FDA Takes Action to Reduce EtO Use

Shutdowns earlier this year of two facilities that use ethylene oxide (EtO) to sterilize medical devices prompted FDA to monitor for supply shortages in the industry because EtO is such a popular sterilization method for medical devices. This week the agency revealed steps it will take to reduce medtech's reliance on EtO sterilization. EtO is a flammable, colorless gas used to sterilize equipment and plastic devices that cannot be sterilized by steam, such as medical equipment. In fact, about half of all sterilized medical devices undergo sterilization using this gas. Breathing air containing elevated EtO levels over many years has been linked to increased risk of some types of cancers, including cancers of the white blood cells (such as non-Hodgkin's lymphoma, myeloma, and lymphomatic leukemia). It also has been found to cause breast cancer in women. In July, FDA challenged medtech innovators to identify new sterilization methods and technologies that could be used as alternatives to EtO. The agency also challenged the industry to identify strategies or technologies that can significantly reduce the amount of EtO used to sterilize medical devices. The agency reported that 46 companies responded to the challenge and from these FDA selected 12 applicants that it will work with to accelerate the development and review of innovative technologies for sterilization processes. The selected ideas include such things as&Acir...
Source: MDDI - Category: Medical Devices Authors: Tags: Sterilization Regulatory and Compliance Source Type: news