Medical Device Sterilization Process

Sterilization is a process that is mandatory for the majority of medical devices quite often required by regulatory authorities. 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. It is a process to make the product free from bacteria and any other microorganism that cannot be eliminated by regular cleaning processes.

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The time between sterilization and use may range from a few minutes to several weeks to many months.

Medical device sterilization process.

Most medical and surgical devices used in healthcare facilities are made of materials that are heat stable and therefore undergo heat primarily steam sterilization. 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. 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 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.

Stearothermophilus spores 10 5 are used to monitor steam sterilization hydrogen. Atrophaeus spores 10 6 are used to monitor eto and dry heat and g. While eto is a very effective sterilant cd has many benefits over eto for a variety of applications. 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.

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. Medical device sterilization chlorine dioxide gas clo 2 cd has been providing true sterilization similar to eto for medical devices for over 25 years. Medical device sterilization process. Medical devices made.

Eto gamma steam shelf life validation 275 00 255 00 this live webinar course will provides guidance on medical device sterilization processes. Power ranges above 35 kw are available but are seldom used in medical device sterilization applications because of the difficulty of precision control at such high process rates for additional information and a comparison of current stand alone system design alternatives please refer to page 29 of medical plastics and biomaterials july august. 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.

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