How do I choose a sterilization technique?
Sterilization is important - it’s one way you can help ensure the safety of your medical device. There are many sterilization techniques available for all kinds of devices, but they all have the same goal of eliminating all microorganisms or other potential pathogens. It is possible to quantify sterilization processes - this is the sterility assurance level (SAL). FDA requires that medical devices attain an SAL of 10-6 in order to be marketed as sterile - this corresponds to a less than one-in-a-million chance of a device not being sterile.
Established or novel sterilization methods
From FDA’s perspective, sterilization methods are broadly divided into two categories - established methods and novel methods. Established methods have a long history of safe and effective use. Some examples of established methods include dry heat, steam, ethylene oxide (EO) gas, and radiation beams. These are examples of what FDA calls “Established Category A” methods, because there are voluntary consensus standards for these processes that are recognized by FDA. Another category of established methods are Category B methods. These methods include hydrogen peroxide and ozone - while there are no consensus standards for these methods, published information on development, validation, and process control are available.
Novel sterilization methods have not been reviewed by FDA in previous device applications and might have little or no published information available. Examples of novel sterilization methods include vaporized peracetic acid, high intensity visible or UV light, microwave radiation, or sound waves. While you are permitted to use novel sterilization methods for your device, it’s important to remember that you will need to provide more information in your premarket application if you use novel methods.
Regardless of the sterilization method chosen for your device, you’ll need to show that the end result of your method is a sterile device. For validation purposes, you’ll need finished devices and you’ll also need to have determined your sterilization method and all of the process settings for your method. Different methods can require different validation protocols - this is one way that using established methods can be advantageous, as there are consensus standards available for validation. For novel methods, you’ll need to provide the full validation protocol for your sterilization method to FDA. For more information on what to include, see FDA’s guidance on sterility information for premarket submissions.
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