Failure to comply with FDA’s wishes landed three companies warning letters.
The duodenoscope manufacturers didn’t comply with requirements to conduct postmarket surveillance studies assessing reprocessing effectiveness.
The company’s ED-3490TK duodenoscopes require replacement of the forceps elevator mechanism and other parts.
The agency released a guidance document with product design recommendations to help prevent contamination from device components.
Complexity of design and frequency of use play a large role in how effectively scopes are reprocessed.
After an FDA expert panel held earlier this year, the agency is offering supplemental reprocessing measures.
Trading the potential health risk to a few patients versus the collective good of all patients is never acceptable. Even the experts are voicing concerns over the effectiveness of duodenoscope reprocessing.
Perhaps now is the time to truly weigh patient outcomes versus the risks associated with the reprocessing of duodenoscopes.
The new recommendations are outlined in a final industry guidance aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection.
As FDA recommended in its comments to healthcare, it is imperative that providers inform their patients of all risks. However, it is incumbent upon patients to become knowledgeable consumers and ask questions about any procedure they are being exposed to, including the use of instruments that may have been reprocessed.