On January 17, 2017, the FDA provided an important update to its February 19, 2016, Safety Communication, informing users about a design issue with the PENTAX ED-3490TK duodenoscope that could increase the risk of patient infection. This communication contained updated recommendations to help prevent the spread of infection associated with the use of these devices.
In February 2016, PENTAX issued updated, validated manual reprocessing instructions for the ED-3490TK Video 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 Video Duodenoscopes train staff on the updated instructions and implement them.
Following the FDA’s issuance of the February 2016 Safety Communication, PENTAX provided the FDA with additional information related to a potential risk associated with the design and manufacturing of the ED-3490K duodenoscope. Cracks and gaps in the adhesive that seals the device’s distal cap to its distal tip can occur, which can lead to microbial and fluid ingress. These areas can be challenging to clean and high-level disinfect, and may increase the risk of infection transmission among patients.
To inform their customers of this issue, PENTAX distributed a Customer Notification Letter on January 17, 2017. The customer letter (1) explained the design issue and described the potential for infection risk associated with the ED-3490TK duodenoscope, (2) outlined PENTAX’s strategy to closely inspect the distal cap area of all customers’ ED-3490TK duodenoscopes, (3) stressed the importance of following the reprocessing instructions according to the device label, and (4) recommended that users closely inspect their duodenoscope and remove from use duodenoscopes that show signs of physical damage.
The validated manual reprocessing procedures for the ED-3490TK duodenoscope outlined in the February 2016 Safety Communication remain the same. Health care facilities should continue to meticulously follow these validated instructions when reprocessing Pentax’s ED-3490TK duodenoscopes, paying close attention to any physical damage. These reprocessing instructions, when followed correctly, are intended to effectively clean and high-level disinfect the duodenoscope channels, elevator area, and exterior, and should reduce the risk of device contamination.
In addition to the recommendations in the February 2016 Safety Communication, the FDA also recommended that facilities and staff that use and reprocess PENTAX’s ED-3490TK Video Duodenoscope take four actions. First, facilities and staff that use and reprocess PENTAX’s ED-3490TK Video Duodenoscope should implement the reprocessing procedures for the devices in accordance with the manufacturer’s reprocessing instructions issued in February 2016. In lieu of manual high-level disinfection, facilities may opt to use the ED-3490TK Video Duodenoscope with an Automated Endoscope Reprocessor (AER) that has provided validation data and test reports to FDA that demonstrate acceptable high-level disinfection or liquid chemical sterilization of duodenoscopes. Second, facilities and staff that use and reprocess PENTAX’s ED-3490TK Video Duodenoscope should immediately remove from service for assessment, and repair or replace any duodenoscope that shows visible signs of damage. Examples of damage may include: loose parts, damaged channel walls, kinks or bends in tubing, holes in the distal end, cracks and gaps in the adhesive that seals the device’s distal cap or other signs of wear or damage. Third, facilities and staff that use and reprocess PENTAX’s ED-3490TK Video Duodenoscope should train appropriate staff on PENTAX’s validated reprocessing instructions and implement them. Fourth, facilities and staff that use and reprocess PENTAX’s ED-3490TK Video Duodenoscope should contact their PENTAX Medical sales representative to arrange for an assessment of in-servicing and training needs with respect to the validated duodenoscope reprocessing procedures.
See the FDA Safety Alert
See the FDA Safety Communication
See the FDA’s Infections Associated with Reprocessed Duodenoscopes webpage
See also Medical Law Perspectives, October 2015 Report: Unclean, Unsterile, Unsafe: Risks of Injury from Unsterilized Medical Equipment
See also Medical Law Perspectives, April 2012 Report: Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous Territory
See also Medical Law Perspectives, January 2012 Report: Hospital-Acquired Infections: Who is Liable and Why
See the Medical Law Perspectives March 11, 2015, Blog: Uncleanable ERCP Duodenoscopes: Manufacturer, Hospital, and Physician Liability?