Georgia state officials claim that Becton Dickinson (NYSE:BDX) has been operating a medical device warehouse without an air quality permit.
The Covington, Ga. warehouse stores devices that have been sterilized using ethylene oxide (EtO), a carcinogenic gas. BD signed a consent order with the Georgia Environmental Protection Division (EPD) in October, agreeing to aerate EtO-sterilized devices for 24 hours after they leave the sterilization chamber.
Based on BD’s Dec. 15 report of 0.65 lbs. per hour in fugitive EtO emissions at the warehouse, the state calculated that the facility could emit 5,600 lbs. per year of the gas. Any facility that has emitted or may emit more than 4,000 lbs. per year of EtO must apply for a state permit to do so.
The EPD ordered the company to:
- Stop storing EtO-sterilized medical devices at the Covington warehouse from Dec. 23 through Jan. 6, 2020.
- Submit a list of the amount of products currently at the warehouse that were sterilized at BD facilities in Covington and Madison, Ga., as well as products sterilized at non-BD facilities within and outside of Georgia.
- List other Georgia warehouses where EtO-sterilized devices are stored.
- Explain why the amount of fugitive EtO emissions from sterilized devices is higher than the company estimated in its air-quality permits for its Covington and Madison plants.
- Submit a plan to remove Foley catheter procedural trays from the Covington warehouse until the warehouse has an air-quality permit, and to stop storing additional Foley catheter trays there.
The state also gave BD 30 days to submit a schedule for air monitoring at or adjacent to the nearest residential neighborhood to the Covington warehouse and to conduct that monitoring for 24 hour periods every three days.
“These results are highly concerning, and we are demanding answers from @BDandCo to remedy this unlawful activity,” Georgia Gov. Brian Kemp tweeted. “I have directed state officials to act as swiftly as possible to secure compliance.”
BD did not immediately respond to questions about the alleged violations.
The company voluntarily shut down its Covington sterilization plant from Oct. 30 to Nov. 6. The FDA has been warning of medical device shortages since the February shutdown of a major Sterigenics EtO plant in Willowbrook, Ill. State and local scrutiny and public outcry over EtO emissions from sterilization plants in Illinois, Georgia and Michigan have ensued, as have lawsuits filed by residents living near EtO plants claiming they have been sickened by the gas.
EtO 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.
The EPA is due to come out with proposed rules regarding commercial EtO operations in May 2020. Meanwhile, the FDA is seeking public input on alternatives to EtO and on methods to reduce emissions. The agency has been mum about responses to its pleas, issued in July. Medtech advocates argue that even if a viable alternative surfaces, it would take years and significant investments to institute, including the time to validate the new method for each device it would sterilize.
EtO is used to sterilize about 50% of all devices sold in the U.S. that require sterilization – more than 20 billion medical devices per year, according to the FDA.
