What is the status of PPE manufacturing - who is making masks and what issues are they facing?

Authors: Ellen Kettler MS3, Danielle Urman MS1; UC San Diego School of Medicine

Completed on:  April 8, 2020

Last updated on:  Not yet updated

Reviewed by: Marsha-Gail Davis MD

Reviewed on: April 20, 2020

This summary was written as part of the CoRESPOND Earth 2.0 COVID-19 Rapid Response at UC San Diego.  For more information about the project, please visit http://earth2-covid.ucsd.edu

Key findings:

• Of the medical-grade masks used in the USA, 95% are made overseas. Both the manufacturers and the materials suppliers are located predominantly in China.
• Non-woven polypropylene, the material used to make N95s, and the machines used to cut and meld filters into masks are in short supply.1 Additionally, those that are new to making masks have had difficulty finding the equipment, training, and regulations required to create medical-grade masks.2 
• The federal government is beginning to take charge and regulate the next steps in manufacturing for large medical supply companies. However, it remains unclear how smaller companies can unify, obtain supplies, and train their workers and how larger companies will obtain the supplies they need to produce effective masks.

Related topics:

• PPE decontamination (Table)
• Hospital equipment sterilization

Summary of information:

Early in the pandemic, China restricted the exportation of masks to conserve them for local use, including those coming from American companies such as 3M.3 Established companies such as 3M and Honeywell have since ramped up production.4 Other companies, such as GM, have repurposed facilities to make masks, but have run into supply issues. Non-woven polypropylene, the material used to make N95s, and the machines used to cut and meld filters into masks are in short supply.1 Additionally, those that are new to making masks have had difficulty finding the equipment, training, and regulations required to create medical-grade masks.2 These companies have had to use a variety of sources, from individual doctors to health care systems to the FDA, to dictate what is the best use of their facilities.

Ultimately, a lack of centralized leadership and back-ordered supplies has made it difficult for new companies to join in the efforts. Organizations like JAMA have tried to make a platform where need can be assessed and items properly distributed (https://www.projectn95.org/).5 

The president has since invoked the Defense Protection Act Program to become a centralized body, but there is still work to be done to unify efforts.6 The FDA has issued emergency use authorization for expired masks or those certified by regulating bodies outside of the USA.7 The FDA has additionally set up a hotline for manufacturers.8

Finally, medical students at Cornell have compiled a list of PPE suppliers:  GETMEPPE.TODAY

Companies currently making PPE:

3M (will be making 50 million by the end of June), Honeywell (more than doubled its production of N95) GM, Ford, Nike, GE, Gap, Eclipse International, Hedley & Bennett, Nomad (currently seeking FDA approval of its product), and many more small and large companies. It is clear that the desire and effort to make PPE is present. In addition to repurposing facilities and materials they typically use, companies are experimenting with innovations like 3D printing of masks, respirators, and ventilators.

Problems companies are encountering:

Many of the small businesses not listed above are making cloth masks and establishing their own criteria on what constitutes an appropriate mask. While local and state governments have stepped in to help guide these companies and unify efforts, they are all left with the same major problems: lack of supplies, inability to train workers, unclear regulations, and machines that do not perfectly fit the task.9  It is not just small companies encountering problems. All companies are running out of supplies and heavily rely on unattainable supplies from overseas.

Current mandates due to the Defense Protection Act Program:

The Trump administration will facilitate the supply of ventilator materials for six companies: General Electric, Hill-Rom Holdings, Medtronic, Resmed, Royal Philips N.V. and Vyaire Medical. They will authorize FEMA to obtain as many N95 masks as possible from 3M and push GM to make masks.

Additional Resources:

GetUSPPE.org

Gaps in knowledge:

References:

1.         Evans AH and M. Critical Component of Protective Masks in Short Supply. Wall Street Journal. https://www.wsj.com/articles/coronavirus-pressures-supply-chain-for-protective-masks-11583552527. Published March 7, 2020. Accessed April 21, 2020.

2.         Accardi N. These retailers are using their manufacturing facilities to make masks and hospital equipment. nj.com True Jersey. https://www.nj.com/business/2020/03/these-retailers-are-using-their-manufacturing-facilities-to-make-masks-and-equipment.html. Published March 26, 2020. Accessed April 21, 2020.

3.         Abrams R, Silver-Greenberg J, Jacobs A, Friedman V, Rothfeld M. Governments and Companies Race to Make Masks Vital to Virus Fight. The New York Times. https://www.nytimes.com/2020/03/21/business/coronavirus-masks-hanes-trump.html. Published March 21, 2020. Accessed April 21, 2020.

4.         Wayland M. GM offers manufacturing blueprints for face masks to 600 auto parts suppliers amid virus pandemic. CNBC. https://www.cnbc.com/2020/04/05/gm-encouraging-suppliers-to-produce-face-masks-amid-covid-19-pandemic.html. Published April 5, 2020. Accessed April 21, 2020.

5.         The National COVID-19 Medical Equipment Clearinghouse. Project N95. https://www.projectn95.org/. Accessed April 21, 2020.

6.         Defense Production Act Program | FEMA.gov. https://www.fema.gov/defense-production-act-program. Accessed April 21, 2020.

7.         Office of the Commissioner. Coronavirus (COVID-19) Update: FDA takes action to help increase U.S. supply of ventilators and respirators for protection of health care workers, patients. FDA. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-help-increase-us-supply-ventilators-and-respirators. Published March 30, 2020. Accessed April 21, 2020.

8.         Center for Devices and Radiological Health. Device Advice: Comprehensive Regulatory Assistance. FDA. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance. Published April 4, 2020. Accessed April 21, 2020.

9.         Small Manufacturers Look for Leadership to Fight Coronavirus | Time. https://time.com/5808500/small-manufacturers-coronavirus/. Accessed April 21, 2020.