America Makes is partnering with its member, the Food and Drug Administration (FDA), to help ensure the additive manufacturing industry can effectively and safely meet the needs of America’s health care workers on the front lines of the Coronavirus crisis [You can find more information on this effort and how to join it here]. Today, March 30th, at 12 pm EDT, 5 pm GMT, America Makes Executive Director John Wilczynski provides a briefing during the webinar on COVID-19 initiatives underway along with the Capabilities and Needs Repository developed in partnership with the FDA.
This effort will connect the capabilities of the additive manufacturing industry with the specific needs of health care providers via this online repository. This site will record necessary information from both the additive manufacturing industry and health care providers, and eventually include a pathway for designs to be uploaded for review to ensure they meet medical standards and can be downloaded for use in production.
Always attentive to the opportunities offered by AM in the healthcare segment, the FDA has been quick to recognize that many stakeholders are interested in designing and producing 3D printed devices during the COVID-19 public health emergency, although many of them 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, to share data, and coordinate on open-source medical products for the COVID-19 response. These agencies are also working closely with America Makes, to provide resources that will connect health care providers and 3D printing organizations.
The FDA has published a set of questions and answers relating to 3D printing during the coronavirus pandemic. Other information can be obtained through the FDA-VA-NIH-America Makes public-private partnership. This page includes information and links to the Department of Veterans Affairs Innovation Ecosystem connector site, America Makes COVID site; Connecting Manufacturers and Health Care entities, National Institute of Health 3D print Exchange COVID Collection, and certain ASTM International standards.
These resources within the public-private partnership may be able to provide you some of the assistance you are seeking to manufacture 3D printed medical devices to support the shortages associated with COVID public health emergency.