ERCPs, the CDC, the FDA, & You
Before doing medical malpractice work, I took for granted that doctors and hospitals would only use clean instruments and tools on patients. That naivete is long since gone, and FDA Safety Communications like this reaffirm why.
A bit of medical background:
Gastroenterologists and their staff who help with procedures called endoscopic retrograde cholangiopancreatography (ERCP) use duodenoscopes hundreds of thousands of times a year. Duodenoscopes are flexible, lighted tubes that doctors thread through the mouth, throat, stomach, and upper part of the small intestine to examine patients internally and drain fluid from the pancreatic and biliary ducts. They are intended to be cleaned and disinfected between uses.
These are not your average scopes used for colonoscopy and endoscopies. They have more parts. They are more complex. And, as the Centers for Disease Control and Prevention (CDC) explained in 2013, they might be harboring multidrug resistant bacterial infections.
The FDA followed in 2015 with a Safety Communication. It provides recommendations for everyone potentially affected by duodenoscopes used in ERCPs — including patients, doctors, hospitals, and virtually everyone in between. The FDA noted that the complex design of duodenoscopes may prevent effective cleaning.
Given this concern, the FDA made the following important recommendations:
Recommendations for Health Care Providers:
- Inform patients of the benefits and risks associated with ERCP procedures.
- Discuss with your patients what they should expect following the ERCP procedure and what symptoms (such as fever or chills, chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools) should prompt additional follow-up.
- Thoroughly disinfect duodenoscopes between uses and have in place a comprehensive quality program for reprocessing.
- Take a duodenoscope suspected of being associated with a patient infection following ERCP out of service and meticulously disinfect it until it is verified to be free of pathogens.
- Submit a report to the manufacturer and to the FDA if you suspect that problems with reprocessing a duodenoscope have led to patient infections.
Recommendations for Patients:
- Discuss the benefits and risks of procedures using duodenoscopes with your physician.
- Ask your doctor what to expect following the procedure and when to seek medical attention.
When it comes to your medical care, especially procedures that involve specialized medical instruments, take time to educate yourself. If you are scheduled for a ERCP procedure, consider the FDA’s recommendations, and be sure your doctor can answer your questions about them.