How Did We Get Here?
In the beginning stages of the Covid-19 pandemic, it quickly became clear that the stock of Personal Protection Equipment, or PPE, for U.S. front-line health care personnel (HCP) was very limited. Due to this limitation, the Secretary of the Department of Health and Human Services issued an Emergency Use Authorization (EUA)for PPE, which releases special emergency funds, and reduces restrictions on medical devices such as PPE. The severe shortage of PPE caused the EUA to allow non-NIOSH surgical masks and respirators, among other medical devices, to be used by HCP. The FDA recognizes that while these devices and this gear are not NIOSH approved, it is better than nothing. In response to the EUA, on April 24th the FDA issued a list called Appendix A that contained close to one hundred Chinese manufacturers that claimed their respirators met similar NIOSH standards, but were not approved by NIOSH. Appendix A allowed these manufacturers to distribute their unapproved equipment to frontline healthcare workers. The loosening of requirements to distribute respirators is needed to supply U.S. HCP given the severe shortage, but it would have its negative effects as well.
The Wild West
Where we’re concerned in this article is the counterfeit sales of unauthorized, unapproved “N95” respirators or “KN95” (Chinese version of an N95 respirator). “The ‘N95’ designation means that when subjected to careful testing, the respirator blocks at least 95 percent of very small (0.3 micron) test particles,” states the CDC (N95 Respirators and Surgical Masks (Face Masks) . Once the EUA was authorized, it didn’t take long for the Chinese to bombard U.S. importers with “N95” equivalent respirators or other masks to be sold to U.S. hospitals and other health care organizations. To help importers/buyers better identify good imported sources, the FDA issued the “Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China” appendix A” list. As stated earlier, the authorized list meant that manufacturers that met equivalent filtration standards as that of the N95 respirators could be sold as “equivalent” non-NIOSH approved respirators. Soon after the appendix A release, complaints started to come in that the respirators being received, even the ones coming from the non-NIOSH approved list, did not meet the standard criteria that they advertised.
On May 7th, 2020, the FDA announced that it will no longer accept Chinese manufacturer test results for respirators, and that the CDC/NIOSH will conduct surveillance of respirators through verified third party testing. “The FDA updated the eligibility criteria by making a few main changes, including revising one of the criteria that required an accredited and independent lab test to now require that certain respirators previously listed in Appendix A must pass CDC/NIOSH testing,” stated the FDA from their “Daily Roundup May 7, 2020”. After just two weeks, the list of over 80 Chinese manufacturers previously given authorization to sell surgical respirators into the U.S. was reduced to 14. Unfortunately, it’s very hard to tell how much counterfeit respirators remain unused in the U.S. While over 80% of the manufacturers were removed, the FDA did stipulate that if the manufacturer could prove they met the new criteria, that they could become re-authorized.
Back on the List
On May 18, the CDC released it’s updated “NPPTL Respirator Assessments to Support the COVID-19 Response” to include certain Chinese manufacturers that had been previously removed from the FDA’s appendix A list. If a previously removed Chinese manufacture met the minimum level of filtration efficiency as tested by the CDC, it is now presumed safe to buy and/or sell their imported products to our health care personnel for the duration of the EUA, sort of. It’s important to note that the CDC’s Respirator Assessments list is only guidance, writes the CDC, “These assessments were developed as an assessment of the filter efficiency for those respirators represented as certified by an international certification authority, other than NIOSH, to support the availability of respiratory protection to US healthcare workers and other workers due to the respirator shortage associated with COVID-19.”
During normal times, the beforementioned EUA approved respirators would go through much more rigorous testing, which would include site visits to the manufacturing facility. Also included would be a much larger sample size to test, compared to the 10-piece sample size tested in their recent assessment. Again, during this time of emergency/crisis/shortage, something is better than nothing. But it is very important to use all information available to determine the best path forward, and the CDC is trying to offer help with their recent assessment.
We Can Help
This article isn’t to suggest that the FDA is at fault for the large amount of counterfeit respirators. Not many could see that we would be extremely overwhelmed in our hospitals, which would then result in the severe shortage of PPE. This article rather wants to bring awareness that scammers (Chinese and/or U.S. citizens) are out there trying to make a quick buck by pushing counterfeit PPE (knowingly and unknowingly), at the expense of our health care personnel. Make sure you know who you’re dealing with, and what they’re offering. Biederman Farlow can help you make sound decisions regarding PPE respirators and masks, as well as other supplies during these uncertain times.
Authored by Josh Farlow
Edited by Carson Biederman
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This article was originally published on May 21, 2020