Product News and Recalls

FDA Orders Duodenoscope Makers to Surveil Devices in Hospitals

fda orders new standards on duodenoscopesThe U.S. Food and Drug Administration (FDA) recently ordered all three duodenoscope manufacturers marketing in the United States to conduct postmarket surveillance studies to assess how their devices are reprocessed (or cleaned) in “real-world settings.”

Duodenoscopes, a type of reusable medical device used in endoscopic procedures, have received a great deal of attention recently after being linked to several deaths and hundreds of infections at two L.A. medical centers. According to investigators, dangerous antibiotic-resistant bacteria were able to survive inside duodenoscopes due to their hard-to-clean design. In response, the FDA has cracked down on standards for reusable medical devices, and duodenoscope manufacturers have scrambled to release updated cleaning and maintenance instructions.

Now the FDA is requesting that the three duodenoscope manufactures selling their devices in the United States—Olympus America, Inc., Fujifilm Medical Systems, U.S.A., Inc., and Hoya Corp.—submit reports within 30 days detailing “their plans to conduct studies to evaluate, among other things, how well health care personnel are following instructions to clean and disinfect duodenoscopes between patients and to better understand the rate of contamination of clinically used duodenoscopes.” The agency hopes data collected from these postmarket studies will aid in lowering the number of infections transmitted by duodenoscopes during endoscopic procedures.

Do you believe you or someone you know was sickened by a contaminated duodenoscope? If so, contact the attorneys at Lopez McHugh today for a free consultation. We can help assess your legal options.