FDA Update – Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection

Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection

As we move further along with this Corona Virus Pandemic situation, with the “world” trying to get their PPE, most importantly, face masks, the quality of the masks is under suspect. To assure that the masks are providing the protection that they claim they are providing the masks were tested to check on their safety.  Since most of the masks were coming from China, the FDA decided to test these different masks suppliers

The FDA is concerned that certain FFRs from China are not adequate and do not provide consistent respiratory protection to health care personnel exposed to COVID-19. This is based on additional information gathered by the National Institute for Occupational Safety and Health (NIOSH), the National Personal Protective Technology Laboratory (NPPTL) and the Centers for Disease Control and Prevention (CDC). The FDA has revised and reissued the April 3, 2020 EUA on May 7, 2020.

The update on May 7, 2020 was to revise the criterion for authorization of respirators based on review of test reports from recognized independent test laboratories submitted to the FDA by the manufacturer or importer. Due to this revision, a number of Respirators were removed from Appendix A of the EUA that did not meet their labeled performance standard and are no longer eligible and are no longer authorized to be marketed or distributed in the United States as respirators. They may be re-labeled as face masks under the Face Mask EUA.

The FDA encourages health care providers to review the considerations made by the FDA. The information is specific to respirators that are designed to achieve a very close facial fit and to filter airborne particles. However, these considerations are not applicable to surgical masks or face masks that are loose-fitting and create a physical barrier between health care personnel’s mouth and nose and potential contaminants in the immediate environment.

• Respirators that no longer appear in Appendix A may not reliably provide a minimum percent particulate filtration efficiency of 95 percent.
• Among products removed from Appendix A to date, the following failed to demonstrate a minimum percent particulate filtration efficiency of 95 percent in testing conducted by NIOSH:
  • CTT Co. Ltd
  • Daddybaby Co. Ltd
  • Dongguan Xianda Medical Equipment Co., Ltd.
  • Guangdong Fei Fan Mstar Technology LTD
  • Guangdong Nuokang Medical Technology Co., Ltd.
  • Huizhou Huino Technology Co., Ltd.
  • Lanshan Shendun Technology Co
• NIOSH regularly updates its list of testing results (most recent update as of May 15, 2020)
  • Respirators that have been tested by NIOSH and failed to demonstrate a Minimum Particulate Filtration Efficiency of 95 percent may be considered for use as face masks for source control, to help slow the spread of infection when a person speaks, coughs, or sneezes. Health care facilities should be aware that this use of face masks is different from personal protective equipment for health care personnel.
  • Health care facilities with these respirators that failed the NOISH testing may wish to consider a number of factors in deciding to use these products as face masks, including current need, inventory, facility practices, and acceptable uses.
• The FDA believes respirators that no longer appear in Appendix A may not be reliably decontaminated in any decontamination system authorized for use during the COVID-19 pandemic.
• If you have respirators that were removed from Appendix A and you want NIOSH to test their filtration efficiency, you can request NIOSH testing by submitting the International Respirator Assessment Request.

The FDA continues to take action and actively monitor and mitigate any potential shortages in the supply chain including the medical device supply chain. The FDA continues to collaborate with the CDC to increase the availability and ensure the integrity of respirators during the COVID-19 public health emergency. Additional information is included in the FDA’s Letter to Health Care Providers as well as ways to report any adverse events to the FDA.

mdi is presently working with several supplier of masks to assist them to get back on the

Appendix A.

mdi Consultants can assist with reviewing your product/product labeling to ensure compliance with the latest FDA guidelines. Any other questions you may have, please feel free to reach out to mdi for assistance via email at info@mdiconsultants.com RE: COVID19.