The Food and Drug Administration says it still needs more information from Columbus research firm Battelle about how it would respond to "adverse events" with its personal protective equipment decontamination machine.
In a letter published Wednesday, the FDA says Battelle needs to improve its reporting procedure to comply with the emergency use authorization given for the machine that decontaminates N-95 masks for reuse by frontline healthcare workers.
The letter follows August correspondence with Battelle that the FDA initiated after officials say they “became aware that there may be deficiencies in Battelle’s process.” The letter does not say what those alleged deficiencies are.
Concerns outlined in the FDA's letter include:
- A lack of instructions for how Battelle "will evaluate information about an event to make (medical device) reportability determinations in a timely manner."
- A lack of "internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting."
- No "internal systems that provide for timely transmission of complete medical device reports."
- Battelle "does not describe how your firm will address documentation and record-keeping requirements.”
Battelle was widely lauded by city, state and federal officials when it rolled out the Critical Care Decontamination System last spring. Battelle said the machines, built out of shipping containers and easily transportable, were capable of cleaning up to 80,000 pieces of PPE at a time.
WOSU was given the first tour of the machines that were seen as a potential lifeline for health care workers, who in some parts of the country were experiencing shortages of PPE during the COVID-19 pandemic.
Gov. Mike DeWine and President Trump both intervened to push the FDA to give its full approval to Battelle, which then sent the devices to cities hardest-hit by the coronavirus.
By early June, Battelle said the machines had decontaminated roughly 650,000 masks for 18,000 health systems. However, some nurses raised concerns about cleaned masks not fitting as well as new ones.
Battelle initially brokered two contracts with the federal government – the first for $78 million to create 60 systems to be sent around the country, and the second with a ceiling of $400 million for a workforce to man the machines.
