Sterilization is a crucial part of the medical equipment supply chain. The most common method employs ethylene oxide, which known to pose health risks to people exposed to it over time. Phiex Technologies is introducing a nontoxic means of sterilization built directly into device packaging to offer the market an alternative to EtO as its availability diminishes due to lawsuits and facility closures.
When medical devices need to be sterilized before sale and use, about half the time they are sent to a third-party facility where the devices are placed in a sealed chamber and treated with ethylene oxide (EtO) gas to kill microbes on the device. However, confirmed to be a human carcinogen in 2014, EtO has been the subject of EPA scrutiny for years. More recently, a National Air Toxics Assessment warning has caused local communities that surround the facilities concern for their health that in some cases has escalated to lawsuits and closures in the US and in Europe. (See “States Hold Sway on Device Sterilization Access,” Market Pathways, November 20, 2019.)
As pressure from neighbors and regulators alike causes more EtO centers to scale back or cease operations, a bottleneck in the sterilization supply chain delays the release of medical products. In 2022, this problem has been exacerbated by the identification of nearly two dozen plants that pose potential risk to surrounding communities, affecting Medtronic plc, Edwards Lifesciences, and BD, among others. With EtO constituting nearly half the sterilization market, used to treat more than 20 billion items annually in the US, the FDA and medical device companies are both searching for an alternative.