Roxby gets EUA status for Zoe-Ann system to decontaminate N95 respirators

Roxby Development has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Zoe-Ann decontamination system.

The EUA status enables Zoe-Ann system to decontaminate compatible N95 respirators for healthcare personnel single-user reuse during the coronavirus pandemic.

Utilising Bioquell Clarus C Hydrogen Peroxide Vapor Generator, Roxby’s Zoe-Ann system is expected to decontaminate a maximum of 22,500 compatible N95 respirators per cycle.

Roxby stated that it will immediately begin accepting masks from healthcare facilities for decontamination in their Wheeling facility in West Virginia.

Wheeling facility to decontaminate more than 100,000 masks per day
At present, the Wheeling facility has the capacity to decontaminate over 100,000 masks per day in one chamber.

The EUA also facilitates the construction of additional decontamination chambers to enhance the capacity of respirators decontaminated by Roxby for reuse by healthcare professionals.

All participating healthcare facilities will receive an authorised labeling system to help personnel bag their own respirators, which will then be shipped by Roxby to the decontamination facility.

Upon receipt, each respirator will be assessed by trained personnel to decontaminate up to four times before being discarded.

Later, the decontaminated respirators are packaged based on the facility and unit code to return to the original user.

Roxby Development president Jeffrey Morris said: “When the pandemic hit, we were compelled to activate in order to support our country and community.

“Roxby was in the unique position with the available resources and network of experts to develop a decontamination system in the heart of Appalachia that would enable the reuse of N95 respirators, extending supply during a significant shortage, while simultaneously creating jobs in our community.” NS Medical Devices