42 results

• FDA Calls For Duodenoscope Manufacturers To Create New Easier-To-Sterilize Designs

  August 30, 2019

  Irvin Jackson

  The FDA says current duodenoscope designs cannot be adequately cleaned, and are calling for hospitals to shift to designs that are disposable or have disposable components.

• Duodenoscopes May Be Impossible To Sterilize Safely and Need to be Recalled, Experts Tell NYT

  August 7, 2019

  Irvin Jackson

  Some medical experts are calling for duodenoscopes to be removed from the market, due to problems sterilizing them and the risk of patient infections.

• More Than 200 Duodenoscope Problems Reported to FDA Since October, But Number is Declining

  April 15, 2019

  Irvin Jackson

  The FDA received more than 200 adverse event reports linked to duodenoscopes since October, including 45 incidents of patient infections.

• Duodenoscopes Contamination Rates Still “Higher-Than-Expected”, FDA Officials Warn

  December 11, 2018

  Irvin Jackson

  The FDA warns that duodenoscopes are still showing higher-than-expected infection rates despite updated cleaning instructions and design changes.

• FDA Clears Custom Ultrasonics Reprocessors For Cleaning Some Duodenoscopes

  April 11, 2018

  Irvin Jackson

  The FDA has cleared Custom Ultrasonics AERs for the cleaning of some duodenoscopes, which have been linked to hospital infection outbreaks.

• Duodenoscope Manufacturers Get FDA Warning Letters For Falling Behind On Postmarketing Studies

  March 12, 2018

  Irvin Jackson

  The FDA has issued warning letters to the three manufacturers of duodenoscopes, warning that they have fallen behind on required postmarketing studies imposed after a number of infection outbreaks were linked to the endoscopy scopes.

• FDA Issues New Standardized Duodenoscope Protocols Following Infection Outbreaks, Recalls

  February 28, 2018

  Irvin Jackson

  The FDA has issued new voluntary protocols for hospitals to help ensure that duodenoscopes are properly cleaned and sanitized following a number of deadly hospital infection outbreaks in recent years.

• Following Infection Outbreaks, Pentax Duodenoscope Recall Design And Label Changes Approved By FDA

  February 8, 2018

  Irvin Jackson

  The FDA has approved design and label changes announced in a Pentax duodenoscope recall, designed to make the device less likely to spread infectious material to patients.

• FDA Approves Endoscope With Disposable Cap To Prevent Duodenoscope Infections

  September 21, 2017

  Irvin Jackson

  The FDA has approved a new type of Pentax duodenoscope with disposable parts that are designed to prevent the spread of hospital infections.

• Olympus Duodenoscope Lawsuit Results in $6.6M Jury Award Over Superbug Infection Risk

  July 26, 2017

  Irvin Jackson

  Olympus has been ordered to pay $6.6 million to a Washington state hospital where a deadly superbug outbreak took place due to problems with the company's duodenoscopes. The decision includes a $1 million payment to the family of a man who died of a CRE infection.