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– Medical Device, the first to enter the European market with an innovative and sustainable sterilization approach with chlorine dioxide gas
BRANCHBURG, N.J., Dec. 5, 2023/PRNewswire/ — The first CE mark was awarded to a medical device sterilized with chlorine dioxide gas following new MDR regulations. Sterilization services are performed by ClorDiSys Solutions, Inc at its FDA registered contract sterilization facility in New Jersey. The device is a Class II medical device which is a surgical lighting device for providing illumination to an electrocautery pen during surgery. The device contains a built-in battery, which imposes restrictions on the sterilization mode. Ethylene oxide is becoming a growing concern for the medical device industry due to its environmental and health concerns and its limited sterilization ability. However, it is also explosive, meaning the built-in battery was not compatible. Material compatibility and overall effectiveness eliminated conflicting methods such as gamma irradiation, dry heat, vaporized hydrogen peroxide, E-Beam and other methodologies. This left chlorine dioxide as the clear sterilization method due to the materials and the inclusion of an integrated battery within the device.
Since establishing its Pure CD™ as the primary method of replacing ethylene oxide gas in the United States due to its environmental and health concerns, it is now further expanding the technology to Europe. Chlorine dioxide gas works almost identically to ethylene oxide. However, Chlorine Dioxide gas from ClorDiSys is neither carcinogenic nor explosive and is a registered sterilant with the United States Environmental Protection Agency (EPA).
The ClorDiSys method of generating chlorine dioxide gas was developed by Johnson and Johnson and produces a non-acidic gas that is gentle on materials. The process also does not generate harmful waste, which is a concern often experienced with ethylene oxide sterilization. A sterilization feature that is also of great interest is that the cycles do not require a temperature increase as does ethylene oxide. This allows temperature-sensitive devices to be highly successful under chlorine dioxide sterilization. Chlorine dioxide cycles are much shorter than ethylene oxide, typically lasting between four and six hours, from preconditioning to aeration.
Founded in 2001, ClorDiSys Solutions, Inc is a New Jersey-based company that manufactures sterilization equipment and provides services. ClorDiSys developed its technology through Johnson and Johnson, and chlorine dioxide gas has provided true sterilization of medical devices for more than 25 years.
Contacto de medios: Emily Lorcheim, ClorDiSys Solutions, Inc, Tel: 908-236-4100, emilylorcheim@clordisys.com, 50 Tannery Rd, Suite 1, Branchburg, NJ 08876
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