FDA releases approved alternatives for STERIS System 1
As promised, the Food and Drug Administration (FDA) released a list of FDA-cleared alternatives to the STERIS System 1 (SS1) device processing system.
Once again, the FDA recommends each facility identify which devices they currently reprocess using the SS1, review the manufacturer’s instructions for each device, review relevant guidance from the CDC, select a reprocessing device, and contact the manufacturer to ensure that device is compatible with your equipment.
The FDA then provides a list of FDA-cleared devices including:
- Endoscope washer disinfectors/automated endoscope reprocessors (AER)
- Liquid chemical sterilants/high level disinfectants
- Low temperature sterilizers using hydrogen peroxide or ozone
- Ethylene oxide sterilizers
- Steam sterilizers
The release also notes that some companies have been acquired by other companies or have gone out of business, products may now be marketed by other companies or under new names, or companies have changed their locations and contact information.
For additional resources on the FDA warning, read “Quick IC tips on FDA recommendations for the Steris System 1 processor,” of the FDA Q&A conference call. You can also download sterilization and disinfection checklists on the Tools page.
« H1N1 numbers dip, but pandemic report finds holes | Home | Reading between the lines of state and federal requirements for H1N1 »
Leave a Comment