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All Medical Procedures Come with Risk: Reusable Medical Devices

Terri Ackerman

Last updated: October 20, 2016 7:18 pm

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As safe and technologically advanced as medical procedures are today as compared with those performed decades or just years ago, patients still face a degree of risk. Procedures involving reusable medical devices, in particular, may expose patients to contaminated medical instruments. 1

Some commonly performed procedures involving reusable medical devices include the following:

  • Colonoscopy
  • Bronchoscopy
  • Endoscopic retrograde cholangiopancreatography (ERCP) 2

Colonoscopy

A colonoscopy is a medical procedure in which a physician examines the inside of a person’s colon and rectum using a colonoscope. A colonoscope is a long, thin, flexible tube. It has a very small camera and a light on one end. The examination can reveal irritation, abnormalities, ulcers, polyps, cancer and other diseased tissue. 3

Bronchoscopy

A bronchoscopy is an examination that allows a physician to see inside the lungs and airways. Using a bronchoscope, generally a thin, flexible tube roughly two feet in length, the physician can look for lung disease or abnormalities, such as cancer. Sometimes, the doctor can perform certain kinds of treatments during the exam. 4

Endoscopic Retrograde Cholangiopancreatography (ERCP)

This procedure allows a physician to examine the gallbladder, bile ducts, pancreas and liver using a specialized endoscope called a duodenoscope. The scope can reveal diseased or unhealthy tissue and other abnormalities. The doctor may also be able to perform some treatments during the procedure. 5

Multiple Use Medical Equipment Can Expose Patients to Contamination

According to the U.S. Food and Drug Administration (FDA), reusable medical devices, such as stethoscopes, surgical forceps and endoscopes, can “become soiled and contaminated with microorganisms. “ 6

FDA Instructs Manufacturers of Duodenoscopes to Study Devices Further

The FDA is looking into the safety of duodenoscopes and the potential for their “role in infection transmission.” After the FDA “identified evidence that duodenoscopes have contributed to the transmission of infections, including antibiotic resistant infections,” manufacturers of duodenoscopes have been ordered by the FDA to “study the devices in the clinical setting where they are being used.” 7

According to the FDA, evidence suggests that for duodenoscopes, the “complex design of the devices makes it difficult to remove contaminants compared to other types of endoscopes.” 8

Gastrointestinal Endoscopy Complications

According to the Mayo Clinic, although the risk of infection is low, gastrointestinal endoscopy complications are possible. These include the following:

  • Bleeding
  • Infection — risk increases when other procedures are performed simultaneously
  • Tearing of the gastrointestinal tract–risk increases when other procedures are performed simultaneously 9
  1. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ReprocessingofReusableMedicalDevices/ucm454636.htm 

  2. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ReprocessingofReusableMedicalDevices/ucm454636.htm 

  3. http://www.niddk.nih.gov/health-information/health-topics/diagnostic-tests/colonoscopy/Pages/diagnostic-test.aspx 

  4. https://www.nlm.nih.gov/medlineplus/ency/article/003857.htm 

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

  6. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ReprocessingofReusableMedicalDevices/default.htm 

  7. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465639.htm  

  8. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465639.htm 

  9. http://www.mayoclinic.org/tests-procedures/endoscopy/basics/risks/prc-20020363; http://www.hopkinsmedicine.org/healthlibrary/test_procedures/gastroenterology/esophagogastroduodenoscopy_92,p07717/