FDA Found Problems With Scope-Cleaning Machines in 2012

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.