The specter of infection looms over all healthcare to some degree. But in recent years, a number of small outbreaks of sometimes fatal microbial infections in people undergoing endoscopy have drawn media attention — and increased scrutiny from the U.S. Food and Drug Administration (FDA) — on the use of reprocessed endoscopes.
The outbreaks have provoked concerns that people could contract a serious, or even deadly, infection during a routine colonoscopy or upper endoscopy—despite the fact that this is unlikely to happen.
Every year, endoscopists and gastroenterologists perform more than 10 million endoscopic procedures in the U.S. These procedures often require endoscopes that, unlike some medical instruments, are not disposable.
They are used in one patient after another, undergoing a thorough disinfection, known as reprocessing, after each use. Since endoscopes come into contact with intimate mucosal surfaces, there is a risk of transmitting bacteria, viruses, or fungi from one patient to another by way of a contaminated endoscope, possibly resulting in infection.
But concerns about contamination should be addressed with some perspective.
Infection risks differ
The microbial exposures in the reported infectious outbreaks occurred in patients who were undergoing a highly advanced, very technical procedure known as endoscopic retrograde cholangiopancreatography (ERCP), which is used to examine the duodenum, bile ducts, and pancreatic ducts and gallbladder.
According to the American College of Gastrointestinal Endoscopy (ASGE), most people will never need an endoscopic retrograde cholangiopancreatography, although it is a potentially lifesaving procedure.
The ASGE also notes that the risk of infection associated with the specialized endoscopes used in ERCP, known as duodenoscopes, does not apply to the endoscopes used in routine colonoscopy and upper gastrointestinal endoscopy.
All endoscopes have a light source and optics contained in a long, flexible tube, but some endoscopes are more complex, containing narrow-gauge channels to aspirate, flush, and allow for the passage of other medical equipment.
Duodenoscopes have additional components that allow the operator to conduct a thorough examination and special elevators to allow instruments to move at better angles during procedures. These features include small spaces that can harbor microbes and make duodenoscopes more difficult than other endoscopes to properly clean, clear, and disinfect.
Like all endoscopes, duodenoscopes cannot be truly sterilized, which would require exposure to temperatures in excess of 200 degrees Celsius (392 degrees Fahrenheit), resulting in damage to the instruments.
But they do undergo a thorough process that includes manual brushing of all accessible channels, disinfecting with strong cleansers, rinsing and drying, and transport to storage in a way that avoids recontamination.
In the past decade, medical device manufacturers have expanded the steps in their instructions for disinfecting endoscopes to tighten up already stringent standards, and the reprocessing of endoscopes is considered safe, given strict compliance with the established protocols.
Nonetheless, infectious outbreaks—though relatively rare—are concerning. They are happening in some cases despite adherence to standard reprocessing guidelines.
Relatively recently, 32 cases of multidrug-resistant E. coli were identified in Seattle in patients who had undergone ERCP. A review of the reprocessing protocols showed that all the applicable steps had been followed exactly as recommended.
Despite this, half of the duodenoscopes used were found to be contaminated. This has caused some experts to question whether the current standards for reprocessing are thorough enough, especially with the rise of multidrug-resistant “superbugs,” such as carbapenem-resistant Enterobacteriaceae (CRE).
What’s being done?
Scary as the risk of an infection with a superbug may be, the benefits tend to outweigh the risks in the approximately 500,000 people who do undergo ERCP annually in the United States. According to the FDA, possible microbiotic transmission has been reported in only 135 people in the United States.
There are no equivalent alternative procedures that accomplish the same goals as ERCP without major surgery or discomfort from deliberately puncturing the liver from outside the skin.
ERCP is generally considered safer and less risky than these other procedures, which makes it a more attractive option for patients who need such examination.
Even after the infectious outbreaks that had both patients and providers concerned about exposure to potentially contaminated duodenoscopes, the FDA did not recommend that providers cancel ERCP procedures for patients who need them.
But in January 2016, the FDA approved a new version of a duodenoscope redesigned by its manufacturer to form a tighter seal. This redesign should reduce the risk of a patient’s fluids leaking into a part of the instrument that is especially challenging to clean.
Once the FDA cleared the new design, the manufacturer stated that it would recall its older models and replace them with the new one, which it believes is less vulnerable to contamination.
Other concerned parties are also stepping up to the plate to reduce the risk of duodenoscope-related infection. The ASGE, FDA, and Centers for Disease Control and Prevention, as well as endoscopic device manufacturers, are investigating and rapidly applying novel cleaning techniques to limit future risk of contamination.
Recognizing that current safety measures may be falling short, experts are calling for better ways to gauge the success of high-level disinfection.
The ASGE has advised its physicians to address the risk of infection with their internal infection control officers, and has urged hospitals to reassess their disinfection practices on a routine basis and to ensure that all staff involved in reprocessing are doing a complete job.
What you can do
Unfortunately, although there has been a lot of focus on the issue of duodenoscope-transmitted infection, it will be some time before research reveals fail-safe ways to reprocess duodenoscopes, or before manufacturers are able to design devices impervious to contamination. Until then, there are measures that you can take to help protect yourself.
The first step is to make sure that your gastroenterologist meets the highest standards of the profession.
A high-quality provider should have a medical license, be a graduate of an accredited medical school and residency program, and be formally trained in gastrointestinal endoscopy by a certified gastroenterologist or gastrointestinal surgeon. Your primary care physician should be able to guide you to a trusted gastroenterologist and endoscopy center.
Given the amount of attention ERCP-related infectious outbreaks have generated, your gastroenterologist should be prepared and willing to discuss the risk of contamination, and tell you what his or her practice and hospital are doing to keep any risks as low as possible.
Ask about how carefully cleaning protocols are carried out. For instance, staff involved in reprocessing endoscopes should be following the manufacturer’s instructions for cleaning and handling, such as using the recommended cleaning materials and letting the instruments soak the recommended amount of time. They should also be routinely testing to ensure there is no contamination.
Most general endoscopic procedures are safe and rarely have infectious complications. Your gastroenterologist will describe symptoms that may indicate infectious or other complications.
Recognize that any procedure carries risk. Always be sure to quickly seek medical attention if you have fever, chills, severe abdominal pain, trouble swallowing, black stools, or nausea or vomiting after any procedure.
Read more about infections that can land you in the hospital.