Emergency Ventilator Project
Bessel is helping the teams from TTHSC and UTEP with the FDA Emergency Use Authorization process and in preparing to scale availability. 
MIT has a similar effort and helpful resources here:
https://e-vent.mit.edu/

Useful Links for response to the COVID-19 Pandemic

Bessel LLC has extensive medical device experience and is directly involved in several COVID-19 projects.  Bessel's medical device network of resources actively responding to COVID-19 include contract R&D and manufacturing; quality assurance and quality engineering; and clinical and regulatory affairs (FDA) support. 

New information is released on a daily basis and distributed first by email and public webinars prior to the update of official websites.

Please reach out to see if we might help you directly or connect you to a resource that can.

CDC 
CDC FAQs on PPEs

https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirator-use-faq.html

AAMI

AAMI serves at the intersection of healthcare professionals (including biomedical engineers in hospitals) and industry. They have longstanding collaborations with FDA and with standards bodies. This link can point you to AAMI Design Guides for emergency devices, and many other helpful resources, including for PPE and sterilization/disinfection.

https://www.aami.org/news-resources/covid-19-updates/coronavirus-resources-for-the-field

America Makes / FDA / VA / NIH

 

America Makes is the national accelerator for additive manufacturing (AM) and 3D printing (3DP), and is an Institute of Manufacturing USA.

America Makes, the FDA, the VA, and NIH partnered to activate a response.

https://www.americamakes.us/statement-on-covid-19/

There are many useful links on this site to a range of resources. Including a link to the ASTM PPE standards free reading room and a quick-guide to the  VA approach to masks and respirator submissions:

https://www.americamakes.us/wp-content/uploads/sites/2/2020/04/VA-3D-Printing-FAQ_v8.pdf

NIH 3D Print Exchange,
COVID-19 collection:

https://3dprint.nih.gov/collections/covid-19-response

The Extras tab for the Stopgap Face Mask has build instructions, bill of materials, instructions for use, and risk-based test evaluations: 

https://3dprint.nih.gov/discover/3dpx-013429

 

© 2020 by Bessel LLC

Origin, Origin Foundations, and Ethics Guided Design are Trademarks of Bessel LLC

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