patient safety movement

Health Care Associated Infections (HAIs)

According to the Centers for Disease Control and Prevention (CDC), approximately 1 out of every 25 hospitalized patients in the US contract healthcare-associated infections.

In American hospitals alone, the Centers for Disease Control (CDC) estimates that HAIs account for an estimated 1.7 million infections and 99,000 associated deaths each year.  (

FDA Meeting Presentation, Jan. 9, 2020

Every year there are over 75 million endoscopic procedures in the US that allow healthcare providers to perform hundreds of essential procedures, ranging from colonoscopies to treatment of pancreatic cancer. FDA facilitates patient access to the world’s best endoscopic technologies and ensures that endoscopes can be safely used. An ongoing challenge related to endoscope use has been antibiotic-resistant bacterial infection outbreaks. Research has shown that biofilm can build up inside endoscopes over time, making current cleaning and disinfection procedures (called "reprocessing") less effective. To address this problem, the FDA has proactively taken measures with several warnings to manufacturers and healthcare facilities.

The FDA required manufacturers to study endoscopes being used in the clinic, and the results showed that about 2-5% of endoscopes do in fact have bacterial contamination

The Spread of Superbugs

“Regardless of how strong any sterilant or disinfectant is, the narrow channels and ports are hard to reach and the debris trapped in those places can harbor germs as dangerous as CRE through multiple uses and cleaning cycles. The complex and tedious process used to “clean” scopes consumes over half an hour of labor and requires up to 43 steps to merely reduce – but not eliminate – the risk of one person infecting another."