With the current coronavirus pandemic, certain medical supplies are in urgent need. Medical staff require personal protective equipment, nasal swabs are needed to conduct testing and a sufficient number of respiratory ventilators are lacking.
Because of the constrains on the supply chain, with many of the manufacturing areas located in China already badly affected by the pandemic, new digital manufacturing companies are emerging to fill the supply gaps. Using 3D printers, these manufacturers are developing medical masks and face shields, nasal swabs as well as components for ventilators.
In anticipation of the 3D printing of components and accessories, the European Commission has published a statement on the conformity assessment procedures for 3D printing to be used in the for medical devices needed to fight COVID-19. This statement lists a number of standards relevant for 3D printing including IEC Standards on the safety of machinery and the safety of laser products.
Other groups, such as the joint IEC and ISO technical subcommittee on office equipment (ISO/IEC JTC 1/SC 28), also develops standards for 3D printers.
Examples of 3D printing in action
There are a number of examples of how 3D printing has been used to make devices that are urgently needed right now. They include:
- A team at Northwell Health has made available a template for 3D printed nasal swabs. Already, one manufacturer has plans to use its 3D printers to produce 100 000 nasal swabs each day.
- A global printing manufacturer has announced that it has delivered more than 1 000 3D-printed face masks, face shields, mask adjusters, nasal swabs and respirator parts to local hospitals in Spain and the United States. Plans are also underway to develop hospital-grade face masks and parts for a mechanical bag valve mask.
- Nagami Design in Spain has converted the use of its robotic arm from making furniture to 3D printed face shields with a production of up to 500 shields each day.
- Researchers at the University of Minnesota and MIT are each working on the design for low-cost ventilators that hospitals could produce in case of an emergency shortage.
- According to media reports, 3D printers have been brought into a hospital in Italy to design and produce venturi valves needed in the intensive care unit.
- A small company in the United States is providing face shields to local health workers based on a printing template that it has developed and shared. Similarly, researchers at Northwestern University have generated 1 000 face shields in one day from a single 3D printer.
As noted by the founders of Nagami Design, “3D printing has emerged as the ultimate tool for local manufacturing, reducing the production chain to the bare minimum. With the COVID-19 emergency, this technology provides the opportunity to efficiently produce affordable tools, which are now essential to help save lives”.
However, the use of these new tools should only be seen as a stop-gap measure necessary in an emergency.
Authorities voice caution
As per the statement from the European Commission, authorities need to ensure that medical devices conform to regulations, including those produced by 3D printers. For low risk medical devices, manufacturers can issue their declaration of conformity.
In the United States, the FDA has expressed some reservations whether 3D printed products, such as personal protective equipment, can provide the same level of protection as conventional products. Risks emerge when products are made outside of the traditional regulatory regime.
It will be necessary to trust that digital manufacturers have undertaken the proper design and testing measures to ensure that their products work effectively and safety. Standards can provide the necessary safeguards and ensure performance, safety and reliability.