Defective endoscopes linked to spread of superbug | Bart Durham Injury Law

Defective endoscopes linked to spread of superbug

Patients in Tennessee undergoing exploratory surgical procedures trust in the medical community to use only those devices that are deemed safe. A recent spread of superbugs linked to some types of endoscopes (also known as duodenoscopes) have called attention to manufacturer practices as well as the timeliness of the U.S. Food and Drug Administration’s response to device defects.

While infections related to use of endoscopes were first reported in 2012, the FDA only issued a safety alert regarding the problem in 2015. The aim of this alert was to raise awareness of health issues posed by the design of endoscopes, which must be sterilized before reuse. However, even in cases where endoscopes were sterilized according to specifications, the transmission of multi-drug resistant infections (such as those caused by Carbapenem-Resistant Enterobacteriacea) still occurred.

Adverse event reports forwarded to the agency include 75 potentially defective medical devices affecting approximately 135 patients, although more cases may be unreported. While the FDA is urging medical professionals to fully inform patients of the risk of duodenoscopes and ensure that these devices undergo proper sterilization, the agency has not called for a full-scale recall. According to CNN, these actions have caused the FDA to come under fire from numerous government officials.

In addition to claims that the FDA acted too slowly regarding this issue, the current surveillance system for medical devices has also been criticized as being far too lenient and too reliant on manufacturer response. Many officials call for the creation of a new system to track medical devices that would be similar to the monitoring system in place for prescription drugs. The proposed system would make use of insurance claims, as opposed to relying solely on adverse event reports. Bar codes may also be used on devices, which would make for easier identification should a particular instrument cause harm. 

No Comments

Leave a comment
Comment Information
Bart Durham Injury Law

You Deserve To Be Paid For What You've Gone Through

Our attorneys have more than 75 years of experience helping people like you.

Results For Our Clients

  • $3 Million Settlement - Passenger Hit By A Drunk Driver
  • $1 Million Judgment - Passenger Hit By A Drunk Driver
  • $1,450,000 Settlement - Passenger Hit By A Truck
More Client Results


  • "All of the staff members at Bart Durham Injury Law are very friendly and great to work with. They have open lines of communication with their clients, and respond in a timely manner. I trust them with my legal matters, and would advise anyone else in need of a lawyer to contact them first." - Julia Batson
  • "Bart Durham has a great team of people who are quick to respond and quick to help. The first time I met with them, they were kind and welcoming, and really listened to what I had to say. After my accident, I wasn't sure what to do, or how to get started. They took me through the process step by step, and got me the help I needed to continue on with my life. This is a friendly team with a dedication to helping people, and I'm so thankful for them!!" - Kara Davidson
More Testimonials