N95 NIOSH Approved Markings
#15,359
Six months into the 2020 COVID-19 Pandemic, and PPEs (personal protective equipment) remain in short supply in the healthcare industry, and it appears destined to remain so going into this fall and winter.
Of all of the missteps in preparing for, and responding to, this COVID-19 pandemic - this was the most avoidable - and perhaps the most egregious.
In 2007, the HHS estimated we would need 5 billion N95 respirators for a severe pandemic, and yet our national stockpile has never contained more than about 2% of those needs. In 2014, we looked at NIOSH: Options To Maximize The Supply of Respirators During A Pandemic, and have revisited the problem dozens of times over the years (see here, here, and here).
Despite more than a decade of warnings - including the shortages seen in the opening days of the 2009 H1N1 pandemic and again during the Ebola scare of 2014 - nothing tangible was ever done to rectify the situation.
Instead public officials and politicians decided a pandemic was a `low-probability' event - one which would probably not happen on their watch - and simply promised to do something about it `next year'.
`Next year' never came. But the long-predicted next pandemic inevitably did.
So millions of HCWs around the world are now forced to work around infectious patients without proper N95 respirators, disposable gowns, and face shields - often reduced to using surgical masks - or sometimes even home brewed cloth face covers.
Gear that would provide marginal protection for `large-droplet' transmission of a virus, but is wholly inadequate for a likely aerosolized `airborne' virus, like SARS-COV-2 (see Scientists `Airborne' Letter To WHO & Another SARS-CoV-2 Ventilation Dispersal Study).
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| CDC Recommended PPE |
Since then, however,complaints have emerged over the quality of some of these KN95 respirators and numerous blatant knockoffs with fake NIOSH certifications have been discovered, prompting legal action (see WSJ U.S. Files Charges Against Chinese N95 Mask Maker).
Last month the FDA issued a letter to healthcare providers warning:
Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory ProtectionThe problem being, while some Chinese manufacturers are producing reasonably reliable products, others are clearly not. On June 9th the FDA issued a letter listing 66 manufacturers of N95/KN95 masks that are no long authorized by the EUA.
Five weeks ago, we visited the NIOSH website which listed dozens of fake and/or counterfeit N95 respirators being sold as `NIOSH Approved', complete with bogus NIOSH certification numbers. Follow the link below for an eye opening list (with scores of photos) of even more fake N95s flooding the market.
Counterfeit Respirators / Misrepresentation of NIOSH-Approval
Updated July 10, 2020
Counterfeit respirators are products that are falsely marketed and sold as being NIOSH-approved and may not be capable of providing appropriate respiratory protection to workers.
When NIOSH becomes aware of counterfeit respirators or those misrepresenting NIOSH approval on the market, we will post them here to alert users, purchasers, and manufacturers.
How to identify a NIOSH-approved respirator:
NIOSH-approved respirators have an approval label on or within the packaging of the respirator (i.e. on the box itself and/or within the users’ instructions). Additionally, an abbreviated approval is on the FFR itself. You can verify the approval number on the NIOSH Certified Equipment List (CEL) or the NIOSH Trusted-Source page to determine if the respirator has been approved by NIOSH. NIOSH-approved FFRs will always have one the following designations: N95, N99, N100, R95, R99, R100, P95, P99, P100.
Signs that a respirator may be counterfeit:Additional Tips for Spotting Counterfeit Respirators Before You Buy
- No markings at all on the filtering facepiece respirator
- No approval (TC) number on filtering facepiece respirator or headband
- No NIOSH markings
- NIOSH spelled incorrectly
- Presence of decorative fabric or other decorative add-ons (e.g., sequins)
- Claims for the of approval for children (NIOSH does not approve any type of respiratory protection for children)
- Filtering facepiece respirator has ear loops instead of headbands
How many of these counterfeit N95s are currently being used by HCWs is unknown, as is the level of protection they may (or may not) afford. While one might assume they are at least as protective as surgical masks (albeit at 10 times the cost), we don't have any hard data on that.
The lack of PPE procurement over the past decade is one of the reasons why - until early April - masks and face coverings were widely denounced as unnecessary (or even harmful) by many Western nations (including the United States) and the WHO.
Of course, we'll never know.
The argument that we didn't have `proof' of the benefits of face covers back then is, at best, disingenuous (see Dec 2019 HK CDW: Surgical Masks For Respiratory Protection). The evidence for their efficacy - while not conclusive - has long been highly suggestive of being beneficial in slowing disease transmission.
Our hubris as a nation is that we've invested billions of dollars over the years into sexy `high-tech' pandemic solutions - while utterly neglecting the most basic and practical steps (like PPEs) - that are desperately needed to get us into a position where next-gen vaccines and cutting edge therapeutics can be deployed.
COVID-19 is unlikely to be the last pandemic to come down the pike. In fact, we'll be lucky if it's the worst and only pandemic we see over the next 10 years. In addition to gearing up for the fall wave of COVID, we need to be preparing for the next pandemic.
And next time, we need to get at least the basics right.
