Each year, there are more studies raising concerns about infections associated with endoscopic procedures and the techniques used to clean and sterilize or high-level disinfect (HLD) endoscopic devices.

This whitepaper, sponsored by Boston Scientific, epidemiologist Cori L. Ofstead, MSPH, President and CEO of Ofstead & Associates, St Paul, Minnesota, presents a real-world view of ureteroscope reprocessing effectiveness and what has happened since the Food and Drug Administration’s (FDA’s) letter to healthcare providers in April 2021.

The FDA, in its letter, says it wants to raise awareness among health care providers about the risk of infections associated with reprocessed urological endoscopes, including cystoscopes and ureteroscopes.

The agency also says it has received and is investigating numerous Medical Device Reports (MDRs) that describe post-procedure patient infections or other possible contamination issues associated with reprocessing.

The FDA emphasizes the importance of following the manufacturer’s labeling and reprocessing instructions for use (IFU) for these devices and their accessory components.