COVID-19 Update: FDA Alert on N95 Respirators and New Mask Regulations

Situation Report | September 7, 2021 

FDA Alert on Certain N95 Respirators 

On August 25, 2021, the U.S. Food and Drug Administration (FDA) issued an alert to warn health care facility risk managers, procurement staff and health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacturing Co., Ltd. (Shanghai Dasheng).  

The Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) revoked all respirator approvals previously issued to Shanghai Dasheng because the company did not implement, maintain and control a quality management system. All previously authorized Shanghai Dasheng respirators are no longer authorized for emergency use as a result of the loss of the National Institute for Occupational Safety and Health (NIOSH)-approval. 

The FDA recommends that agencies: 

  • Stop using N95 respirators manufactured by Shanghai Dasheng and intended for emergency use (including those bearing other brand names).  
  • Replace any Shanghai Dasheng respirators with respirators approved by NIOSH that are found on the NIOSH Certified Equipment List. Respirators on the NIOSH Certified Equipment List are authorized under the Emergency Use Authorization (EUA) 
  • Contact group purchasing organizations, distributors, and state or regional resources if you are having difficulty obtaining NIOSH-approved respirators through existing vendors.  
  • Report any issues with the quality or performance of respirators to the FDA 

More information is available on the FDA website. 

Face Masking/Covering Requirements 

The state Department of Health (DOH) issued guidance on indoor masking requirements.

Under this guidance, all personnel, regardless of vaccination status, in a health care setting, including facilities or entities regulated under Articles 28, 36 (home care) and 40 (hospice) of the Public Health Law must wear an appropriate face mask in accordance with applicable exceptions by the U.S. Centers for Disease Control and Prevention.

Monoclonal Antibody Webinar 

The New York City Department of Health and Mental Hygiene (NYC DOHMH) will host a webinar, Use of Monoclonal Antibodies (mAbs) for the Treatment and Prevention of COVID-19, on September 14 at 10 a.m. It is geared to the clinical staff of New York City adult care facilities and home care agencies.  

Because there are a limited number of openings, NYC DOHMH suggests that facilities and agencies, whenever possible, join in small (COVID-precautioned) groups as needed to maximize capacity. 

Registration is available here.