Letter to the Editor: Did the FDA Say Duodenoscopes Were Safe? Part 2

A post on February 24, 2016 by PSQH was headlined “FDA: Duodenoscopes from three major companies now safe to use with updated instructions.”  The article went on to say that “The announcement means that scopes from the three major manufactures…are now safe to use with their updated instructions.” However a proper reading of the FDA announcement shows that the FDA was much more constrained in its wording than PSQH.

For example, with respect to one such announcement the FDA did not even use the word “safe” (although it was posted as Safety Communication). What the FDA more carefully said was that “The FDA reviewed these updated reprocessing instructions and the validation data and recommends that facilities using PENTAX ED-3490TK Video Duodenoscopes train staff on the updated instructions and implement them as soon as possible.” In this regard the FDA also noted that its effort has been to “further enhance the safety margin of their devices and show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes.” A further enhancement of the safety margin is certainly a good thing, but it doesn’t make them safe. Also a high degree of assurance leaves a low probability of lack of assurance, especially in the context of reliance on instructions and following them correctly. Note that the design of the devices themselves have not been made any more safe. 

Validation data and updated instructions are important in enhancing safety but they do not by themselves make devices safe. Moreover the emphasis on training, and in turn staff compliance, means that for given designs the safety or lack thereof continues to be in the hands of the reprocessors.

More generally, it is important for readers to understand what it is that the FDA does, and what their actions are based on. For the most part this focuses on manufacturer supplied information. And if the FDA carefully avoided using “safe” or “approved,” news sources should not insert these loaded words, and end users should not be too quick to think that a problem has been solved.

William Hyman is professor emeritus of biomedical engineering at Texas A&M University. He now lives in New York, where he is adjunct professor of biomedical engineering at The Cooper Union.

Editor’s Note: We updated the original piece to correct the impression the FDA said duodenoscopes are safe to use with the release of updated reprocessing instructions. You can read the updated post here.