Having granted Battelle Memorial Institute's respirator decontamination system an EUA in March, the FDA has now issued a warning letter over the system
The FDA has issued Battelle Memorial Institute with a warning letter over an “inadequate adverse event reporting process” relating to its EUA-approved respirator decontamination system.
In March, Ohio-based science and technology development company Battelle received an EUA (emergency use authorisation) that permitted its Critical Care Decontamination System to clean certain N95 respirators so they could be reused by healthcare staff.
Following a request for information in August, however, the US Food and Drug Administration has now determined that Battelle does not have a process in place for reporting adverse events relating to its decontamination system – something that is considered a mandatory requirement under the EUA.
The FDA has given the company 15 working days to respond to the warning letter with details about how it will correct these violations, and stated that failure to do so may result in regulatory action being initiated without further notice.
Dr Binita Ashar, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health at the FDA, said: “It is critical that manufacturers have an effective process in place for reporting adverse events related to the use of authorised 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.
“We will hold companies accountable if they fail to fulfill their regulatory obligations.”
Battelle’s EUA-approved respirator decontamination system
Battelle’s Critical Care Decontamination System is authorised, under an FDA-issued EUA, for use in decontaminating certain N95 respirators when there are insufficient supplies of filtering facepiece respirators due to the Covid-19 pandemic.
This was done in response to shortages of these types of respirator device – which are designed to be single-use only, but are being decontaminated and reused where necessary by healthcare staff during the public health crisis.
The FDA said that, in August, it became aware that there may be “deficiencies” in the Battelle’s process for reporting adverse events relating to these uses of its decontamination system, and requested additional information from the company in a letter.
The letter detailed several examples of these reportable events – including infections in respirator wearers, allergic reactions or irritation to the eye, mouth or nose, and evidence that a decontaminated respirator is unable to perform its intended function.
The information the FDA received from Battelle did not provide sufficient evidence of a proper process for reporting these types of events and – in line with its ongoing commitment to evaluating medical devices issued with an EUA during the pandemic – the regulator has now given Battelle 15 working days to respond.