FDA Continues Efforts to Support Innovation in Medical Device Sterilization

Sterilization of medical equipment is a critical step in the fight against dangerous illnesses. In order to make sure that these devices are safe for patients and healthcare professionals who use them, the U.S. Food and Drug Administration continuously monitors sterilising techniques for them.

A gas called ethylene oxide, or EtO, is employed in manufacturing procedures to sterilise a wide range of items, both medical and non-medical. Contrary to certain other sterilising techniques, the use of ethylene oxide is a well-known and scientifically validated means of preventing hazardous germs from multiplying and causing diseases without compromising the product. Medical device makers frequently employ it as the most popular approach for sterilising medical equipment in the United States.

In reality, ethylene oxide sterilisation accounts for around half of the devices that need sterilisation and is used to sterilise more than 20 billion devices marketed in the United States each year. Wound dressings, more specialist devices like stents, and kits used in common medical procedures or operations with several components made of various materials are all examples of these devices. Patients undergoing a variety of medical procedures may get life-threatening infections as a result of improper sterilisation.

In order to combat ethylene oxide emissions from industrial sterilisers, the Environmental Protection Agency, which oversees industrial facilities to guarantee that harmful emission levels are not released into the environment, stated today that it will later this year submit an air pollution rule. The EPA has performed a study as part of their proposal.

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