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FDA alerts hospitals, others to shortage of sterilization indicator

May 27, 2014

The Food and Drug Administration Friday alerted hospitals and others to a shortage of indicators used with certain Sterrad sterilizers to monitor and confirm the effectiveness of the device sterilization process. Advanced Sterilization Products expects to increase production and be able to meet demand for the Sterrad Cyclesure 24 Biological Indicators by August, FDA said. Meanwhile, FDA recommends, among other actions, using an alternative low-temperature sterilizer if available, or prioritizing indicators for sterilization loads that contain the most critical instruments for the most urgent patient cases. The agency also is allowing a different company, Steris Corp., to distribute its VERIFY 24 biological indicator for use in most Sterrad chemical sterilization cycles. Facilities that run out of indicators and do not have an alternative low-temperature sterilizer should consider using single-use disposable devices; coordinating or contracting out sterilization with another facility; delaying elective surgeries and procedures; or transferring patients to an alternate facility, FDA said.