COVID-19 Preparedness for Health Care Institutions with Dr. Paul Biddinger of Massachusetts General Hospital

The coronavirus has spread beyond the point of containment, and there’s a looming shortage of personal protective equipment. Those are two of the takeaways from the March 13 webinar sponsored by WCG and Accumen. It featured Massachusetts General Hospital’s (MGH) Paul Biddinger, MD, and former FDA Commissioner, Scott Gottlieb, MD. The on-demand recording of the webinar is available here.

We have summarized key points and observations from Dr. Biddinger below, followed by questions addressed during the Q&A portion.

Insights from Dr. Paul Biddinger, Massachusetts General Hospital

Dr. Biddinger holds the MGH endowed chair in emergency preparedness and is the director of the Center for Disaster Medicine, and vice chairman for emergency preparedness in the department of emergency medicine at MGH. He is also the director for emergency preparedness at Partners Healthcare and serves as the director of the Emergency Preparedness Research, Evaluation and Practice (EPREP) Program at the Harvard T. H. Chan School of Public Health. He is an active researcher in the field of emergency preparedness and has responded to previous incidents, including Hurricane Katrina and the Boston Marathon bombings.

Asymptomatic spread:

COVID-19 is spread by both asymptomatic and symptomatic individuals, like influenza and unlike the coronaviruses SARS and MERS. “That makes it much more difficult, I would argue, impossible to control with public health measures directly.”

Mitigation, not containment:

We’re seeing significant community transmission in much of the United States. As a result, messaging, response efforts, and other activities are shifting from containment to mitigation. We must focus on how to mitigate the impact of this outbreak.

Blunting the curve:

“I don’t think it’s possible to put the genie back in the bottle. I think we’re going to continue to see rising numbers of cases.” Most efforts are now focused at blunting that epidemic curve, keeping the peak as low as possible. The higher that peak is, the more people we may see who need hospitalization, who need intensive care, who need resources such as ventilators.  

Personal protective equipment shortages:

Patient surges are expected in both the ambulatory and inpatient care settings. At the same time, supply chain challenges have been huge. Personal protective equipment (PPE) is probably the greatest challenge on the medical care side. N95 respirators were already in short supply in January. Other medical PPE, including gowns, gloves, and eye protection, are also difficult to obtain.

Lack of testing capability:

The problems with testing in the United States have been extremely well documented and unbelievably frustrating for everyone involved in this response.

It’s extraordinary to look and see how different the US’s ability to test is compared to almost anywhere else in the world. There are 23 tests per million people [at the time of this webinar] in the US and that’s the lowest of any industrialized country that we know of; compare that to 3,600 tests per million people in South Korea.

Lack of testing affects resources:

There’s an especially urgent need for testing in the inpatient side of hospital care and for healthcare workers. If we don’t know if you have the disease and you have compatible symptoms, we must treat you as though you have the disease until we know otherwise. That means we use more and more PPE, it means we use more and more of our isolation capacity in the hospital, whether that’s, again, on the floor or up in the intensive care unit.

If we can’t test quickly as we make decisions to admit people to the hospital, as we identify what gear we’re going to wear, we are going to consume a huge amount of resources we shouldn’t need to consume. And we’re going to run out of isolation spaces.

Location matters:

We do want as much testing as possible, but we really do not want a centralized ED-based or urgent-care-based strategy for testing. Because we saw in China, we saw in South Korea, those healthcare systems being overwhelmed by patients with mild illness coming in for testing, mixing with those that don’t have illness and overwhelming the healthcare system.

Our testing strategies for broad-based public testing must be much more thoughtful. Obviously, people have seen something with drive-thru clinics and others which don’t bring the well and the ill together and don’t overwhelm the care systems--those are the things we really need to look at.

Ambulatory care--avoiding face-to-face contact:

Many practices are trying to defer visits by older patients, given that mortality increases substantially with age; there is an inflection point at about age 50. And the slope of the curve continues to increase with each decade of life after that. Telemedicine--virtual visits--protects both provider and patient and decreases clinic traffic, but some patients must be seen in person.

Designated clinics:

Many systems are developing specialized respiratory clinics. Patients who do need an in-person clinical evaluation can go to one of these. This concentrates patients with acute respiratory illness rather than spreading them out across a large network of primary care offices. The PPE is concentrated and staff training is optimized. So again, from both the healthcare worker and the patient perspectives, these risks are minimized.

Some of these clinics need to be located near emergency departments, because many people turn to an emergency department (ED) as their first source of care. But many will not need an ED evaluation, and it’s important to preserve the ability of an ED to care for patients.

EDs are already crowded and, as such, are not great settings for infection control in the first place. As the crowding worsens, the opportunity for disease transmission increases.

Inpatient capacity:

It’s no secret to anyone that hospitals operate at close to full occupancy to stay economically viable, so surge capacity is quite limited in terms of beds as well as the nurses and physician staff. We’re really concerned about that supply and demand mismatch. And that’s unfortunately exactly what we’re seeing play out in Italy.

Demand for equipment is expected to overwhelm supply, especially for ventilators and extracorporeal membrane oxygenation (ECMO) devices (colloquially called life-support machines). It’s been widely reported that peak demand in the U.S. could potentially be on the order of 900,000 to a million ventilators across the outbreak. But the most optimistic assessment of the US healthcare system is that we have about 100,000 ventilators.

That’s why we need to flatten the curve. The more we can do that, the more we can do to make sure we have lifesaving resources. But competitive healthcare systems don’t do a great job of identifying where they have capacity and where they don’t.

Standards and standardization:

If we do end up in a circumstance where that supply/demand mismatch is so substantial, we have to start moving down the path of something called Crisis Standards of Care. This is something that the Institute of Medicine--now the National Academy of Medicine--has been working on for more than a decade.

We need to have protocols and policies that are fair, that are transparent. They must be evidence-based, consistent and shared across healthcare organizations so that a hospital in one system does not do something vastly different than another hospital in another healthcare system which undermines the confidence of the public in our ability to respond.

PPE protocol is crucial:

The doffing process--how you take off your personal protective equipment--may be one of the most important things any healthcare organization can focus on. Aerosolization can happen if you take off your PPE incorrectly. If you take off your suit after removing your respiratory protection, a bunch of small droplets get kicked up in the air and you breathe them in.

MGH has very tight sequences--put in place during Ebola--to take off your PPE. We have developed the same for COVID-19. We’re trying to get the word out to everyone who’s actually donning and doffing PPE how important being methodical and being careful during doffing is going to be for personal protection.

Support from bench scientists:

On the bench side, many academic healthcare systems, including MGH, have tried to see what they can mobilize from the research community to better assist the response. This includes equipment, technicians, and reagents. Many hospitals are working on developing their own test; MGH  has rolled out its test. However, it is a heavily manual process: “We have to extract the RNA, we have to run it on a special instrument and use reasonably sophisticated technicians in order to get the result, which is vastly different than what we do in almost all of our other microbiology testing.”

Redeploying research tools:

“We across Harvard ... have made an emergency call for RNA extraction kits, repurposing certain instruments, and potentially looking at creating a volunteer corps of trained microbiologists and others who are comfortable with RT PCR in this lab work, to be redeployed to assist us.”

The clinical research side poses serious challenges. It’s increasingly difficult to support clinical encounters with patients where either the research assistant or the researcher may come in contact with COVID-19, just from a risk management standpoint. Resource utilization is a critical issue, too: “We cannot use a single piece of personal protective equipment that could be used otherwise to protect the healthcare worker and a patient in the course of clinical care.”

Balancing research and safety:

At the same time, there’s an incredible need for knowledge. With an unprecedented outbreak like this, we certainly must understand what is going on. We must continue to acquire knowledge.

“We don’t want to ... put the entire scientific enterprise on hold for a year and stop the advancement of medical knowledge. So, we’re having some very hard discussions about how to continue selected research studies and when we need to stop other research studies. And again, it’s that balance of safety, resource utilization, and importance of the project.”

 

Audience Questions:

The presentation generated hundreds of questions. Here are a few; questions and the responses have been lightly edited.

Q. Can you give any simple guidelines of what products--bleach, isopropyl alcohol or whatever--are best to use for disinfecting COVID-19?

Biddinger: We certainly think that unfortunately the virus probably can live on many surfaces for up to a week, maybe longer. So, good environmental decontamination is absolutely essential. But the CDC has a good resource on disinfection, and includes a link to the EPA list of registered antiviral disinfectants appropriate for the coronavirus.

 

Q: The last time we prepared for a large infectious disease outbreak was Ebola in 2014. Are there lessons from that experience that can help us prepare to respond to COVID-19?

Biddinger: Yes, I think so. One thing that happened is that the United States government established the the National Ebola Training and Education Center (NETEC), to conduct research not just on Ebola but on any other emerging special pathogens.

It has a network of regional programs, and MGH hosts one of them. And what we’ve been doing is preparing for something like this coronavirus outbreak. So, for the last five years, we’ve been planning, developing protocols for how you hospitalize someone who needs this isolation.

We’ve developed donning and doffing protocols, specialized RTPE protocols, we’ve developed training videos, planning tools, etc. (MGH’s corona virus toolkit is publicly available.)

The other thing that I would say specific to Ebola is, although COVID-19 and Ebola are very different diseases in so many ways, the importance of donning and doffing personal protective equipment carefully is one of our most important lessons learned.

About the Author

Dr. Lindsay McNair, MD, MPH, MSB | Chief Medical Officer, WCG

Dr. Lindsay McNair has extensive experience in the pharmaceutical industry. Prior to joining WCG, she was a consultant to pharmaceutical and biotechnology companies, providing medical guidance on clinical development strategies and study designs for new drug studies, and medical oversight of all phases of clinical trials. Dr. McNair teaches graduate-level courses on the scientific design of clinical research studies. She has been actively involved in IRB work for 18 years, and has a Master’s of Science in Bioethics with a concentration in research ethics.

Follow on Twitter Follow on Linkedin Visit Website More Content by Dr. Lindsay McNair, MD, MPH, MSB | Chief Medical Officer, WCG
Previous Post
COVID-19 Insights from Former FDA Commissioner, Scott Gottlieb, MD
COVID-19 Insights from Former FDA Commissioner, Scott Gottlieb, MD

The coronavirus has spread beyond the point of containment, and there’s a looming shortage of personal prot...

Next Post
Essential Considerations for CTMS Integrations and Data Migrations
Essential Considerations for CTMS Integrations and Data Migrations

Webinar Series: Clinical Trials in the Era of COVID-19

Register Now