Advanced Sterilization Products Receives FDA Clearance for Washer/Disinfector Designed to Eliminate Requirement for manual Endoscope Cleaning

IRVINE, Calif. -- Advanced Sterilization Products, a Johnson & Johnson Company, Division of Ethicon Inc., announced today that the U.S. Food and Drug Administration has cleared for use the new EvoTech Endoscope Cleaner and Reprocessor (ECR), a washer/disinfection system in the U.S. designed to eliminate labor-intensive manual cleaning of endoscopes. This pioneering system establishes a consistently high standard of automated endoscope cleaning 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.  (Manual cleaning of medical devices (endoscopes) is required when selecting the Disinfect only or Disinfect/Alcohol Flush Cycle.)  EvoTech ECR will be available for purchase in first half of 2007. 

The Millennium Research Group, in its U.S. Markets for Gastrointestinal Endoscopy Devices 2005 report, stated that approximately 21 million endoscope procedures in gastrointestinal suites are conducted annually in the United States. Current professional society guidelines for endoscope reprocessing (such as the guideline published by the Society of Gastroenterology Nurses and Associates) involve a multi-step, labor-intensive process, which recommends meticulous manual cleaning, achievement of high-level disinfection, water rinsing, proper handling and storage.  Automated endoscope reprocessors (AERs) available today disinfect endoscopes only after the manual cleaning process is complete.  Key EvoTech ECR features include:

· Automated Cleaning Cycle that eliminates requirement for manual cleaning.

· Automated leak and block detection at the start and finish cycles to ensure endoscope integrity.

· Automated Channel Blockage and Disconnect Detection through independent monitoring of each channel for optimal quality control.

· Automated cycle parameter verification to document each step of the process for consistency. 

· Single-shot high-level disinfection using CIDEX OPA Concentrate, developed based on the excellent materials capability of CIDEX OPA.

· Performs comprehensive cleaning, reprocessing, and cycle parameter verification procedures in only 30 minutes.

The EvoTech ECR reduces the risk of human variation in cleaning endoscopes, an important consideration in infection prevention, said Barbara Trattler, RN, director of education at ASP. The EvoTech ECR will allow healthcare professionals who were responsible for manual cleaning to allocate more of their time to patient care activities.

With the elimination of manual cleaning, the EvoTech ECR is a revolution in endoscope reprocessing and helps further establish ASP as a leader in instrument processing technologies, said David Powell, worldwide president of Advanced Sterilization Products. At ASP, we are committed to developing innovative products that make it easier for healthcare professionals do a better job of preventing infection.

Source: Advanced Sterilization Products