Breakthrough advancement for the medical industry gets FDA nod

The United States Food and Drug Administration (FDA) has approved chlorine dioxide gas for contract sterilization of medical devices.  

This breakthrough advancement for the medical industry has been awarded to ClorDiSys Solutions, headquartered in Branchburg, NJ. 

This news follows public safety hazards of the industry standard, ethylene oxide.  

ClorDiSys utilizes chlorine dioxide gas, a non-carcinogenic, United States Environmental Protection Agency (EPA) registered sterilant.  

Another advantage of the chlorine dioxide sterilization approach is the ability to sterilize devices containing embedded batteries. Previous methods, such as ethylene oxide, do not allow for the sterilization of such devices due to the explosivity of the gas posing a potential danger when interacting with one another.  

Chlorine dioxide vacuum pressure sterilizers allow for the option of the sterilization of complex designed devices within bulk packaging. 

The other gamechanger is the vast reduction in cycle time and complexity of the chlorine dioxide gas sterilization process. Items can be loaded into a single sterilization chamber and the entire cycle, including aeration, occurs inside. Cycles range depending on each device's requirements, but typically last 2–8 hours, start to finish.  

Chlorine dioxide gas sterilization stands to be a major disruptive force in the industry. The technology provides new opportunities to manufacturers with advanced device technology and introduces a new environmentally friendly means of sterilization to an industry that is decades deep in carcinogenic emissions.  

Established in 2001, ClorDiSys Solutions is a New Jersey-based business that manufactures sterilization and disinfection equipment, and provides decontamination services. The company developed its technology through Johnson and Johnson, and chlorine dioxide gas has been providing true sterilization of medical devices for over 25 years on items such as suture products, artificial joints, and implantable contact lenses.