Medical Devices
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Information About STERIS System 1
Updated December 22, 2011: Health Care Facilities Must Replace their Steris SS1s
STERIS Corporation (STERIS) 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.
This page lists the documents that explain this situation. It will be updated as new information becomes available.
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List of Documents Associated with Steris System 1 (SS1)
Steris System 1 (SS1) Processor: Second 6 Month Extension for Health Care Facilities to Replace STERIS System 1 with a Legally-Marketed Alternative Questions and Answers about the Steris System 1 Processor (SS1) For Health Care Facilities Alternatives to STERIS System 1 Steris System 1 Processor: 6 Month Extension for Healthcare Facilities To Transition to Legally-Marketed Alternatives STERIS System 1 Update: FDA Grants Extension for Healthcare Providers Using STERIS System 1 To Submit a Certificate of Medical Necessity FDA Notice: Concerns About the Steris System 1 Processor, Components, and Accessories, and FDA Recommendations Transcript: December 10, 2009 Steris Conference Call (PDF - 141KB)
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Letter to Endoscope Manufacturers
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