Contaminated duodenoscopes linked to 3 new deaths, 45 more infections

FDA says manufacturers must increase post-market studies


Medical device reports from between Oct. 15, 2018, and March 31, 2019, included three reports of death, 45 reports of patient infection and 159 reports of device contamination tied to inadequate reprocessing of duodenoscopes used in procedures involving the pancreas and bile duct, according to an article on the MedTech Dive website.

The  Food and Drug Administration (FDA) also released interim results from post-market studies by device makers showing contamination rates in the scopes significantly higher than preliminary findings released in December.

A total of 5.4% of all samples tested positive for “high concern” bacteria, versus 3% reported previously. 

Manufacturers Olympus, Fujifilm and Pentax have not complied with agreed-upon timetables for completing the post-market studies, FDA said.

Read the article.



April 24, 2019


Topic Area: Infection Control


Recent Posts

Texas Law Limits Backup Power Mandates for Senior Care Facilities

As Texas relaxes generator mandates, healthcare facility managers now face tough decisions about emergency power investments and resident safety.


Cyber Crossfire: Why Healthcare Is Becoming a Battleground in Global Conflicts

As geopolitical tensions escalate, hospitals and critical suppliers are increasingly targeted in cyberattacks.


UPMC Presbyterian Receives $65 Million Gift for New Bed Tower

The tower is projected to open for patient care in early 2027.


Premier Health Partners Falls Victim to Cyber Incident

The incident occurred in July 2023.


Backup Power's Expanding Role in Emergency Preparedness for Healthcare

Manufacturers discuss design strategies, code shifts and lessons learned from real-world disasters.


 
 


FREE Newsletter Signup Form

News & Updates | Webcast Alerts
Building Technologies | & More!

 
 
 


All fields are required. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.