With nearly 700,000 endoscopic procedures done every year in the U.S., the Food and Drug Administration (FDA) is eager for remedies to prevent “superbug” infection outbreaks that have plagued patients and hospitals alike. A change to duodenoscope design by Japanese device maker Pentax that involves the use of disposable device caps has federal officials optimistic about potential reductions in infections that will protect patient health.
Last year, the FDA reported that as many as 350 patients at 41 medical facilities across the nation and worldwide had been infected by tainted medical scopes from January 2010 to October 2015. Health officials have been alerting American hospitals about the superbug outbreak on an ongoing basis in attempts to regulate and restrict these often deadly infections.
This week, the FDA approved Pentax’s new ED34-i10T model with a disposable distal cap feature intended to significantly improve internal device access for cleaning (also known as reprocessing). In addition to the detachable and disposable cap, the new duodenoscope design includes a simpler user interface, improved ergonomics, improved image quality, and a reduced overall length.
“We believe the new disposable distal cap represents a major step toward lowering the risk of future infections associated with these devices,” said Dr. William Maisel, the acting director of the FDA’s Office of Device Evaluation, in a statement reported in the Medical Device and Diagnostic Industry newsletter. “We encourage companies to continue to pursue innovations that will help reduce the risk to patients.”
As noted by the Los Angeles Times, an advantage to a removable cap design is that it “would allow hospital cleaning staff better access to tiny crevices and small parts at the tip of the scope. Some areas are hard to reach with brushes and washing machines, increasing the risk of bacteria being passed from one patient to another.” Such inter-patient infection transmissions have resulted in superbug outbreaks and unnecessary patient deaths.
“I think it may be a step in the right direction to have single-use components whenever possible. But we still have gaps here,” said Cori Ofstead, a researcher and epidemiologist in St. Paul, Minnesota.
In January 2017 the FDA issued a safety communication to health care providers highlighting the critical need for improved cleaning procedures relating to an earlier model Pentax duodenoscope, the ED-3490TK, noting the potential for cracks and gaps to develop in the adhesive that seals the scope, and that fluids and tissue could leak into the device through those cracks and gaps and pass potentially lethal bacteria from one patient to another.
Endoscope Infection Personal Injury Attorneys
Lieff Cabraser has successfully represented thousands of patients across America injured by defective and dangerous medical devices. We currently represent patients who developed “Superbug” CRE infections after undergoing endoscopic retrograde cholangiopancreatography (ERCP), as well as the families of patients who died as a result of such infections.
If you or a family member developed CRE following an endoscopic procedure, please contact an experienced injury lawyer at Lieff Cabraser to discuss your case. You can also call us toll-free at 1 800 541-7358 and ask to speak to injury attorney Lexi Hazam or Wendy Fleishman. There is no charge or obligation for our review, and your information will be held in the strictest confidence.