By now, we are all familiar with the recent discussion around sterilization in the medical device industry. Ethylene oxide or EtO is the most popular sterilization modality in the industry accounting for approximately half of the market. EtO is a colorless gas, and long-term exposure can pose serious health risks. Some US communities located in and around EtO sterilization facilities have become increasingly concerned, ultimately forcing the FDA to take action.
Good for community members, but potentially problematic for the medical device industry, including hospitals and patients who need the devices impacted by this. To put it bluntly, the FDA is in a bit of a Catch-22 situation with the question becoming: do they allow sterilizers to release harmful gas knowing it may be dangerous, or do they allow a shortage of medical devices that could save lives?
The FDA is currently working with sterilizers to reduce or abate the EtO being released into the atmosphere (99% destruction of EtO is required), while looking into new & innovative ways to sterilize medical devices. EtO has become the most popular form of sterilization for many reasons, with capacity and scalability being a top area of focus. A vaporized hydrogen peroxide sterilizer, for example, is roughly 80 to 100 cubic feet, whereas an EtO sterilizer is about 1500 to 3000 cubic feet.
The good news is that new medical devices can anticipate and prepare for a different sterilization modality. The bad news … that still leaves hundreds of thousands of medical devices on the market today using EtO. The FDA recently issued an innovation challenge to the industry. And while we will do everything we can to support our partners through this, we also look forward to the innovation that will result from this exercise. Any time we are forced to look at our industry through a different lens, resourcefulness and creativity emerge.