BDX · 10-Q · 2026Q2 · Full report

Ethylene Oxide Sterilization Capacity

BECTON DICKINSON & CO · 2026-08-06 · Importance 37 · Surprise 42

Ethylene oxide remains the most frequently used sterilant for U.S. medical devices and healthcare products and, in some cases, the only available option for critical products. New emissions and pesticide-use requirements could force BD or third-party sterilization providers to suspend or curtail operations, reduce available sterilization capacity, interrupt production, and increase operating costs. BD installed fugitive-emissions controls at its East Columbus, Nebraska and Sandy, Utah facilities and is investing in new technologies and work practices to meet revised requirements. The company’s sterilization facilities received a two-year compliance exemption, but BD continues implementation work and is monitoring proposed EPA revisions to the NESHAP rule.

Key facts

• Additional regulatory requirements associated with the use and emission of ethylene oxide may be imposed in the future domestically or outside the United States and could require BD or sterilization service providers to temporarily suspend operations to install additional emissions control technology, limit the use of ethylene oxide or take other actions which would impact BD’s operations and further reduce the available capacity to sterilize medical devices and healthcare products. source
• If regulatory requirements result in suspension, curtailment or interruption of sterilization operations at BD or at medical device sterilizers used by BD, or otherwise limit the availability of third-party sterilization capacity, this could interrupt or adversely impact production of certain products or lead to civil litigation or other claims against BD. source
• BD has business continuity plans in place to mitigate the impact of potential sterilization disruptions, although these plans may not be able to fully offset such impact. source
• BD proactively installed fugitive emissions controls at its facilities in East Columbus, NE and Sandy, UT. source
• Ethylene oxide is the most frequently used sterilant for medical devices and healthcare products in the United States and in certain cases is the only option to sterilize critical medical device products for safe administration to patients. source