Is a KN95 Respirator Safe to Use?
The short answer to the question, "Is a KN95 respirator safe to use?" is probably. Here's the backstory…
We find ourselves practicing nursing and medicine in conditions we've never experienced in our lifetimes. Reusing personal protective equipment (PPE), refusing to see patients who report mild symptoms of COVID-19, preserving supplies for essential personnel only, and using PPE supplies from other countries such as China.
The pandemic of COVID-19 has caused an immense shortage of required PPE such as eye protection, surgical masks, particulate-filtering respirators (FFRs), gloves, and gowns. Healthcare workers caring for patients suspected of or confirmed with the novel coronavirus require layers of protection that are intended to be single-use-then-discard items. Not only are we changing our practice to now reuse these flimsy items, but we are also now allowing equipment to be quickly imported in order to provide PPE to those at risk. Given the nature of today's environment of dwindling supplies, especially protective filtering facepiece respirators, we find ourselves needing to settle for "good enough" standards in order to provide staff with life-saving equipment.
On March 24th, the FDA issued Emergency Use Authorizations (EUAs) to several countries such as Mexico, Australia, and the UK, where standards are similar to the stringent U.S. testing standards, which allows for the purchase and import of FFRs not typically allowed. Initially, the KN95 respirator developed and distributed in China was not on the list of approved devices. The FDA bases this on the totality of scientific evidence available - that certain imported respirators are appropriate to protect the public. However, countries such as the Netherlands reported that the FFR from China was poorly constructed.
In response to this accusation, China admitted that numerous pop-up shops had emerged in China to fraudulently produce KN95 devices, even marking the units with the approved "KN95" stamp. China has since committed to ensuring only high-quality PPE will be exported from their country, and on April 4, 2020, the FDA announced plans to allow the KN95 respirator to be used in U.S. healthcare facilities. However - buyer beware.
Importers and distributors are responsible to ensure items purchased from China have a certificate of authenticity. So, what does this mean for you as you slip on the KN95 device and start your shift? As with any PPE, always inspect the device for any noticeable defects. If the unit is clearly not to standard, report the device to your supervisor and supply-chain manager for investigation.
Organizations are scrambling to locate PPE to protect staff caring for infected patients, and even asking staff to decontaminate their own respirators each shift. The KN95 respirator is most likely an appropriate device to use as part of a hero's armor and certainly better than no protection at all.
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