It perplexes Michael Milllenson, an internationally known healthcare expert, why infection control has not been taken more seriously in healthcare. It seems to perplex him even more that that might still be the case despite what we’re going through with the COVID-19 pandemic. In a wide-ranging interview with 

, Millenson argues that zero tolerance for infections in healthcare settings must be a goal, and not just a slogan. Millenson, the president of Health Quality Advisors LLC, and an adjunct associate professor of medicine at Northwestern University Feinberg School of Medicine, says that the impossibility of accurately tracing contamination removes an element of personal responsibility from the mix. That needs to be addressed.

You’ve been lately investigating how COVID-19 might change infection prevention. What have you found?

To be honest, I am surprised that when I go and I talk to people and dig a little bit, that COVID-19 is by no means a sure thing to cause a lot more investment in infection control. Now, it may cause a lot more investment in infection control supplies, putting up some TVs, buying more masks, etc, etc. If I was a thermometer salesman, I guess I’d be in seventh heaven. But if you’re talking about investing in infection preventionists, investing in people, investing in new processes, investing in better technology, it’s by no means a slam dunk, which to me at least was surprising.

You've mentioned before how outraged you were that infection prevention was ignored for decades.

I think that it’s kind of one of those things that’s been in the basement of a hospital. Right? It’s kind of like: “Yeah, yeah, yeah, we do that.” Right? As opposed to having an aspiration to do it right all the time to keep people safe as possible. We’re a kind of a check-off-the-boxes, regulatory thing, then an aspirational to-do-things-the-best. I think what I might have said in our last conversation, where I talked about a comparison to clinical care, you would never have anybody say: “You know what, I think this this week, we gave cancer care according to the guidelines. I’m pretty sure we did, but we’ll check that box.” Whereas with regulatory kind of attitudes towards infection control, it’s often kind of: “Well, we did what we had to do.” And it’s people's lives. You know, one of the things that would shock anybody outside healthcare—but seems completely not shocking within healthcare—is referring to infection control as a cost center, not a profit center. And I think anybody outside of the healthcare world would be shocked by that. “Wait a second. You’re not investing in keeping me safe because it’s not profitable?” It’s bizarre, but yet, as you know very well and as your colleagues know very well, that’s a commonplace in infection control.

Henry Ford famously said that if he had asked people what they wanted, they would have said a faster horse. Is infection control still looking for that faster horse? Or is it looking at what might be rolling over the horizon?

What I think is going to happen is that the technology is going to enable us to look at variables in ways that we didn’t think of. It’s going to open up avenues. Clearly, if Henry Ford had been selling his cars to people who had regulatory requirements to check off how their horse performed, he would have looked for a faster horse. Right? And that’s part of the problem. In the hospital: “This may be great, but I can’t check the box.” I think the box checking is a problem. Having said that, once you unleash the technology, the ability to find new things and do things differently, is something that’s going to grow over time. The second thing that’s going to help—again this is going to take time—is if you take a look at the medical literature on AI and a lot of these other technologies with surveillance and infection control, it’s really in a very early stage. The studies don’t agree. The studies are new. How much money is it saving? I think as you get more of an evidence base, which again takes time, you’ll get more adoption. Now, on the other side of helping patients you have: “Will these kind of surveillance systems help protect my workers?” And so, if you start to make the case that this is going to help you protect your nurses and doctors and others from being hurt, or burning out or whatever, that’s a completely different business case. And that might—if we get there—that might incent adoption. On the other side of the ledger, you have hospitals saying: “We lost a ton of money. We shut off the spigot for all our surgeries, all our electric procedures. Everybody coming in here. And this technology may be great, but right now we don’t have the bandwidth to look at anything other than get back running again, get the cash machine turned on, deal with the here and now.” And that’s completely understandable. We have to see how that plays out.

I wonder why, over the years, the demand for better infection control and prevention hasn’t bubble up from the bottom? By that, I mean, why haven’t doctors, nurses, infection preventionists, environmental services staff, and others who work in the trenches demanded it?

That’s a question I’ve thought about a lot. And I think there are several answers. And they all really revolve around culture. You have a bunch of smart people trying hard, trying to do the very best they can in a complex system. And when there have been infections, there’s been a tendency to see them as inevitable and not preventable. And even when the medical literature sometimes says it can [be prevented], people are busy in their day-to-day life and say, “You know what? These people are sick, really sick. They’re vulnerable. That’s why they’re getting infections.” Second thing is that there’s no individual accountability in a sense. So, if you were on a nursing shift, and the patient falls, you may think it’s because a lot of reasons, but at least you know, the patient was OK. These people were supposed to keep them from falling, and he fell. There’s at least some sort of chain of events that you can look at. Whereas when it comes to infections, if I touch somebody and pass on a pathogen, a little red light doesn’t go off. There’s not a siren. Nobody says that was me who did it as opposed to somebody else, or it was our healthcare team here as opposed to the guys earlier on or in the community. There’s not a feeling of responsibility. You look at hand hygiene, which might be sloppy. They genuinely don’t realize that they’re causing problems. If you see the problems without any direct accountability, if people are trying hard, if people kind of say, “Well, you know, stuff always happens in healthcare. It’s inevitable.” You don’t end up with a bottom up demand, particularly when you then add the attitude that this is a cost center. When people were being paid extra for infections, or if infection control is simply seen as adding a bunch of people to meet regulatory requirements, and there’s no sense of—shame, accountability, chagrin—I don’t know what you want to call it, for the infections that happen, you end up with: “Let’s put a system in the basement and have a couple of people keep track of what’s happening. It’s a shame. I find it outrageous, troubling, and incredible this persists. But what makes it again so difficult is there’s no bad people doing this. It’s kind of apathy and inertia, and just people who are trying to do the best and don’t see that they’re not succeeding. Plus, quite frankly, infection preventionists are not exactly at the top of the hierarchy. Right? And medicine in hospitals is very hierarchical. That’s just the way it is.

Do you think COVID-19 is going to change that? Infection preventionists will move up in the hierarchy?

I think it is. But again, when I talk to the people who’ve been in the frontlines, they’re not as certain that it will. But I think it is, and I think it will, in part, because the impact of infections has been felt by hospital staff, as well as by patients. And in part frankly, because this pandemic is not going away anytime soon. And so the visible effects of lack of infection control are going to be with us a long time. Plus, you’re going to need to reassure patients, reassure payers, right, so the visibility of infection control has gone up and becomes more important. You know, hopefully, the ones that are not as visible don’t end up being ignored. I think it should cause infection control over the long term to be more important. Unfortunately, and understandably, hospitals and doctors are still adjusting to the short-term shock of basically having income go down to zero.

If you had the power, how would you change infection control in this country?

Frankly, for infection control and everything else to do with patient safety, I would say we need the culture of your hospital to be a high reliability organization. And you and I, have seen over the years. How many PowerPoint slides comparing hospital quality processes to, say, military ones and an aircraft carrier or a submarine or something like that. I’ve visited submarines and other military facilities to see what goes on. You need to have the culture which says: “We’re a high reliability organization.” And then you go to the processes and products and people that help you achieve that. How do you treat your people? How do you give them the authority to stop the line? How do you give them the authority to make complaints that make their way up to the top? How do you establish that culture? And then you look at the products and the processes. I will tell you having spent some time a number of years ago, looking at the nuclear submarine industry, there are two things that went along with the reliability there. One was the admiral who started it, Admiral Hyman G. Rickover,realized that if they ever had a nuclear accident, that was going to be the end of the program. One nuclear accident and the entire program would be scrapped. He took personal responsibility for instilling certain values in every officer and every single person on that sub. And then the second thing, of course, is remember, you’re on that sub. If something happens, nuclear accident or not, you’re on that sub, and you’re in deep trouble. So, people train and train and train and train. Yeah, they do it on aircraft carriers too, and other places and other aspects of the military. But it’s that sense of personal responsibility and accountability for zero harm. Paul O'Neill recently died who had been the CEO of Alcoa and he instilled that at Alcoa. He went to Alcoa from the government. Their attitude was making aluminum is really dangerous. And it is, if you’ve ever been in those kind of plants with the smelters, and all the rest of that kind of fire. But if there’s an accident, rather than accepting it as inevitable, I’m going to put together all the senior staff, 

 the senior staff, and we’re going to talk about it and how it can be prevented. Whether you’re the lawyer or the marketer or whatever. And so he established a culture that workplace accidents were important and preventable, and the accidents went down. And that’s what we need to do. It’s not that anybody is intentionally unsafe. Not true at all. And everybody in hospitals tries to do the right thing. But we do not have a culture that looks at zero harm as a goal as opposed to a slogan. And that’s the thing that I would do if I had any power over what actually happens in the frontlines.

This interview has been edited for clarity and length.

Videos

Michael Millenson: “Infection preventionists are not exactly at the top of the hierarchy. Right? And medicine in hospitals is very hierarchical.”

Q&A: COVID Experience Might Not Bolster Infection Control’s Standing, After All

The coronavirus disease 2019 (COVID-19) epidemic has continued to spread with infections spiking in the southern States. Marked increases are seen in the states of Oklahoma, South Carolina, Arizona, Texas, and Florida. Over a two-week period, in Arizona, cases per day increased from 700 cases to over 3000, in Florida from approximately 800 to over 3000, and in Texas from 1545 to 3961. The false narrative that this is because the United States has increased testing is being spread in an attempt to mitigate these numbers. But the rise in cases far outstrips the rise in testing. And increased testing does not over the course of weeks increase COVID-19 case numbers; testing identifies and then through case-tracking and self-isolation results in decreased cases. This is how one stops an epidemic. Many countries are currently testing less than the United States, simply because their infection rates have 

fallen and less tests for case-tracking are required.

The European Union has approximately the same population as the United States and the number of daily Sars-CoV-2 cases between the two is telling. Cases per day in both peaked at over 30,000. In the EU, they have fallen to a low level of 4000 per day, but in the United States they are rising, up to 24,000 and recently to over 30,000.

The narrative that the infection will burnout especially with the high rate of asymptomatic carriers is not supported by data. Recent observations in California

 found lower than expected antibody levels in their populations. A recent study published in the 

 found that at eight weeks after discharge from a hospital, IgG coronavirus antibodies levels were decreased, with 40% of individuals who had asymptomatic infections and 13% of individuals who had symptomatic infections becoming seronegative.

The narrative that this peak in viral activity is not of concern since death rates are still falling is also misleading for three reasons. First, this new peak is being driven by a younger age group of patients as they attend bars, beaches, and college parties. They are less likely to have a fatal outcome with COVID-19 but can still easily spread the virus to their parents and grandparents. Second, deaths are a lagging indicator and may occur weeks after a positive test or symptoms develop. Finally, we now know how to better manage COVID-19 patients, including the proning of respirator-dependent patients, treating the common and deadly coagulopathies with anticoagulation, along with the use of dexamethasone, remdesivir and antibody containing serum.

Thus, death rates would be expected to fall, the best metric of this pandemic would be hospitalizations. Unfortunately, the impact of his epidemic is being mitigated by referring to patients who are discharged from the hospital as “recovered” in actuality, many are far from recovered, but merely have survived the acute viral episode.

Lasting effects of COVID-19 are all too common in patients who have been hospitalized. Unlike the flu, Sars-CoV-2 can affect almost every organ in the body. Up to 20% will develop heart damage

. COVID-19 patients are complaining of chronic fatigue

. In past SARs infections, 27% of hospitalized patients met the CDC criteria for chronic fatigue syndrome6. If a patient requires respiratory support, either oxygen administration or ventilation, pulmonary fibrosis and disability will be very common. Renal insufficiency can occur in up to a third of ICU patients. The hypercoagulability caused by the virus can cause strokes in the young

 and in children, the virus can be associated with a delayed inflammatory response, multisystem inflammatory syndrome.

Thus, the young are not shielded from the viruses’ devastating effects. We need to take this pandemic seriously, the public needs to wear masks and practice social distancing. As stated by Avindra Nath, MD, the senior investigator at the Section of Infections of the Nervous System at National Institutes of Health: “It’s quite possible some will never get their health back.”



(1) Lin RG. A coronavirus mystery: How many people in L.A. actually have COVID-19? Los Angeles Times. June 5, 2020. 

https://www.latimes.com/california/story/2020-06-05/how-many-people-in-l-a-actually-have-coronavirus-why-health-officials-still-dont-know-for-sure



(2) Kennedy N. Sweden is still nowhere near 'herd immunity,' even though it didn't go into lockdown. CNN. May 21, 2020. 

https://www.cnn.com/2020/05/21/health/sweden-herd-immunity-coronavirus-intl/index.html



(3) Long QX, Tang XJ, Shi QL, et al. Clinical and immunological assessment of asymptomatic SARS-CoV-2 infections. Nature Medicine. June 18, 2020. 

https://www.nature.com/articles/s41591-020-0965-6



(4) Shi S. Qin M, Shen B. Association of Cardiac Injury With Mortality in Hospitalized Patients With COVID-19 in Wuhan, China. JAMA Network. March 25, 2020. 

https://jamanetwork.com/journals/jamacardiology/fullarticle/2763524?resultClick=1



(5) Vastag B. Mazur B. Researchers warn covid-19 could cause debilitating long-term illness in some patients. Washington Post. May 30, 2020. 

https://www.washingtonpost.com/health/could-covid-19-cause-long-term-chronic-fatigue-and-illness-in-some-patients/2020/05/29/bcd5edb2-a02c-11ea-b5c9-570a91917d8d_story.html



(6) Lam MHB, Wing YK, Yu MWM. Mental Morbidities and Chronic Fatigue in Severe Acute Respiratory Syndrome SurvivorsLong-term Follow-up. JAMA Network. Dec. 14, 2009. 

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/415378



(7) Doctors consider possible stroke and COVID-19 connection. American Heart Association News. May 12, 2020. 

https://www.heart.org/en/news/2020/05/12/doctors-consider-possible-stroke-and-covid-19-connection



(8) Centers for Disease Control and Resistance. May 29, 2020. 

Articles

COVID-19 cases in many states have risen and the false narrative is that this is because of increased testing. But the rise in cases far outstrips the rise in testing.

Viewpoint: Despite Happy Talk, We’re Far From Out of the COVID Woods

Ready to use (RTU) disinfectant wipes have been a hot topic since the arrival of coronavirus disease 2019 (COVID-19) in the United States and quickly became a hot commodity as hospitals struggled to maintain an adequate supply, and the public bought as many as they could, emptying entire store shelves doing so. But information about just how to use the wipes to greatest efficiency is also hard to come by, according to a pre-proof 

The wipes vary considerably in their composition and the disinfectants that they’re using, according to the study’s author, John M. Boyce, MD, a healthcare consultant in Middletown, Conn.

“With reusable dry wipes, the ratio of wipe material to disinfectant and the amount of disinfectant absorbed by the wipe and delivered to surfaces is difficult to standardize, which may affect their efficacy,” the study states. “The manner in which wipes are used by healthcare personnel is highly variable, due in part to insufficient instructions for use and inadequate education of relevant personnel.”

Hospitals and other healthcare facilities need to provide better access to educational materials dealing with RTU wipes to environmental services (EVS) teams and nurses. They need to tell them how to best use wipes and invite feedback from healthcare workers to monitor compliance and to also find out what might be hindering disinfecting efforts and/or the following of disinfecting protocols.

In addition, there needs to be created “an internationally-accepted standard method for evaluating the efficacy of wipes, taking into account the mechanical effects of wiping and the impact of impregnated disinfectants.”

No such standardized guidelines currently exist when it comes reusable wipes, says the study. The ratio of the size of the wipe and disinfectant on it to the size of the area being wiped down varies widely. Healthcare workers using the wipes tend to rely on their own judgment when it comes to just how long a wipe should be used before it’s discarded. Boyce says that’s due in part because of a lack of instructions for use and training for the workers who will be using the wipes, in many cases members of the EVS teams.

“Combining disinfectants effective against target pathogens with the appropriate wipe material and assuring that they are applied correctly are essential to obtain optimal removal of bacteria from surfaces and prevent the transfer of microorganisms from one surface to another by wipes,” the study states.

Boyce makes some recommendations. For instance, the makers of liquid disinfectants that are used as sprays or for soaking dry wipes need to say what fabrics the wipes should be composed of. Conversely, the manufacturers of dry wipes should tell customers what fabrics or fibers those wipes are made of.

“Manufacturers of various disinfectants should collaborate with the [US Environmental Protection Agency] to assure that adequate and practical contact times are listed on product labels, which will facilitate compliance with label claims,” the study states. “RTU wipe manufacturers should provide detailed instructions for use, including recommendations on how large a surface can be disinfected with a single wipe. End users should periodically test the concentration of disinfectants that require dilution or mixing, and concentrations released from wipes that are soaked in reusable buckets. This is particularly important if cotton or microfiber cloths are used with quaternary ammonium-based disinfectants.”

The data were collected via comprehensive searches of the Pubmed database and internet of articles published from 1953 to September 2019. Pertinent online documents were also reviewed.

Disinfectant wipes became all the rage when coronavirus disease 2019 (COVID-19) struck but a study in the works says there's a dearth of knowledge about just how they should be used.

How Many? How Often? How Long? Proper Use of Disinfectant Wipes a Mystery

Jaan Sidorov, MD, knows both the provider and the insurer side of healthcare fairly well. He at one time was the medical 

director at Geisinger Health Plan. He’s now the CEO of the PA Clinical Network, a provider network that focuses on integrated approaches to care. The coronavirus disease 2019 (COVID-19) helped highlight the crucial role that infection preventionists (IPs) play. Sidorov believes that the IP role will become even more important in the post-COVID healthcare system. They’ve shown what they can do. Sidorov recently sat down with 

What challenges do you see for infection preventionists and other healthcare professionals at hospitals as America strives to return to normal?

Now that the pandemic is waning—it hasn’t gone away, obviously but it’s waning—it’s now time to start making our clinics safe and, more importantly, making our patients feel that our clinics are safe. Our healthcare institutions are safe. The inpatient settings are safe to both be cared for in as well as to visit. There are a number of guidelines that are being developed by the various bodies and societies around the globe, including the Centers for Disease Control and Prevention, that include all the things that healthcare institutions need to do. Maintain the social distancing. Make sure that the environment is sanitized after patient encounters and patient visits. I mean, everything that’s known to the folks that are looking at this. In addition to implementing those guidelines, however, I think the other big challenge is that…. The first is that patients need to not only know that it’s safe to return to the clinics, but they need to become aware of that. It’s one thing to convince me that it’s a safe environment. It’s another thing to reach out to me and remind me that it’s a safe environment. I think in the last few weeks and months, patients have gotten used to foregoing health care. This is not top of mind with everything else that is going on, although it should be. Vaccination rates are dropping, for example. And it’s now time to start bringing patients back and we need to begin a campaign. I almost think of it as public relations campaign to convince patients that it’s now safe to see your doctor. Once we raise that as an issue, once we break through the bandwidth and make them aware of that, we need to be able to communicate exactly what we’re doing in the clinics to do it. And that’s followed obviously by the things that the infection preventionists are doing to actually make the clinics safe.

What are they doing to make the clinics safe? And when you say clinics, you’re including hospitals and urgent care centers?

Right. I’m thinking the integrated delivery approach. So, it’s not just the hospital. A hospital is more than just an operating room and inpatient units. There are the facilities that take care of patients on an in-and-out basis. They’re the parts of the system. That care of patients out in the clinic. There’s follow-up. All the other services that are provided to the public, from the visiting public to the patients in the intensive care unit. These guidelines go across that entire spectrum.

One of your bailiwicks is integrated healthcare, integrating different disciplines, different specialties in providing care for the patient. How would the infection preventionist fit into such a system?

Well, they have a leg up because I think we’re all aware of the fact that now healthcare is increasingly becoming a team sport. A matter of fact, the official moniker is team-based care under the direction ultimately of a physician. So, team-based care that comprises a number of members and professionals from pharmacists to nurses to registered dieticians. And now, infection preventionists.

What surprised you the most about COVID-19 and what do you think will be its most lasting legacy?

The thing that surprised me the most about COVID-19 is how well the system ultimately worked. I mean, we really did…. The loss of life and everything that’s happened is a tragedy. But looking back, I think we’ll see that what could have happened was notably avoided. We saved a lot of lives. I think Americans did a pretty good job of following the public health admonitions. Our political and our our healthcare leaders. We could have started earlier. I think there are lessons learned. But by and large, I was really, really impressed by what we saw versus what could have been. In terms of lasting legacies? A few things. The first is that I think there is going to be a continuing commitment to doing everything we can to keep our working environments as safe as possible from infectious diseases. So, I think the infection preventionists that have now arrived, they can look forward to a long role in the healthcare system. We are always going to be prone to pandemics. We were warned about it. It finally happened. We’re not going to let this happen again and the infection preventionists are going to continue to be needed for the foreseeable future. The other legacy, however, is that we’re learning. I think that the stay-at-home orders and the orders for extreme social distancing that we’ve seen, cannot last forever. And we’re figuring out that there comes a point where democratic American society like ours won’t put up with this for months and months at a time. We’re beginning to see leaks of this and I think a lot of folks are just getting tired of it. I’m not saying that’s right. I’m not saying that’s wrong. But people are anxious to get out and start living their lives again. I think the third thing is that we’ve been reminded, much like a two-by-four across the head, that our economic well-being is tightly aligned with our social well-being is tightly aligned with our medical well-being. And I think we are just now beginning to discover some statistics. Some outcomes that have arrived as a result of the social isolation. The classic example is that we’ve seen an increase in drug and alcohol use related to people staying at home more. There’s been an increase in domestic violence as a result of this. I think we’re going to see that there are some downstream impacts from people not getting their healthcare screenings done. I think we’re going to see a decrease in childhood immunization in 2020. And I think the next time we need to address a pandemic, and we consider whether or not we want to deploy social isolation, I think we’re going to have to think about not only the very real and short-term benefits of social isolation, but we’ll also need to factor in: OK, based on what happened in 2020, we know that there are going to be some downstream social and health effects as a result of this.

What changes do you see in terms of how people are cared for?

The biggest change that I agree with—and I did not come up with this—is the blossoming of remote technology. I was reading in a trade journal that even the companies that run the big distance technology meeting software, you know who they are, I won’t mention them. But even they did not deploy their own technology on their workforce. That they too, while they were trying to sell this technology, had big office buildings filled with people in desks. And they were surprised that when they use their own technology and distributed workforce, working from home, how well it worked. I think we’re going to find that all that real estate overhead that businesses have been using to maintain offices and cubicles, that companies are going to shed that in favor of distance technology. That’s a pan-industry event. I’ve gotten used to using desk distance technology to visit with my grandchildren. You know, it’s inculcating everywhere in the social fabric of the United States and healthcare is no exception to that. We are not going to see distance technology go away in terms of doctor visits. I think there’s still a role for face-to-face visits and the traditional doctor relationship behind closed doors with a hands-on physical examination. But I think for other aspects of healthcare, a follow-up visit, or “how are you doing?”, or even post-operative visits from the hospital, you know, “Let me take a look at that scar and your shoulder. OK, it doesn’t look too red. It doesn’t look infected. Can you move it around? OK, you're OK.” You don’t need to do that on an in-person basis. I think we’re going to see distance technology that we’re using right now occupy a double-digit percentage of the healthcare footprint. It’s only a matter of how much. Is it going to be 10% of healthcare? Is it going to be 20%? Is it going to be 60%? It’s probably going to depend on specialty. It’s going to depend on area of the country. It’s going to depend on age groups and all that. But this is a genie that’s not going back in the bottle. And I can say that with significant certainty.

This article has been edited for clarity and length.

Jaan Sidorov, MD, the CEO of PA Clinical Network and the former medical director of Geisinger Health Plan talks about the many changes infection preventionists and other healthcare professionals will most likely face.

How Healthcare Will Change After COVID-19

Right now, the certification of infection preventionists (IPs) occurs on a state-by-state basis. Meaning, some states require certification, and some don’t. Ann Marie Pettis, RN, BSN, CIC, FAPIC, the president-elect of the Association for Professionals in Infection Control and Epidemiology, thinks that one of the results of the COVID-19 pandemic will be placing more emphasis on the need for IP certification. That’s just one of many things that will change for IPs, says Pettis. She also believes that IPs will get a seat at the table when it comes to running healthcare institutions and she worries that a second wave of COVID-19 might piggyback on the flu season, and IP expertise will have to ride to the rescue again. She recently sat down with 

 to discuss the many challenges IPs face and how their jobs will change. 

  Do you think the COVID experience will encourage hospital administrators and other healthcare leaders to lean more on the knowledge that infection preventionists have? I mean more of an influence on the day-to-day workings of your typical hospital now?

  I think in general it definitely has and will continue to. I do think some of it depends on where you’ve been practicing as an infection preventionist. I talked to some of my colleagues who actually have not been as much in the forefront as they would like to be. But I would say the majority of us have been more in the forefront than perhaps we would like to be because [COVID-19’s] emphasis on infection prevention obviously has been huge, and rightfully so. I do think that we will definitely feel a positive effect in terms of being more at the table, if you will, as we move forward. But some of it does depend on your own facility and whatnot. But I think in general, yes, we’ve been front and center through all of this.

  When you say infection professionals will probably have more of a voice at the table, how do you see that playing out?

  Well, I think the ability to influence the C-suite, if you will, as far as what new technology might be out there that should be incorporated into infection prevention. I think it might be a little bit easier to make those arguments moving forward, given the dire consequences of COVID-19 on our patients. And all of the different things that we’re having to look at putting in place that perhaps we didn’t have in place before. I think much more influence and ability to influence decisions as well as purchasing appropriate PPE, personal protective equipment. And as I mentioned, additional types of technologies that perhaps aid in the assistance of healthcare associated infections, as well as COVID.

  If a hospital administrator asked you in your capacity as an infection preventionist: “OK, Ann Marie, what do you want? What do you need right now today?” How would you answer?

  Well, you know, we’re still on a day-to-day basis making sure that we have appropriate and adequate PPE. As far as testing goes, in particular for PCR [polymerase chain reaction] testing, making sure that we have all the other things that are necessary to do that testing has been a day-to-day, week-to-week dance I’d say, because we’ve really had to go to a lot of different sources and work with our health departments, both local health departments, as well as the state health departments. And so even though right now, most of us are feeling a little better about our ability to provide the appropriate PPE, I think moving forward, it’s very important that we don’t let our guard down and that we continue to try to ramp up our supplies. What they’re recommending is at least having a 90-day supply of PPE. So that’s one of the main things that we’re working on, on an ongoing basis, as well as all the testing materials and all the other things that are required as far as taking care of COVID patients. And as far as preventing additional cases and providing safety for our patients. We’re looking at bringing back visitors, for instance, in our state. So, we need to keep everybody safe. And that’s going to require more and more personal protective equipment. I think that that is one of our biggest tasks, and that’s one of our biggest challenges is to not let our guard down and continue to think about surge availability for beds and we’re constantly planning. In other words, you hope for the best because our numbers have come down. There are certain hotspots in the country. But where I am, which is New York State, our numbers are the lowest that they’ve been. But again, you don’t want to get complacent. And so we need to plan from an emergency preparedness standpoint for the fall where, unfortunately, we may start to see a surge again. And, and as things open up, which they are, the businesses, and as we’re bringing patients back into the scene for those tests that are so vital for them and for procedures that are vital as well as elective surgeries-all of that requires additional PPE, additional planning for social distancing.

And the whole idea of PPE fatigue on the part of the healthcare workers. It’s exhausting to have to wear masks and face shields and all of it-the gowns and gloves and whatnot. Then you start to worry about, again, people letting their guard down. So, it’s an ongoing challenge to continue to remind and audit and educate staff. You asked what my wish list is. It’s that the country continues to ramp up our manufacturing ability. So that if and when we get another surge, or even some of the hotspots right now that are experiencing it, that we don’t end up with the desperate shortages that have required us to do things we would have never dreamt of doing from an infection prevention standpoint. And I do worry some about us being able to take back some of the things that we’ve been doing that might not be safest and might not be things that we would normally condone. But yet because we’ve been sort of desperate, we’ve had to do things that have not been something we would have enforced before. And because if indeed a second wave comes, you know, what will be our steps? So again, I think lessons learned is what we focus on. I think moving forward, we really need to emphasize the importance for things that we can do. We don’t have a vaccine yet. We don’t have very good treatments yet. But we do have flu shots. And I do think that late summer into the fall and well into the winter, it’ll be very important to make a concerted effort to do an even better job than what’s been done in the past. Certainly, infection preventionists have been struggling for years to get the attention that flu vaccination deserved. But I think now our state governments will realize how important it is as well. And for those organizations that can get mandatory vaccine in place for their healthcare providers, healthcare workers, I think that would be great. Some of us have been more successful than others around the country in already being able to do that. Get that enforced. But that’s something to think about. Because if indeed flu comes at the same time a second wave of COVID comes, that’s going to be difficult-unbelievably difficult because the symptoms obviously are somewhat similar. We’ll be trying to rule both of those things out. It will create more of a risk for a surge, and it will put more taxing on our PPE supplies. I think flu vaccine is one thing that we can do. Anybody six months and above should really get a flu vaccine in this coming year. More important than ever. Always important, but even more important.

  Yes. We’re still having weekly meetings throughout our system to continue to look at: Are there additional places we could put surge beds? Are there ways that we could make it safer for our long-term care patients in our community? We’re looking at alternate sites that we could dedicate as, for instance, a COVID center, if you will. But you could do the same thing with influenza. We had a terrible season nationally with influenza last year. During swine flu, we had a pandemic basically. I think we are working right now as we speak. Even though the numbers are coming down for COVID. We’re trying to ramp up our ability to deal with this come next fall and winter Those efforts are continuing locally. They’re continuing in our facilities across the country. And they’re happening at the state levels all throughout the country as well. So, yes, the work goes on.

  I get the feeling infection preventionists-before they became the rock stars they are now-felt a little bit underappreciated and underutilized. Is that a fair assumption? Or was I misreading the mood?

  I think it is fair. I have been doing this for more than 30 years. And you always felt a little bit like the Maytag repairman. And as we move through things like HIV and then into the different pandemics, H5N1, swine flu, SARS, and COVID-each time I think infection prevention has gotten more and more attention. I do think that-what do they say-don’t let any crisis go to waste. I do think that things have gotten better and better. The only thing that’s changed is the emphasis. Be careful what you pray for, because now the spotlight is so great on infection prevention. And sometimes it is true, the resources have not kept up with the demand and the needs. But nonetheless, I think that the emphasis has improved the attention placed [on IPs]. I think APIC has done a very good job helping the C-suite understand what infection prevention brings to the table. I also think the efforts to require certification for infection preventionists is very important. There are some states that already require that. Others were also previously focusing on it, but once COVID came…. But once we’re not in such crisis mode, we’ll be able to focus again on requiring certification for IPs, so that there’s a level playing field of what people can expect from their knowledge base. And I think all of those things together will continue to help promote the importance of not just the infection preventionist but epidemiology and infection prevention in general.

This interview has been edited for clarity and length. 

Ann Marie Pettis, RN, BSN, CIC, FAPIC: “If indeed flu comes at the same time a second wave of COVID comes, that’s going to be difficult-unbelievably difficult because the symptoms obviously are somewhat similar. We’ll be trying to rule both of those things out. It will create more of a risk for a surge, and it will put more taxing on our PPE supplies.”

Q&A: States Need to Mandate That Infection Preventionists be Certified

While cases in New York City have been on the decline and many states are reopened or in the process of reopening, across the United States, 6 states are seeing record high cases. Arizona, Florida, Oklahoma, Oregon, and Texas are all seeing major spikes in their cases of COVID-19. For many, this is 

 of rapid reopening efforts, but also Memorial Day weekend events and gatherings possibly paid a part. In fact, 17 states saw their new cases rises within the last week. (Oklahoma saw cases rise by 68%.)

With well over 2 million cases in the United States, the question then becomes has the second wave begun or are we still experiencing the first wave? Or has the first wave been so rough that it’s blending into the second wave? 

For many, it seemed like the first wave of COVID-19 cases was mild and didn’t feel as chaotic as what we saw across some U.S. cities, while others experienced deeply traumatizing, overwhelmed hospitals. That so many of us were in different periods of the outbreak often lends itself to many thinking we’re through the first wave … or even the pandemic. Cheer down. As we’re seeing in many states, that’s just not the case. For many, 

Those of us in healthcare and infection prevention must focus on sustainable efforts to combat COVID-19. How do we maintain readiness and response without burnout? There’s no solid answer to this, but a big piece really goes into the establishment of plans and education. 

For those scaling down, what are your indicators for scaling back up? Sometimes the hardest thing is recognizing when we need to start looking again at personal protective equipment (PPE) re-use efforts, surge capacity, and all the other aspects of pandemic response that had to be implemented initially. 

The good thing is that we have knowledge on our side, both in terms of lessons learned and hopefully having some more processes already in place; processes that don’t need to be created or revised. Having COVID-19 plans, like information on extended use of N-95 masks, or duration of isolation, available online on intranets can be immensely helpful. 

Another piece to this is reiteration of training and screening. While most are using universal masking practices for all hospital employees, how confident are we in their compliance or habits? Now is the time to do educational roadshows on PPE and isolation precautions. They don’t have be long, but it’s a nice way to stop by units not treating COVID-19 patients and discuss proper masking practices. (For instance, wearing PPE all day is rather novel for most of us.) 

Moreover, this is the time to chat with staff about hospital plans and address questions they might have. Using those quiet moments to invest in sustainable COVID-19 infection prevention goes a long way and helps to reduce the long-term burden on the infection preventionists. Giving staff the skills to not only be safe, but also critically think through infection prevention situations, is critical to their safety and that of the patient. 

In the beginning, we were rapidly trying to do training and education, acquire PPE, and develop educational materials and processes. Now is the time to regroup and refine our practices, like ensuring staff understand when isolation precautions for COVID-19 patients can be discontinued, or where the information is available to give to patients being sent home, but still requiring isolation. These are a just a few lessons learned and a handful of things that can help guide us to a more sustainable approach to COVID-19.

Infection Preventionists Prepare to Ride the Second Wave of COVID

The use of decontaminated masks puts infection preventionists and other healthcare professionals at risk, two nurses’ unions said today. The Massachusetts Nurses Association (MNA) and National Nurses United (NNU) asked an expert to review a report by the Mass General Brigham (MGB) Center for COVID Innovation that deals with the efficacy of decontaminated masks. That expert, Richard Peltier, PhD, has serious doubts that decontaminated masks can keep healthcare workers safe.

“In my opinion, there is no doubt of the many open questions to decontaminated masks, but I fear there are some who simply do not want to know the answers to the questions we are asking.,” Peltier said in a 

Peltier said he felt disheartened that independent scientific inquiry is disregarded. Peltier applied his independent inquiry to a 

 by the MGB Center for COVID Innovation that measured the efficacy of a mask decontamination method invented by Battelle, a company based in Columbus, Ohio. The report contained the caveat, “A limitation of the experiment is the static application of virus to the respirators unlike the clinical use cases where there is active air flow through the respirator via inhalation by the healthcare worker.” That’s a huge caveat, Peltier and the nurses’ unions indicated, given that masks are all about air flow.

At the end of March, Battelle announced that its machines can decontaminate 80,000 N95 respirators a day, a breakthrough hailed as a 

 at a time when hospitals and other healthcare facilities were in even more desperate need for N95s than they are now.

On its website, MGB says that its mission is to “facilitate the development of new innovations that flatten the COVID-19 curve and protect frontline clinical staff across the MGB community and beyond.”

But Peltier said that the desire for innovation might encourage the dismissal of data that doesn’t gel with an outcome everybody wants—more workable N95s.

“N95 respirators used by clinical workers are surprisingly complicated safety devices and are really meant to be disposable—under ordinary circumstances, you’d use it once and toss it in the trash,” Peltier said. “But these are not ordinary times and hospitals are grasping at solutions to find ways to extend their limited supplies to keep workers safe.”

Peltier took a look at the data on vaporized hydrogen peroxide effects on five respirators and has some concerns. “Unfortunately, respirator decontamination was rush-approved by the FDA with no further safety testing to measure whether these respirators continue to work as they were designed,” Peltier said. “In fact, none of these respirators were designed to be reprocessed at all.

“At the same time, there are many different decontamination methods being used by clinical centers across the U.S., and we just do not know whether these masks continue to protect wearers adequately. Of the limited data that is available, almost all of it comes from the decontaminating companies themselves, or the hospital groups that have signed on to use these services.”

Jane Thomason, the lead industrial hygienist with NNU, also laid out her case against decontamination of respirators, saying that the process must meet 3 criteria. It needs to:

inactivate the pathogen, it can’t damage or degrade the N95 in any way, and it should not introduce an additional hazard to the healthcare worker.

“We have not seen any decontamination method meet these three criteria; in fact, several methods currently in use may be harmful by one or more criteria,” Thomason said. “Decontamination and reuse of N95 respirators endangers the health and safety of nurses and other healthcare workers.”

Thomason added that “instead of seeking safer alternatives, hospitals and our state and federal governments have rushed to embrace untested, dangerous decontamination and reuse policies. Hospitals have largely ignored more protective, safely reusable respirators such as powered air-purifying and elastomeric respirators, and our state and federal governments have refused to mandate increased production of N95 respirators and other PPE.”

N95 decontamination must meet 3 criteria. It needs to: inactivate the pathogen, it can’t damage or degrade the N95 in any way, and it should not introduce an additional hazard to the healthcare worker. 

Mask Decontamination Endangers Healthcare Workers, Nurses’ Unions Charge

Just what infection preventionists (IPs) do and how much time they spend doing it remains somewhat of a mystery because of a lack of evidence-based guidelines on this matter, according to a 

. The way in which IPs spend their “time varies significantly from hospital to hospital and is driven in part by regulations, by the priorities of hospital administration and supervisors of IP, and by the strengths and interests of the IP,” according to the study.

But the common method used to determine IP staffing-using a ratio of IPs to the number of beds or the number of patients-might not be the best way of determining just how many IPs an institution needs. 

Instead, hospital administrators and others who determine IP staffing should use the World Health Organization’s Workload Indicators of Staffing Need (WISN) method, say investigators with the All India Institute of Medical Science, in New Delhi, India. As the name suggests, WISN looks at the workload, and not solely at the numbers of IPs, patients, or beds. 

“The WISN method is a human resource management tool that determines how many health workers of a particular type are required to cope with the workload of a given health facility and assesses the workload pressure of the health workers in that facility,” the study states. 

Investigators wanted to find out just what the correct staffing levels should be for acute care hospitals. To that end, they used the WISN method, dividing the work IPs do into 3 categories: control activities, support activities, and additional activities. The control activities are directly tied to infection prevention and performed by all IPs; support activities were also performed by all IPs but did not necessarily have to do with infection prevention, and additional activities were performed by only a few IPs. 

The investigators calculated how many IPs with an available working time of 6,132 hours it would take to handle a workload that should take 6,238.25 hours to complete in an acute care hospital with 182 beds and 69,331 annual admissions. 

“Core infection control activities consumed 78% time,” the study stated. “Support and additional activities consumed the remaining 22% time. Active surveillance required 44% time and education consumed 32% time. WISN ratio of available staff and required staff was 0.75.” In other words, there needs to be 4 IPs on staff, not 3 as would have been the case if common ratio calculations were used. 

Active surveillance consumed most of the IP workload; 44% out of the total available time adding up to about 14 hours a week. And most of that surveillance was conducted on central line associated blood stream infections (CLABSIs).

The study concluded that “staffing for infection control can no longer be made on the basis of bed numbers or patient census but rather must reflect the scope of the program, characteristics of the patient population and the workload involved, techniques for applying scientific knowledge base about IP, and the unique and/or urgent needs of the institution and community. WISN is a valuable method that can prospectively measure all infection control activities and translate workload into IP FTEs [full-time employees]. Staffing guidelines based on WISN will require periodic revisions.” 

The common method used to determine IP staffing-using a ratio of IPs to the number of beds or the number of patients-might not be the best way of determining just how many IPs an institution needs. 

New Method Needed to Determine Infection Preventionist Staffing Levels

Bug of the Month helps educate readers about existing and emerging pathogens of clinical importance in healthcare facilities today. Each column explores the Bug of the Month's etiology, the infections it can cause, the modes of transmission, and ways to fight its spread. The pathogen profiles will span bacterial, viral, fungal and parasitic species. We encourage you to use Bug of the Month as a teaching tool to help educate healthcare personnel and start a dialogue about microbiology-related imperatives.

Bug of the Month helps educate readers about existing and emerging pathogens of clinical importance in healthcare facilities today.

June 2020 Bug of the Month

Ernest Hemingway described courage as “grace under pressure.” A study of the psychological challenges to-and changes in-nurses on the frontlines fighting COVID-19 uses the term “growth under pressure.” The 20 nurses in the study, when first assigned to COVID-19 patients, felt a lot of anxiety brought on by fatigue, discomfort (often caused by the wearing of personal protective equipment (PPE) for hours), and helplessness caused by heavy workloads and fear of either catching the disease, or becoming an asymptomatic carrier and bringing it home to their loved ones. 

, the nurses gradually developed coping mechanisms that included making lifestyle adjustments (trying to keep to their exercise schedules, for instance), performing acts of kindness, and getting support from other members of the care team. 

Investigators wrote that the “nurses adopted avoidance, isolation, speculation, humor, self-consciousness, and other psychological defenses to psychologically adjust to the situation.” 

This, in turn, led to “growth under pressure, which included increased affection and gratefulness, development of professional responsibility, and self-reflection.”

Investigators concluded that psychological counseling for nurses caring for COVID-19 would be most effective if given early on in the experience. They also cited the importance of establishing “early support systems, such as adequate supplies of protective materials, reasonable allocation of human resources, elderly and infant care services for nurses’ families, pre-job training, and interpersonal interaction among nurses to facilitate nurses’ adaptation to the antiepidemic tasks,” the study states 

The study, which used the Colaizzi’s phenomenological method to qualitatively analyze the psychological experiences of the nurses, was conducted in China at the First Affiliated Hospital of Henan University of Science and Technology from January 20 to February 10, 2020 by investigators who worked for that institution. It’s a small study and just how much of it can be extrapolated to other healthcare institutions in other countries at other times during the pandemic can’t be known because “the medical system and culture of different countries varies,” the authors admit.

However, the novelty of COVID-19 makes reports from the frontlines valuable they argued, and the study contains tables of quotes that the nurses gave to the psychologist who conducted the interviews. 

The psychologist asked three main questions: What do you feel about the COVID-19 patients? How do you cope with those feelings? What lessons have your learned from the pandemic? 

What the investigators described as “subquestions” were also asked. They included: How did you feel when you agreed to the assignment? Were there any changes in your life? If so, how did you cope with changes on the job and in your life? What are your thoughts and feelings about fighting COVID-19? 

Here are some examples of how the nurses answered, under the general themes.   

Significant amount of negative feelings in the beginning.

·       “After putting on protective clothing, nursing duties are awkward to carry out. Protective clothing needs to be worn for 8 hours or more without drinking water and eating food and urinating was done with adult diapers.” 

·       “After all, it is a new disease and the patient’s condition is unpredictable. I am always worried about what to do if the patient’s condition deteriorates in the next second.” 

·       “I am the only child and my mother cries every day and fears that I will be infected, and I worry more about them...”

·       “We encourage each other. It doesn’t feel like I’m fighting alone, I’m not afraid.”

·       “In fact, the chance of medical staff infection is very low and the protection of negative pressure wards is better than other departments.” 

·       “When using diapers, I tell myself you’re young enough to become a baby [laughs].”

·       “I write a diary and sometimes write letters.”

·       “The progressive breathing relaxation method recommended by my colleague is good, I often use it.”

·       “After work I find the sky is blue and everything is beautiful.” 

·       “I used to work to earn a salary, but now it feels like a responsibility.”

·       “I never thought I could be so strong.”

·       “After entering the negative pressure ward, I saw that both the patient and the doctor were protected. So, I felt safe and relieved.”

·       “Every time I take care of the patients, they will take the initiative to put on a mask. I feel particularly safe in my heart. After treatment, they will keep saying ‘thank you’ and it feels good.”

·       “Patients are very cooperative with our work. Although some patients have emotions due to illness, they show great respect to us.”

·       “My family calls or sends WeChat greetings every day, and I feel very happy.” 

Some of the study’s findings will sound all too familiar to nurses dealing with COVID-19 patients throughout the world. For instance, a lot of anxiety felt by the nurses at first had to do with having to reuse PPE and wear that PPE for long shifts. The nurses’ fear peaked when they entered the negative pressure ward for the first time. “They were mainly concerned about the unknown conditions of the patients, severe emergencies, and the patients’ psychological state,” the study stated.

Investigators compared their findings to other studies that show how epidemics can traumatize caregivers. The nurses in their study “grew psychologically” under the pressure of coping with COVID-19. They reevaluated their values, and found motivation by being grateful for the support they received from family, friends and colleagues. 

“The sense of responsibility brought by professional ethics in an epidemic, encouraged nurses to actively participate in antiepidemic tasks and boosted their professional identity and pride…,” the study states. “Our finding of the existence of positive emotions in our nurses such as confidence, calmness, relaxation, and happiness, which simultaneously or gradually appeared with negative emotions, was in contrast to the results several studies that describe only the presence of a large amount of negative emotions during outbreak stress.” 

The nurses in the study “grew psychologically” under the pressure of coping with COVID-19. They reevaluated their values, and found motivation by being grateful for the support they received from family, friends and colleagues. 

How Nurses Adjust to the Trauma of Taking on COVID-19

 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 

 to discuss the implications of his findings.

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.

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.

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.

And when you talk about the guidelines, you’re talking about guidelines from the US Centers for Disease Control and Prevention?

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.

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?

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 

 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 

 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.

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.

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.

Have you gotten much feedback from people? Have you heard from a lot from fellow healthcare professionals?

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 

, 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

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?

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.

Have other studies come out since your article that back up what you said?

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 

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.

Any advice for infection preventionists, EVS teams, hospital administrators, procurement teams as far as masks are concerned?

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 

 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.

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.”

Q&A: Nearly All Healthcare Workers Fighting COVID-19 Need N95s

The search for a vaccine to for coronavirus disease 2019 (COVID-19) got a push from the US Food and Drug Administration (FDA) yesterday when the agency granted fast track status for 2 products under development. The agency gave the go-ahead to Pfizer and Biopharmaceutical New Technologies (BioNTech) for the investigational vaccines BNT162b1 and BNT162b1. The vaccines are the result of a joint research venture between the biopharmaceutical companies.

BNT162b1 and BNT162b2 are the two most advanced vaccine candidates in the 2 companies’ BNT162 program currently being evaluated in ongoing Phase 1/2 clinical studies in the US and Germany.

“The FDA’s decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2,” Peter Honig, senior vice president, Global Regulatory Affairs, Pfizer, said. “We look forward to continue working closely with the FDA throughout the clinical development of this program, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates.”

Project Lightspeed is a vaccine development program, which is based on BioNTech’s proprietary mRNA-based technology platforms and supported by Pfizer’s global vaccine development capabilities. The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world.

“We are pleased to have received Fast Track designation from the FDA for two of our vaccine candidates and look forward to working closely with the FDA, along with our partner Pfizer, to expedite the clinical development path forward,” Chief Medical Officer Özlem Türeci at BioNTech reiterated.

Pfizer and BioNTech are developing these novel vaccines with pre-clinical and clinical data at the forefront of all decision-making of both companies.

Along with the development and manufacture of health care products, including medicines, Pfizer has a well-established footprint in vaccines.

BioNTech is an immunotherapy company working on novel therapies for cancer and other serious diseases.

The companies are expecting to start a Phase 2b/3 trial possibly later this month and are anticipating enrolling up to 30,000 subjects.

Biopharmaceutical New Technologies (BioNTech) for the investigational vaccines BNT162b1 and BNT162b1. The vaccines are the result of a joint research venture between Pfizer and Biopharmaceutical New Technologies (BioNTech).