FDA Issues Warning Letter to Manufacturer of Respirator Decontamination System

Battelle Memorial Institute failed to meet Emergency Use Authorization requirements for reporting adverse events.

The FDA issued a warning letter to Battelle Memorial Institute on October 7 for failing to comply with regulatory requirements for medical device reporting.

The institute did not meet requirements specified in the Emergency Use Authorization (EUA) for the Battelle Critical Care Decontamination System. Under the EUA, the Decontamination System is authorized for use in decontaminating certain N95 respirators for reuse by health care workers in the event of insufficient supplies due to the pandemic.

“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,” said Binita Ashar, M.D., director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health. “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.”

This warning letter arrives after the FDA sent the institute a letter in August requesting information about their process for submitting reportable adverse events to the FDA.

The FDA advises health care professionals to report adverse events related to devices to the agency’s Adverse Event Reporting program. More information can be found at fda.gov.

About the Author

Nikki Johnson-Bolden is an Associate Content Editor for Occupational Health & Safety.

Product Showcase

  • The MGC Simple Plus

    The MGC Simple Plus

    The MGC Simple Plus is a simple-to-use, portable multi-gas detector that runs continuously for three years without needing to be recharged or routinely calibrated after its initial charge and calibration during manufacturing. The detector reliably tests a worksite’s atmosphere for hydrogen sulfide, carbon monoxide, oxygen and combustible gases (LEL). Additionally, it is durable enough to withstand the harshest treatment and environments, which is why it has an IP 68 rating. The MGC Simple Plus is also compatible with a variety of accessories, such as Gas Clip Technologies’ new GCT External Pump. Visit gascliptech.com for more information. 3

  • Magellan X Pte Ltd

    Hesitate No More with SOL-X Connected Worker Health & Safety Solution

    According to the National Safety Council, work-related medically consulted injuries total 4.26 million in 2021 in USA alone. SOL-X solution prevents “human factors” safety issues by anticipating incidents and improving compliance workflows. Leverages digital technologies (IIoT, AI and analytics) to predict patterns from occurring and make informed decisions. Control Of Work - gets rid of tedious paperwork and experience digital workflows. Crew Protect - maximises safety and situational awareness with health trackers and situational indicators. Award-winning Intrinsically Safe SmartWatch – innovative features that enable near real-time visibility and connected well-being. Works well with major connectivity protocols like Wi-Fi, Bluetooth, and Long-Range Bluetooth! 3

Featured