Medical Devices

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

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

ASP is now recalling all lots of Sterrad Cyclesure 24 Biological Indicators manufactured between February 2008 and December 2011. This is in addition to the lot numbers of Sterrad Cyclesure 24 Biological Indicators that are listed in ASP’s July 3, 2012 Recall Alert disclaimer icon . In order to determine if you have any Sterrad Cyclesure 24 Biological Indicators subject to these recalls in your inventory, please refer to the list of affected lots found in ASP’s July 3, 2012 Recall Alert  disclaimer icon and ASP’s Nov. 7, 2012 Recall Alert disclaimer icon .

Original Date Issued: July 3, 2012

Date Updated: Nov. 8, 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 two voluntary recalls:
  1. Certain lots of Sterrad Cyclesure 24 Biological Indicators distributed after December 2011 due to the revised expiration time (shelf life) from 15 months to 6 months
  2. All lots of Sterrad Cyclesure 24 Biological Indicators manufactured between February 2008 and December 2011, because of insufficient data to support the labeled expiration time (shelf life).
  • In order to determine if the Sterrad Cyclesure 24 Biological Indicators you have in inventory are subject to these recalls, please refer to the list of affected lots found in ASP’s July 3, 2012 Recall Alert disclaimer icon and ASP’s Nov. 7, 2012 Recall Alert disclaimer icon
  • Use of affected Sterrad Cyclesure 24 Biological Indicators from both recalls may prevent verification of proper sterilization. The FDA believes that the risk of infection for an individual patient is very low because 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.
     
Summary of Problem and Scope:

For products affected by the July 3, 2012 recall:
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.disclaimer icon Use of affected Sterrad Cyclesure 24 Biological Indicators beyond their 6-month shelf life may prevent verification of proper sterilization.

For products affected by the Nov. 7, 2012 recall:
While reviewing data from the July 3, 2012 Sterrad Cyclesure 24 Biological Indicators recall, ASP determined that it may not have enough data to support the entire duration of the labeled shelf-life of all lots of Sterrad Cyclesure 24 Biological Indicators manufactured between February 2008 and December 2011. As a result, on Nov. 7, 2012, ASP recalled all lots of Sterrad Cyclesure 24 Biological Indicators manufactured between February 2008 and December 2011.

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, because 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:

For products affected by the July 3, 2012 recall:

  • 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.disclaimer icon

  • 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, new product with correctly-labeled expiration dates is now available. Product with correct labeling will have an eight digit lot number, compared to the six digit lot number on affected product. 

  • Use an alternative to a low-temperature sterilizer, when appropriate. 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.
     

For products affected by the Nov. 7, 2012 recall:

  • Check the lot number printed on packaging components of Sterrad Cyclesure 24 BI and determine if products are 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 Nov. 7, 2012 Recall Alert disclaimer icon .
  • STOP using affected Cyclesure 24 Biological Indicators.
  • Immediately return affected products to the manufacturer in accordance with the “Product Return Instructions” section found in ASP’s Nov. 7, 2012 Recall Alert disclaimer icon .
  • Use an alternative low-temperature sterilizer, if available. Use of affected product may result in not being able to verify proper sterilization conditions.
     
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:
  1. ASP’s July 3, 2012 Device Recall Alert  disclaimer icon
  2. ASP’s Nov. 7, 2012 Device Recall Alert disclaimer icon
  3. ASP’s Frequently Asked Questions: Sterrad Cyclesure 24 Biological Indicator Recall, All product manufactured between February 2008 and December 2011 disclaimer icon
  4. Centers for Disease Control and Prevention: Guideline for Disinfection and Sterilization in Healthcare Facilities
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.

Page Last Updated: 06/03/2014
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