Medical Devices

Product Shortage of Advanced Sterilization Products Sterrad Cyclesure 24 Biological Indicator: FDA Safety Communication

Date Issued: May 23, 2014

Audience:

  • 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
  • Nursing staff

Medical Specialties: General Surgery, Surgical Technology, and any medical specialties that use chemical sterilization processes.

Device: The Sterrad Cyclesure 24 Biological Indicator, manufactured by Advanced Sterilization Products (ASP), is a product used with Sterrad sterilizers to monitor and confirm the effectiveness of the device sterilization process.

ASP has notified the FDA of a critical shortage of Sterrad Cyclesure 24 Biological Indicators due to a machine performance issue on its production line. ASP is able to ship only 30 percent of its normal capacity for the Sterrad Cyclesure 24 Biological Indicator.

ASP expects to increase production by July 2014 and anticipates being able to meet the full product demand by August 2014.

The FDA does not have safety concerns about the Sterrad sterilizers, which are used for heat-sensitive medical devices that must be sterilized at low temperatures and low moisture, such as flexible endoscopes, cameras, some rigid scopes, light cords, batteries, and power drills.

The Sterrad Cyclesure 24 Biological Indicator is indicated for use only with the following Sterrad models and cycles:

MODELCYCLE
STERRAD®  I OOSStandard
STERRAD® 50Standard
STERRAD® 200Standard
STERRAD® NX®Standard
Advanced
 STERRAD® 100 NX®Standard
Flex
EXPRESS
 Duo Cycle

Other sterilizers and biological indicators are not impacted by this shortage.

Purpose: This information is intended to help hospitals prioritize use of existing supplies of Sterrad Cyclesure 24 Biological Indicators based on patients with the most critical need until supplies are able to meet demand.

The FDA is issuing this communication to:

  1. Provide hospitals with information that will help them appropriately plan and prioritize use of the existing Sterrad Cyclesure 24 Biological Indicators.
  2. Inform hospitals about an alternative biological indicator that can be used in the Sterrad sterilizers.

Summary of Problem and Scope: In January 2014, ASP informed its customers and the FDA of the reduced availability of Sterrad Cyclesure 24 Biological Indicators. At that time, ASP did not expect the reduced availability to result in a device shortage.

However, on May 16, 2014, ASP informed the FDA that due to machine performance issues on its production line, it cannot meet current product demand, and this has resulted in a shortage of Sterrad Cyclesure 24 Biological Indicators that will likely continue through July 2014.

Recommendations for Health Care Facilities:

Maximize your supply of individual Sterrad Cyclesure 24 Biological Indicators

  • Use an alternative low-temperature sterilizer, if available.
  • When possible, prioritize using Sterrad Cyclesure 24 Biological Indicators for sterilization loads that contain the most critical instruments for the most urgent patient cases.
  • Consult your hospital procedures and the Sterrad Cyclesure 24 Instructions for Use to determine if an indicator can be used beyond the recommended 24 hours.
  • Maximize the number of devices processed in each sterilization load. Please refer to your Sterrad System user guide and labeling for detailed information on load requirements and limitations.
  • Reduce your use of Sterrad to only 1 cycle per system per day.

ASP is working with the FDA to determine if the instructions for use (IFU) can be modified for less frequent use of Sterrad Cyclesure 24 Biological Indicators than currently indicated in the product’s IFU.

We will provide updates on any revised IFU for this product if they become available.

Use an alternate biological indicator

To help mitigate the impact of a shortage and allow hospitals to meet the needs of patients requiring necessary procedures, the FDA is allowing a different company - Steris Corp. - to distribute the Steris VERIFY 24 biological indicator—normally used only in Steris sterilizers—for use in most Sterrad chemical sterilization cycles, except for the Sterrad 50 sterilizer and the Sterrad 100NX Duo Cycle. The Steris VERIFY 24 cannot be used in test packs of all Sterrad Cycles.

The Steris VERIFY 24 biological indicator is currently FDA cleared, although it is not yet specifically cleared for use with Sterrad sterilizers. The FDA has reviewed performance data supporting the Steris VERIFY 24 biological indicator’s use in Sterrad sterilizers and the agency is satisfied that the data supports its safe and effective use.
Therefore, the FDA has authorized Steris to distribute the VERIFY biological indicators for use with Sterrad sterilizers without 510(k) clearance until November 17, 2014. Steris anticipates that additional supply of its VERIFY 24 biological indicators will be available by May 28, 2014.

Manage patient risk should your facility run out of Sterrad Cyclesure 24 Biological Indicators

  • Should you run out of Sterrad Cyclesure 24 Biological Indicators and Sterrad is unable to resupply you, we recommend using alternative sterilization methods available to you.
  • If you do not have an alternate sterilizer, then you should consider:
    • Using single-use disposable devices;
    • Coordinating sterilization with nearby facilities or contract out sterilization with another facility that uses a different sterilizer;
    • Delaying elective surgeries and procedures, when possible; and
    • Transferring higher-risk patients to an alternate facility that can assure the sterility of instruments for critical surgeries.

FDA Activities: The FDA is working closely with ASP and stakeholders to notify facilities about the shortage and to provide alternatives and recommendations for the use of this device.
The FDA will continue to monitor the shortage and its effect on the public health and will issue updates to this communication as new information becomes available.

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 or experience a problem with Sterrad Cyclesure 24 Biological Indicators and/or the VERIFY 24 Biological Indicator, please 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 FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Contact Information:

If you have any questions about your supply of Sterrad Cyclesure biological indicators and about finding ways to maximize your existing inventory in accordance with the Instructions for Use (IFU), please contact ASP at 1-888-783-7723 or speak to your local ASP representative.

If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@cdrh.fda.gov or 800-638-2041.
 

 

 

Page Last Updated: 06/03/2014
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