The FDA is warning Battelle Memorial Institute that it must improve its adverse event reporting procedure for decontaminating N95 masks for reuse by frontline healthcare workers treating COVID-19 patients.
The agency granted an emergency use authorization (EUA) in March for the Battelle Critical Care Decontamination System (CCDS), which uses vaporized hydrogen peroxide to reprocess used N95 masks.
The FDA said today that it sent Battelle a letter in August requesting information about its process for reporting adverse events after the agency “became aware that there may be deficiencies in Battelle’s process.” While it did not name the deficiencies, the agency provided examples of reportable events, including allergic reactions or eye, mouth or nose irritation, evidence that a decontaminated respirator cannot perform its essential function, events related to hydrogen peroxide residuals or user contact with them, infection in respirator wearers, or malfunctions of the generator used to decontaminate the respirators.
In May, NBC and the Boston Globe published reports questioning the ability of the Battelle system (CCDS) to safely reprocess used N95 respirators up to 20 times, as the company has claimed. In response, 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.”
The FDA was unsatisfied with Battelle’s response to its August letter and today gave the institute 15 working days to respond to the warning letter or face unannounced regulatory action, according to a news release.
Deficiencies cited by the agency include:
- No instructions for how Battelle will evaluate information about an event to make timely reporting decisions.
- No procedure to put in place a standardized review process on which events require reporting.
- No description of how it will address FDA documentation and record-keeping requirements, including which information was evaluated to determine if an event was reportable, and documentation of deliberations and decision-making processes used to determine if an adverse event was or was not reportable.
“It is critical that manufacturers have an effective process in place for reporting adverse events related to the use of authorized systems for decontaminating respirators. When there is an inadequate adverse event reporting process, the ability to detect problems and address them in order to assure the safety and performance of decontaminated respirators is compromised,” said Dr. Binita Ashar, director of the office of surgical and infection control devices in the FDA’s Center for Devices and Radiological Health (CDRH). “We will hold companies accountable if they fail to fulfill their regulatory obligations.”
The federal government contracted with Battelle to manufacture up to 60 of the portable systems for deployment to healthcare facilities.
Battelle did not immediately respond to a request for comment on the warning letter, which you can read here.