An endoscope is a is a lighted optical instrument that can be introduced into the body to provide a view of its internal parts. The endoscope is usually introduced into the body through a natural opening such as a mouth or anus. The endoscope may be used for diagnostic or treatment purposes and often has multiple “channels”.
Investigation of outbreaks: The danger of improperly sterilized endoscopes
Infections are generally considered a known risk and complication of endoscopy procedures. However, recently these concerns have been brought into the public light because of several high publicity cases.
The investigation of some of these outbreaks revealed that the endoscopes, sometimes called duodenoscopes, may contain bacteria which remain even after conventional sterilization. Because the endoscopes are reusable, the infections can be passed from patient to patient. The doctor assumes the device is sterile, but now they know that they may not be able to have confidence that the scopes they are using are actually sterile. Unfortunately, neither the FDA or the manufacturers of the endoscopes have offered much advise to doctors or to the public.
Response from the FDA and other organizations
In February 2015, the Food and Drug Administration (FDA) issued a bulletin warning of the risk of infection due to the complexity of the endoscope device, which contains many small working parts with hidden, often difficult to reach crevices.
The FDA concluded that the design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes may impede effective cleaning. So, this means that the devices themselves may be considered defective in their design if they are unable to be cleaned properly even when healthcare facilities follow the manufacturer’s instructions.
The Association for the Advancement of Medical Instrumentation (ANSI/AAMI) has concluded that endoscopes can be removed of all harmful bacteria if the manufacturers’ cleaning instructions are followed, the person performing the disinfection is competent, the environment in which the disinfection is performed is free of contaminants and the manner in which the endoscope is stored does not expose it to contaminants.
The Society of Gastroenterology Nurses and Associates (SGNA) has also promulgated Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes (2016)