Healthcare professionals should stop using Steris’ System 1 (SS1) processor and switch to a legally marketed device within 18 months, the FDA says,
extending its original deadline of 3 to 6 months. Steris chose not to seek clearance of the device, which is misbranded and adulterated, according to the
agency. The FDA issued a MedWatch in December for the SS1, alerting healthcare providers to the risk of burns following exposure to a sterilant solution.