In a recent report, the FDA noted that the majority of products are not sterilized correctly. There are several factors that can affect the effectiveness of a sterilization process. While a common standard is desirable, it is often impossible to meet. The following guide describes the main aspects of medical device sterilization, including the modes of action and advantages of different methods. In addition, you’ll learn about the differences between various types of sterilization.
The FDA has two challenges to find alternatives to ETO for medical devices. The first, AAMI/ISO 11137, was published in 1996, followed by AAMI/ISO 13409 in 1996. The second, a collaborative effort of AAMI and Illinois’ Environmental Protection Agency, called the Sterigenics Willowbrook plant, was closed in early 2018 due to high levels of ETO emissions. The FDA’s challenge will be a major opportunity for companies in this industry to develop better methods and equipment.
The final method involves a steam emitted after the device has been sterilized. It is important to understand the risks and benefits of each method and choose the best one for your product. It can make the difference between compliant and noncompliant devices. To learn more, check out the details of the sterilization process and choose the right method for your specific product. If you’re not sure which one to use, check with your vendor.
The FDA has also recognized that there are many ways to sterilize devices. The goal is to minimize the risk of bacterial contamination. Moreover, sterilization should be fast and efficient. While radiation-induced oxidation may cause a sterilization risk, the process itself should be relatively safe. For instance, radiation-treated devices are more likely to be contaminated with the EO. A better way to sterilize metallic devices is through mechanical aeration.
Depending on the type of medical device, the process used for sterilization can help patients avoid potentially harmful reactions. For example, gamma-ray sterilization uses gamma-rays to destroy microorganisms. This is an ideal method for devices of all sizes and densities. It is also faster and more effective than ETO. The most commonly used sterilization method is the E-Beam sterilization method.
In addition to these methods, there are other methods that can be used to sterilize medical devices. ETO, for example, uses ethylene oxide. The latter method is primarily used for reusable medical devices. It is also ideal for loaned medical devices. But if you’re unsure of the best solution, you can consult the FDA for more information. However, the FDA doesn’t require the sterilization process to be fully traceable.
While ETO is the most common method, steam sterilization is the fastest. It requires little to no heat, and can be done on-premise or in a medical facility. Vapor hydrogen peroxide is the most commonly used form of sterilization. It is also compatible with other medical devices. Ultimately, it is the best option if you have the ability to sterilize your products properly. Aside from saving money, a steam sterilization method can also reduce the risk of infection.
