Date Issued: February 7, 2018
Audience: Users and reprocessors of the Pentax Medical (Pentax) Duodenoscope Model ED-3490TK including:
- Gastrointestinal surgeons
- Endoscopy nurses
- Staff working in endoscopy reprocessing units in health care facilities
- Infection control practitioners
- Facility risk managers
Medical Specialties: Gastroenterology, Infection Control
Device: Pentax duodenoscope model ED-3490TK is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Purpose: The FDA is issuing this communication to provide updated status information about FDA clearance of a modified version of Pentax's ED-3490TK and to amplify Pentax's Urgent Medical Device Correction and Removal notification , issued on February 7, 2018.
Summary of Problem and Scope:
As noted in the FDA's February 2015 Safety Communication, the complex design of duodenoscopes may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. The FDA has been working with duodenoscope manufacturers as they modify and validate their reprocessing instructions to further enhance the safety margin of their devices and show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes.
In February 2016, Pentax issued updated, validated manual reprocessing instructions for the ED-3490TK Duodenoscope to replace those provided in the original device labeling. The FDA reviewed these updated reprocessing instructions and the validation data and continues to recommend that facilities using Pentax ED-3490TK duodenoscopes train staff on the updated instructions and implement them, if they have not already done so.
In January 2017, Pentax informed customers about a potential issue associated with the distal cap of the ED-3490TK and began a program to inspect all customers' ED-3490TK duodenoscopes. On February 7, 2018, Pentax issued an Urgent Medical Device Correction and Removal notification informing customers of its voluntary recall of all ED-3490TK duodenoscopes in order to replace the forceps elevator mechanism, O-ring seal and distal end cap, and to update the Operation Manual to recommend annual maintenance. The design changes are intended to reduce the potential for leakage of patient fluids into the closed elevator channel and under the distal cap. The FDA cleared the updated design and labeling for the ED-3490TK on February 7, 2018. The reprocessing instructions for the recently cleared ED-3490TK have not changed since the February 2016 update.
Recommendations for Health Care Facilities:
Based on currently available information, the FDA recommends health care facilities:
- Acknowledge Pentax's Urgent Medical Device Correction and Removal notification and identify affected products in your facility.
- Return the field correction response form.
- Indicate if you do NOT have any affected duodenoscopes or Operation Manuals.
- Upon receipt of the new Operation Manuals, remove and dispose of any older operation manuals in your facility.
- Be aware of the manual reprocessing procedures outlined in FDA's January 17, 2017, Safety Communication "UPDATE: Importance of Following Validated Reprocessing Instructions for Pentax-ED-3490TK Video Duodenoscopes."
- Continue to use these validated instructions when reprocessing Pentax ED-3490TK duodenoscope models. The validated reprocessing instructions, when followed correctly, are intended to effectively clean and high-level disinfect the Pentax ED-3490TK duodenoscope.
The FDA continues to closely monitor the association between reprocessed endoscopes and the transmission of infectious agents by:
- Working closely with duodenoscope and Automated Endoscope Reprocessor manufacturers as they validate their reprocessing instructions to a level adequate to clean and high-level disinfect duodenoscopes.
- Proactively communicating recommendations to health care providers and end users to help reduce the risk associated with infection transmission and reusable medical devices.
- Working with the health care community, professional societies, international public health agencies, federal partners, and state and local governments to investigate the association between reprocessed reusable medical devices and cases of bacterial infection in health care facilities.
Visit the FDA's Infections Associated with Reprocessed Duodenoscopes webpage for a complete listing of actions the Agency has taken on this issue. The Agency will continue to provide updates as appropriate.
Reporting Problems to the FDA:
Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with the use of medical devices. Health care providers should submit voluntary reports of the transmission of an infection due to an inadequately cleaned duodenoscope to the Agency via the Medical Device Reporting (MDR) process.
If a health care provider suspects bacterial contamination – either because of an increase in infections, or because of the results of bacterial surveillance culturing of duodenoscopes – we encourage the health care provider to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. User facilities participating in the FDA's Medical Product Safety Network (MedSun) should report all their device-related adverse events through the MedSun reporting site, not through MedWatch.
- FDA orders duodenoscope manufacturers to conduct postmarket surveillance studies in health care facilities (ARCHIVED)
- Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication (ARCHIVED)
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff (PDF - 805KB)
- Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication (ARCHIVED)
- Infections Associated with Reprocessed Duodenoscopes
- Information about Automated Endoscope Reprocessors (AERs) and FDA's Evaluation
If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV. 800-638-2041 or 301-796-7100.