Makers of Endoscope Prepare to Update Device Labeling

Five of the largest endoscope manufacturers in the U.S. will have to update their device labels to remove the Steris System 1 (SS1) as a recommended sterilization system. Boston Scientific, Karl Storz, Olympus, Stryker and Smith & Nephew include the SS1 as a sterilizing option on some of their product labels. The FDA has given them one year to change their labeling and any online information that references use of the SS1.
The GMP Letter