FDA Requires Duodenoscope Makers to Conduct Safety Studies

After Personal Injuries Associated with Duodenoscopes, FDA Requires 3 Manufacturers to Conduct Post-Market Safety Studies

Duodenoscope Defective Medical DeviceAfter several hospitals in the US reported superbug infections in patients after duodenoscope procedures, the FDA has investigated the potential causes of the infection spread, and recently ordered three major duodenoscope manufacturers to conduct post-market studies regarding the safety of the devices.

When superbug outbreaks began, investigators initially blamed hospitals, claiming that the facilities were not properly cleaning their surgical equipment. However, hospitals retaliated, saying that they followed all federal and state safety guidelines to protect their patients. The duodenoscopes, used in procedures to diagnose problems in the gallbladder, liver, pancreas, and biliary systems, were difficult to clean, according to hospital representatives.

Now, FDA investigators believe that duodenoscopes have significant design flaws that allow infectious diseases to remain on the device, and infect other patients with potentially deadly bacteria.

“The FDA has undertaken an in-depth investigation into the factors that may play a role in infection transmission associated with duodenoscopes, and is now requiring manufacturers to study the devices in the clinical setting where they are being used,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health.

Until recently, duodenoscopes have been considered one of the safest, least-invasive methods to diagnose digestive tract problems. Over 500,000 ERCP procedures are performed annually in the US. However, duodenoscopes were linked to two patient deaths after ERCP procedures earlier this year at Ronald Reagan UCLA Medical Center in Los Angeles, California. The wrongful deaths launched the FDA’s investigation.

The three duodenoscope manufacturers under FDA review are Olympus America, Inc; Fujifilm Medical Systems, USA, Inc; and Hoya Corp. The FDA will require these medical device manufacturers to perform real-world post-market surveillance studies involving duodenoscopes, patient safety, and device cleanliness. The manufacturers have one month – 30 days – to create a test plan and submit their study strategy to the FDA for review. The proposals must detail all aspects of the study plan, including how well healthcare personnel can follow the manufacturer’s instructions to clean and disinfect the duodenoscopes between procedures. The FDA’s review pointed toward problems with the duodenoscope designs, as well as issues with healthcare professionals cleaning the devices properly, “as these instructions are labor intensive and prone to human error,” according to investigators.

“However, the results of the postmarket surveillance studies could help inform the FDA’s next steps and future risk mitigation strategies, such as informing new labeling for the devices to include different reprocessing instructions or other administrative or regulatory actions necessary to protect the public health,” the agency said.

Personal injuries and wrongful deaths due to superbug infections are becoming more common – in part because bacteria have begun developing more resistance to antibiotics and standard cleaning solutions. If duodenoscope design allows bacteria to remain in difficult-to-reach crevices on the device, or the cleaning instructions are too difficult to follow, then patients are at higher risk of developing an infection, especially from antibiotic-resistant bacteria. While the healthcare industry debates best procedures to prevent superbug transmission and subsequent patient reinfection, personal injury, or death, medical device manufacturers must also make their internal-use devices simpler to clean and re-use.



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