PENTAX Medical Reaffirms Commitment to Work with FDA and Industry Partners To Address Duodenoscope Infection Issues

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May 14, 2015, 07:00 ET

MONTVALE, N.J., May 14, 2015 /PRNewswire/ -- As the FDA Advisory Panel on Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee prepares to meet, PENTAX Medical affirms its commitment to work with the FDA, industry partners and the medical community to resolve issues related to infections that have occurred in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) procedures.

PENTAX Medical has been in active and ongoing discussions with FDA regarding the development and testing of new reprocessing protocol changes for duodenoscopes that are used in ERCP procedures.

"Working with the FDA to resolve this health issue is our highest priority," said Mark Koppel, Chief Medical Officer, PENTAX Medical Americas.

In addition to the FDA, PENTAX Medical is working with the professional societies, including the American Society for Gastrointestinal Endoscopy (ASGE) and the American Gastroenterological Association (AGA) as part of its commitment to patient safety.

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

SOURCE PENTAX Medical