What’s the word on ethylene oxide?
The coronavirus pandemic has pushed a lot of news out of people’s minds, but medtech has other big issues to deal with. For instance, 8 months have passed since the FDA issued a public challenge for alternatives to ethylene oxide (EtO) as a sterilant for medical devices. As I write this editorial, the agency has not revealed them.
Even if a new technology emerges, it would take years to build the capacity to sterilize the billions of medical devices that EtO does annually, not to mention the validation process that each device would have to undergo to make the switch.
Ethylene oxide is a human carcinogen, but it also provides the most effective and costeffective form of device sterilization, decades after its introduction. Its ability to work at low temperatures makes it a viable option for devices made of multiple components and materials. It can also penetrate different types of device packaging, enabling sterilizers to process truckloads’ worth of devices simultaneously.
After processing, devices have to go into aeration chambers to remove EtO residue, but the chambers don’t always do the trick. Georgia state officials in December ordered Becton Dickinson to apply for an air quality permit for a warehouse that housed EtO-sterilized devices. A report that BD submitted to the state revealed 0.65 lb per hour in “fugitive” EtO emissions from the warehouse, leading state environmental officials to conclude that the facility could emit 5,600 lb per year of the gas. Any facility that has emitted or may emit more than 4,000 lb per year of EtO must apply for a state permit to do so.
EtO sterilization plants in Illinois, Georgia Michigan and Pennsylvania have become the targets of neighbors’ protests, state and local government officials’ attempts at regulation, and lawsuits alleging the gas caused illnesses and deaths.
The commercial EtO industry, of which medtech sterilization is a part, is also due for new regulations from the EPA in May. They’ll be the first new regulations in 14 years and will come on the heels of much stronger controls the EPA issued for industrial EtO sources in November 2019. Most of the facilities they’ll cover are older, and upgrading their emissions-control technology will cost millions. Stay tuned.
Also this month, executive editor Chris Newmarker details some of the latest news coming out of the 3D-printing industry. It’s not about printers, though; it’s about the software that enables them to churn out evermore amazing medical devices.
Senior editor Danielle Kirsh tells the story of Otis Boykin, an African American engineer whose work led to the pacing technology that cardiac pacemakers have today.
And finally, you can read how a former Medtronic senior project manager has raised millions to develop the Abilitech Assist, a device that allows people with limited use of their arms to independently perform tasks that most of us take for granted every day.
Thanks for reading! Let us know what you think!
Medical Design & Outsourcing