Many types of medical devices are sterilised using ethylene oxide. In fact, nearly half of all surgical kits contain at least one ETO-sterilized device. It is also effective at sterilizing some polymers and glass, and is safe to use for sterilization. The United States’ medical supply chain depends on the availability of ethylene. However, despite these benefits, there are many concerns about the safety of this procedure.
The safest level of ethylene oxide for sterilization is 400 mg/L. The dose of ethylene gas depends on the process temperature. In order to ensure sterility assurance, the product should undergo validation based on ISO 11135:2014. In addition, the product must be fully trained and vetted by the AAMI. Once the AAMI has given the green light, the company can move forward with the process of sterilization.
The process of EO sterilization is widely used in medical devices and has been in use for over 30 years. It is a safe process that does not expose products to high temperatures or radiation. The process uses a mixture of oxygen and nitrogen to kill germs and bacteria. In the event that a biohazard is encountered during a patient’s treatment, the patient is unable to get a sufficient dosage of the disinfectant.
In fact, the process of ethylene oxide sterilization of medical devices is very simple and is effective in eliminating harmful microbes. The process is highly effective and does not require high temperatures to kill germs. In addition, it is easy to use. A gas-permeable package is a great way to achieve the highest level of sterilization. The sterilization of medical devices is a cost-effective method of sterilization.
EO Sterilization of Medical Devices is an environmentally-friendly process that requires a combination of four variables. The time of exposure, the temperature, and the relative humidity of the devices are crucial variables. In addition, the temperature of the sterilization chamber will be used to sterilize the devices. Moreover, the Ethylene Oxide Sterilized products are safe to use for the patient.
Typically, a medical device will be sterilized using ethylene oxide to kill germs. It is essential to understand that the process is a safety-sensitive process and must be done in a safe environment. It is recommended to use an ethylene-free solution for medical devices. This method is highly effective and the FDA has even issued a guide that shows the differences.
There are three primary advantages of ethylene oxide sterilization. Its benefits include extended device lifespan. While ethylene oxide is flammable and explosive, it will not harm delicate materials. It also has a sweet, pleasant odor. It can be used for bulk sterilization and moisture-sensitive medical devices. In addition to extending the lifespan of a device, it will reduce the risk of infection.