40 results

• FDA Orders Studies on Duodenoscope Infection Transmission Factors

  October 6, 2015

  Irvin Jackson

  The FDA has ordered duodenoscope makers to conduct new studies to see how the devices are being cleaned in hospitals and what is working and what is not.

• Bronchoscope Infection Risk Highlighted in FDA Warning

  September 21, 2015

  Irvin Jackson

  The FDA is warning of potential hospital-acquired infections associated with reprocessed bronchoscopes.

• Duodenoscope Makers Get Warning Letters Over Manufacturing, Reporting Problems

  August 18, 2015

  Irvin Jackson

  The FDA has issued warning letters to three manufacturers of a type of endoscope linked to treatment-resistant infection outbreaks.

• Duodenoscope Cleaning Measures Expanded To Avoid Hospital Infection Outbreaks

  August 5, 2015

  Irvin Jackson

  The FDA has issued new instructions for cleaning duodenoscopes following a number of hospital infection outbreaks and concerns that manufacturers' cleaning instructions were inadequate.

• Duodenoscope Lawsuit Filed Against Olympus Over UCLA Infection

  July 10, 2015

  Irvin Jackson

  A California woman is the latest to sue Olympus over an endoscopic surgery infection linked to duodenoscopes that may not be cleaned properly even when the manufacturer's instructions were followed.

• ERCP Duodenoscopes Unsafe, FDA Advisory Committee Says

  May 20, 2015

  Irvin Jackson

  An FDA advisory panel warns that duodenoscopes are unsafe, but that the benefits still outweigh the risks of drug-resistant infections.

• Duodenoscope Infection Warnings Could Have Been Issued Earlier, FDA Reviewers Say

  May 6, 2015

  Irvin Jackson

  A new report finds that the FDA new about the infection risk of duodenoscopes as early as fall 2013 before issuing a safety warning this year.

• Wrongful Death Lawsuit Filed Against Olympus Over ERCP Infection

  April 22, 2015

  Irvin Jackson

  Olympus faces a wrongful death lawsuit from the family of a young boy who died as part of the UCLA medical center drug-resistant infection outbreak linked to the company's duodenoscopes.

• ERCP Endoscope Testing By Companies Flawed, Advisory Hearing Planned: FDA

  March 3, 2015

  Martha Garcia

  The FDA is calling an advisory meeting to review endoscope cleaning protocols following deadly outbreaks and poor manufacturers' testing.

• ERCP Infection Lawsuits Filed Against Duodenoscopes Makers Over CRE Outbreak

  February 27, 2015

  Irvin Jackson

  A wrongful death lawsuit has been filed against Olympus related to a superbug outbreak spread during ERCP endoscopic procedures.