Major media outlets are questioning the ability of the Battelle Critical Care Decontamination System (CCDS) to safely reprocess used N95 respirators up to 20 times, as the company has claimed.
The FDA granted the nonprofit tech development company an emergency use authorization in March for its vaporized hydrogen peroxide system to decontaminate N95 respirators used by healthcare providers during the COVID-19 pandemic.
Nurses and nurses’ organizations have complained that respirators reprocessed by Battelle’s system began to fail after fewer than the 20 cycles the company claims is safe, according to reports by NBC and the Boston Globe.
In April, National Institutes of Health scientists said N95 respirators can be decontaminated effectively and maintain functional integrity for up to three uses. The study tested decontamination in the form of vaporized hydrogen peroxide, 70 °C dry heat, ultraviolet light and 70% ethanol spray.
Masks treated with vaporized hydrogen peroxide showed no failures, suggesting the potential for three-time reuse. Normally, N95 respirators are designed for single-use, but the authors of the study concluded that vaporized hydrogen peroxide was the most effective decontamination method for allowing more uses, with no virus detected after a 10-minute treatment.
In an email to MassDevice, Battelle cited an FDA-supported study it submitted to the agency in 2016 that said the system can reprocess N95 masks up to 20 times. (The agency subsequently published the report.) After 20 cycles, the company’s testing showed, the masks’ straps fragmented during stretching, which “may potentially impact the fit or comfort of the respirator exposed to the (vaporized hydrogen peroxide) cycles.”
“Human subject testing would be needed to assess the impact, if any, on fit and comfort,” the study concluded.
“CCDS is based on sound and proven science. We developed this technology over a two-year period with the FDA, and the findings are published,” company spokesperson Rose Rankin said in an email to MassDevice. The technique has been independently validated by a research team at Duke University, and U.S.-based scientific consortium N95Decon cited three studies confirming its effectiveness in eliminating SARS-CoV-2 spores.
A nurses’ labor union representative, however, told the Boston Globe that the Battelle system treats nurses “like guinea pigs in an experiment that could threaten their long-term health.”
In a blog post released Tuesday, Battelle president and CEO Lou Von Thayer characterized the attack as political. “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,” Thayer said.
The EUA requires the company to collect feedback from users of decontaminated masks.
“There have been 5 reports submitted to the FDA, which represents well below a tenth of a percent of all masks processed,” Battelle spokesperson Katy Delaney told MassDevice in an email.
The NBC report also questioned the size of the company’s federal contract to manufacture the systems. That contract ballooned from a total of $60 million for 60 systems on April 3 to up to $413 million a few days later, according to the network. Battelle pointed out that the $413 million includes “all construction and operation, and that amount isn’t paid out to Battelle upon signing the contract,” Rankin said. “It’s a legal limit of what Battelle can invoice.”
Columbus, Ohio-based Battelle has deployed 50 of the 60 decontamination systems in the U.S., Delaney said. “As the current COVID-19 pandemic worsened, our scientists revisited that study and scaled up operations so that we could decontaminate thousands of masks,” she added.
Thayer told the Columbus Dispatch that the NBC report contained “several factual errors” and that it “ignored proven science.”
Decontamination is just one tool to rely on during the COVID-19 pandemic, Thayer said in his blog post.
“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,” he said. “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.”
This article has been updated with responses from Battelle.