May 29, 2015 — The Los Angeles Times has learned that the FDA knew about problems with a popular endoscope-cleaning machine years ago.

The manufacturer, Custom Ultrasonics, was ordered to stop manufacturing and selling the machines, known as automated endoscope reprocessors, in September 2012. Even so, over 1,000 hospitals and clinics still use the machines, and the company continues to provide service.

The FDA was concerned about computer problems that could interrupt the cleaning cycle, which could increase the risk of disease-transmission on contaminated endoscopes. According to an investigators:

“[Custom Ultrasonics] failed to fully identify the health risk to the patient population if current products in distribution with potentially nonconforming computer hardware components should fail.”

Custom Ultrasonics even issued recalls in 2008 and 2013. However, the FDA allowed the machines to remain in use while they were being fixed. In 2012, one hospital found that the machine was not effective at sterilizing the scopes.

Following several deadly outbreaks of “superbug” infections, the FDA has asked Custom Ultrasonics and other manufacturers to provide data proving that their scope-cleaning equipment actually works.

Until now, most of the attention has focused on a design flaw in the tip of the duodenoscope that makes it extremely difficult to sterilize between uses. This adds more evidence that the FDA knew about many potential safety risks — at least 152 reports of possible disease-transmission on contaminated scopes were reported to the agency between 1992 and March 2015.


Meet Your Attorney

Collen A. Clark

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

“Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

To contact Collen, please fill out the contact form below:

Free Confidential Case Evaluation

Verified 100% Secure SiteTo contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (866) 879-3040.
  • This field is for validation purposes and should be left unchanged.