Preconditioning, sterilization, and aeration are conducted during an EO sterilization process. This type of sterilization procedure is used to destroy microorganisms that are on medical devices. The process ensures that disease transmission is prevented during the use of standard medical equipment.
A Gas Sterilization Process
Medical devices that will be used to treat patients must undergo a sterilization process. The FDA (Food and Drug Administration) has outlined sterilization procedures that manufacturers can use as guidelines. EO sterilization is one of the most prevalent sterilization procedures. This type of sterilization process is used to kill microorganisms that are commonly found on plastic, metal, and other materials that medical devices are constructed of.
EO sterilization involves the use of ethylene oxide. This gas sterilization process may result in trace amounts of EO being left on medical devices. The FDA has outlined what an acceptable amount of EO residue is. This amount will not be harmful to a medical professional or a patient who comes into contact with a medical device that has been sterilized.
A New Way Of Manufacturing A Product
The FDA and the EPA (Environmental Protection Agency) both play a role in providing safety standards for the use of sterilization procedures. The EPA promotes a clean air act, which will require that EO testing is conducted on each product that has been sterilized. It is a medical device manufacturer's responsibility to ensure that sterilization processes are strictly regulated.
Products that are mass-produced must contain clear labeling that will indicate that a medical device has been sterilized. Any equipment that is being shipped to a hospital, a doctor's office, or another medical facility must be sterilized at the place where the product was originally manufactured. Occasionally, a manufacturer will upgrade the manner in which a product is manufactured, sterilized, or packaged.
If any changes are made at a manufacturing plant, testing processes must be conducted. Even if a product was originally sterilized with an EO sterilization process, efforts must be made to ensure that this type of sterilization process can be used to kill microorganisms on an upgraded product.
A manufacturer may be advised to formally submit a form, which will outline the modifications that are being made to a product. Before a product can be mass-produced it must pass the testing phase. Afterward, the EO sterilization process can be used to kill microorganisms that may be on the surface of all the equipment that is being manufactured.
To learn more, contact a company that offers EO device sterilization.