FAQs on KN95 reversal by FDA
KN95 bans confuse dental practices
by KEVIN KUO DDS, MMSc | May 8, 2020
On May 7th, the United States Food and Drug Administration reversed course on many KN95 by removing most Chinese manufacturers from its approved imported respirator list. This significant change left dental practices in difficult situations with many unanswered questions. Here are some answers:
When did the FDA first create the approved list?
On March 28th: The FDA first listed masks appropriate for use by healthcare personnel from six countries/continents: Australia, Brazil, Europe, Japan, Korea, and Mexico. China was not listed at the time due to perceived low quality and effectiveness.
On April 3rd: The FDA decided to allow KN95 masks from China, likely due to continual N95 shortages in the United States. Some hospital workers voiced their concerns against using KN95 masks.
What criteria were there to add respirators to the authorized list under the FDA Emergency Use Authorization?
There were two criteria:
Respirators needed to meet performance standards with product classifications from their respective countries. For instance, the acceptable product classification from Europe was FFP3 and FFP2.
Respirators needed to have marketing authorization for regulators in their respective countries. For instance, the European CE Mark was needed for FFP3 and FFP2 masks.
How did companies/brands add themselves to the authorized respirator list under the EUA?
Simply, manufacturers and/or importers needed to submit a request to the FDA via email with proof with the above two criteria. They also have to estimate the number of respirators being imported and submit a copy of the product labeling.
When did the FDA decide to remove most KN95 manufacturers from its list of approved respirators?
On May 7th, the FDA changes course, again, in a month. This time removing most KN95 manufacturers from the approved list. The FDA cited quality concerns as the primary issue.
Who tested the imported KN95s?
The National Institute for Occupational Safety and Health (NIOSH) is the agency responsible for conducting research involving work-place safety. Within NIOSH, there is the National Personal Protective Technology Laboratory (NPPTL) responsible for testing personal protective equipment. The NIOSH-approved respirators are tested to filter a minimum amount of test particles, amongst many other requirements. This is the gold standard in the United States. Imported respirators cannot receive NIOSH approval. Keep in mind the approval list of imported respirators are only effective under the EUA.
It was the NPPTL that found several imported products from China, originally on the approved list, to be of low filter efficiency and quality. Those included:
CTT Co. Ltd
Dongguan Xianda Medical Equipment Co., Ltd.
Daddybaby Co. Ltd
Guangdong Fei Fan Mstar Technology LTD
Guangdong Nuokang Medical Technology Co., Ltd.
Huizhou Huinuo Technology Co., Ltd.
Lanshan Shendun Technology Co.
The rest were removed due to not satisfying the new criteria listed below, particularly the new requirement to have NIOSH testing. Those companies/manufacturers will have 45 days to have their respirators tested by NIOSH to be re-listed.
How will the FDA approval process change to prevent poor quality respirators from being imported?
Importers can no longer apply for EUA. Only manufacturers can provide a list of importers.
Respirators from China need to be certified by the Chinese National Medical Products Association
And most importantly, NIOSH testings needs to confirm performance standards.
Will distributors/manufacturers have to refund the masks purchased by dentists if their respirators are no longer on the FDA approved list?
On March 17th, 2020, the Public Readiness and Emergency Preparedness Act was issued by the Department of Health and Human Services thereby extending “immunity from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from administration or use of qualifying products used to combat or reduce the spread of COVID-19.” This act offers protections for manufacturers, distributors, and others during the PPE shortage. There needs to be a serious injury for there to be any sort of compensation.
Furthermore, manufacturers on the original FDA approved list, who were later removed, may be able to be re-listed if they pass NIOSH testing. Only the above companies have been testing and failed. The rest were removed due to a lack of NIOSH testing.
Are all ear-loop KN95 of poor-quality or fake?
No. Many respirators on the newly approved FDA list are ear-loop masks. Ear-loop respirators are popular in China.
Should KN95s be used in the first place?
According to the Centers for Disease Control and Prevention (CDC), KN95s should not “be used during aerosol-generating medical procedures unless the alternative is a loose-fitting surgical mask or improvised device.”
The American Dental Association (ADA) has listed KN95 as an option for dental personal protective equipment for COVID-19. In their interim guidelines, the ADA listed KN95 use as a low risk of viral infection when used.