Moving away from using ethylene oxide in sterilization for medical devices remains difficult with the current minimal market interest to address what is considered a niche problem.
There are many ways to wage wholesale death and destruction upon the microscopic world. Chemical, thermal, radiation, and other energy-based means abound. The real challenge has always been to find a method that would not cause equal damage to what is being sterilized, or the humans in the room. Metal surgical tools can be rendered safe with heat and steam, but when plastics exploded into medical use starting in the 1960s, a new form of low temperature chemical sterilization grew rapidly alongside it.
Today, according to FDA, more than 20 billion devices sold in the United States every year are sterilized with ethylene oxide (EtO), accounting for roughly 50% of devices that require sterilization. To meet this demand, there are over 100 different EtO gas sterilization facilities sprinkled across the United States. Some of these, like the now-famous Willowbrook, IL facility, began operation in the 1980s, 30 years before the U.S. Environmental Protection Agency (EPA) would classify EtO as a human carcinogen. Community advocacy groups, government officials, and medtech industry organizations are readying themselves for what is sure to be a monumentally difficult challenge to resolve.
Aside from the legal and ethical challenges, the technical and logistical challenge around steering those $20 billion devices safely out of the EtO pipeline is overwhelming. Alira Health, a global consulting firm, listed sterilization as one of the top major concerns of the medical industry in their recent 2022 contract manufacturing report, on par with raw material shortages and domestic workforce challenges.