Monday, February 22, 2021

FDA-Approved Contract Sterilization of Medical Devices

ClorDiSys Solutions, Inc is recently approved by the United States Food and Drug Administration (FDA) for contract sterilization of medical devices using our chlorine dioxide gas process (registration # 3013115071).  The ability for chlorine dioxide gas sterilization to be used in such a way is a tremendous advancement for the industry.  Ethylene oxide (EtO) has typically been the industry standard for medical device sterilization, especially in terms of contract sterilization.  However, for years, there has been a concern over EtO’s harmful environmental and health impact, as well as its overall volatility that prevents certain items like embedded batteries to be decontaminated.  In fact, in 2019, EtO contract sterilizer firms in Illinois were shut down over health concerns due to harmful emissions, an issue that rose in magnitude after five women claimed that working at the plant led to their cancer diagnosis.  Although these plants are dangerous, officials warned that shutting them down could lead to medical device shortages.  This dilemma stresses the need for alternative medical device sterilization options to become more prevalent in the industry.  Chlorine dioxide gas is a direct replacement for EtO, without the negative aspects that ethylene oxide is known to have.  Chlorine dioxide is a non-carcinogenic residue free gas that is a registered sterilant by the United States Environmental Protection Agency (EPA).  Its non-explosive behavior allows for items with sensitive components, such as embedded batteries, to be safely and effectively sterilized.  With no need for capital expense or additional in-house labor, contract sterilization services from ClorDiSys provide an affordable option for medical device manufacturers.  The devices can be initially sent to ClorDiSys so a cycle can be validated, and any necessary regulatory actions can be pursued.  Then, on an as needed or pre-scheduled basis, the device manufacturer can ship items for sterilization following their customized protocol.  Overall, contract sterilization provides a low-risk and low-cost option that ensures effective results with greater ease and peace of mind.

Learn more about ClorDiSys Contract Sterilization services here

Contact us for more information on any of the listed applications or to explore additional applications not listed. Specific testing with your device is always recommended.