In recent years, the U.S. Food and Drug Administration has recommended facilities transition to either single-use duodenoscopes or models containing disposable components.
The recommendation stems from concerns over reprocessing and patient cross-contamination from reusable duodenoscopes.
“The goal obviously was noble,” Lawrence F. Muscarella said recently on a podcast he co-hosts. “Switching from the fixed end cap of the duodenoscope to the new models with the removable end cap, it is reducing the contamination rate. It is facilitating cleaning, enhancing cleaning if you will, but there's two adverse events. There's a price to be paid.”
Muscarella is the president of LFM Healthcare Solutions LLC, an independent quality improvement and healthcare safety company that he founded in 2013. An independent safety expert, Muscarella — who is an Ambu consultant — advises hospitals, manufacturers and the public about medical errors, the safety of medical devices and the causes of infections in healthcare facilities.
He additionally hosts Transmission Control, a public health podcast with Justin Poulin. Muscarella recently detailed two rare adverse events associated with improper attachment of disposable duodenoscope endcaps during a mini-conversation with Poulin shared on the podcast’s LinkedIn page.
If not attached according to manufacturers’ instructions for use, there is a risk that disposable endcaps could become detached inside of the patient — possibly inside the stomach, esophagus or duodenum, according to Muscarella. While posing health risks, this would additionally extend the procedures while the physician locates and removed the detached piece. Muscarella added that he’s come across few, rare reports of detachment inside a patient’s airway.
Muscarella also drew attention to instances of mucosal tearing or lacerations because of improper attachment. Particularly during suctioning, he said, if there is a gap at the distal end of the duodenoscope, tissue can be drawn in. If a doctor unknowingly removes the scope while this occurs, it may cause tearing, or in rare cases, bleeding.