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.
Reusable devices have become more difficult to clean, disinfect and sterilize. FDA is now requiring clear instructions for effective reprocessing.
With the consent decree, the risk of financial death is very real.
Complexity of design and frequency of use play a large role in how effectively scopes are reprocessed.
The acting commissioner reflects on the agency’s achievements in the last year.
If complex medical devices such as endoscopes and duodenoscopes cannot be reprocessed safely, why is this practice permitted?
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.
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.