Product Liability: Do KN965 masks put healthcare workers at risk?

Are KN95 masks provided to healthcare workers reliable? The high demand of N95 masks has disrupted the usual supply chain. Therefore hospitals and other healthcare facilities had to turn to non traditional suppliers of PPE here in the US or in other countries. While things are not as bad as they used to be at the beginning of the covid-19 crisis, disruptions still occur and a lot a unscrupulous manufacturers are trying to sell counterfeit or defective products to hospitals.

When turning to non traditional suppliers how can healthcare providers make sure that they are buying masks that will protect their workers?

The ECRI institute recently published a video with recommendations form experts on how to vet a new mask supplier.  Here are the top 10 recommendations:

1. Make sure that the supplier has a valid website
2. Get an insight on the manufacturer’s history of supplying masks. Did it recently move from manufacturing another product type to PPE?
3. Check the product specifications
4. Make sure that the manufacturer has accreditations. Is the supplier a NIOSH-approved holder? Can the manufacturer provide ISO/IEC 17025 accredited test reports showing the filtration efficiency?
5. Is there a FDA registration?
6. Get a reference list of other American providers who are getting PPE equipment from the supplier
7. Look at product pictures
8. For domestic providers, make sure they have a Tax ID
9. Vet the delivery terms and buying options
10. Make sure to get sample products before agreeing to buy anything. While this was not possible at the beginning of the pandemic, now many of the non traditional suppliers do offer samples.

One source of confusion is N95 mask versus KN95 masks. What is the difference?

Each country that produces masks has a standard of testing and the designation is related to that specific test. While N95 is related to a specific test made in the US, KN95 is a different type of test which is very similar to the N95. They both require 95% of filtration.

The ECRI also raises the alert on very well executed counterfeits with NIOSH stamps that can be difficult to distinguish from real products. Documentation provided by the suppliers is also often falsified and can look legitimate with fake FDA stamps and NIOSH stamps.

To help healthcare providers, ECRI and NIOSH collaborated together and  tested masks from suppliers in the US and internationally. The results were surprising with more than half of the masks failing tests of filtration efficiency. One of the most disturbing events was to test two identical boxes of masks from the same supplier and find that one box passed the test and the other one did not.

The ECRI Institute recommends healthcare providers only use KN95 masks as a last resort alternative for N95 masks and if they do so, they should refer to the results of these tests effectuated by ECRI and NIOSH that are available here.

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