Dan Glucksman
ISEA Director of Government Affairs

The current demand for respirators around the world is unlike anything I’ve seen in my 20 years in the personal protective equipment industry. Before 2020, it was rare to meet someone outside the industry who understood what PPE or N95 meant, and now these are household terms.

I see a silver lining to this global crisis: the general public is now more aware of its personal safety in the workplace and beyond, and they see the diligent efforts PPE manufactures and distributors take to ensure workers are protected. Unfortunately, this silver lining has a cloud – fraud.

Reports and confirmations of fraudulent, substandard, and even counterfeit PPE have become more prevalent in recent weeks, especially in the case of respiratory protective devices, or respirators. While manufacturers around the world have ramped up efforts to produce respirators, including those certified by NIOSH, the FDA also has authorized importation and use of disposable respirators made in and regulated by China, as well as other nations. When these masks live up the level of protection they claim, they have similar performance characteristics and allowed to be used while the COVID-19 public health emergency is in place.

However, the government is finding this isn’t always the case. The NIOSH National Personal Protective Technology Laboratory (NPPTL) created the International Respirator Assessment program to assess the filter efficiency performance of international respirator products for federal and state agencies, employers, and healthcare systems.

NPPTL has completed assessments for many products, the results of which it has posted here. For each model listed, 10 respirators were submitted for evaluation. According to NIOSH, 60% failed the test (offering a less-than 95% filtration rate).  One of the worst offenders tested at only between 34-24% in filtration efficiency.  This could be quite dangerous for the end user.

Do you have an imported respirator?

Have it tested by NIOSH. Here’s the site to make a request. This site has an entry form, which allows NIOSH to keep track of the requests. NIOSH can complete these in 5-7 days, but keep in mind it’s only a filtration test, not the full certification testing.

Most of these products NIOSH tested have an ear loop design. NIOSH-approved N95s typically have head bands. So, if the respirator has ear-loops and claims NIOSH certification, beware.  While filter efficiency shows how well the filter media performs, users must still ensure a proper fit is achieved.

For those considering purchasing non-NIOSH respirators from China, view NIOSH’s evaluations of international (Chinese-made) respirators. This list can be checked against the full FDA list (this list now includes only 14 Chinese-made respirators) of approved non-NIOSH-approved respirators made in China.

As of May 11, 2020, none of the substandard respirators on the NIOSH list are on the FDA’s Appendix A, which lists 14 non-NIOSH respirators made in China approved for import and use in healthcare settings to keep workers safe from COVID-19 exposures.

 

Have you experienced fraudulent PPE?

ISEA is working with the Department of Justice to help combat misconduct in the distribution of faulty or fraudulent PPE. If you have information on hoarding, counterfeit, or price gouging of critical supplies, you can report it to the National Center for Disaster Fraud (NCDF) by calling the National Hotline at (866) 720-5721 or by submitting the NCDF Web Complaint Form.