PENTAX Medical announces that the company updated the Reprocessing and Operation Instructions for Use (IFU) for the PENTAX Medical ED-3490TK Video Duodenoscope. These instructions include updated validated procedures for cleaning, high-level disinfection and sterilization.
Following publicized reports of multi-drug resistant bacteria being linked to endoscopes used for Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures, PENTAX Medical has been working with the Food and Drug Administration (FDA) to validate the reprocessing procedures that are provided in the updated Reprocessing IFU. The FDA's communication regarding the updated IFU is available here: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm486772.htm/
"We have been working closely with FDA to update these Instructions. Maintaining patient safety and quality is our utmost priority," says Dr. Frank Canonica, chief infection control officer for PENTAX Medical. "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."
In addition, PENTAX Medical has announced that it has retired service and support of discontinued PENTAX Medical 30, 40, and 70 Series duodenoscopes. These endoscopes were introduced into the market more than 10 years ago and have since been replaced with the current generation model, ED-3490TK Video Duodenoscope. PENTAX Medical representatives will be reaching out to customers who own or lease one or more of the retired duodenoscope models to invite them to transition to the current model, the ED-3490TK.
Source: PENTAX Medical