As the EPA prepares to issue new regulations for the carcinogenic sterilant gas ethylene oxide, the industry must decide whether to invest in expensive emissions-control upgrades, switch sterilization processes or — in the case of some small sterilization companies — exit the business.
Nancy Crotti, Managing Editor
In the next few months, the U.S. Environmental Protection Agency will update its rule governing emissions of the most commonly used substance for sterilizing medical devices: the carcinogenic gas ethylene oxide, or EtO.
Although it’s been in use as a medtech sterilant since the 1960s, EtO has really only been under heightened scrutiny for little more than a year. EtO sterilization plants have shut down in Illinois, Georgia and Michigan over concerns about emissions; the FDA has warned about device shortages (although few have materialized); concerned citizens have formed protest groups and filed lawsuits against sterilization companies; and state and local governments have been wrangling over who has the right to regulate sterilization plant operations.