FDA Efforts to Connect Manufacturers and Health Care Entities: The FDA, Department of Veterans Affairs, National Institutes of Health, and America Makes Form a COVID-19 response Public-Private Partnership
July 9, 2021: The FDA has made publicly available a report on the use of additive manufacturing by non-traditional producers in support of the U.S. COVID-19 response. The study shows successes, challenges, and key lessons learned to build on and improve future crisis response. The FDA is reviewing the report to assess gaps in the response and potential mitigations for future public health emergencies. See Advanced Manufacturing Public-private partnerships for more information about ongoing public-private partnerships to address challenges presented by advanced and continuous manufacturing technologies.
FDA recognizes that many stakeholders are interested in designing and producing 3D printed devices during the COVID-19 public health emergency. We are also aware that stakeholders often do not know what device designs to choose or how much to print. In light of this and as part of our effort to protect the public to the extent possible, FDA is facilitating information-sharing regarding the use of 3D printing and other advanced manufacturing technologies in the context of personal protective equipment (PPE) and other medical device parts.
To this end, the FDA entered a Memorandum of Understanding (MoU) with the Department of Veterans Affairs (VA) Innovation Ecosystem and the National Institutes of Health (NIH) 3D Print Exchange [1], to share data, and coordinate on open-source medical products for the COVID-19 response. These agencies are also working closely with America Makes [2], to provide resources that will connect health care providers and 3D printing organizations.
Partner efforts are already underway:
- The FDA is processing Emergency Use Authorization Applications to make available medical devices to respond to COVID-19. FDA is also coordinating with U.S. government agencies and public private partnerships to identify ways that stakeholders can mitigate severe PPE and other medical device parts shortages while maintaining safety for health care providers and patients. FDA-funded research projects may also provide useful information for health care providers.
- The VA Innovation Ecosystem includes many hospitals and clinics in the VA health care network that have 3D Printing design and engineering expertise. They have created a website to help connect health care organizations with 3D printing service providers.
- America Makes is a large public-private partnership with members, including FDA, that span all sectors of the 3D printing industries. It has created a website that will track the capabilities and capacity of 3D printing companies and other manufacturing services, and healthcare organizations that have specific needs during the COVID-19 outbreak.
- The NIH 3D Print Exchange is creating a collection for 3D model designs that can be used for 3D printing masks or medical device parts for responding to the pandemic.
- All these partners will work continuously with other stakeholders to evaluate 3D printable parts and other improvised designs for their effectiveness and identify several designs that are likely to be the most useful for health care providers and patients in shortage situations.
Other members of the stakeholder community are also providing free or open resources to help with the COVID-19 response:
- ASTM International opened free access to Standards related to COVID-19
- In 2013, Cambridge university published research into how well household materials perform as filters
1. A resource from the National Institute of Allergy and Infectious Diseases at the NIH. This MoU allows the Agencies to collaboratively perform on-demand research projects
2. The Department of Defense Manufacturing Innovation Institute for additive manufacturing