The Food and Drug Administration (FDA) slammed a device manufacturer for not having a way to report adverse health events stemming from its N95 decontamination system used by hospitals and healthcare facilities.
The FDA sent a warning letter on Wednesday to Battelle Memorial Institute over its Critical Care Decontamination System. The letter focuses on a controversial practice of decontaminating N95 masks, which are normally single-use, but hospitals have been forced to reprocess them due to a scarcity of personal protective equipment (PPE) from the COVID-19 pandemic.
FDA found that Battelle didn’t have a process for reporting adverse events, which is a condition of the decontamination system’s emergency approval.
“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 Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, in a statement.
The agency asked the nonprofit science and technology company back in August to detail its process for submitting adverse health events to the FDA.
The agency detailed some of the potential adverse events, which include allergic reactions or eye, mouth or nose irritation. Other events include residuals from the hydrogen peroxide used to reprocess the N95 mask or malfunctions in the generators used to decontaminate the PPE.
FDA’s most recent letter did not list how many adverse events may have occurred while using the system.
Battelle has 15 days to respond to the letter. The company told Fierce Healthcare that it appreciates the FDA’s clarity on the requirements and it will respond to the agency.
“It is of great importance to us to remain in compliance with the FDA’s Emergency Use Authorization,” the company said.
Battelle did not divulge the number of adverse events that have taken place from the decontamination system.
The process of decontaminating PPE has become a major controversy among providers since the onset of the COVID-19 pandemic. Normally, a provider is not allowed to reprocess or decontaminate an N95 mask. But the FDA relaxed those requirements after the COVID-19 pandemic created an unprecedented demand for PPE.
Nurses’ union National Nurses United has slammed the practice, saying that it puts nurses and other front-line healthcare workers in danger. But some health systems defend the practice to preserve precious supplies of PPE.