FDA Announces Important Product Safety Communication
The FDA is informing the public of an important product Safety Communication on Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicators, and invites you to participate in a briefing for stakeholders to discuss the following:
- ASP has issued a voluntary recall of 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 the Sterrad Cyclesure 24 Biological Indicators cannot effectively monitor the sterilization process throughout a 15-month shelf life.
- Use of 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 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.
The teleconference will be held Thursday, July 5, 2012 from 12:00 to 1:00 p.m. ET. The toll-free number is 888-946-7205. The pass code is FDA.
The briefing will include a brief summary of the safety communication, followed by a question and answer session. The briefing will be moderated by Cathy Miller, Office of Special Health Issues.
In preparation for Thursday’s briefing, the following documents are available for your review: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm310549.htm
A replay of the call will be available one hour after the briefing ends until Aug. 5, 2012. To hear the replay, callers can dial 866-428-3805.
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