FDA Safety Communication: Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicators — Revised Expiration Dates

Date Issued:  July 3, 2012

Medical and Surgical Specialties: General Surgery, Surgical Technology, and any specialty that uses devices that must be sterilized at low temperatures

Device:

The Sterrad Cyclesure 24 Biological Indicator, manufactured by Advanced Sterilization Products (ASP), is a product used periodically to monitor and confirm the microbicidal effectiveness of the sterilization process in Sterrad sterilizers. A biological indicator is used, in conjunction with other methods, to monitor sterilization systems.

ASP’s Sterrad Cyclesure 24 Biological Indicator is the only biological indicator that can be used with the Sterrad sterilizer. Biological indicators from other manufacturers are not designed for this use and have not been cleared by the Food and Drug Administration (FDA) for use in Sterrad sterilizers.

Sterrad sterilizers are used for devices that must be sterilized at low temperatures, such as multiple single-channel flexible endoscopes, cameras, some rigid scopes, light cords, batteries, and power drills.

Purpose:

The FDA is issuing this communication to inform personnel at facilities that utilize Sterrad sterilizers of the following:

• ASP has issued a voluntary recall 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 the Sterrad Cyclesure 24 Biological Indicators cannot effectively monitor the sterilization process throughout a 15-month shelf life.

Use of 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. 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.

• 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.

Recommendations:

• Check the expiration date printed on the packaging components to determine the new expiration date.      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].

For example, if the expiration date printed on packaging components is “2013-02,” then after subtracting 9 months, the new expiration date will be “2012-05.”

For more information on how to determine new expiration dates on existing product inventory, please see ASP’s Recall Alert³.

• Manually re-label the non-expired product cases with the newly‑calculated expiration date. Until you receive correctly-labeled product, continue to calculate new expiration dates and manually label product that has not reached a 6‑month shelf life with the newly-calculated expiration date.

FDA Activities:

The FDA is working with ASP to evaluate appropriate data that will support the expiration dates for these biological indicators so that they continue to be available for safe use by hospitals and other health care facilities. The FDA will continue to monitor this issue.