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FDA Orders Endoscope Manufacturers to Perform Safety Studies: How it Affects You

A number of healthcare facilities around the country have reported Carbapenem-resistant Enterobacteriaceae (CRE) infections in patients following endoscopy-related procedures.Many of  the recent infections occurred after patients underwent endoscopic retrograde cholangiopancreatography (ERCP), which uses a duodenoscope, a specialized endoscope that contains an elevator channel and other features that are challenging to properly disinfect, even when following manufacturer instructions. The Food and Drug Administration (FDA) recently ordered duodenoscope manufacturers to conduct post-marketing safety studies in healthcare facilities.2

In March 2015, the FDA released new guidelines for how reusable medical devices, such as scopes and catheters, should be cleaned.The Centers for Disease Control and Prevention (CDC) also released an interim duodenoscope surveillance protocol in March 2015 to assist hospitals in reducing the possibility of biofilm formation or other contamination on scopes, and validate the effectiveness of reprocessing by culturing key components.4

In the last three months, outbreaks of CRE and other multidrug resistant organisms have also been linked to gastroscopes, cytoscopes and bronchoscopes.The FDA has issued a warning about possible contamination of the reprocessing equipment used to clean endoscopes, as well as safety communications about difficulty properly cleaning duodenoscopes and bronchoscopes.6,7 A study published in the American Journal of Infection Control in August found that viable microbes and biologic debris persisted on colonoscopes and gastroscopes following cleaning and disinfection, indicating that following manufacturers’ instructions does not ensure successful decontamination even for devices that lack elevator channels.8

Tracking and Preventing the Spread of HAIs

With these recent developments, central processing and infection prevention departments should understand current recommendations for disinfection and/or sterilization of reusable medical devices. They can also minimize the spread of healthcare-associated infections (HAIs) from CRE or other pathogens by properly documenting equipment use and reprocessing and identifying colonized or infected patients.

Documentation should include when staff members were trained in cleaning and reprocessing procedures, verification of competence assessments at least annually and following every change in procedure, written and clearly displayed procedures for reprocessing reusable medical devices, and maintenance of logs providing the name and medical record number of the patient, the cleaning personnel, reprocessing equipment and cycle used and culture results following reprocessing.If an HAI potentially associated with a device is detected, these logs will enable the hospital to quickly identify the equipment used, patients exposed and potential problems with the device or disinfection procedures.



  1. CDC Statement: Los Angeles Couty/UCLA investigation of CRE transmission and duodenoscopes. Healthcare-associated infections. CDC. February 20, 2015.

  2. FDA orders duodenoscope manufacturers to conduct post market surveillance studies in health care facilities. FDA News Release. October 5, 2015.

  3. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Guidance for Industry and Food and Drug Administration Staff.

  4. Interim Duodenoscope Surveillance Protocol. Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing. CDC. Updated April 3, 2015.

  5. Peterson M. Serious infections tied to medical scopes go far beyond issues with single device. Los Angeles Times. August 2, 2015.

  6. Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) May Impeded Effective Cleaning: FDA Safety Communication. Updated March 4, 2015.

  7. Infections Associated with Reprocessed Flexible Bronchoscopes: FDA Safety Communication. September 17, 2015.

  8. Ofstead CL, Wetzler HP, Doyle EM, Rocco CK, Visrodia KH, Baron TH, Tosh PK. Persistent contamination on colonoscopes and gastroscopes detected by biologic cultures and rapid indicators despite reprocessing performed in accordance with guidelines. AJIC. August 1, 2015; 43(8):794-801.

  1. Endoscopy-Related CRE Outbreak Necessitates Improving Prevention Protocols. Executive Insight. Advance Healthcare Network. May 15, 2015.

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