers to find nearby 3D printers; and the National Institute for Occupational Safety and Health published a guide on 3D printing with filaments.
- Licensing and liability protection: The Open COVID Pledge promotes the removal of intellectual property obscables by sharing licenses of designs during COVID-19. Even beyond IP considerations, open-source solutions carry some risk; good samaritan laws offer legal protection from civil lawsuits for those providing reasonable aid to people who are injured, ill, in danger, or otherwise incapacitated.
Distribution and logistics
- Several initiatives are helping to collect and distribute PPE directly to Health Doers: GetUsPPE aggregates PPE needs and facilitates donations across the country; Project N95 connects PPE manufacturers with healthcare workers who need equipment; the COVID-19 Emergency Supply Chain matches hospitals, governments, and large organizations with verified PPE suppliers; and PPE Link helps research labs donate equipment to hospitals.
- Other initiatives are aimed at members of the public: Mask Match, Masks for Docs, and Protect A Nurse enable individuals to donate PPE directly to hospitals; Relief Crafters of America and NYC Makes PPE are bringing makers together to create and disseminate PPE.