If you manufacture medical devices, an important goal to have in mind is keeping them sterile. There are a number of ways you can approach this, but one of the more common practices is using EO (ethylene oxide). As long as you follow these protocols, EO device sterilization will go according to plan each time.
Make Sure Devices Are Compatible
Even though EO sterilization is extremely versatile and can treat a lot of different medical devices that have varying surfaces and materials, it's still smart to make sure your specific medical devices can be treated with this sterilization product without suffering in a negative manner.
This is something you need to discuss with a company that performs EO device sterilization services on a regular basis for manufacturers like yourself. Explain to them what devices you need to be sterilized and go into detail about their properties. Then if EO is appropriate, you'll get the green light and can thus proceed with this method knowing devices won't be harmed at all.
Submit Specific EO Sterilization Methods to the FDA
After you figure out how EO device sterilization is going to take place around your manufacturing environment where there are medical devices that need sterilization, you'll need to submit these methods to the FDA.
They need to approve them before you get started, as this ensures your medical devices will truly be sterile before they're shipped off to destinations across the globe potentially. Just fill out the necessary request forms and send them to the FDA before you do anything from a sterilization standpoint.
Work With a Specialty Company For Application
If your EO device sterilization methods are approved by the FDA, the next thing to do is hire a specialty company for application. You'll want to do this because these companies can ensure EO is applied in a compliant and effective manner to all of your medical devices.
They can transport EO sterilization products in a safe manner and then follow the correct application protocols from start to finish. That saves you from having to perform a lot of extra tasks that you may not be competent enough to handle successfully.
EO is one of the better sterilization products to use on medical devices because not much heat is needed and a lot of materials can be treated. If you plan out these particular sterilization practices carefully, nothing should stop you from effectively sterilizing your medical devices and thus ensuring they're safe to use.