PENTAX Medical has updated the reprocessing and operation instructions for its ED-3490TK Video Duodenoscope. These instructions include new procedures for cleaning, high level disinfection and sterilization.
What’s the problem?
February 19, 2016 – Following multiple reports of drug resistant bacteria linked to endoscopes used for Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures, PENTAX Medical has been working with the FDA to validate the reprocessing procedures for the ED-3490TK Video Duodenoscope.
“We have been working closely with FDA to update these Instructions. Maintaining patient safety and quality is our utmost priority,” said Dr. Frank Canonica, Chief Infection Control Officer at PENTAX. “We have alerted our customers about the updated IFUs. In addition, PENTAX Medical has a dedicated team of clinical specialists who will be visiting customer facilities to conduct reprocessing in-servicing and training.”
Additionally, PENTAX announced that it has retired service and support of discontinued 30, 40, and 70 Series duodenoscopes. These endoscopes were introduced more than 10 years ago and have since been replaced with the ED-3490TK Video Duodenoscope. The company will be reaching out to customers who own or lease retired duodenoscopes to invite them to transition to the newer model.