The Illinois Department of Public Health is warning consumers and partner agencies — hospitals, schools, local health departments — about faulty imported KN95 masks from China as well as counterfeit KN95 masks that are reportedly “flooding the marketplace.”
Kane County Office of Emergency Management Director Sean Madison shared a state of Illinois SIREN Alert on Wednesday night saying the IDPH “recommends discontinuing the use of any imported KN95 respirators for procedures that require the use of an N95 or similar respirator unless their authenticity and performance (through fit testing) can be verified.”
According to the alert:
- KN95 masks from China may not meet performance standards
- Counterfeit KN95 masks are reportedly flooding the marketplace
- Illinois has distributed KN95 masks throughout the state
Ways To Authenticate Your Respirator
- The authenticity of a respirator can be gauged by checking Appendix A (https://www.fda.gov/media/136663/download) to FDA’s emergency use authorization
- Only respirators that meet FDA’s eligibility criteria will be added to Appendix A as an authorized respirator. (https://www.fda.gov/media/136664/download).
- End users may also want to check NIOSH’s website (https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html), as well as the manufacturer’s website for additional information.
An increasing number of imported respirators from China have received an emergency use authorization from the U.S. Food and Drug Administration.
The Illinois Department of Public Health is aware of at least two instances of vendors offering for sale counterfeit versions of such respirators.
Monday afternoon, the state of Missouri announced that it is recalling approximately 48,000 KN95 respirators that had been distributed to first responders during the first week of April.
According to the announcement shared with Missouri’s emergency response partners, testing by the Missouri Department of Health and Senior Services demonstrated that some of these respirators did not meet standards.
They included respirators (masks) labeled “Huabai” and “Sanqi” as well as unmarked respirators that did not bear a brand name; however, the state of Missouri is recalling all previously distributed KN95 respirators.
IDPH recommends the following to partner agencies that have received personal protective equipment from the state of Illinois:
1. Discontinue using any KN95 respirators for procedures that require the use of an N95 or similar respirator unless their authenticity and performance (through fit testing) can be verified.
2. Stop distributing any KN95s that have not been added to Appendix A of FDA’s emergency use authorization.
3. Remove from service any KN95s that have already been received.
4. Do not use KN95s whose performance cannot be verified through successful fit testing.
The use of respiratory protection in workplaces is governed by the U.S. Occupational Safety and Health Administration Respiratory Protection Standard (29 CFR 1910.134). This standard includes a requirement to perform an initial fit test to ensure employees are provided with a respirator that properly fits their face.
Employees must be fit tested using the exact size, make and model respirator they will actually wear so first responders, health care providers, and others who receive newly purchased or donated respirators that differ from the respirators employees normally wear should be conducting fit testing for each new make or model respirator to confirm a proper fit.
Employees should only utilize respirators that fit properly in conjunction with a written respiratory protection program.
Moreover, employees should be trained to perform a user seal check every time they put on the respirator using procedures recommended by the manufacturer.
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