FDA Scrambles to Prevent Shortages Amid Sterilization Shutdowns

Shutdowns of two facilities that use ethylene oxide to sterilize medical devices have raised concern about potential shortages in the medtech industry because this is such a popular sterilization method for medical devices. Ethylene oxide (EtO) is a flammable, colorless gas used to make a range of products. EtO also is 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. According to the EPA, long-term exposure to EtO can irritate the eyes, skin, nose, throat, and lungs, and harm the brain and nervous system (causing headaches, memory loss, and numbness). Studies show that breathing air containing elevated EtO levels over many years increases the 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. Sterilization of medical devices is critical to the healthcare system, and ethylene oxide sterilization helps ensure the safety of medical devices and helps deliver quality patient care, according to outgoing FDA Commissioner Scott Gottlieb. Devices sterilized with EtO range from wound dressings to stents, as well as kits used in routine hospital procedures or surgeries that include multiple components made of different materials, the commissioner noted. &...
Source: MDDI - Category: Medical Devices Authors: Tags: Sterilization Regulatory and Compliance Source Type: news

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