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ERCP Duodenoscopes FDA News

The FDA has received multiple reports of adverse events related to ERCP duodendoscope procedures, including CRE illnesses, causing the agency to review the device and issue a safety communication for healthcare professionals and patients.

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The U.S. Food and Drug Administration (FDA) approved ERCP duodenoscopes for use in gastrointestinal endoscopy procedures in the 1990s.

Not until 2009 did the agency become aware of the device’s potential to harbor and spread the antibiotic-resistant bacteria now blamed for deaths and serious illnesses at hospitals in several states.

Superbug Outbreak

It was in 2009 that 16 patients in France became infected with a pathogen that appeared to be resistant to antibiotics. The outbreak began after the patients underwent ERCP duodenoscope procedures. 1

The FDA responded to news of this outbreak overseas by issuing a notice to American hospitals, doctors and other healthcare professionals in which they were alerted to the risk of infectious germs being passed from patient to patient via ERCP duodenoscopes. 2

Sterilization and Cleaning of Scopes

Around this same time, the FDA began investigating ways of improving the cleaning and disinfection or sterilization protocols of complex medical instruments in general, not just ERCP duodenoscopes. 3

In 2011, the agency held a public meeting to discuss the problem of properly cleaning and disinfecting or sterilizing medical devices. 4 That same year, the FDA published a draft guidance document to assist healthcare providers in their efforts to prevent bacterial infections spread by improperly cleaned and disinfected or sterilized devices. 5

The agency also began working with organizations that devise industry standards at both the U.S. and global levels to resolve the cleaning and disinfecting or sterilization issues surrounding ERCP duodenoscopes. 6

Also in 2013 and continuing into 2014, the FDA received numerous adverse event reports describing patients who had undergone ERCP duodenoscope procedures and developed serious illnesses caused by CRE, despite the devices having been cleaned and disinfected or sterilized in accordance with manufacturer recommendations.

CRE Bacteria and and Adverse Events

In 2013, the FDA was notified by the U.S. Centers for Disease Control and Prevention that it had firmly established that ERCP duodenoscopes could become contaminated with the pathogen carbapenem-resistant Enterobacteriaceae (CRE). 7

Also in 2013 and continuing into 2014, the FDA received numerous adverse event reports describing patients who had undergone ERCP duodenoscope procedures and developed serious illnesses caused by CRE, despite the devices having been cleaned and disinfected or sterilized in accordance with manufacturer recommendations. 8

The FDA spent much of 2013 acquiring insights about this phenomenon in an effort to properly understand the problem and be able to initiate appropriate actions in response. 9

During that time of information gathering, the agency reviewed documents from manufacturers as well as peer-reviewed journal articles. It also talked to hospital administrators and clinicians, leaders of medical professional societies, and others with a stake in the outcome. 10

FDA Issues Safety Communication

In addition, the FDA recommended that healthcare professionals inform patients of the potential risks of infection accompanying the use of ERCP duodenoscopes and that symptoms of infection “should prompt additional follow-up” after an ERCP procedure.

In February 2015, the FDA issued a “safety communication” to advise healthcare professionals and patients of the risks present in ERCP duodenoscope use, but has not immediately imposed new safety procedures. 11

Reuters, the international news service, reported in February 2015 that the FDA can, if it chooses, require manufacturers to redesign ERCP duodenoscopes and thereby eliminate the cleaning and disinfection or sterilization challenges healthcare providers currently face. 12

New Procedures for Cleaning ERCP Scopes

In March, 2015 the FDA released Updated Information for Healthcare Providers Regarding Duodenoscopes, in which it noted that one type of ERCP duodenoscope marketed by Olympus, the TJF-Q180V, still had its 510(k) application pending review by the FDA. In addition, the FDA recommended that healthcare professionals inform patients of the potential risks of infection accompanying the use of ERCP duodenoscopes and that symptoms of infection “should prompt additional follow-up” after an ERCP procedure.

The FDA says it will continue evaluating “alternative cleaning protocols, test antibiotic-resistant organisms to assess their susceptibility to high-level disinfectants and explore additional strategies to reduce the risk of infections, such as the use of surveillance cultures of duodenoscopes.” 13

On March 26, the FDA issued a new Safety Communication — New Reprocessing Instructions Validated for Model TJF-Q180V Duodenoscopes that indicated there are new and validated reprocessing instructions that have been issued by Olympus. There have been key changes to the processing procedures on precleaning, manual cleaning, and manual high level disinfection.

The FDA also includes recommendations for facilities and staff using and reprocessing the Olympus TJF-Q180V, including the implementation of new manual cleaning and high level disinfection procedures, which are to take effect immediately.

The FDA is also planning to convene an Advisory Committee Meeting on May 14-15 on the reprocessing of duodenoscopes and other endoscopes. Expert clinical and scientific opinions will be presented. The Committee will make recommendations regarding various aspects of cleaning these medical devices and the way it should be done for maximum effectiveness and patient safety.

  1. Sharon Begley and Toni Clarke, “FDA knew devices spread fatal ‘superbug’ but does not order fix,” Reuters, published at Business Insider, February 19, 2015, http://www.businessinsider.com/r-fda-knew-devices-spread-fatal-superbug-but-does-not-order-fix-2015-2
    . Accessed on March 2, 2015. 

  2. Sharon Begley and Toni Clarke, “FDA knew devices spread fatal ‘superbug’ but does not order fix,” Reuters, published at Business Insider, February 19, 2015, http://www.businessinsider.com/r-fda-knew-devices-spread-fatal-superbug-but-does-not-order-fix-2015-2. Accessed on March 2, 2015. 

  3. William Maisel, “Bacterial Infections Associated with Duodenoscopes: FDA’s Actions to Better Understand the Problem and What Can be Done to Mitigate It,” FDA Voice, February 23, 2015, http://blogs.fda.gov/fdavoice/index.php/2015/02/bacterial-infections-associated-with-duodenoscopes-fdas-actions-to-better-understand-the-problem-and-what-can-be-done-to-mitigate-it/. Accessed on March 2, 2015. 

  4. William Maisel, “Bacterial Infections Associated with Duodenoscopes: FDA’s Actions to Better Understand the Problem and What Can be Done to Mitigate It,” FDA Voice, February 23, 2015, http://blogs.fda.gov/fdavoice/index.php/2015/02/bacterial-infections-associated-with-duodenoscopes-fdas-actions-to-better-understand-the-problem-and-what-can-be-done-to-mitigate-it/. Accessed on March 2, 2015. 

  5. William Maisel, “Bacterial Infections Associated with Duodenoscopes: FDA’s Actions to Better Understand the Problem and What Can be Done to Mitigate It,” FDA Voice, February 23, 2015, http://blogs.fda.gov/fdavoice/index.php/2015/02/bacterial-infections-associated-with-duodenoscopes-fdas-actions-to-better-understand-the-problem-and-what-can-be-done-to-mitigate-it/. Accessed on March 2, 2015. 

  6. William Maisel, “Bacterial Infections Associated with Duodenoscopes: FDA’s Actions to Better Understand the Problem and What Can be Done to Mitigate It,” FDA Voice, February 23, 2015, http://blogs.fda.gov/fdavoice/index.php/2015/02/bacterial-infections-associated-with-duodenoscopes-fdas-actions-to-better-understand-the-problem-and-what-can-be-done-to-mitigate-it/. Accessed on March 2, 2015. 

  7. William Maisel, “Bacterial Infections Associated with Duodenoscopes: FDA’s Actions to Better Understand the Problem and What Can be Done to Mitigate It,” FDA Voice, February 23, 2015, http://blogs.fda.gov/fdavoice/index.php/2015/02/bacterial-infections-associated-with-duodenoscopes-fdas-actions-to-better-understand-the-problem-and-what-can-be-done-to-mitigate-it/. Accessed on March 2, 2015. 

  8. Sharon Begley and Toni Clarke, “FDA knew devices spread fatal ‘superbug’ but does not order fix,” Reuters, published at Business Insider, February 19, 2015, http://www.businessinsider.com/r-fda-knew-devices-spread-fatal-superbug-but-does-not-order-fix-2015-2. Accessed on March 2, 2015. 

  9. William Maisel, “Bacterial Infections Associated with Duodenoscopes: FDA’s Actions to Better Understand the Problem and What Can be Done to Mitigate It,” FDA Voice, February 23, 2015, http://blogs.fda.gov/fdavoice/index.php/2015/02/bacterial-infections-associated-with-duodenoscopes-fdas-actions-to-better-understand-the-problem-and-what-can-be-done-to-mitigate-it/. Accessed on March 2, 2015. 

  10. William Maisel, “Bacterial Infections Associated with Duodenoscopes: FDA’s Actions to Better Understand the Problem and What Can be Done to Mitigate It,” FDA Voice, February 23, 2015, http://blogs.fda.gov/fdavoice/index.php/2015/02/bacterial-infections-associated-with-duodenoscopes-fdas-actions-to-better-understand-the-problem-and-what-can-be-done-to-mitigate-it/. Accessed on March 2, 2015. 

  11. Sharon Begley and Toni Clarke, “FDA knew devices spread fatal ‘superbug’ but does not order fix,” Reuters, published at Business Insider, February 19, 2015, http://www.businessinsider.com/r-fda-knew-devices-spread-fatal-superbug-but-does-not-order-fix-2015-2. Accessed on March 2, 2015. 

  12. Sharon Begley and Toni Clarke, “FDA knew devices spread fatal ‘superbug’ but does not order fix,” Reuters, published at Business Insider, February 19, 2015, http://www.businessinsider.com/r-fda-knew-devices-spread-fatal-superbug-but-does-not-order-fix-2015-2. Accessed on March 2, 2015. 

  13. William Maisel, “Bacterial Infections Associated with Duodenoscopes: FDA’s Actions to Better Understand the Problem and What Can be Done to Mitigate It,” FDA Voice, February 23, 2015, http://blogs.fda.gov/FDAvoice/index.php . Accessed on March 2, 2015.