Medical Devices

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

The following information is an update to our July 3, 2012 communication:

Only the lot numbers of Sterrad Cyclesure 24 Biological Indicators that are listed in ASP’s Recall Alert are affected by ASP’s voluntary 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.

Original Date Issued: July 3, 2012

Date Updated: July 6, 2012

Audiences:

Materials Managers in Hospitals and Surgical Centers
Medical Instrument Sterilization Technicians
Administrators in Hospitals and Surgical Centers
Risk Managers in Hospitals and Surgical Centers
Infection Control Professionals in Hospitals and Surgical Centers
Health Care Associations

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 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.
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.
U se of affectedSterrad 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.

Summary of Problem and Scope:

An FDA review of ASP data showed that certain lots of Sterrad Cyclesure 24 Biological Indicators cannot effectively monitor the sterilization process throughout the indicated 15-month shelf life. After reviewing additional ASP data, the FDA believes that the product may be used with a 6-month shelf life.

Hospitals and health care facilities should check their inventory for affected Sterrad Cyclesure 24 Biological Indicators that have exceeded 6 months of shelf life. These products should be returned to ASP immediately as outlined in ASP’s product return instructions. U se of affected Sterrad Cyclesure 24 Biological Indicators beyond their 6-month shelf life may prevent verification of proper sterilization.

Biological indicators are one of three methods used in conjunction 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.

Recommendations:

Check the lot number and expiration date printed on the packaging components to determine the new expiration date. If your facility has purchased affected 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 which lots are affected and how to determine new expiration dates on existing product inventory, please see ASP’s Recall Alert.
Manually re-label the non-expired affected product cases with the newly‑calculated expiration date. Until you receive correctly-labeled product, continue to calculate new expiration dates and manually label affected product that has not reached a 6‑month shelf life with the newly-calculated expiration date.
According to ASP, a limited supply of new product with correctly-labeled expiration dates will become available the week of July 9, 2012. Product with correct labeling will have an eight digit lot number, compared to the six digit lot number on current product.
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.

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.

Reporting Problems to the FDA:

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with the Sterrad Cyclesure 24 Biological Indicators, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Please include the following information in your reports, if available:

Adverse event details (date adverse event occurred, nature of the event)
Expiration date and/or lot number listed on the Sterrad Cyclesure 24 Biological Indicators

Other Resources:

Contact Information:

If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.