Medical Device Sterilization Process

However since 1950 there has been an increase in medical devices and instruments made of materials e g plastics that require low temperature sterilization.

Medical device sterilization process.

The materials and techniques used for packaging must allow the sterilant to contact the device during the sterilization process as well as to protect the device from contamination during storage and handling before it is used. Medical devices made from certain polymers plastic or resin metals or glass or that have multiple layers of packaging or hard to reach places for example catheters. Medical device sterilization process. Medical device sterilization chlorine dioxide gas clo 2 cd has been providing true sterilization similar to eto for medical devices for over 25 years.

For many medical devices sterilization with ethylene oxide may be the only method that effectively sterilizes and does not damage the device during the sterilization process. Atrophaeus spores 10 6 are used to monitor eto and dry heat and g. If review of the device history records including process control and monitoring records acceptance activity records etc reveals that the sterilization process is outside the firm s tolerance. While eto is a very effective sterilant cd has many benefits over eto for a variety of applications.

Medical devices made. Spores used to monitor a sterilization process have demonstrated resistance to the sterilizing agent and are more resistant than the bioburden found on medical devices 179 911 912. For many medical devices sterilization with ethylene oxide may be the only method that effectively sterilizes and does not damage the device during the sterilization process. The time between sterilization and use may range from a few minutes to several weeks to many months.

It is a process to make the product free from bacteria and any other microorganism that cannot be eliminated by regular cleaning processes. Most medical and surgical devices used in healthcare facilities are made of materials that are heat stable and therefore undergo heat primarily steam sterilization. Eto gamma steam shelf life validation 275 00 255 00 this live webinar course will provides guidance on medical device sterilization processes.