Duodenoscopes are lighted tubes used to diagnose and treat digestive issues. While duodenoscopes offer many benefits, they have also been known to cause serious health issues.

A year ago, those in the medical community were alerted to an issue with the PENTAX ED-3490TK duodenoscope. Many duodenoscopes, including the PENTAX ED-3490TK, were linked to bacterial infections due to the design making it difficult to clean and disinfect. As a result, in February 2016, PENTAX updated cleaning instructions for its ED-3490TK Video Duodenoscope.

Subsequently, PENTAX became aware of additional information and informed the Food and Drug Administration (FDA) about further design flaws. The adhesive that seals the distal cap to the tip is prone to gaps and cracks. Because its flawed design makes it difficult to keep clean, bacteria can easily grow between those gaps and cracks. This can lead to infections that spread from patient to patient.

On January 17, 2017, PENTAX released a Customer Notification Letter. This letter – sent to affected healthcare professionals – includes the following information:

  • Explanation of the design issue and the potential for risk of infection
  • PENTAX’s strategy to inspect the distal cap of all ED-3490TK duodenoscopes
  • Recommendations for preventing infection, such as closely inspecting duodenoscopes and remove those that show signs of damage
  • Importance of following the reprocessing instructions on the device label
  • Support to health care professionals who have questions or concerns

FDADespite this recent communication, there are no changes to the validated manual reprocessing procedures outlined in the FDA Safety Communication of February 2016. Healthcare providers should now be able to effectively clean and disinfect all parts of the duodenoscope, including the elevator area, channels and exterior of the device. When meticulously followed each and every time, these instructions should reduce the risk of contamination through the duodenoscope.

It is also recommended that health care providers do the following:

  • Implement PENTAX’s validated reprocessing instructions and train appropriate staff.
  • Immediately remove any duodenoscope that shows signs of damage. Damage may include the following:
    • Loose parts
    • Bends or kinks in tubing
    • Damaged channel walls
    • Holes in the distal end
  • Gaps and cracks in the adhesive that seals the distal cap
  • Contact your PENTAX Medical sales representative for training or service as needed.

The FDA is doing its part to keep the public safe by working closely with duodenoscope manufacturers as they update recommendations. The agency also provides important information to health care professionals and asks that any adverse events be reported promptly so they can be investigated.

The Law Firm of Nadrich & Cohen, LLP continues to actively investigate duodenoscope infection claims throughout the country.