Critically ill Americans’ access to life-saving medical treatment is in jeopardy as states’ regulators crack down on cancer-causing pollution from the plants that sterilize medical devices.
The Food and Drug Administration, which regulates the medical devices these facilities clean, has said that even a single closure could threaten patients’ access to everything from feeding tubes for premature babies to equipment for heart surgeries and hip replacements.
Caught flat-footed, FDA is now scrambling to find alternative sterilizing processes, as the Environmental Protection Agency and states consider tightening emissions standards for these facilities, potentially threatening the industry’s ability to continue operating. Experts say it is unclear if the technology even exists to reduce facilities’ emissions enough to protect nearby communities from elevated cancer risks, according to EPA’s calculations.
Now, EPA is preparing to review the hazardous air pollutant regulations governing more than 100 sterilizers around the country.
As part of that review, the agency can consider the importance of sterilizers to public health, said Janet McCabe, who led EPA’s air office under the Obama administration.
“The [Clean Air] Act allows EPA to consider issues in addition to air quality impacts of regulatory requirements,” she said. “It’s a reasonable thing for EPA to consider what are the implications for the medical sterilization needs if new regulations are put on the sterilizing companies.”