Overview of Sterilization Methods

Sterilization refers to any process that effectively kills or eliminates transmissible agents (such as fungi, bacteria, viruses, spore forms, etc.) from a surface, equipment, article of food, medication, or biological culture medium.

Medical devices are sterilized initially at the time of manufacturing and, if reusable, must be routinely sterilized and validated to conform to regulatory standards. The sterilization method chosen is based on the product’s ability to withstand heat and extent of sterilization required.

Devices are pre-packaged before they are put through the sterilization process. This is done so that after sterilization, products aren’t exposed to the elements, and therefore remain sterile at the time of use. Specialized packaging/pouches are used which allow the sterilizing agent such as rays/heat/chemicals to penetrate and purify the device, but also protect the device from external contaminants.