Monthly Archives: May 2015

Filthy endoscopes linked to superbug outbreaks at hospitals

(NaturalNews) A common procedure used by doctors to evaluate the health of their patients’ internal organs has been identified as the cause of multiple “superbug” outbreaks at several U.S. hospitals. A new report published in Morbidity and Mortality Weekly Report has found that filthy endoscopes, which are inserted into the body during an endoscopy, were responsible for infecting dozens of patients with a rare superbug known as carbapenem-resistant Enterobacteriaceae (CRE), which produces an enzyme known as New Delhi metallo-beta-lactamase, or NDM, that renders antibiotics useless.

The report, which was led by researchers from the U.S. Centers for Disease Control and Prevention (CDC), looked at a specific cluster of NDM-producing CRE infections that occurred at a single hospital in northeastern Illinois in 2013. Nine patients at this one particular hospital were among 69 total cases of NDM-producing CRE infections that occurred throughout the year, a figure that is 250 percent higher than the number of patients who came down with the infection during the four years between 2009 and 2012.

To identify the cause of this sudden outbreak, the research team looked at where each of the patients were treated, as well as what he or she was treated for. After identifying one hospital in particular where many of the infections occurred, the team collected samples from various equipment at the hospital to look for contamination, which led them to endoscopic retrograde cholangiopancreatography (ERCP) endoscopes that apparently were not being properly sanitized.

Even though the machines had undergone an intense disinfection process that should have eliminated any and all bacteria that may have been lurking, NDM-producing CRE was still found to be present. The reason for this, experts say, is that NDM, an enzyme produced by the superbug, renders most antibiotics useless, the likely result of persistent antibiotic overuse at hospitals and on factory farms.

“It turns out that the endoscopes, which had undergone high-level disinfection, still tested positive for the NDM CRE and another bad bug, KPC-producing Klebsiella pneumoniae, also highly resistant to nearly all antibiotics,” writes JoNel Aleccia for NBCNews.com.

Hundreds of patients at Illinois hospitals exposed to deadly NDM-producing E. coli

According to Medscape.com, 91 patients were initially identified as having been exposed to the culture-positive endoscope, which was being used at Advocate Lutheran Hospital in Park Ridge, Illinois. Each of these patients were notified about his or her exposure and asked to return for surveillance cultures — and among the 50 who returned, nearly half tested positive for the deadly bacteria.

But according to the CDC’s Melissa Dankel, who works for the agency’s National Center for Emerging and Zoonotic Infectious Diseases, the number of exposed patients was actually far higher. As many as 243 patients at the hospital are said to have been exposed to the contaminated endoscope since January 1, 2013, a figure that hospital officials refused to discuss with the media.

“At this time, CDC recommends facilities reprocess endoscopes as directed by the manufacturer,” stated Dankel to the media. “[F]acilities should review their endoscope reprocessing practices to ensure all manufacturers’ reprocessing recommendations are followed exactly.”

Endoscope-linked superbug outbreaks could be more widespread than we even know, say experts

While somewhat isolated in nature, these recent outbreaks could be the tip of the iceberg, infection control specialist Lawrence F. Muscarella, Ph.D., stated to Medscape Medical News. Many other types of infectious agents are likely being spread by dirty endoscopes, he says, but they are probably being overlooked in patients who have healthy immune systems or who are already being treated with antibiotics.

“This bacterium’s resistance apparently caused a ‘perfect storm’ to present itself and to reveal the problem,” he is quoted as saying.

Learn more: http://www.naturalnews.com/043559_superbug_outbreaks_endoscopes_hospitals.html#ixzz3aVhHDsiL

Christiane Farazli’s endoscopy work called abusive, unconscionable

An Ottawa doctor has quit practising medicine, but that didn’t stop the College of Physicians and Surgeons of Ontario from reading her the riot act at Thursday’s disciplinary hearing.

Christiane Farazli, an internist at the centre of an HIV and hepatitis scare in late 2011, used to run an endoscopy clinic on Carling Avenue near The Ottawa Hospital’s Civic campus.

While practising, the College’s disciplinary panel says Farazli subjected her patients to a “very real risk of significant harm.”

“For more than 10 years, you practised with blatant disregard for the safety of your patients and ignorance of the fundamental principles of infection control,” according to the College.

“Your actions resulted in emotional distress and anxiety for thousands of patients as well as major costs to society for the investigations of blood-borne disease that were subsequently necessary.”

Farazli escapes ‘most severe’ penalty, College says

Farazli gave up performing endoscopies at her clinic in September 2011, but months earlier her clinic failed an inspection by the College of Physicians and Surgeons of Ontario.

In the college’s inspection report, Farazli was accused of using unsterilized instruments and having “gross cross-contamination” from a dirty scope, among other allegations.

She was then barred from performing endoscopies on the premises or anywhere else in Ontario.

On Thursday, the disciplinary panel said had Farazli not given up her practice, she “would have been subjected to the most severe penalties available to the College.”

They also said her treatment of patients was “abusive”.

“It is hard to think of a more vulnerable position for these patients. To treat patients in this position with gross insensitivity and disregard of their discomfort is unconscionable,” the College said.

Public health scare in 2011

An Ottawa Public Health investigation accused Farazli of using improper cleaning procedures for patients treated between April 2002 and June 2011.

Public health officials sent 6,800 letters to former patients warning them to get tested for HIV, hepatitis B and hepatitis C. But after a year-long investigation, officials said they found no cases linked to the clinic.

A $10-million class-action lawsuit was filed against Farazli in late 2011, but there has been no legal movement since the doctor filed her defence a few months later.

None of the allegations against Farazli have been proven in court. She could not be reached for comment.

HOW IT WORKS: THE ENDOSCOPE CAMERA IN A PILL

THE TINIEST ENDOSCOPE YET TAKES 30 TWO-MEGAPIXEL IMAGES PER SECOND AND OFFLOADS THEM WIRELESSLY. SEE HOW IT WORKS INSIDE THE BODY IN AN ANIMATION

Pop this pill, and eight hours later, doctors can examine a high-resolution video of your intestines for tumors and other problems, thanks to a new spinning camera that captures images in 360 degrees. Developed by the Japanese RF System Lab, the Sayaka endoscope capsule enters clinical trials in the U.S. this month.

How the Pill Films Your Innards

Easy Pill to Swallow

Luis Bruno

The Sayaka is 40 percent smaller than previous endoscope cameras

Down the Hatch
The patient gulps down the capsule, and the digestive process begins. Over the next eight hours, the pill travels passively down the esophagus and through roughly 20 to 25 feet of intestines, where it will capture up to 870,000 images. The patient feels nothing.

Power Up
The Sayaka doesn’t need a motor to move through your gut, but it does require 50 milliwatts to run its camera, lights and computer. Batteries would be too bulky, so the cam draws its power through induction charging. A vest worn by the patient contains a coil that continuously transmits power.

Start Snapping
When it reaches the intestines, the Sayaka cam begins capturing 30 two-megapixel images per second (twice the resolution of other pill cams). Fluorescent and white LEDs in the pill illuminate the tissue walls.

Spin For Close-Ups
Previous pill cameras place the camera at one end, facing forward, so the tissue walls are visible only in the periphery of their photos. Sayaka is the first that gets a clearer picture by mounting the camera facing the side and spinning 360 degrees so that it shoots directly at the tissue walls. As the outer capsule travels through the gut, an electromagnet inside the pill reverses its polarity. This causes a permanent magnet to turn the inner capsule and the image sensor 60 degrees every two seconds. It completes a full swing every 12 seconds—plenty of time for repeated close-ups, since the capsule takes about two minutes to travel one inch.

Offload Data
Instead of storing each two-megapixel image internally, Sayaka continually transmits shots wirelessly to an antenna in the vest, where they are saved to a standard SD memory card.

Deliver Video
Doctors pop the SD card into a PC, and software compiles thousands of overlapping images into a flat map of the intestines that can be as large as 1,175 megapixels. Doctors can replay the ride as video and magnify a problem area up to 75-fold to study details.

Leave the Body
At around $100, the cam is disposable, so patients can simply flush it away.

What is an Endoscope?

An endoscope is an instrument used by Doctors and Surgeons.
An endoscope has a bundle of very thin optical fibres
which are used with lenses to see inside a body. Only a
small hole in the skin is necessary to insert the endoscope.
This minimizes the trauma and possible damage to the patient.
How does an Endoscope Work?

Some of the optical fibres take light down to the end of the
endoscope which shines inside the body. Other optical fibres
in the bundle collect the reflected light using lenses.
The reflected light is sent along the fibres to a computer
which displays the information as a picture on a monitor.
It is sometimes possible to perform medical operations inside people
by using an endoscope, rather than making a large cut in the skin.

Endoscopes

Think back to what medicine was like only a hundred years ago. Suppose you’re a 19th-century physician and a patient knocks on your door complaining of acute pains in their abdomen. You can ask them questions and examine their body with your hands. You can prescribe them drugs and watch how they respond over days, weeks, or months. But ultimately, unless you cut their body open and examine it directly, you have no way of knowing with complete confidence what’s wrong. So do you take a risk, do nothing, and wait to see how things turn out? Or do you operate immediately, potentially wasting time and money and putting your patient through disruptive and traumatic surgery? Thanks to medical imaging devices such as endoscopes, decisions like this are a thing of the past: physicians can see exactly what’s going on inside your body without cutting it open. Let’s take a closer look at how they work!

Photo: Endoscopes not only allow physicians to see into your body, they can also be used to carry out delicate, minor surgery. You can see the three key tubes in an endoscope at work here. The big black tube in the middle carries the image of the patient’s body into the doctor’s eye. The smaller black tube on the right, coming down at an angle, is where light shines into the endoscope from a lamp (not shown) in the operating room. The tube on the upper left at the top (with the silver crown) is where tiny surgical tools can be inserted. The doctor is pressing on a cable that enters the patient’s body through this tube to take a tissue sample. Photo by courtesy of National Institutes of Health (NIH).

What is an endoscope?

An endoscope is a bit like a bendy telescope a physician can use for seeing inside one of the body’s cavities. Unlike a telescope, which is a very rigid tube, the part of an endoscope that enters a person’s body is relatively flexible. It consists of two or three main optical cables, each of which comprises up to 50,000 separate optical fibers(made from optical-quality glass or plastic). One or two of the cables carry light down into the patient’s body; another one carries reflected light (the image of the patient’s body) back up to the physician’s eyepiece (or into a camera, which can display it on a TV monitor), as illustrated in the box below.

The optics of an endoscope are similar to those in a telescope. At the remote (distal) end, there’s an objective lens, which links to one or more bendy sections of fiber-optic cable (sometimes called relays) that carry the light back out of the patient’s body to a second lens in the eyepiece (or to a monitor or CCD), which can be swiveled from side to side to adjust the focus (much like the eyepieces on binoculars). Typically the lenses and cables are about 0.5cm (1/5 inch) in diameter (sometimes slightly bigger, sometimes slightly smaller).

Endoscope surgery

Most modern endoscopes aren’t limited to piping light in and out of a patient’s body: they can also be used to carry out small surgical operations and other minor, medical procedures. Typically, the remote end of the endoscope can be moved around by turning knobs or pulling on cables, which swivel and bend it from side to side. A secondary tube attached to the main optical cables can be used for sucking out obstructing material (for example, obstacles that block the bronchial tubes in the lungs) or carrying out biopsies (removing small tissue samples for testing) with tiny forceps. Surgeons can also shine powerful, precision lasers down endoscopes to destroy diseased tissue, make accurate incisions, or heal wounds, all the time watching what they’re doing through the eyepiece or on the TV monitor. This type of procedure is called minimally invasive surgery and it’s simpler, quicker, less expensive, and far less traumatic than conventional operations. However, it still generally needs the patient to have an anesthetic and it’s not always without drawbacks and complications.

How do endoscopes work?

Artwork showing how endoscopy involves light shining into a patient's body cavity and then reflecting back out again

Here’s how endoscopy works:

  1. One of the two main endoscope cables carries light from a bright lamp in the operating room into the body, illuminating the cavity where the endoscope has been inserted.
  2. The light bounces along the walls of the cable into the patient’s body cavity.
  3. The diseased or injured part of the patient’s body is illuminated by the light shining in.
  4. Light reflected off the body part travels back up a separate fiber-optic cable, bouncing off the glass walls as it goes.
  5. The light shines into the physician’s eyepiece so he or she can see what’s happening inside the patient’s body. Sometimes the fiber-optic cable is directed into a video camera (which displays what’s happening on a television monitor) or a CCD (which can capture images like adigital camera or feed them into a computer for various kinds of image enhancement).

What are the different kinds of endoscopes?

Image of stomach cancer as seen through an endoscope

“Endoscope” is the generic name for an instrument used to look inside any part of the body in this way. Endoscopes used for specific forms of examination have the following names:

  • Arthroscope: Joints
  • Bronchoscope: Esophagus and lung
  • Colonoscope: Colon and bowel
  • Coloposcope: Vagina and cervix
  • Cystoeurethroscope: Bladder and urethra
  • Cytoscope: Bladder
  • Duodenoscope: Small intestine
  • Esophagogastroduodenoscope: Esophagus, stomach and small intestine
  • Fetoscope: Womb
  • Gastroscope: Stomach
  • Hysteroscope: Womb
  • Laparoscope: Abdomen
  • Laryngoscope: Larynx
  • Peritoneoscope: Peritoneum
  • Proctosigmoidoscope: Lower part of the large intestine
  • Sigmoidoscope: Large intestine
  • Thoracoscope: Thorax
  • Ureteroscope: Pelvis and ureter

Endoscopes aren’t just used for medical diagnosis: they’re incredibly useful for inspecting inaccessible areas of buildings or parts of machines where people can’t easily see. Industrial endoscopes used in this way are called borescopes and fiberscopes.

Photo: Images of stomach cancer seen through a gastroscope. Photo by courtesy of National Institutes of Health (NIH) Image Bank.

How are fiber-optic cables different in endoscopes?

You might be wondering what’s the difference between fiber-optic cables used in endoscopes and those used for carrying telephone calls, cable TV, and Internet data. Telecommunications cables are designed to carry data in digital form over very long distances; by contrast, the cables used in endoscopes carry pictures over much shorter distances and in analog form. In other words, while telecoms cables carry binary data (long strings of zeros and ones) that represent everything from MP3 music tracks to digital photos of rock stars, endoscope cables carry the actual pictures of someone’s insides!

Who invented endoscopes?

Labelled patent artwork showing the 1961 fiber-optic gastroscope designed by Hirschowitz, Curtiss, and Peters.

Attempts to see inside the body with crude endoscopes go back to the late 19th century; the earliest US patent I’ve found using the term is dated 1911. These early medical endoscopes were crude and bulky by modern standards, because they placed the light source itself inside the body cavity that needed to be examined. Typically, that meant using tiny bulbs, which produced little light and burned out quite quickly (because they had to be turned up so brightly). They also produced quite a lot of heat, which meant they risked burning or drying out the body tissue under examination. In the early 1950s, Max Fourestier and colleagues at the Centre National de la Recherche Scientifique in Paris, France developed an endoscope using rods made of quartz or Plexiglas, which enabled light from a source outside the patient’s body to be shone down inside a body cavity. It was an important breakthrough—and a major stepping stone to the fiber-optic endoscope.

The basic technology behind the modern endoscope was developed in the early 1950s by English physicist Harold Hopkins (1918–1994) and his Indian-born student Narinder Kapany (1927–), who’d been asked for help by a group of surgeons. After a great deal of research, Hopkins and Kapany developed a way of making flexible pieces of glass that became known as optical fibers—thicker versions of modern fiber-optic cables that are now so widely used in telecommunications.

By the mid-1950s, three University of Michigan scientists (Basil Hirschowitz, Lawrence Curtiss, and C. Wilbur Peters) had used optical-fiber technology (which they neatly defined as “long, thin, highly flexible, rope-like tube for use in transmitting light”) to build an instrument called a gastroscope that could be used to see inside a patient’s stomach. The same technology was later used to study other body cavities.

Artwork: The highly flexible fiber-optic gastroscope designed by Hirschowitz et al in the 1950s. The right-hand end is inserted into the patient; the left-hand end is the bit the doctor looks into. Some of the key bits include 1) Light source (interestingly, still positioned inside the patient); 2) Prism; 3) Focusing lenses; 4) Gear-driven focusing mechanism (shown in more detail in the pullout illustration); 5) Optical fibers surrounded by protective waterproof and air-proof membrane; 6) Metal shell that transmits forces down the tube, allowing it to be manipulated along its entire length by twisting and turning; 7) Air tube allows the body cavity to be inflated; 8) Eyepiece lenses. Original artwork courtesy of US Patent and Trademark Office (with colors and new numbering added for explanatory purposes). For more details, please see US Patent 3,010,357: Flexible light-transmitting tube.

Pill cam: the endoscope of the future?

Artwork showing parts inside a miniaturized endoscope pill camera.

Endoscopes are brilliant inventions, but no-one really enjoys having a camera tube stuffed inside them!

What’s the alternative? In the future, doctors hope to shrink endoscopes to the size of a tiny pill you can swallow. Inside the pill, a miniature camera will pick up images of your insides and a radio transmitter will beam them out to a monitor nearby.

The top part of the artwork shows how much technology is packed in a pill-cam. Does it sound impossible? Not really! LEDs are smaller than pills and have lenses built into them. CCDs are not much thinner than a piece of card. Watch and calculator batteries are pretty tiny too. And even complex electronic circuits can be made very small and thin. So the whole thing sounds feasible.

And here’s how it works:

  1. You swallow the pill-cam and it tumbles through your body, taking pictures of damaged or diseased tissue.
  2. The LEDs at the front of the pill-cam fire out enough light to generate an image.
  3. The CCD chip picks up the reflected light and generates a digital image.
  4. The radio transmitter sends digital images to a computer outside your body.

Endoscopes linked to bacterial outbreaks made by Pennsylvania company

The FDA says medical devices at the center of serious bacterial outbreaks at hospitals in Philadelphia and California did not have its approval.

Earlier versions of the Olympus-made endoscopes did get green-lighted, but the company did not seek clearance when it modified the device in 2010.

At least 15 people, including eight at a Philadelphia hospital authorities have not named, are believed to have contracted the bacterial infection Carbapenem-resistant Enterobacteriaceae, or CRE.

Chris Lavanchy with medical device watchdog group the ECRI Institute says sterilizing endoscopes has long been a challenge.

“It’s not news that these devices are difficult to clean properly,” he said. “But I think with the emergence of CRE, its made it even more of an issue, and increased the visibility of the difficulty of cleaning these instruments.”

He says it isn’t clear if the newest version of this endoscope made that process harder.

“It is difficult to say that the change made it worse, in fact maybe it is better than it was before.”

Olympus, which has its American headquarters in Center Valley, Pa. points out that devices made by competitors have also been linked to outbreaks. FDA data shows 135 infections in 2013-2014 related to endoscopic retrograde cholangiopancreatography, the procedure these scopes are used in.

“The emergence of drug-resistant microorganisms is a challenge to the entire healthcare community,” the company said in a statement.

“Olympus is working with relevant medical societies and our customers in research of this emerging issue and the development of additional safeguards to prevent infection associated with endoscopic procedures.”

The FDA says more than 500,000 procedures are performed each year involving these scopes, and only a small fraction of transmissions reported. It is reviewing Olympus’s application for the device, which was submitted in October 2014, but won’t pull the units from the market.

“While we are working to determine what more can be done to reduce the incidence even further, the risk of transmission of multi-drug resistant bacteria must be weighed against the consequences of not seeking necessary treatment,” writes the agency.

“Pulling these devices from the market would prevent hundreds of thousands of patients from access to this beneficial and often life-saving procedure. The FDA believes at this time that the continued availability of these devices is in the best interest of the public health.”

‘SUPERBUG’ ENDOSCOPE MANUFACTURER DID NOT GET MODIFICATION APPROVED BY FDA

One of the manufacturers of the endoscopes at the center of the “superbug” outbreak at Ronald Reagan UCLA Medical Center did not get government approval for a modification to the device implemented in 2010.

The Food and Drug Administration noticed in 2014 that Olympus had not received clearance for the modifications and informed the company to do so.

In October, the company submitted the request, which is still pending.

The modification is the same change implemented by the two other endoscope manufacturers, which did get FDA clearance for the alteration.

All three manufacturers have received reports of infections associated with their endoscopes.

Meantime, hospitals are still allowed to use the scopes as long as they follow the FDA’s recent safety communications on how to clean and disinfect the devices.

Olympus is facing two lawsuits. The first one was filed on behalf of an 18-year-old, who remains hospitalized after becoming infected. The lawsuit claims negligence by Olympus.

The second lawsuit is being brought by the family of 48-year-old Antonia Cerda, who died last November. That suit is for wrongful death, negligence and fraud, accusing the company of failing to update the cleaning protocol of the device. So far, Olympus has not commented on the lawsuits.

Last month, at least 179 patients at Ronald Reagan UCLA Medical Center were likely exposed to the “superbug,” also known as carbapenem-resistant Enterobacteriaceae (CRE). Seven have confirmed infections and two of those patients have died. The bug spread on contaminated scopes used in procedures between October 2014 and January 2015.

According to the Centers for Disease Control and Prevention, CRE is difficult to treat because the germs have high levels of resistance to antibiotics. The bacteria can cause infections of the bladder or lungs, leading to coughing, fever or chills.

Breaking News: FDA Issues Safety Alert for Duodenoscopes (ERCP endoscopes)

The FDA wants to raise awareness among healthcare professionals, including those working in reprocessing units in healthcare facilities, that the complex design of endoscopic retrograde cholangiopancreatography (ERCP) endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. Recent medical publications and adverse event reports link multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.

AAMI Releases ‘Must-Have’ Guide for Endoscope Reprocessing

A new standard that compiles information on the reprocessing of flexible and semi-rigid endoscopes from a number of sources into a single volume has made its debut.

The standard, titled ANSI/AAMI ST91:2015,Comprehensive guide to flexible and semi-rigid endoscope processing in health care facilities, comes at a time of heightened public concern about the cleanliness and decontamination of these devices. Infections caused by carbapenem-resistantEnterobacteriaceae (CRE) have been reported in North Carolina, Pittsburgh, Los Angeles, Chicago, and Seattle. These infections have been linked to a complex type of endoscope.

“The publication of this standard is timely, given the clinical focus on flexible endoscopes as a source of cross-contamination, infection outbreak, and other patient complications such as toxicity,” said Gerry McDonnell, vice president of STERIS Corporation.  “It is a natural extension to the recently published standard AAMI/ANSI ST58: Chemical sterilization and high-level disinfection in health care facilities.  ST91 focuses on the same aspects as ST58, but with a particular focus on flexible endoscopes, which have some unique criteria.” He added that ST91 builds on guidance from the U.S. Food and Drug Administration (FDA).

The standard initially started out as a less formal document, known as a technical information report. However, the AAMI Endoscope Reprocessing Group saw there was a need for more formal guidance and determined a standard would be more appropriate.

“Healthcare personnel are constantly facing challenges with the new, sophisticated devices being developed for patient care,” said Nancy Chobin, vice president for sterile processing services at Barnabas Health in West Orange, NJ, and co-chair of the working group. The processes of cleaning, sterilizing, and disinfecting flexible endoscopes are particularly challenging because of the numerous lumens and channels found in endoscopes, she added. There was no single document to turn to for guidance, and existing resources sometimes contradicted each other.

“I believe ST91 will be one of those ‘must have’ documents for hospitals,” said Sue Klacik, the International Association of Healthcare Central Service Materiel Management representative on AAMI committees dealing with sterilization standards. She added that those who worked on the document represented a great cross-section of disciplines, including regulators, users, and manufacturers. “It provides a 360-degree view, providing information that readers might not have even thought about,” she added.

For example, the standard advises that personal protective equipment (PPE) used during decontamination should not be worn when handling the scope or accessories that have gone through disinfection. “PPE should be removed and hands washed. Clean gloves not manufactured with natural rubber latex or dried natural rubber latex should then be worn when handling the scope and accessories,” according to the document.

The release of the document comes ahead of a planned meeting of the FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee. On May 14–15, the panel will hear expert testimony on the reprocessing of duodenoscopes and other endoscopes. It also plans to make recommendations on several topics, including the effectiveness of cleaning, high-level disinfection, and sterilization methods, as well as recommended approaches for ensuring patient safety.

Gastroenterology Societies Discuss Patient Safety in Gastrointestinal Endoscopy

Patient safety is a primary concern for gastrointestinal endoscopists. You may have recently heard or read about the spread of infection of difficult bacteria, called CRE, through a procedure called ERCP. The following information provides background information and explains important concepts.

What is ERCP?

ERCP stands for endoscopic retrograde cholangiopancreatography. It is an advanced highly technical endoscopic procedure.

The vast majority of people will never have an ERCP. For patients who do need it, ERCP is a critical and potentially life-saving procedure.

ERCP is performed using a special device called a duodenoscope. The duodenoscope is different from what is used in routine upper endoscopy or colonoscopy.

ERCP allows gastrointestinal endoscopists to diagnose and treat problems in the bile ducts and pancreatic ducts such as stones, narrowing (called strictures) and even complete blockages of a duct. The bile ducts and pancreatic ducts are the channels that carry fluids from the liver and pancreas to the intestine.

Before an ERCP, the gastrointestinal endoscopist will discuss the benefits and risks of this procedure with the patient and/or family members.

What is CRE bacteria?

CRE stands for Carbapenem-Resistant Enterobacteriaceae (CRE). Some have referred to this germ as a “superbug” because it has become resistant to most available antibiotics. CRE is a challenge for all specialties of medicine, including gastroenterology.

How common is infection by CRE bacteria through ERCP?

It is estimated that more than 500,000 ERCPs are performed each year in the US. From what we know, over the past few years, there have been fewer than 100 known cases of transmission of these problematic bacteria through ERCP.

In general, the infectious complication rate for ERCP overall is in total only about 1 percent, but that includes all types of bacteria and these few CRE cases do not change the overall risk.

How did CRE bacteria spread in these few cases?

As mentioned, ERCP is a highly advanced procedure that requires a specialized device called a duodenoscope. At this point, it is believed that the complex design of the duodenoscope may present a challenge for high-level disinfection of the device.

What we do know is that, when manufacturers’ guidelines for cleaning duodenoscopes are followed, the risk of transmission is extremely low. Of course, all procedures carry infection risks.

It is important to note that there have been no known cases of transmission of CRE bacteria with endoscopes used in routine endoscopy, such as colonoscopy.

What is being done to improve patient safety?

Patient safety is always our number one concern. This is an important issue for gastrointestinal experts. We share the public’s concerns.

First, we have made gastroenterologists and surgeons who perform ERCP aware of the potential for infection by CRE bacteria through ERCP. Second, we have urged increased vigilance around cleaning these highly specialized instruments and strict adherence to manufacturers’ guidelines and infection control guidelines.

We have also encouraged hospitals and other facilities to conduct periodic assessments of their disinfection procedures and practices. Additionally, we have urged these facilities to ensure the competency of all staff involved in disinfecting these devices.

Unfortunately, simple answers are not readily available. The gastroenterology societies continue to work with the Centers for Disease Control (CDC), the Food and Drug Administration (FDA), manufacturers and other groups to evaluate and address this complex issue.