Georgia state officials are fining an Atlanta-area medtech sterilization plant $3,000 per day for failing to install a filtration system to reduce ethylene oxide (EtO) emissions by the agreed-upon deadline of Dec. 31, 2019.
Sterilization Services of Georgia operates a 40,000-square-foot plant near Atlanta, where it sterilizes disposable medical devices using the cancer-causing gas. The company had agreed to install new filters to reduce EtO emissions by the end of 2019, but ran into a delay and could not comply, according to a consent order the company signed with the Georgia Environmental Protection Division.
Without admitting wrongdoing, the company must pay the daily fine through the end of January or until the filtration system is installed and operating. If the system is not installed by Feb. 1, the company must reduce its use of EtO by 25% based on a seven-day average. If the system is not installed by Feb. 28, the company must stop using EtO until the system is installed, according to the order.
Sterilization Services of Georgia received the permit to install the additional venting on Nov. 7, 2019 and signed the consent order on Tuesday. It is the third medtech sterilizer in Georgia to come under state scrutiny for EtO emissions. The other facilities are owned by Becton Dickinson (NYSE:BDX) and Sterigenics. The consent order may be downloaded here.
Emissions of ethylene oxide from medical device sterilization plants and warehouses that store EtO-sterilized devices has galvanized state and local officials and residents who live near EtO sterilization plants in Illinois, Georgia and Michigan. The medtech industry and the FDA continue to warn of possible device shortages as they search for other methods that would be as effective and efficient as EtO. Ethylene oxide sterilization works at low temperatures — between 90°F and 135°F — making it a viable option for devices made of multiple components and materials, including plastics, polymers, metals and glass, as well as coatings, bonds and packaging from damage. It can also penetrate different types of device packaging, enabling sterilizers to process truckloads’ worth of devices simultaneously.