Pentax is recalling all its ED-3490TK duodenoscopes, a type of specialized endoscope for diagnosing and treating problems in the pancreas and bile ducts, to replace parts and update the Operation Manual. The design changes are intended to reduce the risk of bacteria passing from patient to patient, which could lead to life-threatening infections.
Pentax issued an Urgent Medical Device Correction and Removal notification to its customers informing them that it would be replacing the forceps elevator mechanism, O-ring seal and distal end cap of the ED-3490TK duodenoscope to reduce the potential for leakage of patient fluids into the closed elevator channel and under the distal cap. The Operation Manual will also be updated to recommend annual maintenance.
The updated design and labeling for the device was officially approved by the Food and Drug Administration (FDA). The company added that the processing instructions for disinfecting the device have not been changed since the February 2016 update.
Duodenoscopes are specialized endoscopes with flexible, lighted tubes that are threated through the mouth, throat, and stomach into the tip of the small intestines, called the duodenum. The devices diagnose and treat severe, life-threatening diseases. But because of their design, bacteria can harbor in small crevasses even after thorough sterilizing and disinfecting. This has led to the spread of bacteria that has created outbreaks of serious bacterial infections in hospitals across the country.
The FDA continues to closely monitor the association between reprocessed endoscopes and the transmission of infectious agents, and has been working with manufacturers as they modify and validate their reprocessing instructions “to further enhance the safety margin in their devices and show a high degree of assurance that their reprocessing instructors, when followed correctly, effectively clean and disinfect the duodenoscopes,” the FDA said in a recall notice.
The FDA said it will continue to provide updates regarding duodenscopes as appropriate.
Source: FDA Recall Notice