FDA advises some Steris customers to change disinfection and sterilization methods

By: December 8th, 2009 Email This Post Print This Post

The U.S. Food and Drug Administration (FDA) issued a safety alert on Dec. 3 because of adverse report by users concerning changes by the manufacturer to the STERIS System 1 sterile processing system (SS1).

“STERIS Corporation has significantly modified the SS1, and FDA has not approved or cleared this modified product. Thus, FDA has not determined whether the SS1 is safe or effective for its labeled claims, including claims that it sterilizes medical devices,” according to the alert.

The FDA says it has received reports of SS1 malfunctions that could produce infection hazards for patients and burn injuries from sterilant exposure to healthcare workers.

The alert makes the following recommendations for users of SS1:

  • If healthcare facilities have an acceptable alternative to the SS1 to meet sterilization and disinfection needs, facilities should transition to that alternative as soon as possible to ensure patient safety
  • If healthcare facilities don’t have an acceptable alternative, facilities should promptly assess patient care needs and sterilization and disinfection requirements, and take steps to obtain legally marketed substitutes for the SS1

The SS1 system is commonly used for surgical and endoscopy device disinfection and sterilization.

Here are links in chronological order to help you follow the FDA’s concern with the STERIS system:


By Janie Ellison on December 8th, 2009 at 9:10 am

My understanding is that Steris made a modification in the lid of the unit which improved it’s funcution but did not in any way change the efficacy of the sterilization process.
Am I to understand that I am to go back to using cidex to soak laparoscopes and hysteroscopes with all the inherent problems to staff and patients?


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