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Harry Peled, MD: “I think for administrators and infection control people, the attitude has to be there is enough evidence that the wearing of N95s should be official. The claim that we’re going to wait for perfect evidence is just not tenable. We don’t do that for anything else in medicine.”
Infection Control Today® recently reported on an opinion piece in the Annals of Internal Medicine in which the authors argued that all healthcare workers in hospitals who have to deal with patients who either have coronavirus disease 2019 (COVID-19) or could have the disease should be equipped with N95 respirators. “We believe that a thoughtful evaluation of past and existing data in the setting of the COVID-19 pandemic strongly supports the use of N95 respirators for all inpatient care of patients with COVID19, not only during AGPs [aerosol-generating procedures],” the authors wrote. They took aim at the notion that in many cases surgical or medical masks can offer healthcare workers enough protection against SARS-CoV-2. “A COVID-19 inpatient unit with multiple patients coughing and breathing will have far higher exposure to droplets, resuspended droplets, and aerosols than an outpatient setting,” they wrote. One of the authors of the piece is Harry Peled, MD, the director of cardiology and critical care at St. Jude Medical Center, Fullerton, Calif. Peled recently sat down with ICT® to discuss the implications of his findings.
Infection Control Today®: What made you decide to write the opinion piece in the Annals of Internal Medicine in the first place?
Harry Peled, MD: Great question. There’s a lot of angst about this issue and there was really a lot of moral distress and a lot of disunity going on. You had healthcare workers who said, “I clearly need to have an N95.” You had administration and supply chain people in good faith saying, “You know what? That’s not guideline-based. I have to save these masks for the aerosol generating procedure. So, you can’t really have these in N95s.” And in the midst of a COVID-19 crisis, you had a really horrible clash between the workers and the administration. Everybody was trying to do the right thing, but it was certainly a very poisoned atmosphere. And whenever people quote the guidelines, I think one of the most important things is to go what is behind the guidelines, right? At the end of the day, guideline writers like all of us try to do the best thing. There are a bunch of people sitting in a room trying to put this together. Especially in a setting where everything was done pretty quickly. So, I took the time to look at the articles which were supporting that the [surgical and medical] face mask or equivalent, and I found that the evidence was just simply not there to say that they were equivalent. And it also was interesting that the data supporting N95s for the AGPs, the aerosol generating procedures, was not very impressive either.
ICT®: What I read in your article is that you think that healthcare workers in a hospital that is treating COVID-19 patients should be wearing N95 respirators.
Peled: That is correct. I think anybody who is on an inpatient side and you’re taking direct care of COVID patients, you should be having an N95.
ICT®: And when you talk about the guidelines, you’re talking about guidelines from the US Centers for Disease Control and Prevention?
Peled: So, it’s interesting. There are differences amongst the guidelines. The CDC guidelines, say that N95 is preferred, but then they say [surgical and medical masks are] acceptable if there is a shortage. And I think the problem there is you are conflating two different issues. If it is preferred based on the science, it is preferred. Now, if they’re not enough and you have to ration them, then one has to admit that you are rationing something useful. I think the CDC guidelines are a bit problematic when they say the N95 is preferred, but it is acceptable to use [surgical or medical masks] when there is insufficient supply. I think that’s where the problem is on the CDC guidelines. When you look at the Surviving Sepsis Campaign guidelines, they actually explicitly say that face masks are preferred to N95s based on the evidence that I think in particular, is not at all supported by a careful look at the evidence and by their own footnotes and references.
ICT®: Do you think the guidelines will be adjusted in light of what you wrote or what others are writing or just the idea of having healthcare workers be as safe as possible?
Peled: That is my sincere hope. One of my goals when I was writing this was very specifically for the guidelines to be changed. There is a difference between saying I’ve proven the N95s are superior versus saying I’ve unequivocally shown equivalency between N95s and face masks. And I think it is simply based on the evidence: One cannot say that equivalency has been shown. You know, one study is done on outpatients, so that’s not a reasonable extrapolation. You look at the Loeb study and that study, the people wore the N95 only when they walked into the room. They’re just an extrapolation without evidence behind it. So, you have those two studies, which are a bit more towards the negative side. When you look at the two randomized control trials by MacIntyre done in China, those actually showed a benefit when you look at clinical respiratory illness. So very much the hope is that the guidelines will be changed. They’re continuously updated. You know, people do the best they can, and I’m hoping that they will be updated.
ICT®: Again, I’m paraphrasing from what you wrote, and tell me if I'm wrong here, but I think you made the point that this allowing surgical masks and medical masks to be used in circumstances where N95s should be used detracts from the effort to supply enough N95s.
Peled: I think you hit the nail on the head. And that is a fundamental problem. As long as the guideline writers and society say that they are leveling, you’re not going to have the focused effort to make the N95s. I think once that we as a society admit that there is reasonable evidence to show that N95s are better, my hope is that we will produce them. One has to remember that before this all started, the cost of an N95 mask was about $1. And 3M has made a point of saying that they’ve actually not jacked the prices up. You might not be able to get a 3M N95, but they have not jacked the prices up. Remember, it’s a piece of plastic and it’s made from oil and a crude barrel of oil is relatively cheap. So, I think exactly as you said it, that if we admit that there is reasonable evidence that N95s are better than face masks for impatient here, instead of us fighting over the supply, we will increase it.
ICT®: Have you gotten much feedback from people? Have you heard from a lot from fellow healthcare professionals?
Peled: Well, I got a little feedback. I mean, I’ve sort of been getting feedback over the past, you know, month or two, on this when we get well-intentioned with the system. And so I got one comment already on the article. They made the point that although we showed a benefit for the N95, the confidence interval didn’t cross 1. The comment was correct. So, we actually did give them several other examples where there was benefit to N95 and the confidence interval completely favored that. Certainly, some feedback that you’ve not definitively proved the point. And again, one can criticize the randomized controlled trials, but the question is, right, if you want to be somewhat a precautionary principle. Right? How certain do I have to be? I don’t think it has to be 99% sure. And the question is, what is the magnitude of benefit? If you look at the Rabinovich outpatient study, they felt that, you know, if I got the flu, it probably wasn’t that big a deal. So, unless I reduce the incidents by 20% to 25%, it’s not a big deal. Well, that may be true if your case mortality rate is 0.1%. If the case mortality rate is 1%, then that same risk of infection becomes much greater. I think it’s making sure people get the extrapolation that we know that this is more infectious than H1N1. That case mortality rate is certainly higher than regular seasonal flu. We can argue the magnitude. So, I do get pushback, somewhat on the interpretation, but I think it’s important that we separate the interpretation from the facts
ICT®: We had to postpone our interview twice because you’re in Fullerton, California, and you’re in the midst of a surge right now. Do you have enough N95s where you’re working?
Peled: Thank goodness we do have enough PPE. We do have enough N95s. You know, one sometimes has the problem that what you have is not necessarily what people are fitted for. But overall, I think that this we’ve been doing OK with that.
ICT®: Have other studies come out since your article that back up what you said?
Peled: Everybody is still fighting over those four randomized control trials. There have been no new randomized control trials. Loeb, who’s one of the authors, is actually planning on doing a randomized control trial. I’m not sure where they are with that. Sort of that came out before we published this. There was the Lancet article that got a lot of press about the possibility of aerosols and N95s being better. Again, that was critiqued as being an observational study, rather than a randomized control trial. But again, one has to do the best they can. There was another article that sort of did a more detailed review than we did of these four randomized control trials, and sort of came to the same conclusion that there is evidence that N95s are better by some criteria, not by other criteria. But again, as a society we’re not allocating the resources for the PPE and the N95s.
ICT®: Any advice for infection preventionists, EVS teams, hospital administrators, procurement teams as far as masks are concerned?
Peled: I think it’s a very tough position for them to be in. And in my article, I actually commented on that, because I think the term moral distress can often be thrown around too loosely. I think these people have serious moral distress. And it doesn’t do society or anybody good for frontline healthcare workers to beat up on these people, right? These people got a supply chain. They have guidelines that say we have to keep them for the aerosol generating procedures, even if the risk is much less. Those are the guidelines. You can’t fault the administrative people for following the guidelines. I think they’re put in a tough spot. But I do think from the administrator point of view, you have to look at the other side. If you look carefully at the evidence, you cannot fairly extrapolate from some of these outpatient studies of 20 patients. I think when healthcare workers uniformly say, “We’re on the frontline, this is what we think we need.” And they have evidence to support that. I think the plan has to be that we will supply N95s for you, understanding that there has been evolution in the guidelines. The other thing I should mention since we started this paper in April—it takes a while before it comes out—is that the American College of Physicians has very specifically endorsed N95s for COVID care defined as being within six feet of the patient. So again, you’ll know guidelines are in flux, and the evidence is in flux. I think for administrators and infection control people, the attitude has to be there is enough evidence that the wearing of N95s should be official. The claim that we’re going to wait for perfect evidence is just not tenable. We don’t do that for anything else in medicine, and goal has to be how are we going to get N95s in sufficient quantity. Everything is mitigation right now. Nothing we do is going to be perfect. I think people have to remember that we’re mitigating risk, we are not eliminating risk.
This interview has been edited for clarity and length.