Industry talk continues about a future with less or no EtO sterilization. It is a sea change, even though the controversy first appeared decades ago. It is a far cry from the buzz of a 1928 discovery that the gaseous compound was an effective insecticide. EtO quickly earned a prominent role in fumigating hospital rooms and treating WW II troop rations. These successes, no doubt, fueled the expansion of EtO use to the supply side of the medical field, sterilizing instruments.
As such a versatile and powerful compound, with its broad material compatibility and ability to wipe out pathogens of all sorts, EtO was the industry’s darling. Not only was it effective, but it was also adaptable and efficient for large volume sterilization in a rapidly growing field. Unfortunately, that darling had a dark side that didn’t take long to emerge.
A 1948 study found that EtO was also a mutagen, altering cells and elevating cancer risks. In the ensuing decades, further evidence against the safety of EtO grew, yet with few practical alternatives, we plodded on. Last year’s EtO sterilization crisis refocused the industry, and the FDA, on reducing the use of EtO.
As 2019 ended, the FDA rolled out a series of new actions to find new options and mitigate medical product shortfalls as we navigate our way to a safer, yet productive path:
