Multi-Drug Resistant Bacterial Outbreaks Linked With Duodenoscope
Family Practice News reports that the FDA has sent out a safety alert to health care providers warning that use of duodenoscopes can spread multidrug resistant bacterial even when manufacturer cleaning instructions are followed and that the designs of the devices might be the problem.
What are Duodenoscopes?
Duodenoscopes are long, flexible tubes with instrumentation and a camera at the end, inserted in the nose or mouth and passed through the stomach to the small intestine, according to the New York Times.
The LA Times reports that the scopes are used during a procedure called endoscopic retrograde cholangiopancreatography, ERCP, which involves inspecting and possibly removing blockages from the ducts draining bile and fluids into the small intestine from the liver, gallbladder, and pancreas.
Reuters reports that the duodenoscopes are manufactured by Olympus, Fujifilm, and Pentax. Roughly 500,000 procedures using the duodenoscopes are performed each year in the United States according to the LA Times.
Design and Inadequate Cleaning Instructions Linked to Bacterial Outbreak
Medscape reports the FDA has warned that the design of the duodenoscopes can allow for bacteria and bodily fluids to remain on the scopes even when manufacturer-cleaning protocol is followed precisely.
The duodenoscopes contain microscopic crevices, which prevents proper cleaning from removing all bacteria and bodily fluids on the scopes, according to the New York Times. Business Insider reports that the Food and Drug Administration, FDA, asked the manufacturers of the duodenoscopes to test their cleaning protocols but the tests were flawed or showed the cleaning protocols to be unreliable as the duodenoscopes remained contaminated.
The New York Times reports that when the Centers for Disease Control and Prevention, CDC, investigated the cleaning of the duodenoscopes, the CDC found that hospitals were following the manufacturer cleaning protocol but the duodenoscopes remained contaminated.
The FDA conducted an engineering assessment of the duodenoscopes that found the design of the scopes complicated cleaning and allowed for bacteria to remain on the scopes, according to Medscape.
Hundreds of Infections and Dozens of Deaths Linked to Duodenoscopes
The New York Times reports that the most serious contaminations involve bacteria from the carbapenem-resistant enterobacteriaceae, CRE, which are resistant to all antibiotics.
USA Today reports that these bacteria can infect many body systems:
- Soft Tissues
- Blood stream
- Urinary tract
The LA Times reports that if the CRE bacteria reach the bloodstream it is deadly in 40-50% of cases and that at least 6 outbreaks have been linked to contaminated duodenoscopes since 2012.
There have been deadly outbreaks associated with contaminated duodenoscopes across the United State:
- 32 people infected, 11 deaths associated with bacterial contamination of duodenoscopes in Seattle, Washington
- 179 people exposed and 2 deaths associated with contaminated duodenoscopes in Los Angels, California
- 70 people infected, 15 deaths associated with contaminated duodenoscopes in Florida
- 39 people infected by contaminated duodenoscopes in Park Ridge, Illinois