U.S. health agencies partner to oversee 3D printed medical equipment

NIH, FDA, VHA and America Makes to provide AM design guidelines and coordinate production of open-source medical products.

0 March 29, 2020
by DE Staff

NIH spproved 3D-printed face shield design
(Photo credit: Dr. Beth Ripley and Timothy Prestero)

While many in the additive manufacturing community have offered 3D printer STL files for the production of various emergency medical equipment in recent months, health agencies in the U.S. warn they may not all be up to the job, no matter how well intended the effort.

To focus production in a medically sound direction, the U.S. Federal Food and Drug Administration (FDA) announced it has entered in a memorandum of understanding with the Department of Veterans Affairs (VA) Innovation Ecosystem and the National Institutes of Health (NIH) 3D Print Exchange, to share data and coordinate on open-source medical products for the COVID-19 response. The agencies are also working with America Makes, the National Network for Manufacturing Innovation, to connect health care providers with 3D printing organizations.

The goal is to evaluate 3D printable parts, and other improvised designs, for their effectiveness and identify those likely to be the most useful for health care providers and patients in shortage situations.

For its part, the FDA is currently processing Emergency Use Authorization Applications for medical devices to respond to COVID-19 and is coordinating with U.S. government agencies to identify ways that stakeholders can mitigate severe medical device parts shortages. The agency has also produced design guidelines to ensure 3D printed equipement meet medical requirements: FDA Q&A for 3D printed medical devices, including PPE

The VA Innovation Ecosystem, which includes hospitals and clinics with 3D printing expertise, has created a website to help connect health care organizations with 3D printing service providers: Department of Veterans Affairs Innovation Ecosystem connector site

Similarly, America Makes has created a website to 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: America Makes COVID-19 site: Connecting Manufacturers and Health Care entities

Finally, the NIH 3D Print Exchange is creating a collection of tested and approved 3D model designs for masks or medical device parts: National Institutes of Health 3D Print Exchange COVID Collection

Other members are providing free or open resources to help with the COVID-19 response, including ASTM International open access to Standards related to COVID-19 and Cambridge University’s research into how household materials perform as filters.


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