N95 NIOSH Approved Markings
#15,310
Sunday morning (see link) we looked at research published in the EID Journal on the effectiveness of various decontamination options for N95 respirators, and their impact on reusability. In it I mentioned that some problems and/or concerns with some of these reconditioned respirators have emerged.
Sunday afternoon, the FDA sent out an email of changes to the EUA (Emergency Use Authorization) which restricts the types of respirators that may be decontaminated and reused.Under normal circumstances, only NIOSH approved N95 respirators are licensed for use in U.S. healthcare settings, but in early April - due to the extreme shortage of PPEs - the FDA authorized the use of foreign `equivalents', including the KN95 respirator from China.
Over the past couple of months 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).NIOSH maintains a web page with pictures and descriptions of literally dozens of fake `Non-NIOSH Approved' N95 masks that have been misrepresented and sold in the United States.
Counterfeit Respirators / Misrepresentation of NIOSH-Approval
Updated June 5, 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.
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| Just a few of over 40 examples |
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If you have bought N95s directly from China, or from online retailers - even before 2020 - you may want to check their authenticity.
While some manufacturers of KN95 masks are still FDA approved under the EUA, there remain concerns over the durability and reusability of these respirators, which prompted yesterday's announcement excluding them from decontamination and reuse.
Coronavirus (COVID-19) Update: FDA Reissues Emergency Use Authorizations Revising Which Types of Respirators Can Be Decontaminated for Reuse
For Immediate Release:June 07, 2020
In response to public health and safety concerns about the appropriateness of decontaminating certain respirators, the agency is reissuing certain emergency use authorizations (EUAs) to specify which respirators are appropriate for decontamination. Based on the FDA’s increased understanding of the performance and design of these respirators, the FDA has decided that certain respirators should not be decontaminated for reuse by health care personnel.
For example, the FDA has learned from the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH) testing that authorized respirators manufactured in China may vary in their design and performance. As such, the FDA has determined that the available information does not support the decontamination of these respirators and has accordingly revised the relevant EUAs. In addition, the FDA is also revising relevant EUAs to no longer authorize decontamination or reuse of respirators that have exhalation valves.
“During this unprecedented global pandemic, the FDA continues to provide flexibility and adapt to the evolving needs of Americans based on data and science. We are committed to carefully evaluating available information and will continue to take action when there is a need to do so to protect the public health,” said Anand Shah, M.D., FDA Deputy Commissioner for Medical and Scientific Affairs. “While we continue to support efforts to meet the urgent need for respirators, we are also doing everything in our authority to ensure health care personnel are adequately protected. As part of those efforts, we are announcing that we have revised and reissued a number of EUAs to amend which respirators are authorized to be decontaminated.”
Among other things, the FDA has reissued the EUAs for: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China by revising the Scope of Authorization such that authorized respirators listed in Appendix A will no longer be authorized if decontaminated.
Multiple decontamination systems so that they 1) are no longer authorized to decontaminate respirators manufactured in China, where applicable, and 2) only authorize decontamination of non-cellulose respirators that do not have an exhalation valve that are either authorized in the NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency EUA or that are authorized and identified in Exhibit 1 of the EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators to be decontaminated.
According to CDC’s recommendations, decontaminated respirators should only be used when new FDA-cleared N95 respirators, NIOSH-approved N95 respirators, or other FDA authorized respirators are not available. The decontamination systems are only authorized to decontaminate non-cellulose compatible N95 respirators.
As such, health care personnel should not reuse a respirator that is incompatible with an authorized decontamination system but has nonetheless been decontaminated. Users of any respirator (whether or not decontaminated) should always assess for proper fit after placement. Respirators with poor fit, visible soiling, or damage should not be used.
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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. Despite more than a decade of warnings - including the shortages seen in the opening days of the 2009 H1N1 pandemic - nothing tangible was ever done to rectify the situation.
As a result many HCWs have been forced to reuse their N95s beyond their normal life, use sketchy respirators imported from China, or worse - forego wearing N95s altogether.Our dependence upon imported PPEs of questionable quality during a pandemic is not only a national security issue - with hundreds of HCWs apparently lost to COVID-19 - it is a national tragedy as well.
Whether it is a second wave of COVID-19 in the fall - or the arrival of another pandemic virus down the road - we must do better by our front line workers.
