FDA Warns Duodenoscope Manufacturers Over Studies

All three manufacturers of duodenoscopes in the US drew warning letters on Friday for failing to conduct postmarket surveillance studies and submit the data to the US Food and Drug Administration (FDA).

Following nationwide outbreaks of infections associated with bacteria transmitted to patients who underwent surgery with contaminated duodenoscopes over the past few years, the agency has “taken important steps to improve the reprocessing of duodenoscopes,” FDA Center for Devices and Radiological Health Director Jeff Shuren said in a statement. The reusable and flexible tubes are used during surgical procedures that can be potentially life-saving.

A major step FDA took to help address the problem involved its October 2015 orders on the three US manufacturers -- Olympus, Fujifilm Medical Systems, and Pentax Medical -- to report study findings of healthcare facilities’ ability to properly clean and disinfect their duodenoscopes...

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