If WTF is written all over your face on this one--we are with you! So read on to uncover: What’s The Focus…
The focus here, are KN-95 Respirators. As many clinicians may have come to prefer these duck-billed muzzles (when compared to N-95 respirators). KN-95s will now, need to be un-looped, folded-up and renounced from clinical use.
As of July 6th, 2021, the FDA rescinded the EUA (Emergency Use Authorization) for healthcare use & import of the KN95 Respirators. These are commonly being used during the COVID Emergency. The FDA specifically states: “As of the effective date of the revocations, KN-95 Respirators, will no longer be authorized for use by healthcare personnel in healthcare settings.” KN-95s are no longer on the FDA EUA list & major dental suppliers will no longer offer these devices for purchase.
Click here to Read the full FDA Announcement
WHAT SHOULD WE USE?:
If your clinicians are currently using KN-95s, please, make the switch to use only NI OSH N-95 type Respirators (or NI OSH PAPRs). The FDA & CDC approve the use of NI OSH N-95 or PAPR Respirators for use during aerosol dental procedures.
Click here to view NI OSH Approved N-95s
WHY CANT WE USE KN-95s?
These were only approved for use, during the emergency pandemic timeframe. Manufacturers of more highly-regulated NI OSH Respirators have now caught up with supply demands. Since the KN-95s are not as strictly, nor safely regulated, (they are made in either Korea or China, without USA regulatory safety standards), it is in a clinician’s best long-term health interest, that they switch over to a NI OSH approved respirator. We understand that the design of KN-95s may be more comfortable and tolerable to wear, but compliance with this new ruling is important. In the near future, look for new designs in N-95s that should provide better fit & comfort. In the meantime, work with your dental suppliers to get proper NI OSH N-95s or NI OSH PAPRs for your clinical team.
HOW SHOULD WE CARE FOR OUR RESPIRATORS?
Within the same FDA announcement, they mention that going forward, NI OSH N-95s should not be decontaminated, nor stored for reuse. Instead, utilize NI OSH N-95s per the manufacturer’s directions, for only the allotted timeframe that is intended. Then discard, preferably in BMW bag. NI OSH PAPRs should be worn and disinfected according to manufacturer’s specifications.
NEED MORE INSIGHT?
For more Infection Control & OSHA Safety insights, feel free to contact our OSHA Compliance Coaches at, Dental Enhancements, Inc. We are happy to help clarify any and all, of these new mandates. We can also provide insight about your current OSHA & HIPAA status. Your dental supply reps should have helpful information as well.
Stay Safe & Healthy---
Dental Enhancements, Inc.
Reach us at: 941-587-2864