AUDIENCE: Risk Manager, Nursing, Surgery
ISSUE: 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.
BACKGROUND: 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. 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.
RECOMMENDATION: 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. See the FDA Safety Communication for additional information and recommendations.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[05/23/2014 - FDA Safety Communication - FDA]