- These products have been authorized by FDA under an Emergency Use Authorization for use by healthcare providers as personal protective equipment.
- These products are only authorized for the duration of the declaration that circumstances justifying the authorization of emergency use under Section 564(b)(1) of the Act, 21 USC 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
Face Shield Use Instructions
Design Update 4.13.2020
We have completed another revision of our design files for those wishing to produce face shields for healthcare providers
- There are 2 design options
- Contact GCMI if you are interested in manufacturing, assembling, or kitting and packaging components
- We are seeking manufacturers with quality system certifications
Immediately needed, any qualified GMP compliant 3D manufacturers should contact us for more information.
The Global Center for Medical Innovation is pleased to announce the collaboration with Dr. Joanna Newton, MD along with Georgia Tech Researchers and Students, Children’s Healthcare of Atlanta Pediatric Technology Center, in collaboration with Georgia Tech and Global Center of Medical Innovation. The collaboration became essential as Dr. Newton, MD, heard from many colleagues around the country that healthcare front line employees’ access to personal protective equipment (PPE) was becoming depleted in the face of increasing demands due to novel coronavirus (COVID-19).
A team was assembled including Georgia Tech (GT) researchers who are working toward rapid response for mass manufacturable medical face shields. Dr. Chris Saldana (ME) and Dr. Bhamla (CHBE), along with their students, are exploring rigid frame face shields and origami-style face shields for open source design and manufacture of these critical products.
The team is leveraging multiple rapid prototyping/manufacturing capabilities at GT including the Flowers Invention Studio and the Global Center for Medical Innovation (GCMI). These centers provide capabilities such as selective laser sintering, 3-D printing with FDM, laser cutting and water jet cutting to rapidly prototype and fabricate the face shields. The goal is to produce hundreds of these shields per day to provide to hospitals as well as provide the open source design for others to fabricate anywhere in the world.
Personal Protective Equipment Collaboration with:
Dr. Joanna Newton, Pediatric Hematologist/Oncologist, Aflac Cancer and Blood Disorders Center of Children’s Healthcare of Atlanta, Assistant Professor of Pediatrics, Emory University School of Medicine
Children’s Healthcare of Atlanta Pediatric Technology Center, part of Georgia Institute of Technology
Global Center for Medical Innovation, an affiliate of Georgia Institute of Technology
More COVID-19 PPE News
From the CEO: WE ARE ON THE FRONTLINE OF THE COVID-19 RELIEF EFFORT. AND YOU CAN HELP.
From the beginning of the COVID-19 crisis, my team and I have been focused on how GCMI can lend a hand. Today, I am asking you to help us accelerate our efforts.
We are on the frontline of the COVID-19 relief effort. We are part of a collaboration, together with Georgia Tech and Children’s Healthcare of Atlanta, that is addressing the severe shortage of personal protective equipment (PPE) for our nation’s healthcare workers. Our initiative provides, free of charge, the designs, with necessary regulatory guidance, for any Good Manufacturing Practice-compliant manufacturing facility to use in the production and distribution of face shields to hospitals.
COVID-19 – How to make a reusable respirator as a replacement for N-95 mask.
Our colleagues at Boston Children’s Hospital and Harvard Medical School Teaching Hospital “propose an alternative reusable respirator for use in crisis situations where the standard of care PPE is not readily available, or must be conserved for particular aspects of patient care. This alternative device can be made from standard hospital equipment. By shifting the demand away from high-demand items such as N-95 masks and by providing a safe and viable alternative, we hope to conserve N-95 masks for use in specific tasks (e.g. surgical or bedside procedures, intubation), while also engaging and stimulating alternate supply chains to increase production.”
GCMI JOINS EXXONMOBIL TO ACCELERATE INNOVATION FOR PERSONAL PROTECTIVE EQUIPMENT
“In response to the unprecedented challenges from the COVID-19 pandemic, ExxonMobil is applying its deep knowledge and experience with polymer-based technologies in combination with GCMI to facilitate development and expedite third-party production of innovative safety equipment that can be sterilized and worn multiple times.
“A new industrial-style mask is being fast-tracked for production.”
MEDICAL DESIGN & OUTSOURCING: FDA ISSUES FAQ ON 3D-PRINTED EQUIPMENT AGAINST CORONAVIRUS
“University research teams and others have been racing to develop DIY ventilators to help patients whose breathing is restricted by COVID-19. Those seeking to 3D-print accessories or parts for medical devices should use original parts or those with the same specifications, dimensions and performance, if available, the FDA advised. The agency encouraged using plans from original parts and working with relevant medtech manufacturers for guidance.”