Regulatory news: Advanced Sterilization Products gets FDA ok for endoscope cleaner
Advanced Sterilization Products, owned by Johnson & Johnson, has received U.S. FDA cleared for the EvoTech Endoscope Cleaner and Reprocessor (ECR), a washer/disinfection system for endoscopes designed to eliminate labor-intensive manual cleaning. This system provides an automated endoscope cleaning process that is comparable to professional society guidelines for manual cleaning. The EvoTech ECR, as cleared by the FDA, is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME GI) to achieve cleaning and high-level disinfection of heat sensitive (>60° C) semi-critical endoscopes. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the EvoTech System when selecting those cycles that contain a wash stage. EvoTech ECR will be available for purchase in first half of 2007, the company said.