Issues
Pandemic Response
The global coronavirus outbreak tested people, industries, governments and supply chains unlike any crisis since World War II. Manufacturers and suppliers of personal protective equipment (PPE) worked overtime to increase production in response to unprecedented international demand.Â
ISEA member companies and the workers who make PPE have been working hand in hand with the medical field and governments around the world to ensure demand is met for critical PPE. Â
How the Safety Equipment Industry Helped Protect the World
Following the surge in PPE demand at the onset of the pandemic in early 2020, manufacturers engaged in a historic effort to ramp up production of the vital equipment needed to respond to the coronavirus outbreak. While respirators like N95 masks received the greatest attention from the public and media, PPE needs also include protective garments, eye and face protection, gloves, and other components of the specialized ensembles health care professionals use to protect themselves.
Existing producers of vital PPE ramped up production and partnered with government agencies to increase supply of the products they already make.
- ISEA members partnered with the federal government, which placed orders for hundreds of millions of respirators, surgical N95s, and other NIOSH-approved respirators.
- ISEA has made leaders of the Strategic National Stockpile aware that attention must be paid ensure a shortage does not occur. The association fully supports SNS efforts to acquire millions of surgical masks, N95 respirators and surgical N95 respirators.
- PPE producers who specialize in products for other sectors such as industrial or construction protection partnered with medical device producers to shift protection to products needed for outbreak response.
The PPE Emergency is Lifted
To help address concerns about availability during the COVID-19 pandemic, the FDA issued Emergency Use Authorizations (EUAs) for certain PPE products including face shields, other barriers, and respiratory protective devices such as respirators.Â
Many have since been revoked given increased access to FDA-authorized and NIOSH-approved N95s. On June 30, 2021, the FDA announced the revocation of the following EUAs:Â
- Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (effective July 6, 2021)Â
- Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (effective July 6, 2021)
- Decontamination and Bioburden Reduction System EUAs for Personal Protective Equipment (effective June 30, 2021)Â
Historical information regarding these EUAs can be found on Historical Information about Device Emergency Use Authorizations.Â
Current PPE EAUs:Â
Other Key Federal Actions
NIOSH Respiratory ProtectionÂ
NPPTL completed International Assessments for the products for non-NIOSH-approved respirators. Results of efficiency are listed here.Â
CDC Healthcare GuidanceÂ
On May 2021, the CDC reported the supply and availability of NIOSH-approved respirators have increased significantly, and healthcare facilities only use NIOSH-approved respirators where needed. Check the NIOSH Certified Equipment List.Â
FDA Healthcare GuidanceÂ
This EUA states all NIOSH-certified respirators can be used in hospitals.Â
