Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicator Revised Expiration Time due to Potential Infection

Risk Manager, Surgery and Infectious Disease personnel are informed by the U.S. FDA that Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicator cannot monitor the sterilization process for 15 months shelf life effectively and the expiration time is revised to 6 month shelf life.

Background of ASP’s Sterrad Cyclesure 24 Biological Indicator

Sterrad Cyclesure 24 Biological Indicator, by Advanced Sterilization Products (ASP), is used, together with other methods, to monitor the microbicidal effectiveness of the sterilization process in Sterrad sterilizers.

Sterrad sterilizers are used for the sterilization of devices at low temperatures.

FDA Alert on ASP’s Sterrad Cyclesure 24 Biological Indicator

The US FDA reviewed the ASP data revealing that Sterrad Cyclesure 24 Biological Indicator cannot monitor the sterilization process for 15 months shelf life and the dates are revised to 6 months shelf life.

Use of Sterrad Cyclesure 24 Biological Indicator for more than 6 months shelf life may prevent verification of proper sterilization posing a risk of infection for a patient.

FDA Recommendation on ASP’s Sterrad Cyclesure 24 Biological Indicator

• “If your facility has purchased Sterrad Cyclesure 24 Biological Indicators and product remains on hand, a new expiration date can be calculated as follows: [Printed Expiration date (minus) 9 months = new expiration date].
• Manually re-label the non-expired product cases with the newly calculated expiration date.
• Use an alternative low-temperature sterilizer, if available. In order to conserve the amount of non-expired product available in your facility, only use low-temperature sterilization for those items that cannot be sterilized using other methods.”

Contacting the FDA to report cases with ASP’s Sterrad Cyclesure 24 Biological Indicator

In case of detection of adverse events or side effects related to the use of ASP’s Sterrad Cyclesure 24 Biological Indicator, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

AttorneyOne.com is a free nationwide legal referral service. We are not a law firm. We help consumers find the best representation for their legal needs.