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Endoscope Superbug Infection Risk

Surgeons use endoscope devices for certain gastrointestinal procedures. The scopes have been linked to a risk of developing superbug infections with CRE bacteria. The infections result from improper cleaning and sanitation.

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An endoscope is a thin, tube-like surgical tool. It has a light and camera attached that allows surgeons to look inside areas of the body. 1

A duodenoscope is an endoscope that is used to perform endoscopic retrograde cholangiopancreatography (ERCP). This is a procedure performed to explore and treat areas of the gastrointestinal tract. 2

Danger can arise when this scope is not thoroughly cleaned and sanitized between uses. 3 In the most severe cases, patients have died from a “superbug” caused by CRE bacteria, which are resistant to antibiotics. 4

Types of Endoscopy Procedures

The ERCP duodenoscope is used in treating disorders of the:

  • Gallbladder
  • Bile ducts
  • Liver
  • Pancreas 5

Surgeons may perform an endoscopic procedure of this kind to find out if a person’s bile or pancreatic ducts are blocked due to a variety of conditions, and to alleviate the blockage.

Currently, more than 500,000 ERCP duodenoscope procedures are performed annually in the United States. 6

Using this kind of scope also allows a surgeon to visually examine tissues as well as insert instruments through the scope to obtain tissue samples, remove foreign objects and perform other endoscopy procedures.

A video camera in the scope enables the surgeon to view images on a TV-like monitor. Endoscopic and duodenoscopic procedures are minimally invasive because no incisions need to be made on the outside of the body to gain access to affected tissues and organs. 7

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Reasons for Scope Procedures

Patients may have a endoscope procedure for a variety of reasons. These include:

  • Tumors
  • Gallstones and bile duct stones
  • Inflammation due to pancreatitis or another infection
  • Sphincters, or valves, in pancreatic or gallbladder ducts that won’t open the way they need to
  • Scarring. or sclerosis, of the ducts
  • Pseudocysts, which occur when fluid and tissue debris accumulate
  • Cirrhosis, late-stage scarring (fibrosis), of the liver
  • Gastroesophageal reflux disease (GERD), or acid reflux, symptoms include heartburn and regurgitation
  • Gastric ulcers
  • Esophageal or stomach cancer
  • Bile duct diseases
  • Pancreatic cancer 8
An ERCP is a specific type of endoscopic procedure. In this type of procedure, the endoscopist uses a duodenoscope to locate the ampulla of Vater (in the duodenum).

How Duodenoscopes Work

Duodenoscopes are specialized scopes that allow surgeons to look inside parts of the digestive tract. These highly flexible, lighted tubes with cameras on the end are inserted through the mouth. They can then weave down the throat and through the stomach until they reach the top of the small intestine, which is called the duodenum. 9

This intricate, complex scope allows surgeons to view not only to the front but also to the sides. Surgeons can also insert flexible instruments through the scope to diagnose and treat disorders of the digestive tract. 10

An ERCP is a specific type of endoscopic procedure. In this type of procedure, the endoscopist uses a duodenoscope to locate the ampulla of Vater (in the duodenum). This is the place in the digestive tract where the bile duct enters the small intestine.

The surgeon is then able to, among other actions, insert a tiny tube called a catheter through the scope and into the duct. Dye, along with a contrast agent, can be squirted into the bile system or pancreas and a special type of X-ray that conveys moving images, fluoroscopy, is used to visualize areas of blockage or other problems. 11

The scope procedure enables doctors to see the ducts of the bile system, gallbladder and pancreas in real time. Surgeons can then identify any problems and remove obstructions, widen channels, drain fluids, crush or remove gallstones, and perform other endoscopy procedures. 12

ERCP duodenoscopes also contain a movable “elevator” mechanism that allows for further manipulation of tissue in the gastrointestinal tract.

Endoscopy Risks

The most common risks associated with endoscopy procedures include bleeding, tearing of the tissues in the gastrointestinal tract, and infection. 13 Depending on your specific medical conditions, other endoscopy risks may also be present. In rare instances, patients may suffer an allergic reaction to the dyes used in scope procedures. 14

Perhaps of greatest concern is the risk of contracting a superbug infection, during a procedure with an ERCP duodenoscope, caused by CRE bacteria. In worst-case scenarios, patients have died from these drug-resistant bacteria. 15

ERCP duodenoscope manufacturers include Olympus, Fujifilm and Pentax Medical. The problem with these devices lies in the complexity of the scope’s design and its intricate, tiny parts. These parts can harbor bacteria that are hard to extricate.

CRE Bacteria and Superbug Infection

The FDA is taking a hard look at the dangers of endoscopy procedures, specifically the use of duodenoscopes. This scope is linked directly to superbug infections with CRE bacteria (carbapenem-resistant enterobacteriaceae), and, in severe instances, death. The FDA will be holding a meeting of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee on May 14 and 15 to discuss duodenoscopes, other endoscopes, and procedures for how they are cleaned and disinfected, a procedure known as “reprocessing.”

Superbug infections are considered a serious concern because as many as one out of two persons who contract CRE bacteria and develop an infection may die, and few treatment options are available. 16

ERCP duodenoscope manufacturers include Olympus, Fujifilm and Pentax Medical. The problem with these devices lies in the complexity of the scope’s design and its intricate, tiny parts. These parts can harbor bacteria that are hard to extricate.

Even if hospitals follow the manufacturer’s instructions on how to clean and sterilize these scopes between uses in different patients, it may not kill CRE bacteria. Patients may still be exposed to trace amounts of body fluids and tissue contamination from prior patients. 17

Superbug infections generally occur in patients while they are in hospitals, nursing home facilities and similar settings. Patients with compromised immune systems or who are otherwise weakened from illness are also more likely to contract infections. 18

Individuals whose care involves equipment such as ventilators (breathing machines) and catheters, as well as individuals taking certain antibiotics long-term, are at greater risk of being infected with CRE bacteria as well. Also at greater risk are people who have previously been diagnosed with an antibiotic-resistant infection. 19

Recognizing the danger of CRE infections, the FDA has released more rigorous guidelines for manufacturers of scopes and other reusable medical tools. The FDA will also be continuing to evaluate the safety of these instruments. 20

  1. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm; http://news.cancerconnect.com/u-s-fda-issues-warning-about-certain-type-of-endoscope/; http://www.nlm.nih.gov/medlineplus/ency/article/002360.htm 

  2. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm 

  3. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm 

  4. http://blogs.fda.gov/fdavoice/index.php/tag/medical-device/#sthash.Ma7Y763D.dpuf; http://blogs.fda.gov/fdavoice/index.php/tag/medical-device/; http://news.cancerconnect.com/u-s-fda-issues-warning-about-certain-type-of-endoscope/; http://www.californiahealthline.org/articles/2015/3/13/fda-issues-new-rules-for-reusable-devices-after-superbug-outbreak 

  5. http://my.clevelandclinic.org/health/diagnostics/hic_ERCP_Endoscopic_Retrograde_Cholangiopancreatography 

  6. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm 

  7. http://www.hopkinsmedicine.org/healthlibrary/test_procedures/gastroenterology/esophagogastroduodenoscopy_92,p07717/ 

  8. http://www.ncbi.nlm.nih.gov/pubmed/1746037; https://www.niddk.nih.gov/health-information/health-topics/diagnostic-tests/ercp/Pages/diagnostic-test.aspx; http://www.mayoclinic.org/diseases-conditions/cirrhosis/home/ovc-20187218; http://www.nlm.nih.gov/medlineplus/ency/article/007479.htm; http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3117521/; http://www.pancreasfoundation.org/ercp-endoscopic-retrograde-cholangiopancreatography/; http://www.ncbi.nlm.nih.gov/pubmed/15138127 

  9. http://www.nlm.nih.gov/medlineplus/ency/article/007479.htm 

  10. http://www.pancreasfoundation.org/ercp-endoscopic-retrograde-cholangiopancreatography/#sthash.8avGAbKS.dpuf; http://www.pancreasfoundation.org/ercp-endoscopic-retrograde-cholangiopancreatography/; http://www.nlm.nih.gov/medlineplus/ency/article/007479.htm 

  11. http://my.clevelandclinic.org/health/diagnostics/hic_ERCP_Endoscopic_Retrograde_Cholangiopancreatography; https://www.niddk.nih.gov/health-information/health-topics/diagnostic-tests/ercp/Pages/diagnostic-test.aspx 

  12. http://my.clevelandclinic.org/health/diagnostics/hic_ERCP_Endoscopic_Retrograde_Cholangiopancreatography; https://www.niddk.nih.gov/health-information/health-topics/diagnostic-tests/ercp/Pages/diagnostic-test.aspx; http://www.pancreasfoundation.org/ercp-endoscopic-retrograde-cholangiopancreatography/#sthash.8avGAbKS.dpuf; http://www.pancreasfoundation.org/ercp-endoscopic-retrograde-cholangiopancreatography/ 

  13. http://www.mayoclinic.org/tests-procedures/endoscopy/basics/risks/prc-20020363 

  14. http://www.hopkinsmedicine.org/healthlibrary/test_procedures/gastroenterology/esophagogastroduodenoscopy_92,p07717/ 

  15. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm190273.htm; http://www.cdc.gov/HAI/organisms/cre/ 

  16. http://www.cdc.gov/HAI/organisms/cre/; http://www.tuftshealthplan.com/providers/provider.php?sec=news&content=fda_safety_alert_duodenoscopes; http://blogs.fda.gov/fdavoice/index.php/tag/medical-device/#sthash.Ma7Y763D.dpuf; http://blogs.fda.gov/fdavoice/index.php/tag/medical-device/; http://www.asge.org/publications/publications.aspx?id=17913; http://www.usnews.com/news/business/articles/2015/03/12/fda-wants-more-info-on-scopes-linked-to-superbug-outbreaks; http://newsinhealth.nih.gov/issue/feb2014/feature1; http://www.californiahealthline.org/articles/2015/3/13/fda-issues-new-rules-for-reusable-devices-after-superbug-outbreak; http://news.cancerconnect.com/u-s-fda-issues-warning-about-certain-type-of-endoscope/ 

  17. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm190273.htm; http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm; http://www.reuters.com/article/us-fda-superbugs-panel-idUSKBN0M81QL20150312; http://www.cnn.com/2015/02/22/health/superbug-north-carolina/; http://www.californiahealthline.org/articles/2015/3/13/fda-issues-new-rules-for-reusable-devices-after-superbug-outbreak 

  18. https://newsinhealth.nih.gov/issue/feb2014/feature1 

  19. http://www.cdc.gov/HAI/organisms/cre/ 

  20. <http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm190273.htm; http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm; http://www.usnews.com/news/business/articles/2015/03/12/fda-wants-more-info-on-scopes-linked-to-superbug-outbreaks