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The Facts on CCDS

Posted by Lou Von Thaer on Jun 2, 2020

This post is in response to misleading media coverage about Battelle’s important work to maintain the supply of desperately needed respirator masks for health workers on the front lines of the Covid-19 pandemic.

By leaving out the important scientific research and studies that have gone into decontaminating N95 masks – which have shown to be the most effective way to protect nurses, doctors and other professionals – the media coverage is doing a great disservice to these workers. I want to reassure workers that the process for cleaning their masks for reuse is safe and has been validated by independent studies conducted by universities, major hospitals, and government agencies. 

Of the many Covid-19 images we’ve seen, one of the most disturbing is that of nurses reporting for duty in bandanas and scarves as the U.S. supply of N95 masks dwindled to dangerously low levels. Indeed, the fact that our country lacked an adequate supply of medical masks and other personal protective equipment (PPE) was one of the most serious issues we faced as the pandemic took hold. 

Because of early planning by Battelle and the FDA, Battelle was ready to meet this need with a scientifically established process. We know that some of the ties come off during the cleaning and can’t be used. And we understand why anybody would be concerned about their safety during such a virulent epidemic. I hope that the following will help everyone understand how this came about and why it works.

In 2015, following the Ebola outbreak in West Africa, the FDA asked Battelle what could be done if there were a global pandemic and a resulting PPE shortage. We conducted a two-year study to determine if mask decontamination was safe and effective, and we worked to identify the one method that would maintain filter and fit performance through numerous decontamination cycles. Flash forward to 2020 (and the very scenario that the FDA was concerned about) and one can see why Battelle was able to move quickly to engineer a decontamination system to help keep front-line healthcare workers safe. 

Our system is elegantly simple. It uses hydrogen peroxide, a common household disinfectant, in a highly concentrated form. We use modified shipping containers filled with racks and hooks to fit thousands of masks inside. We then pump them full of vaporized hydrogen peroxide to saturate the masks. Chemical indicators throughout the chamber ensure that the proper concentration of vapor phase hydrogen peroxide is present to kill SARS-CoV-2 (as well as other viruses). At the end of the decontamination cycle, the hydrogen peroxide is purged from the chambers leaving the masks free of dangerous pathogens and safe for reuse. This process, based on our two-year study, has been independently verified as effective at killing the virus without damaging the masks. A barcode tracking system ensures that each healthcare facility receives only their masks in return. The entire process, including shipping to and from our sites, takes on average three days. 

Today, approximately 50 sites across 34 states are serving thousands of healthcare workers and first responders. From Massachusetts General Hospital to the California Department of Health, Battelle’s CCDS Critical Care Decontamination System™ provides assurance that front-line workers will never have to treat a patient, nursing home resident, or accident victim unprotected. 

Unfortunately, even when your mission is to help keep the world healthy and safe, politics come into play. There are some organizations who seek to disparage the safety and efficacy of mask decontamination, even if it means putting the healthcare workers that they represent in harm’s way. 

As the world attempts to tamp down this first wave of the pandemic and prepares to face a potential second or third wave, it is critical that we have every effective PPE solution in our arsenal—mask decontamination is one of them. We must therefore prevent false narratives from taking shape by explaining the facts.   

First, it’s important to understand that the safety is not in question. The CDC and FDA both back the use of Battelle’s CCDS and experts at Duke, Harvard, and Tulane University all conducted independent studies to verify that the process was safe and effective. Battelle continues to conduct additional research to build on our body of scientific knowledge around decontamination; to date we have tested over 25 types of N95s through multiple decontamination cycles since introducing CCDS.

Feedback from those on the front lines has been positive.  As one doctor at Riverside Methodist Hospital in Ohio noted, “Having access to appropriate PPE consistently is a huge relief. I have a six-year-old and a nine-month old at home. Knowing that I have access to the tools I need to stay safe for myself, for my patients, and for my family—I’m certainly very grateful for all of that.”  

Second, some members of the media have mischaracterized the cost of mask decontamination as excessive. While decontamination will likely never be as affordable as a new respirator, it is in place as a stopgap measure because manufacturers of N95 respirator masks have been unable to supply the quantity needed. There have been “point in time” calculations, which lead readers to believe the cost of decontamination is not viable. They take the cost of the system and divide it by the number of masks processed. The problem with this math is that when you do that same calculation a week later, after more masks have been processed, the price per mask will be lower, and lower again each day as more masks are processed. The reality is our decontamination system had upfront costs, but now we have these tools for use today, tomorrow, and as part of our national stockpile for the future.   

In the throes of the pandemic the federal government, with state and local partners, mobilized to invest in the process with the goal of bringing the technology to the front lines as quickly and safely as possible. That required us to hire, train, and deploy nearly 800 workers to staff operations across the country. Once again, those upfront and ongoing operational costs are driven down every day with every mask decontaminated as more hospitals and healthcare organizations enroll and make use of the service. 

Finally, it bears repeating that decontamination is but one of the tools we should rely on. It’s not meant to be a substitute for more N95 production. And it should not be used indefinitely. It’s a technology to help essential workers protect themselves while PPE supply chains are reinforced. Decontamination is a temporary measure for times of surge—which our hospitals could well experience again. And today, that is where our focus should be.

Lou Von ThaerIf there is one thing that the Covid-19 pandemic has illustrated it’s that we need to do a better job of preparing for the unknowns. Looking toward the future, we need every solution at our disposal. It’s optimistic, but foolhardy, to assume that another pandemic is not in our future. 

Lou Von Thaer is President and CEO of Battelle.

 

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