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 infection.
In fall 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.
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.
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 system, 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.
The FDA has been working with federal partners, manufacturers, and other stakeholders to better understand the critical factors contributing to bacterial infections associated with duodenoscopes and how to best mitigate them. The FDA is actively monitoring this situation and continues to:
- 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. The FDA's communications are included in Additional Resources.
- 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 and manufacturers of Automated Endoscope Reprocessors (AERs) that reprocess duodenoscopes as stated in their labeling.
- Investigate firms that manufacturer duodenoscopes (Olympus, Fuji, Pentax). The FDA issued 483s and Warning Letters describing violations to the Federal Food, Drug and Cosmetic Act to all three manufacturers and 510(k) status letters to two duodenoscope manufacturers (Fuji and Pentax).
- Evaluate the effectiveness of current duodenoscope reprocessing instructions in health care settings. On October 5, 2015, the FDA ordered the three companies that manufacturer duodenoscopes marketed in the U.S. (Olympus, Fuji, Pentax) to conduct 522 postmarket surveillance studies so the Agency can better understand how duodenoscopes are reprocessed in real-world settings
The FDA continues to evaluate additional strategies for mitigating infections associated with duodenoscopes that we can help support through collaborations with professional societies and federal partners. We are currently collaborating with:
- The Centers for Medicaid and Medicare Services (CMS) and The Joint Commission to strengthen health care facility adherence to duodenoscope reprocessing instructions.
- The CDC, the American Society for Microbiology (ASM) and other endoscope culturing experts to develop a validated culturing protocol that facilities can adopt as a best practice to reduce the risk of infections associated with duodenoscopes.
- Health care facilities and end users to understand their experiences implementing reprocessing protocols.
- In June 2015, FDA participated in a webinar sponsored by The Joint Commission to share the FDA’s past and ongoing activities and respond to end users’ questions related to duodenoscope reprocessing.
The FDA will provide additional information to the public as our investigation continues.
On May 14-15, 2015, the FDA convened the Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee Meeting 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.
Panel members comprised health care, consumer and industry representatives. Over the course of the two-day meeting, panel members heard presentations from the following stakeholders:
- Health care providers in the United States and other countries, notably the Netherlands, Canada and Australia
- FDA subject matter experts
- Federal partners, i.e. the CDC and Environmental Protection Agency (EPA)
- Industry and
- General public
Following two days of presentations, testimony and other input, panel participants were asked to answer six questions related to duodenoscope reprocessing to generate recommendations for all stakeholders, including the FDA. The questions focused on duodenoscope and AER safety and effectiveness, notably strategies to promote adherence to reprocessing instructions, the CDC’s Interim Duodenoscope Surveillance Protocol, and risk communication. From the Advisory Committee meeting discussions, potential strategies emerged in the following areas:
Manual Cleaning and Human Factors
Both panel members and meeting participants emphasized that manual cleaning prior to disinfection or sterilization is critical to effective reprocessing. To ensure that manual cleaning is performed consistently and accurately, the panel recommended:
- strengthening competency training for reprocessing staff in health care facility reprocessing units; and
- incorporating Human Factors testing when developing reprocessing instructions
It is important to consider the device, end user and use environment when developing reprocessing instructions. 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. Based on the panel’s recommendation, the FDA is considering the role of Human Factors testing in the development of reprocessing instructions as part of premarket assessment and review.
Meeting participants stressed the importance that duodenoscopes be designed to enable meticulous cleaning and disinfection or sterilization and urged industry to design duodenoscopes that enable thorough cleaning and effective reprocessing through device disassembly or disposable parts.
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.
The FDA is currently working with manufacturers to explore design innovations incorporating these features.
Microbiological Culturing of Duodenoscopes
Health care facilities may perform microbiologic culturing, which involves sampling duodenoscope channels and the distal end of the scope and culturing those samples to identify any bacterial contamination that may be present on the scope after reprocessing. At the Advisory Committee meeting, a number of health care facility representatives shared their experiences successfully implementing routine or periodic microbiological culturing.
In March 2015, the CDC released an Interim Duodenoscope Surveillance Protocol that includes duodenoscope sampling and culturing protocols, which can be used as a guide for health care facilities to assess the adequacy of their duodenoscope reprocessing.
The panel discussed CDC’s Interim Duodenoscope Surveillance Protocol 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.
The FDA is working with CDC, ASM and other endoscope culturing experts to develop a validated culturing protocol.
Supplemental Measures to Enhance Duodenoscope Reprocessing
At the Advisory Committee meeting, representatives from several health care facilities and the panel discussed additional strategies that they have implemented to reduce the risk of infection transmission, such as: microbiological culturing, sterilization, use of a liquid chemical sterilant processing system and repeat high-level disinfection. In each case, staff applied these supplemental methods in addition to meticulous cleaning as part of strict adherence to the manufacturer’s reprocessing instructions.
The FDA’s August 2015 Safety Communication provides a list of supplemental duodenoscope reprocessing measures that emerged from the Advisory Committee 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.
We recognize that not all health care facilities can implement one or more of these measures, which require specific resources, training, and expertise. Therefore, it is critical that staff responsible for reprocessing duodenoscopes have the manufacturer’s instructions readily available to promote strict adherence to the reprocessing instructions in the device labeling, understand the importance of their role in reprocessing the device, and maintain proficiency in performing these reprocessing tasks. While the risk of infection transmission cannot be completely eliminated, the benefits of these devices continue to outweigh the risks in appropriately selected patients.
FDA Correspondence to Duodenoscope Manufacturers
- 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(PDF - 604KB)
- Hoya (Pentax) Corp 510k Status Letter - August 12, 2015 (PDF - 449KB)
- Olympus 510(k) status letter - March 18, 2014 (PDF - 391KB)
FDA Communications on Duodenoscopes
- Olympus Validates Reprocessing Instructions for Duodenoscope Models TJF-160F and TJF-160VF: FDA Safety Communication (3/15/2016)
Olympus Customer Notification Letter to TJF-160F/VF Customers (3/14/2016)
- FDA clears Olympus TJF-Q180V duodenoscope with design modifications intended to reduce infection risk. FDA News Release. (1/15/2016)
- FDA orders duodenoscope manufacturers to conduct postmarket surveillance studies in health care facilities: FDA News Release (10/5/15)
- Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication (8/4/15)
Updated Information for Healthcare Providers Regarding Duodenoscopes(PDF - 219KB) Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication
- FDA Voice Blog: Bacterial Infections Associated with Duodenoscopes: FDA’s Actions to Better Understand the Problem and What Can be Done to Mitigate It
Updated Duodenoscope Reprocessing Instructions
- PENTAX Validates Reprocessing Instructions for ED-3490TK Video Duodenoscopes: FDA Safety Communication, February 19, 2016
- PENTAX Customer Notification Letter to ED-3490TK Customers, February 19, 2016
FUJIFILM Medical Systems, U.S.A., Inc. Validates Revised Reprocessing Instructions for Model ED-530XT Duodenoscopes: FDA Safety Communication Fuji Customer Notification Letter to ED-530XT duodenoscope customers. December 23, 2015. Fuji Customer Notification Letter to 250 and 450 duodenoscope customers. December 23, 2015.
- 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