As additive manufacturing users around the globe ramp up production on personal protective equipment (PPE) and vital components to help fight the coronavirus pandemic, America Makes has created an online repository to connect those efforts with healthcare providers on the frontline.
America Makes, a leading accelerator of additive manufacturing technologies in the U.S., is collaborating with the Food and Drug Administration (FDA), National Institutes of Health (NIH), and the Department of Veterans’ Affairs (VA) to speed up the delivery of safe and effective supplies, such as 3D printed face shields, to medical professionals across the U.S.
The organisation has described the critical need for a central location to match design and manufacturing capabilities with the needs of healthcare workers. The repository allows designers and manufacturers to submit designs for COVID-19 related devices, which can be placed on fast track for review by the FDA, VA and NIH, to provide confidence to manufacturers and end-users on eligibility for appropriate medical use. Manufacturers wanting to help can submit their AM capabilities to the platform, while healthcare providers can request equipment and be matched with a manufacturer.
The repository also provides links to helpful resources on industry guidelines and standards for AM medical devices, along with the NIH Print Exchange which features open source 3D designs for PPE and other necessary medical devices in short supply.
For anyone wanting to help out, here's all you need to know ...
Who is this repository intended for?
This repository is intended for U.S. manufacturers and 3D print designers that have the authority within their organisation to speak on behalf of the company and dedicate necessary resources.
This site is also intended for authorised procurement representatives from within any U.S. healthcare system to communicate the needs of their work force.
America Makes is capturing the needs of the U.S. healthcare community, additive manufacturing capabilities of U.S. manufacturers, and publicly releasable 3D printing designs to be reviewed for meeting quality and medical standards and usability in production to address equipment shortages within the health care community. Examples of such equipment may include face shields, respirators, masks, and sharps containers.
Will this website really meet the needs of the supply chain in real time?
This website and the data collected are not intended to be an overnight solution for immediate needs. This collection process will streamline the emergency approval process for uploaded designs, allowing manufacturers to rapidly create those items to prioritise delivery where it is needed most.
We are an international company. Can we participate in the repository?
While America Makes cannot ensure a place for international organisations within this effort for a variety of reasons, not the least of which is timing, any international organisations that have a capability or design are encouraged to still follow the appropriate pathway to submit your information through this site.
An overview of the America Makes repository workflow.
What is the NIH repository?
The NIH 3D Print Exchange provides a searchable repository of open-source models in formats that are readily compatible for use in additive manufacturing. Designs submitted through the America Makes process will be reviewed and vetted to ensure they meet quality and safety standards and are approved for medical use.
Which designs are clinically tested, and in what order?
Each submission is given a score to determine where the submission fits in the queue for testing.
Scoring includes the following criteria:
- Demand – Has this item been identified by the community and/or logistics supply chains as being in short supply or at risk of running out?
- Feasibility – Is this design printable as described, and does the design appear to reasonably work as described?
- Completeness – Is the submission complete, with detailed instructions on how the part will be printed and used?
What happens if your design is evaluated and it does not pass?
If design flaws or other concerns, are discovered, you will be notified by email and given constructive feedback. The goal is to help make your design a success. After iteration, the design will be re-evaluated and if the concerns have been successfully addressed, the design will move to the clinically reviewed category.
