Impact of Sterilization Regulations on the Life Sciences Industry

Stakeholders and OEMs in the life sciences and medical devices industry face numerous challenges when it comes to sterilization. Ethylene Oxide (EtO), used to sterilize over 50% of all sterile medical devices in the US, including approximately 95% of surgical kits, has been identified as a toxic air pollutant that the US Environmental Protection Agency regulates. In 2023, there have been over $700M in jury awards and settlements for EtO litigation, mostly involving commercial sterilizers. In fact, the EPA has proposed new regulations to decrease EtO exposure, potentially impacting US commercial sterilization facilities. Implementation would cause facility shutdowns, resulting in widespread delays. Therefore, the crucial question is: How can we ensure compliance with EtO standards?