On February 19, 2015, the FDA issued a safety communication to Gastroenterologists, Gastrointestinal surgeons, Endoscopy nurses, Staff working in endoscopy reprocessing units in health care facilities, Infection control practitioners and Patients considering endoscopic retrograde cholangiopancreatography (ERCP) procedures.
The purpose of the FDA communication is to raise awareness that the complex design of ERCP endoscopes (duodenoscopes) may impede effective reprocessing. Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. The FDA is assessing the association between reprocessed duodenoscopes and the transmission of infectious agents, including multidrug-resistant bacterial infections caused by Carbapenem-Resistant Enterobacteriaceae (CRE) such as Klebsiella species and Escherichia coli, a normal part of the human gut bacteria, which can become carbapenem-resistant.
The acronym CRE is co-incidentally used for the Boston Scientific Controlled Radial Expansion (CRE™ Balloon). It is important to note that the CRE bacteria and the CRE Balloon are not related in any way, other than the acronym.
Boston Scientific is not a duodenoscope manufacturer and our devices for ERCP procedures are sterile and single-use only. However, we support the FDA and their efforts with other government agencies, including CDC, the ASGE and the manufacturers of duodenoscopes used in the United States to identify the causes and risk factors for transmission of infectious agents and develop solutions to minimize patient exposure.
In the safety communication, the FDA provides recommendations to reprocessors, healthcare providers and patients on how to minimize this risk. The FDA also states that for most patients, the benefits of ERCP outweigh the risks of infection. ERCP often treats life-threatening conditions that can lead to serious health consequences if not addressed. The procedure is the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions.
The FDA continues to actively monitor this safety situation and will provide updates as appropriate. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with reprocessed duodenoscopes.