Until recently, the debate over the widely used sterilant gas ethylene oxide (EtO) has been largely waged on state and local levels in the U.S. But now it’s going public at the federal level.
From city council chambers to judges’ chambers, through volleys of press releases and the clamor of citizen picket lines, the stream of information has been relentless since February 2019, when a Sterigenics EtO plant in Willowbrook, Ill. was shut down by state officials.
The stakes are high for the industry, the healthcare systems and the public. More than 20 billion medical devices are sterilized using EtO annually, according to the trade group AdvaMed. The Sterigenics Willowbrook plant closure sent hospitals scrambling for alternative sources of critical devices. Although no major device shortages have ensued, the FDA and the industry have issued dire warnings about that possibility.