BRANCHBURG, N.J., Dec. 4, 2023 /PRNewswire/ -- The first ever CE mark was awarded to a medical device sterilized using chlorine dioxide gas following new MDR regulations. Sterilization services are performed by ClorDiSys Solutions, Inc in their New Jersey, FDA registered contract sterilization facility. The device is a Class II medical device that is a surgical lighting device to provide illumination of an electrocautery pencil during surgery. The device contains an embedded battery, forcing restrictions on the sterilization modality. Ethylene oxide is becoming a growing concern for the medical device industry due to its environmental and health concerns and limited sterilization capacity. However, it is also explosive, meaning the embedded battery was not compatible. Material compatibility and overall efficacy eliminated contending methods such as Gamma irradiation, dry heat, vaporized hydrogen peroxide, E-Beam, and other methodologies. This left chlorine dioxide as the clear sterilization approach due to the materials and inclusion of an embedded battery within the device.
Since establishing its Pure CD™ as the primary method for replacing ethylene oxide gas in the US due to its health and environmental concerns, it is now further expanding the technology into Europe. Chlorine dioxide gas performs in a near identical manner as that of ethylene oxide. However, ClorDiSys' chlorine dioxide gas is non-carcinogenic, non-explosive, and is a United States Environmental Protection Agency (EPA) registered sterilant.
ClorDiSys' method of chlorine dioxide gas generation was developed by Johnson and Johnson and produces a non-acidic gas that is gentle on materials. The process also does not result in harmful residues, which is a concern that is often experienced with ethylene oxide sterilization. A sterilization feature also highly of interest is that cycles do not require an increase in temperature as ethylene oxide requires. This allows temperature sensitive devices to be highly successful under chlorine dioxide sterilization. Chlorine dioxide cycles are much shorter than those of ethylene oxide and typically last between four to six hours, from pre-conditioning through aeration.
Established in 2001, ClorDiSys Solutions, Inc is a New Jersey based business manufacturing sterilization equipment and providing services. ClorDiSys developed its technology through Johnson and Johnson, and chlorine dioxide gas has been providing true sterilization of medical devices for over 25 years.
Media Contact: Emily Lorcheim, ClorDiSys Solutions, Inc, Phone: 908-236-4100, emilylorcheim@clordisys.com, 50 Tannery Rd, Suite 1, Branchburg, NJ 08876
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