Hundreds Infected by Unsafe Medical Devices

Defective Medical Devices

By Desiree Housek, Staff Writer

A Senate health committee report that was published earlier this year found at least 250 patients in Europe and the United States contracted an antibiotic-resistant infection after procedures using duodenoscopes between 2012 and 2015.

Duodenoscopes are used in nearly 700,000 procedures a year and are considered to be a safer alternative to invasive surgery for conditions such as that of the pancreas or bile duct. It is a flexible, lighted tube, which is inserted through the throat and stomach into the top of the small intestine. It is considered to be an important tool in the detection and treatment of medical problems in a minimally invasive way.

Unfortunately, the intricate design of the duodenoscope makes it challenging to sterilize between uses, which has been linked to the spread of a growing number of  “superbug” infections that are antibiotic-resistant. In February of this year, the occurrence of multiple incidents prompted the FDA to notify hospitals and doctors of the difficulties in sanitizing the tool between uses, which contributes the spread of deadly bacteria.

The Senate report also goes on to detail the poor state of the warning system for the situation. The report identifies the manufacturers’ failure to notify health officials of the potential dangers, the hospitals’ failure to alert regulators, and the Food and Drug Administration’s inability to quickly identify the problem and notify the public.

Additionally, the study noted that the leading manufacturer, Olympus, who manufactures 85% of the scopes used in the U.S., knew about the dangerous bacteria as early as 2013 but failed to inform U.S. hospitals until early 2015. 

The only means to address this matter is through the combined effort of all involved, which includes the manufacturers, the FDA, hospitals, doctors, and nurses to ensure long-term, sustainable use of the duodenoscope.

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