The U.S. Food & Drug Administration issued a warning linking contaminated duodenoscopes to a superbug known as the carbapenem-resistant Enterobacteriaceae (CRE). The April 12, 2019 warning provides guidance for users of the scope on how to prevent contamination of the devices. The FDA previously addressed the problem in a December 2018 safety communication concerning the results of previously enacted safety measures.
In 2015, the FDA received 250 reports of contaminated devices linked to patient infections. Fewer than 100 incidents were reported in 2017. However, the FDA reports a recent increase in incidents in recent months. Between October 2018 and March 2019, the number of contaminated devices rose to 159 with 45 patient infections directly related to the devices. Three fatalities resulted from the infection.
What are Superbugs?
The Enterobacteriaceae bacteria family includes E-coli and Pseudomonas aeruginosa. Most antibiotics, including the carbapenem class used mostly for severe infections, have little to no effect on CRE bacteria. These superbugs spread quickly within the body from an initial infection of the skin, lungs, or the urinary tract and can cause outbreaks within healthcare facilities. The highly-resistant nature of the superbug makes it exceptionally dangerous.
What are Duodenoscopes?
Duodenoscopes are flexible, reusable lighted scopes used during endoscopic retrograde cholangiopancreatography procedures. ERCP is a minimally invasive procedure used to diagnose problems in the bile ducts or pancreas. During the procedure, the scope is inserted in the mouth, down the throat and stomach to the top portion of the small intestine. The scope encounters fluids or tissues from the patient requiring thorough cleaning and disinfecting after a procedure. The numerous small parts of the instrument make it highly susceptible to contamination due to inadequate cleaning.
The three manufacturers of duodenoscopes used in the United States are
• Olympus Medical Systems Corporation
• Pentax of America
• Fujifilm Medical Systems USA, Inc
The FDA offers recommendations for manufacturers of duodenoscopes, health care facilities, practitioners, and potential patients.
Health care facilities are advised to
• Clean certain parts of the scope by hand
• Visually inspect recesses and other hard to clean areas
• Develop written quality control procedures
• Adequately train personnel on the proper way to clean and sanitize the device
• Inspect the scope prior to each use to identify any damage
• Test it for leaks in the seals before and after each use
• Return it to the manufacturer once per year for inspection and maintenance
The FDA previously issued a Safety Communication for manufacturers and users of the device. The communication provided detailed information on how to properly sanitize and disinfect the scopes.
Before having an endoscopic procedure, patients are advised to
• Discuss the risks and benefits of the procedure with their health care provider
• Determine if the disinfection system used by the health care facility is adequate
• Find out if there have been any reported superbug infections at the facility
The manufacturers of duodenoscopes are advised to
• Develop innovative ways to minimize duodenoscope related infections
• Maintain current data about contaminated scopes and infections
• Submit results to the FDA on a monthly basis
Speak with a Defective Medical Device Lawyer Today
The Eichholz Law Firm has extensive experience representing plaintiffs with personal injury lawsuits resulting from defective medical devices. If you or a family member developed an E-coli, pseudomonas aeruginosa, or other serious infection after undergoing an endoscopic procedure, please contact the Eichholz Law Firm for a free consultation.
- FDA. “Infections Associated with Reprocessed Duodenoscopes.” Retrieved from https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/infections-associated-reprocessed-duodenoscopes. Accessed on May 2, 2019.
- FDA. “The FDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions: FDA Safety Communication.” Retrieved from https://www.fda.gov/medical-devices/safety-communications/fda-continues-remind-facilities-importance-following-duodenoscope-reprocessing-instructions-fda. Accessed on May 2, 2019.
- Goldschmidt, Debra. “Medical scopes still causing superbug infections and deaths, FDA says.” CNN. Retrieved from https://www.cnn.com/2019/04/12/health/medical-scopes-superbug-infections-fda-bn/index.html. Accessed on May 2, 2019.
- Mayo Clinic. “CRE bacteria: What you should know.” Retrieved from https://www.mayoclinic.org/diseases-conditions/infectious-diseases/in-depth/cre-bacteria/art-20166387. Accessed on May 2, 2019.