FDA orders duodenoscope manufacturers to conduct postmarket studies

Patient Safety Monitor Insider

October 14, 2015

Last week, the FDA ordered the manufacturers of duodenoscopes to conduct studies to better understand how the devices are being reprocessed in healthcare settings.

Olympus America, Inc., Fujifilm Medical Systems, USA, Inc., and Hoya Corp. have 30 days to submit plans describing how they will conduct the studies, with an emphasis on how healthcare professionals are following manufacturer instructions to clean and disinfect the scopes between patients.

The manufacturer’s studies are required to answer three important questions:

  1. Are the current user materials (e.g., instructional manuals, brochures, etc.) for reprocessing the duodenoscopes acceptable?
  2. What percentage of contamination exists after cleaning?
  3.  If contaminated material remains after cleaning, what additional steps are required to adequately decontaminate the device?

The results of the studies will help the FDA determine whether other administrative or regulatory actions are needed, including the possibility of new labeling with different reprocessing instructions.