Chlorine dioxide (CD) gas is now being used for the sterilization of medical devices. Over the past two years, extensive testing has been done to learn more about its limits within the medical device sterilization market. Some of the testing was done in partnership with a leading medical device manufacturer who was looking at new technologies which could replace Ethylene oxide (EO) for certain medical devices types. This testing pushed the boundaries of what conditions CD gas was known to be effective within, and we’ll be discussing that in our upcoming free webinar on July 15th that you can sign up for by clicking here.
Ethylene oxide first began its tenure in medical device sterilization in the in the 1950’s. EO was favored due to a lack of sterilization options for heat and moisture sensitive medical devices, gaining popularity due to its ability to penetrate packaging materials and device lumens, its material compatibility, as well as ease of use. However, EO soon began facing challenges. In 1987 Ethylene Oxide was determined to be a carcinogen by California. In the following years the National Institute of Occupational Safety and Health (NIOSH) studied more than 18,000 workers at 17 sterilization plants and concluded that EO causes breast cancer and lymphomas. In 2006, and after reviewing NIOSH studies, the EPA released a draft of its review of EO and determined it is a human carcinogen. Pressure peaked in 2018 with lawsuits stemming from claims an Illinois plant’s EO emissions resulted in many incidents of cancer throughout the community. This pressure resulted in major facilities closing down and forcing added strain on others. This resulted in increased wait times and overall fears from manufacturers as well as the FDA that the threat of a lack of alternatives besides EO could mean critical medical supplies may not have a mode of sterilization available to them.
Overall, critical disadvantages associated with EO are the lengthy cycle time, cost, and its potential health dangers. Another serious issue is that EO can be explosive, creating a risk for sterilizing devices with embedded batteries. EO’s overall risk profile prevents many medical device and pharmaceutical companies from having in-house EO sterilization chambers due to the complexity and safety complications EO sterilizers result in.
Chlorine dioxide gas is a near identical replacement to ethylene oxide in terms of cycle structure and effectiveness. Chlorine dioxide is non-carcinogenic, non-explosive, and cycles can be completed within one chamber, allowing for a simpler sterilization process. Gaseous chlorine dioxide is a non-carcinogenic, EPA registered sterilant. Since it is a gas, the chlorine dioxide molecules will fill the entirety of a space and reach all areas of a component while retaining high material compatibility. Without the risk of explosion, CD gas is able to sterilize devices containing embedded batteries. Recent testing proved its ability to sterilize devices within packaging, which was thought to be prohibitive in the past. The simplicity of the process also allows firms to install and utilize in-house CD gas sterilizers which can help expedite processes and reduce costs. We have recently registered as an FDA medical device contract sterilization facility (FDA registration number 3013115071), allowing medical devices to be sterilized at our facility before being returned or shipped out to their next location.