N95 Respirators and Competing Regulatory Authorities: What You Really Need to Know

By Lee Slaton, Vice President of Healthcare; Smart Training

We’ve been answering a lot of inquires the last two weeks regarding N95 (and their equivalent) respirators.

Until the COVID-19 pandemic, N95s were a non-issue for dental practices. But with the new TSBDE rule stating, among other things, “DHCP shall implement Transmission-Based Precautions, including N95 respirator masks, KN95 masks, or their substantial equivalent for all DHCP who will be within six (6) feet of any and all procedures likely to involve aerosols,” a new level of infection and exposure control was created for dental practices to contend with.

There’s a lot of fresh ground to plow here, but for today, we’ll just hit the high notes.

N95s are classified as respirators, not surgical masks.

While it might sound like we’re splitting hairs, there is a huge difference in the efficiency of an N95 versus a surgical mask in protecting both the patient and staff.

An N95 respirator filters the airflow through it. A surgical mask allows most of the air breathed in and out (by the wearer) to go around it. Because, among other things, the filtering process of an N95 creates exertion to the wearer, OSHA requires a formal written respiratory program be in place for any entity that requires the use of respirators, or even if the entities’ staff voluntarily wears them.

NIOSH-approved masks aren’t available. What now?

N95 masks, ahem, respirators, are incredibly hard to source right now. There are several agencies weighing in on the issue with regard to dental practices.

What if I can lay my hands on KN95 masks manufactured in another country, you say? Under normal conditions, OSHA requires that only NIOSH-approved N95s be utilized. However, because of the shortage of NIOSH-approved N95s, the FDA has granted a couple of Emergency Use Authorizations (EUA) during the COVID-19 pandemic that allow entities to purchase and utilize KN95s that are not NIOSH-approved.

Well now, that opens up a whole new legal (according to the FDA) source of respirators, doesn’t it?

Even with the EUAs allowing the use of other N95 type of respirators, the supply chain is still falling woefully short in many locales. That’s one of many reasons elective procedures were (and still are, in many cases) postponed.

Enter the strategies developed by the CDC for sterilizing and reusing N95 respirators—a practice that during normal times might see your license suspended. However, OSHA has issued a “Discretion in Enforcement when Considering an Employer’s Good Faith Efforts During the Coronavirus Disease 2019 (COVID-19) Pandemic” memorandum (among other things) that provides a modicum amount of cover for a practice owner. Just be aware that the hazards surrounding re-use of PPE haven’t disappeared. To the contrary, proper donning and doffing protocols for preventing cross-contamination are more important than ever, as this is a wildly contagious virus.

After masks, here’s what you need to have.

“Okay, Lee, I’ve located the respirators I need. Give me the ‘CliffsNotes’ version of what I need to have for my practice to be legal and safe in the eyes of OSHA.”
Here they are:

• An OSHA written respiratory program (which includes record keeping)
• Someone appointed to be in charge of that program
• Training for all employees in the program
• Medical evaluations for all personnel who will be wearing a respirator, no matter whether they’re wearing them on a required or voluntary basis
• Fit tests for all personnel who are required to wear a respirator