41 results

• Cracks and Gaps in Pentax Duodenoscopes Can Lead To Infection Risk, FDA Warns

  January 18, 2017

  Irvin Jackson

  The FDA warns that cracks and gaps in the Pentax ED-3490TK duodenoscope can make them more difficult to clean, potentially increasing the risk of hospital-acquired infections.

• Duodenoscope Recall Issued by Fujifilm For Older Models Linked To Infection Risk

  January 16, 2017

  Irvin Jackson

  Fujifilm is recalling some older model duodenoscopes to replace them with those which have updated cleaning instructions for avoiding hospital-acquired infections.

• FDA Urges Doctors To Stop Using Custom Ultrasonics Reprocessors For Duodenoscopes

  August 18, 2016

  Irvin Jackson

  The FDA is urging hospitals not to use Custom Ultrasonics System 83 Plus AERs for cleaning duodenoscopes, but is allowing them to stay on the market for use on other types of endoscopes.

• Olympus Withheld Information About Duodenoscope Infections: Report

  July 28, 2016

  Irvin Jackson

  Emails between top Olympus Corp. executives indicate that they knew for years about the risks of their duodenoscopes spreading infections, but chose not to warn the U.S. medical community.

• FDA Quietly Backs Off Custom Ultrasonics AER Endoscope Washer Recall

  May 18, 2016

  Irvin Jackson

  Rolling back a recall on Custom Ultrasonics endoscope washers, it appears the FDA is allowing them to stay on the market if they are not used to clean duodenoscopes, which have been linked to a number of infection outbreaks.

• Olympus Knew Duodenoscopes Were Spreading Infections During ERCP Procedures: Report

  April 18, 2016

  Irvin Jackson

  A Senate report highlights problems throughout the healthcare system that led to duodenoscopes spreading antibiotic-resistant infections for years during ERCP procedures.

• Cleaning Instructions for Olympus ERCP Duodenoscopes Validated By FDA

  March 16, 2016

  Irvin Jackson

  The FDA has validated new cleaning instructions for two models of Olympus ERCP duodenoscopes amid infection concerns.

• ERCP Scope Cleaning Instructiosn Validated by Pentax: FDA

  February 22, 2016

  Irvin Jackson

  New reprocessing instructions have been issued by Pentax for one of its lines of ERCP duodenoscopes, in hopes of preventing hospital infections.

• Olympus Duodenoscope Recall Issued Over Elevator Tip Linked To Infections

  January 21, 2016

  Irvin Jackson

  An Olympus duodenoscope recall has been announced to replace forceps elevator tips that may transfer bloodborne infections and diseases from one patient to another between uses.

• Surgical Infections from Dirty Duodenoscopes Highlighted in Senate Report

  January 18, 2016

  Irvin Jackson

  Device manufacturers, hospitals and the FDA knew for years that duodenoscopes were linked to antibiotic-resistant infection outbreaks, a senate report warns.