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FDA warns Battelle over EUA conditions for N95 decontamination system

Posted 07 October 2020 | By Michael Mezher 

FDA warns Battelle over EUA conditions for N95 decontamination system

The US Food and Drug Administration (FDA) on Wednesday warned Battelle Memorial Institute for failing to comply with some of the conditions of its emergency use authorization (EUA) for its decontamination system for N95 respirators.
The warning letter is the first FDA has issued concerning a product being used under an EUA during the COVID-19 pandemic.
In March, Battelle became the first organization to receive an EUA for a decontamination system for N95 respirators, which have seen skyrocketing demand and tight supply throughout the pandemic. Under the most recent version of its EUA, the Battelle Critical Care Decontamination System is authorized to decontaminate compatible N95 respirators for reuse by multiple health care personnel when there are insufficient supplies of filtering facepiece respirators. (RELATED: FDA issues and expands EUA for respirator decontamination system, Regulatory Focus March 30 2020).
The warning letter follows a correspondence between FDA and Battelle that took place in August in which the agency raised concerns about deficiencies in the organization’s medical device reporting (MDR) processes. FDA says its letter detailed a litany of reportable events that may be related to the decontamination system, including, “Allergic reactions or eye, mouth or nose irritation, evidence that a decontaminated respirator is unable to perform its essential function, events related to hydrogen peroxide residuals or user contact with hydrogen peroxide residuals, infection in respirator wearers, or malfunctions of the generator used to decontaminate the respirators.”
After reviewing its response, FDA says it determined Battelle was not in compliance with MDR requirements. According to the warning letter, the organization’s MDR procedures, “Do not establish internal systems that provide for timely and effective identification, communication and evaluation of events that may be subject to MDR requirements.”
FDA also says that Battelle’s internal procedures lack systems to ensure a standardized review process for determining when events meet reporting thresholds and do not facilitate timely transmission of complete MDRs.
Additionally, the warning letter calls on Battelle to review its reports for any reportable events it has been aware of for more than 30 days and submit an MDR for them. FDA says it expects the company to implement corrections to the violations cited in the warning letter within 30 days and to provide a response detailing its planned actions within 15 days.
“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 Binita Ashar, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health.
Ashar added that FDA, “Will hold companies accountable if they fail to fulfill their regulatory obligations.”
FDA, Warning Letter


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