As more and more medical devices are developed, there is an ever increasing need to develop BIs that can be used to monitor the processes used to sterilize these intricate devices. If traditional BIs won’t work and these custom BIs aren’t created, the only alternative is to directly inoculate the devices and that presents a whole new set of challenges.
An existing customer approached us with a situation where they were trying to validate the sterilization of a very long, narrow lumen. No standard BI would fit in the narrow opening and the customer was not interested in direct inoculation. They were particularly interested in verifying that sterilization conditions were achieved throughout the entirety of the long lumen. In order to provide the customer with this information, a 48-inch polyester suture was inoculated at various specific locations along the length of the material. Once inserted into the lumen the inoculated area coincided with the most difficult area of the lumen to sterilize.
After the sterilization cycle, the BI was removed and placed in a bottle of recovery media and monitored for growth. Sounds a lot easier than direct inoculation, doesn’t it? As we move forward and more intricate components/devices and sterilization process are created, it will become increasingly important to ensure we are properly monitoring the sterilization of those items. In some instances, the best way to do this will be with a custom biological indicator.
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