Infections Associated with Reprocessed Duodenoscopes
Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum). They are used during endoscopic retrograde cholangiopancreatography (ERCP), a potentially life-saving procedure to diagnose and treat problems in the pancreas and bile ducts. In the United States, duodenoscopes are used in more than 500,000 ERCP procedures each year.
Duodenoscopes are complex instruments that contain many small working parts. If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient. In rare cases, this can lead to patient-to-patient transmission of infection.
In the fall of 2013, the Centers for Disease Control and Prevention (CDC) alerted the FDA to a potential association between multi-drug resistant bacteria and duodenoscopes. Upon further investigation, it became clear that these cases of infection were occurring despite confirmation that the users were following proper manufacturer cleaning and disinfection or sterilization instructions.
Ensuring the safety of reprocessed medical devices for use in multiple patients is a shared responsibility among the FDA and other federal agencies, public health systems, state and local health departments, medical device manufacturers, health care facilities, professional societies and others. The FDA is actively engaged with many of these stakeholder groups to better understand the causes and risk factors for transmission of infectious agents and develop solutions to minimize patient exposure.
FDA's Ongoing Activities Related to Duodenoscopes
Duodenoscopes are critical to diagnosing and treating severe, often life-threatening diseases. While the overwhelming proportion of procedures with these devices are carried out safely and effectively, the FDA takes the risk of infection very seriously and is working intensively to address it.
|June 30, 2022||The FDA updated the April 2022 Safety Communication to share new information. Fujifilm has completed the sampling and culturing study for the ED-580XT. Final results for this newer model duodenoscope indicate that 0% of samples tested positive for enough low concern organisms to indicate a reprocessing failure and only 1.1% tested positive with high concern organisms. This is better than the 4 to 6% high concern organism contamination observed with similar types of older model duodenoscopes. The FDA’s conclusion remains the same, that use of the newer models of duodenoscopes can reduce the risk of infection for patients, compared to the older fixed endcap duodenoscope models.|
|April 5, 2022||
The FDA issued a Safety Communication to provide new information supporting the transition to fully disposable duodenoscopes and those with disposable components as well as new information on completed postmarket surveillance studies.
The Safety Communication also stated the Warning Letters issued to all three manufacturers (Fujifilm Medical Systems USA, Inc, Olympus Medical Systems Corporation, and Pentax of America) who make duodenoscopes sold in the U.S. are closed.
|Nov 6-7, 2019||The FDA convened a meeting of the Medical Devices Advisory Committee to seek expert scientific and clinical opinion related to reprocessing of duodenoscopes based on available scientific information. Meeting materials, including presentations and a meeting summary, are available on the FDA's panel website.|
|August 29, 2019||
The FDA issued a Safety Communication to provide an update on the mandated postmarket surveillance study results for duodenoscopes used in ERCP since the April 2019 Safety Communication.
This Safety Communication also provided additional FDA recommendations and updates including:
|April 12, 2019||
The FDA issued a Safety Communication to provide an update on the postmarket surveillance study results for duodenoscopes used in Endoscopic Retrograde Cholangiopancreatography procedures (ERCP) since the December 2018 Safety Communication.
The FDA also reminded health care facilities about the importance of strictly adhering to the manufacturer's reprocessing and maintenance instructions, following best practices, and reporting adverse event information to the FDA.
|December 10, 2018||
The FDA issued a Safety Communication to provide interim results from the ongoing mandated postmarket surveillance studies of duodenoscopes reprocessing.
|March 9, 2018||The FDA issued Warning Letters to all three manufacturers (Fujifilm Medical Systems USA, Inc, Olympus Medical Systems Corporation, and Pentax of America), who make duodenoscopes sold in the U.S. for failure to provide sufficient data to address the postmarket surveillance studies requirements under Section 522 of the Federal Food, Drug, and Cosmetic Act (the Act). All three manufacturers responded to the warning letters and submitted plans that outlines how study milestones will be achieved including enrolling new sites and collecting samples.|
|February 26, 2018||The FDA, Centers for Disease Control and Prevention (CDC), and American Society for Microbiology (ASM), together with other endoscope culturing experts, released voluntary standardized protocols for duodenoscope surveillance sampling and culturing. These protocols are an update to the Interim Duodenoscope Surveillance Protocol released by CDC in March 2015, and address the concerns regarding validation of duodenoscope culturing protocols raised in ASM's April 2015 Policy Statement on Culturing of Duodenoscopes. For health care facilities that choose to implement duodenoscope surveillance sampling and culturing, these protocols can be used to help monitor the quality of a facility's endoscope reprocessing procedures. Adequate monitoring may reduce the risk of infection.|
|February 7, 2018||The FDA issued a Safety Communication to provide an Updated Status of Pentax Medical Duodenoscope Model ED-3490TK.|
|September 20,2017||The FDA clears the Pentax ED34-i10T model duodenoscope with a disposable cap, a new feature that will improve access for cleaning and reprocessing.|
|July 21, 2017||The FDA issues a Safety Communication to provide an Updated Status of FUJIFILM Medical Systems, U.S.A., Inc Model ED-530XT Duodenoscopes.|
|January 13, 2017||The FDA issues a Safety Communication to amplify FUJIFILM Medical Systems, U.S.A., Inc. removal of certain older duodenoscope models from clinical use.|
|January 15, 2016||The FDA clears Olympus TJF-Q180V duodenoscope with design modifications intended to reduce infection risk.|
|October 5, 2015||The FDA ordered each U.S. duodenoscope manufacturer (Olympus, Fujifilm and Pentax) to conduct postmarket surveillance studies ("522 study") to better understand how these devices are reprocessed in real-world settings and the resulting contamination rates. Postmarket surveillance studies are important tools for collecting useful data about a device that can reveal unforeseen adverse events, the actual rate of anticipated adverse events, or other information necessary to protect public health.|
|August 4, 2015||The FDA issues a Safety Communication to provide supplemental measures to enhance duodenoscope reprocessing.|
|May 14-15, 2015||
The FDA convened the Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee to seek expert scientific and clinical opinion related to reprocessing of duodenoscopes based on available scientific information. Meeting materials, including presentations and a meeting summary, are available on the FDA's panel website.
From the Advisory Committee meeting discussions, potential strategies emerged in the following areas:
1. Manual Cleaning and Human Factors
It is important to consider the device, end user and use environment when developing reprocessing instructions. Thus, Human Factors testing plays an important role in ensuring that end users will be able to understand and correctly follow the reprocessing instructions in the labeling. The FDA's Reprocessing Final Guidance introduces Human Factors and provides recommendations regarding Human Factors in developing reprocessing instructions.
2. Device Design
Based on the FDA's experience reviewing reprocessed devices and research conducted by the Agency and others, the FDA has identified design features that facilitate cleaning, disinfection and sterilization and reduce the likelihood of retaining debris, which are outlined on the Factors Affecting Quality of Reprocessing webpage.
3. Microbiological Culturing of Duodenoscopes
The panel discussed CDC's Interim Duodenoscope Surveillance Protocol that was released in March 2015 and recommended that additional data and validation testing is needed to demonstrate the methodology is robust and demonstrates consistent and reliable culturing results before health care facilities can incorporate as a best practice.
4. Supplemental Measures to Enhance Duodenoscope Reprocessing
The FDA's August 2015 Safety Communication provides a list of supplemental duodenoscope reprocessing measures that emerged from the Panel meeting. Hospitals and health care facilities that utilize duodenoscopes can, in addition to meticulously following manufacturer reprocessing instructions, take one or more of these additional steps to further reduce the risk of infection and increase the safety of these medical devices.
|February 19, 2015||The FDA issued a Safety Communication to raise awareness among health care professionals, including those working in reprocessing units in health care facilities, that the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing.|
The FDA continues to:
- Encourage innovative device designs to make it possible to transition away from fixed endcap duodenoscopes to those with more modern design features that facilitate or eliminate the need for reprocessing.
- Learn about the challenges with current reprocessing methods and supports expanding the types of validated methods available to reprocess duodenoscopes.
- Evaluate information from multiple sources, including medical device adverse event reports submitted to the FDA, the medical literature, the health care community, professional medical societies, international public health agencies, federal partners and state and local governments.
- Communicate recommendations to health care providers and end users to mitigate the risk associated with infection transmission.
- Work with industry as they modify and validate their reprocessing instructions to enhance the safety margin of the methods used to clean, disinfect and sterilize the duodenoscope, specifically all three companies that manufacture duodenoscopes marketed in the US and manufacturers of Automated Endoscope Reprocessors (AERs) marketed in the US that reprocess duodenoscopes as stated in their labeling.
- Evaluate the effectiveness of current duodenoscope reprocessing instructions in health care settings.
- Collaborate with health care facilities, professional societies and federal partners to evaluate additional strategies for mitigating infections associated with duodenoscopes.
The FDA will continue to provide additional information to the public as new information becomes available.
FDA Correspondence to Duodenoscope Manufacturers
- Warning Letter - Hoya (Pentax) Corporation 3/9/18
- Warning Letter - Olympus Corporation of the Americas 3/9/18
- Warning Letter - Fujifilm Medical Systems U.S.A., Inc. 8/12/15
- Warning Letter - Hoya (Pentax) Corporation 8/12/15
- Warning Letter - Olympus Corporation of the Americas 8/12/15
- Fujifilm Medical Systems U.S.A., Inc., Wayne, NJ, 483 Issued 4-20-2015 (PDF - 535KB)
- Aizu Olympus Co. Ltd - Aizuwakamatsu-City, Fukushima, Japan - 483 Issued 04-17-2015 (PDF - 1.1MB)
- Fujifilm - Ashigarakami Gun, Japan - 483 Issued 05-01-2015 (PDF - 843KB)
- Fujifilm - Hitachiomiya City, Japan - 483 Issued 04-20-2015 (PDF - 362KB
- FujiFilm Optics Co - Sano City, Tochigi, Japan - 483 Issued 04-22-2015 (PDF - 544KB)
- Hoya (Pentax) Life Care Division - Kurihara-shi, Miyagi, Japan - 483 Issued 04-24-2015 (PDF - 1.1MB)
- Hoya (Pentax) Corp - Akishima-shi, Japan - 483 Issued 04-21-2015 (PDF - 2.4MB)
- Olympus Medical Systems Corp - Hachioji-Shi, Japan - 483 Issued 04-24-2015 (PDF - 558KB)
- Fujifilm Corp 510k Status Letter - August 12, 2015
- Hoya (Pentax) Corp 510k Status Letter - August 12, 2015 (PDF - 449KB)
- Olympus 510(k) status letter - March 18, 2014
Updated Duodenoscope Reprocessing Instructions
- UPDATE: Importance of Following Validated Reprocessing Instructions for PENTAX ED-3490TK Video Duodenoscopes: FDA Safety Communication (1/17/2017)
- Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes: FDA Safety Communication
- Letter dated March 26, 2015 to health care facilities and other users of the TJF-Q180V Duodenoscope