Battelle under fire for decontamination system performance

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 far 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.

The NBC report questioned the size of the company’s federal contract to manufacture the systems. That contract ballooned from $60 million on April 3 to $413 million a few days later, and up to $600 million by May 1, according to the network.

Columbus, Ohio-based Battelle operates decontamination systems in 48 U.S. cities, the Globe noted.

Battelle president & CEO Lou Von Thayer told the Columbus Dispatch that the NBC report contained “several factual errors” and that it “ignored proven science.” The company maintains its 20-cycle claim is accurate, the newspaper reported.

Battelle did not immediately respond to a request for comment.