PENTAX Medical Issues Updated Instructions for Use for its ED-3490TK Video Duodenoscope
Montvale, NJ -- PENTAX Medical has announced 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 (“ECRP”) procedures, PENTAX Medical has been working with the U.S. 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," said Dr. Frank Canonica, Chief Infection Control Officer, of 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 over ten 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.
PENTAX Medical is dedicated to reducing the risk of infection in flexible endoscopy by consistently developing new advancements in flexible endoscope design, reprocessing procedures, customer tools, and training. Over 500,000 ERCP procedures are performed in the United States every year. The emergence of multi-drug resistant bacteria presents a formidable challenge to the entire healthcare community. As is the case for many other types of endoscopic procedures, the rate of infection for ERCP remains extremely low, and the FDA continues to acknowledge that for most patients the benefit of ERCP outweighs the risks of infection.
About PENTAX Medical
PENTAX Medical is a division of HOYA Group. Its mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY. Through leading edge R&D and manufacturing, PENTAX Medical provides endoscopic imaging devices and solutions to the global medical community. Headquartered in Japan, PENTAX Medical has a worldwide focus and presence with R&D, regional sales, service, and in-country facilities around the globe. PENTAX Medical employees represent the diverse countries where we do business, allowing us to provide innovative solutions tailored to meet local needs. www.PENTAXmedical.com
Press Contact:
Mariano Franco
Associate Director, Maketing Communications
PENTAX Medical Americas
T: 1.800.750.5558 ext. 244
E: mariano.franco@pentaxmedical.com
