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Sterilization Process Monitoring Device Recalled After FDA Shortens Expiration Date; Potential Risk of Infection


Advanced Sterilization Products (ASP) has issued a voluntary recall of certain lots of Sterrad Cyclesure 24 Biological Indicators due to the revised expiration time (shelf life) from 15 months to 6 months. This recall followed an FDA review of ASP data, which showed that certain lots of Sterrad Cyclesure 24 Biological Indicators cannot effectively monitor the sterilization process throughout a 15-month shelf life. After reviewing additional ASP data, the FDA believes that the product may be used with a 6-month shelf life.

 

Biological indicators are one of three methods used in conjunction with other methods to regularly monitor and confirm the sterilization process. If a sterilizer fails and this malfunction is not detected by the biological indicator, then a chemical indicator (typically used with every load) and the functional monitoring built into the sterilizer itself should detect the malfunction.

 

If a sterilizer malfunction is not detected by the built-in sterilizer cycle monitor, the chemical indicator, or the biological indicator, then medical devices that have not been properly sterilized could expose patients to infection-causing pathogens.

 

While the number of individual patients potentially at risk for exposure to infections may be high, the FDA believes that the risk of a life-threatening infection for an individual patient is very low, given that this biological indicator is only one of three sterilization system monitors and the window of possible exposure to the malfunctioning Sterrad Cyclesure 24 Biological Indicators is relatively short.

 

ASP made a change in the materials used to manufacture Sterrad Cyclesure 24 Biological Indicators. Lots of Sterrad Cyclesure 24 Biological Indicators with the new material were distributed beginning December 2011. Product lots manufactured prior to this material change are not subject to this recall. In order to determine if the Sterrad Cyclesure 24 Biological Indicators you have in inventory are subject to this recall, please refer to the list of affected lots found in ASP’s Recall Alert. 

 

Use of affected Sterrad Cyclesure 24 Biological Indicators beyond their 6-month shelf life may prevent verification of proper sterilization. However, the FDA believes that the risk of infection for an individual patient is very low, given that this biological indicator is only one of three sterilization system monitors and the window of possible exposure to the malfunctioning Cyclesure 24 devices is relatively short.

 

Supplies of Sterrad Cyclesure 24 Biological Indicators may be temporarily reduced. The FDA is working with ASP to make suitable product available and to assure that health care facilities experience little or no disruption.

 

See the FDA Alert

 

 

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