FDA Approves Chlorine Dioxide Gas for Medical Device Contract Sterilization


By: Fran Kritz

April 21, 2021

Categories: AAMI News, Sterilization

Wisps of gas rise from a surface.


The Food and Drug Administration (FDA) recently approved the use of chlorine dioxide gas for contract sterilization of medical devices. The approval was awarded to
ClorDiSys Solutions, Inc, based in Branchburg, NJ.

Chlorine dioxide gas is an alternative to ethylene oxide sterilization, which presents several dangers, according to the Centers for Disease Control and Prevention (CDC). According to ClorDiSys, a key advantage of chlorine dioxide sterilization is the ability to sterilize devices containing embedded batteries such as handheld injection pumps, infusion equipment, surgical lights, pacemakers, and defibrillators.

 

“Chlorine dioxide gas is a reasonable and effective way to sterilize surfaces and inanimate objects from microbiological contamination, says Emanuel Goldman, Ph.D., a professor of Microbiology, Biochemistry & Molecular Genetics.

According to ClorDiSys, chlorine dioxide vacuum pressure sterilizers also allow for the option of the sterilization of complex designed devices within boxes, and for a reduction in cycle time over ethylene oxide. Items to be sterilized can be loaded into a single sterilization chamber and the entire cycle, including aeration to remove the gas, occurs inside. Cycle times range depending on each device's requirements, but typically last from two to eight hours.

Paul Lorcheim, director of operations at ClorDiSys, said the company is already seeing “an overwhelming wave of interest” in the technology. “Medical Devices sterilized by our gaseous chlorine dioxide already have attained EU approval, further expanding industry and regulatory acceptance.”