An Infectious Diseases Specialist On The Front Lines; First Sterilization Of N-95 Masks Is Approved By The FDA

Clinicians on the front lines in hot zones across the United States are speaking out about the crisis that the COVID-19 pandemic is unleashing on their patient care organizations now, in real time. Among the numerous concerns that physicians, nurses, respiratory therapists, all other clinicians, and all non-clinicians working in hospitals, clinics, and other patient care organizations are facing: potentially devastating shortages of personal protective equipment (PPE); shortages of ventilators; and the potential for the infection of clinicians and others on the front lines; as well as their simple exhaustion. With regard to the PPE issue, for the first time, the Food and Drug Administration has approved the sterilization of N-95 masks, on the part of one company, the West Jefferson, Ohio-based Battelle Institute.

With regard to the broad issues, as Healthcare Innovation reported at the end of last week, “In a press briefing on Friday morning, March 27, leaders of the Arlington, Va.-based Association for Professionals in Infection Control and Epidemiology (APIC) released the results of a survey of APIC’s membership, which is revealing tremendous shortages of personal protective equipment (PPE), as well as of hand sanitizers and disinfecting cleansers, in U.S. hospitals, nursing homes, and other patient care organizations. APIC’s leaders released the highlighted results of the survey in a press release Friday morning, on the association’s website, and then spoke to the press through a telephone press briefing. As the press release noted, ‘Nearly half (48%) of U.S. healthcare facilities surveyed are already out of, or almost out of respirators to use in caring for a patient with COVID-19, according to a national survey of infection prevention experts conducted March 23-25, 2020 by the Association for Professionals in Infection Control and Epidemiology (APIC). The online survey asked APIC’s U.S.-based infection preventionist members to categorize their supply of personal protective equipment (PPE) and other items including hand sanitizer and cleaning products on a 5-point scale from having ‘plenty’ to ‘none.’  Of the 1,140 infection preventionists who completed the survey, 233 (20.46 %) reported their facilities have no respirators; an additional 317 (27.83%) say they are almost out of these critical devices used to protect healthcare workers caring for patients with COVID-19 and other infectious diseases.’”

On Monday, Healthcare Innovation Editor-in-Chief Mark Hagland spoke with Aaron E. Glatt, M.D., chairman of the Department of Medicine at Mount Sinai South Nassau Hospital, a 433-bed academic medical center in Oceanside, New York. Dr. Glatt is an infectious diseases specialist and epidemiologist and is a national member expert for the Arlington, Va.-based Infectious Diseases Society of America (IDSA), “a community of over 12,000 physicians, scientists and public health experts who specialize in infectious diseases,” and a professor of medicine at the Icahn School of Medicine at Mount Sinai. Below are excerpts from their interview.

What is the situation in terms of dealing with the crisis at this moment?

It’s very difficult. All the hospitals in the area are being overwhelmed with seeing hundreds of cases of COVID. We’re rapidly becoming a COVID-19 hospital now.

What are your biggest concerns overall?

We want to make sure we have enough machinery and equipment. All these things are very tight. And we have a lot of cases, including a lot of new cases.

How many ICU beds do you have operating now?

All of our ICU beds are filled with COVID-19 patients now. We’re creating essentially a 200-bed ICU almost. It is impossible to continue forward in this way for any period of time. It’s very distressing. So basically, all of our beds are being converted to ICU beds, and the entire hospital is becoming an ICU, treating COVID-19 patients.

Is physical and mental exhaustion becoming a worrisome factor for doctors and nurses?

Yes, staff are overwhelmed. Staff are working very hard.

And what is your situation with regard to personal protective equipment?

There’s a tremendous shortage of PPE; we’re using the PPE quickly. We’re now sterilizing, using the one CDC-approved method right now, the Battelle method, on N-95 masks. [Please see section below on the Battelle method’s FDA approval]

What should healthcare leaders nationwide understand about the situation in the New York metropolitan area?

It is critical that people socially distance. This is not a joke. We really need people to understand that. This virus can potentially be checked, if people maintain social distancing. But if not, this will spread like wildfire. I’ve been practicing for over 30 years. And this is the worst healthcare disaster we have ever faced in that time.

As Marty Schladen reported on Sunday afternoon, March 29 in an article in the Columbus Dispatch, “After a day of pressure from Ohio Gov. Mike DeWine, the U.S. Food and Drug Administration late Sunday rewrote rules to allow full application of a potentially game-changing Battelle technology to sterilize protective masks worn by those treating coronavirus victims. The agency ruled that upgrading its emergency use authorization from partial to full ‘is appropriate to protect the public health or safety.’ DeWine said Sunday night that he and Lt. Gov. Jon Husted ‘just had a very productive call’ with the Food and Drug Administration. ‘I anticipate a positive announcement soon. We must do all we can to protect our front-line workers,” DeWine told USA Today. And Husted tweeted: “This Ohio-driven solution has the potential to save lives now and in the future across the United States.”

As Schladen reported, “Lt. Gov. Jon Husted said: ‘We’re grateful that the president and the FDA moved quickly to help us get this solution back up and running. This Ohio-driven solution has the potential to save lives now and in the future across the United States.’

As a result, “The FDA’s new waiver to Battelle, a Columbus-based nonprofit research institute, said, ‘Battelle is authorized to decontaminate up to 10,000 compatible N95 respirators per chamber load,” in its new machine that decontaminates the safest masks against coronavirus and can allow 20 re-uses of the devices, which are in perilously short supply.’ The company has two machines — each capable of cleaning 80,000 masks a day — ready to go at its West Jefferson [Ohio] facility. Another two are currently being set up on Long Island, with a third headed to New York City soon. It also is deploying machines in Seattle and Washington, D.C. That means the new order could allow for up to 400,000 clean masks a day in the short run.”

And on its website, the not-for-profit, West Jefferson, Ohio-based Battelle Institute stated in a press release Sunday that “Battelle announced today that it has received Food and Drug Administration (FDA) Emergency Use Authorization (EUA) to support front-line healthcare workers as they face critical shortages of personal protective equipment (PPE). The Battelle CCDS Critical Care Decontamination System™ is now operating at Battelle’s West Jefferson, Ohio facility under the EUA and is capable of decontaminating up to 80,000 respirator masks per system each day using concentrated, vapor phase hydrogen peroxide (VPHP). The respirator masks are exposed to the validated concentration level for 2.5 hours to decontaminate biological contaminates, including SARS-CoV-2. Battelle CCDSTM can decontaminate the same respirator mask up to 20 times without degrading the mask’s performance.” And it quoted Battelle’s president and CEO, Lou Von Thaer, as stating that “I want to thank the FDA team for their professionalism and help in authorizing the use of our technology at this critical moment for our nation. Everybody who has worked on this project shares the same goal of protecting first responders and healthcare workers who are at the front lines of the pandemic.”

–HC Innovation Group