FDA Removes N95 Respirators from Shortage List

I think it’s ironic that about the same time a PLOs One study and news articles came out announcing a new method using 8-inch rubber bands for improving the fit of the surgical mask to approximate that of the N95 respirator, the FDA removed the N95 respirator from the medical device shortage list. This is relevant to help protect people from infection with Covid-19 because even vaccinated older people are getting hospitalized with the Omicron variant of the virus.

I’m not saying that the new rubber band method to tighten the fit of the surgical mask is not an improvement. It might come in handy when there is another shortage of N95 respirators.

The method mainly targets health care professionals. It would be difficult to persuade everyone in the community to adopt the technique. It’s tough enough to get people to wear masks even in crowded buildings in high transmission areas.

This is despite the CDC study showing that the elderly population continue to be at high risk for hospitalization from Covid-19 despite being vaccinated with the initial series and one or more boosters.

I think it’s hard to achieve a good fit even with the N95 respirators. The free ones distributed by the Federal government early this year were not widely available and fit poorly because the straps were elastic (similar to rubber bands, only flimsier) and loosened quickly, even after using only 2 or 3 times. At least the ones I got did. Prior to retiring, I was never able to pass a Fit test at the hospital using that type of mask.

I think my surgical masks fit better than the N95 respirators, especially after using the knot and tuck method to get a tighter seal.

Now the newer rubber band method to get a better seal uses two large 8-inch rubber bands to make the mid-face portion of the mask fit closer to your face. It looks a little easier to do than the earlier 3 rubber band technique developed a couple of years ago. That one was even tested at the University of Iowa Hospitals and Clinics by emergency room health care professionals, resulting in a small published study (the “double eights mask brace”).

All of the rubber band mask braces techniques were a response to the shortage of N95 respirators. What’s interesting to me is that, as the authors of the PLOs One study point out, there is a fair amount of variability in how well the N95 mask fits. Differences in the shape of a person’s face can account for some of this.

And there’s no shortage of N95 respirators—for now, at least according to the FDA.

If a non-health care professional wanted to use a rubber band brace, it would take some practice to get a good seal. There’s a bit of a learning curve even for a pro.

I think it would be difficult to persuade the average person to get the rubber bands and the surgical mask out of a pocket or a purse and fiddle around to achieve a good fit if you’re just going to run into Wal Mart—where I could not find that the big 8-inch rubber bands are even in stock. They’re pretty much a “3-day shipping” kind of item and could cost as much as $20 a bag.

Brief Reflections on N95 Masks

The free N95 masks are here. It’s 3M Model Aura 9205+and they’re available in many stores, including Hy-Vee and Walgreens.

I occasionally failed the fit test using this type of mask when I was working at the hospital; however, you can still get a pretty effective seal to make it protective in the community (see my video below). I was one of the few psychiatrists who had to fit test for a mask because I worked on the med-surg side of the hospital in a consult-liaison role.

The N95 flat type mask is probably no more difficult to don and doff than the surgical mask, for which the Slip Knot and Tuck method helps you achieve a pretty good seal (see my video for this).

At times, I had to use an alternative N95 mask, similar to 3M Model 1860, which is a cup-shaped mask. One year I failed the fit test for that one and I had to wear a Powered Air Purifying Respirator (PAPR). I had to wear it only once in the hospital. It was very cumbersome. Following that, I passed the fit test for the 1870+, which is similar to the 9205+.

When you search the web for more information about the N95 masks, you’ll find that there is disagreement about how to interpret eyeglass fogging pertaining to the seal. Some say that if you get any eyeglass fogging at all, you have an inadequate seal and need to fix that or “check with your supervisor.” On the other hand, others will discount that. Even the CDC says that eyeglass fogging indicates a poor seal that means that you have an inadequate seal and this should prompt the user to try another N95 model. On the other hand, others will discount that.

I did only a quick search, but found one open access article on a pilot study which concluded that “Fogging of eyeglasses is neither a sensitive nor a specific predictor for a poor fit of N95 respirators.” (Kyaw S, Johns M, Lim R, Stewart WC, Rojas N, Thambiraj SR, et al. Prediction of N95 Respirator Fit from Fogging of Eyeglasses: A Pilot Study. Indian J Crit Care Med 2021;25(9):976–980).

On balance, since no one who is not a health care professional will ever have to fit test for any N95 mask, the seal you’ll get is probably adequate. If you wear eyeglasses, remove them before donning and doffing the mask. You can get the bows caught in the straps, which can flip them off your face and into the toilet (although this has never happened to me personally). Always do hand hygiene before and after use of the mask.

I’ve read news items indicating that CDC guidelines say you should reuse the N95 only 5 times before disposing of it. It was difficult to find the source, but it’s mentioned here, under the heading “Decrease in N95 FFR fit and filtration performance” (FFR stands for Filtering Facepiece Respirator)”:

CDC recommends limiting the number of donnings for an N95 FFR to no more than five per device. It may be possible to don some models of FFRs more than five times [2]. One study reported that fit performance decreased over multiple, consecutive donnings and fit varied among the different models of FFRs examined [3]. If manufacturer guidance on how many times a particular FFR can be donned is not available, the CDC recommends limiting the number of uses to no more than five per device based on published data on changes in FFR fit from a limited number of FFR models over multiple donnings.

A recent observational study conducted in a hospital emergency room during the COVID-19 pandemic found that extended use and reuse of N95 FFRs as measured by the total hours and shifts the mask was worn and the number of donnings and doffings was associated with an increase in the fit failure of the respirators. This study also showed that it may be possible to don some models of FFRs more than five times [2]. Fit performance during limited reuse should be monitored by the respiratory protection program manager or appropriate safety personnel. 

Reference 2 is a research letter published in JAMA Network, June 4, 2020, a time when there were shortages of PPE (Degesys NF, Wang RC, Kwan E, Fahimi J, Noble JA, Raven MC. Correlation Between N95 Extended Use and Reuse and Fit Failure in an Emergency Department. JAMA. 2020;324(1):94–96. doi:10.1001/jama.2020.9843).

Further on in the CDC guidance is a section entitled “NIOSH recommends limiting the number of donnings to five for a filtering facepiece respirator. What is the science behind that recommendation?”

You can read all of this if you’re interested. I think it’s helpful to note that some experts say you can reuse them until they’re visibly dirty, which I think probably applies to users in the general community.

Facial Hair and the Masked Worker

I’ve seen the news warning us about how facial hair can interfere with the N95 respirator mask seal. It’s connected with the concerns about the novel coronavirus which you no doubt have heard unless you live under a rock. The Centers for Disease Control (CDC) reiterated their warning about how certain beard and mustache styles can interfere with the recommended mask for helping protect you from infection.

As a health care worker, I’m required to be fit tested annually for the N95 respirator mask. “Fit” is not an acronym, by the way; it just refers to how well the mask fits. It’s a twenty-minute test in which a technician or nurse uses a special machine to check for how tight the seal is around the mask in order to ensure protection from airborne particles, including viruses.

I passed my fit test.

I saw the graphic yesterday of all the different facial hair styles that pass muster—most of them don’t. I’ve never heard of half of them. Believe it or not, I didn’t know that little tuft of hair under my lower lip is called a “soul patch.” I guess maybe I’m the one who’s been living under a rock.

I’ve read that some experts think that any facial hair is bad and recommend that you have to be clean shaven. I think some places won’t even allow fit testing on anyone who has facial hair.

However, I found a PubMed study published in the latter part of 2018 which showed that you can pass a fit test “even with substantial facial hair in the face seal area;” the abstract is below:

Floyd, E. L., et al. (2018). “Influence of facial hair length, coarseness, and areal density on seal leakage of a tight-fitting half-face respirator.” J Occup Environ Hyg 15(4): 334-340.

                BACKGROUND: OSHA regulations state that an employer shall not permit tight-fitting respirators to be worn by employees who have facial hair that comes between the skin and facepiece seal. Studies have shown that facial hair in the face seal zone can increase penetration and decrease the fit factor (FF), although the relationship between the amount and characteristics of facial hair and the increase in penetration is not well quantified. This article examines the influence of facial hair length, areal density, and coarseness on FF for one model of half-face elastomeric negative-pressure air purifying respirator. APPROACH: Quantitative fit tests (QNFT) were performed on 19 subjects with beards initially 0.500-in long and subsequently trimmed to 0.250, 0.125, and 0.063 in, then after a razor shave. Three fit tests were performed at each of the 5 lengths, for 285 total tests. The average diameter and areal density of cheek and chin hair were measured. Penetration was modeled as a function of hair length category, beard areal density, and hair coarseness. RESULTS: FF decreased with beard length, especially beyond 0.125 in. However, passing FF scores were achieved on all tests by all subjects at the smooth shave and 0.063 in conditions, and 98% of tests were passed at 0.125 in; seven subjects passed all tests at all conditions. Chin and cheek areal densities were significantly different and were only weakly correlated. Beard hair diameters were normally distributed across subjects (mean 76 microm, standard deviation 7.4 microm). Beard length and areal density, but not coarseness, were statistically significant predictors of fit using an arcsine transformed penetration model. FF decreased with increasing beard length, especially beyond 0.125 in, although FF with a “stubble” beard did not differ significantly from a smooth shave. FF also decreased with increasing areal beard hair density. CONCLUSION: Beard length and areal density negatively influence FF. However, tight-fitting half-face negative-pressure respirator fit tests can achieve adequate fit factor scores even with substantial facial hair in the face seal area.

I generally have a stubble circle beard. When I don’t use the stubble guard on my trimmer for a while, I supposed my chin whiskers could lead to what some have called the “goatee leak.”

The CDC web site posted a funny article in 2017 on their web site entitled, “To Beard or not to Beard? That’s a good Question!” That facial hair chart is in the article. They also remind you check your mask seal every time you use it, no matter what your facial hair status is.

There’s a pretty funny YouTube video about this issue. The title is “The Bearded Guide to N95 Respirator Fit Testing.” My video is below.

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