This article has been updated with comments from Becton Dickinson.
The Covington, Ga. warehouse stores devices that have been sterilized elsewhere using 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 sterilization chambers at is sterilization plants in Covington and Madison, Ga.
Based on a Dec.15 report that BD submitted to the state, which revealed 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.
BD countered products stored at the warehouse “are not meaningfully contributing to higher levels of EtO than what is found in ambient air across the U.S.”
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 residential neighborhood nearest 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 told MassDevice in an email that it is reviewing the notice from the EPD and will respond on or before the Dec. 20 deadline.
“Air monitoring data from inside and outside the facility confirm that BD’s facility is safe for employees and the community,” the company said. “Average EtO levels inside the facility are about 65% below the permissible exposure limits set by the Occupational Safety and Health Administration (OSHA), which is the regulatory authority for EtO levels inside business facilities. BD also conducts ongoing employee monitoring through our industrial hygiene program at the GDC (global distribution center), which also confirms there are no exposures above OSHA-permissible exposure levels. External air monitoring data have also confirmed that EtO levels in the ambient air outside of the GDC is in line with ‘background’ EtO levels found by both Georgia EPD and U.S. Environmental Protection Agency (EPA) at air monitoring sites in Georgia and across the country where there are no industrial sources of EtO.
“This confirms the products stored at the GDC are not meaningfully contributing to higher levels of EtO than what is found in ambient air across the U.S. In addition, laboratory testing has also confirmed BD
products are in compliance with the U.S. Food and Drug Administration (FDA) standards for residual EtO levels that ensure patient and health care worker safety.”
The company voluntarily agreed in October to invest more than $8 million to reduce EtO emissions from its Georgia sterilization plants. BD said today that it has “acted transparently and collaboratively with local and state officials to innovate and identify new methods to voluntarily further reduce emissions from its facilities in Georgia” and that “air monitoring data and analyses from board-certified toxicology experts have confirmed that all of BD’s facilities are operating in a manner that is safe for employees and the community.”
BD said it will continue to work with state and federal officials to propose and implement new ways to further reduce fugitive emissions from its Georgia facilities.
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.