The legal landscape around ethylene oxide (EO) sterilization is changing fast. B. Braun, a large and well-respected medical device manufacturer, has recently settled lawsuits over EO emissions—highlighting a growing wave of litigation risk in the industry.
It appears that the trend of legal challenges and public scrutiny are continuing, regardless of whether companies follow strict safety protocols.
How We Got Here
As we have written previously, our view at NextBeam is that EO is a tremendously high-performance sterilization modality that, almost uniquely, is exceptionally gentle on some of the softer polymers that are used in medical devices. However, the properties that make it so desirable as a sterilization agent also make it hard to control: it is deeply penetrative and inimical to life both inside and outside the chambers in which it is contained.
We Thought This Was Over
Broadly speaking, many viewed the ~$800M of landmark settlements made in 2022 and early 2023 as moves that would draw the litigation around EO to a close. Instead, the opposite seems to have happened, with the announcing of 250 new lawsuits around a Milwaukee facility as well as the pending bankruptcy of an EO facility in NJ due to escalating litigation costs just last November.
Even Industry Leaders Are Vulnerable
B. Braun’s settlement underscores a critical reality—if a sophisticated, responsible operator with extensive compliance measures can face litigation, other manufacturers relying on EO could be next. Where does this end?
Regulatory pressures and legal action are evolving in parallel, making long-term reliance on EO an unpredictable and potentially costly decision.
We can’t shut off EO today—that would be disastrous to the healthcare system. But industry cannot afford to pretend that this risk is going away: given the highly-regulated nature of medical devices, change will not come quickly.
How Manufacturers Can Stay Ahead of the Curve
For companies currently using EO sterilization, now is the time to explore alternative technologies that reduce both compliance burdens and legal risks.
E-beam sterilization offers a chemical-free, highly effective alternative that eliminates EO-related concerns while improving operational efficiency. Compare E-Beam and EO →
At NextBeam, we help manufacturers transition to safer, scalable solutions that meet regulatory requirements without exposing them to growing legal threats. Let’s talk about how E-beam can safeguard your business for the future. Book a 1:1 with a sterilization expert today.
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