FDA Warns Duodenoscope Manufacturers on Postmarket Surveillance Studies

By on 5:55 AM

The U.S. Food and Drug Administration (FDA) has issued warning letters to all three duodenoscope manufacturers.

The letters speak to the failure of Olympus, Fujifilm and Pentax to comply with a federal order concerning the conducting of postmarket surveillance studies to assess the effectiveness of reprocessing duodenoscopes.

In 2015, FDA issued the order to conduct the surveillance study to determine whether healthcare facilities could properly clean and disinfect the devices.

As part of the approved study plans, the three manufacturers are required to conduct a study to sample and culture reprocessed duodenoscopes in clinical use so they can learn more about issues that contribute to contamination. They are also required to conduct a human factors study to assess how effectively trained hospital staff are following the reprocessing instructions.

These orders were issued as part of the ongoing effort to prevent patient infections associated with contaminated duodenoscopes,

FDA states that, as of March 9, 2018:
  • Olympus failed to commence data collection;
  • Pentax and Fujifilm failed to provide sufficient data, as required for their respective studies, to sample and culture reprocessed duodenoscopes that are in clinical use; and
  • Olympus and Pentax did not comply with requirements for their respective human factors studies to assess how well staff are following reprocessing instructions.
Fujifilm has been meeting its human factors study requirements.

"The FDA has taken important steps to improve the reprocessing of duodenoscopes, and we've seen a reduction in reports of patient infections, but we need the required postmarket studies to determine whether these measures are being properly implemented in real world clinical settings and whether we need to take additional action to further improve the safety of these devices," said Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health, in a news release. "We expect these device manufacturers to meet their study obligations to ensure patient safety."

To learn more about the reprocessing issues concerning duodenoscopes, access this 2015 Infection Control Consulting Services special report on reprocessing medical devices.

Phenelle Segal, RN, CIC, FAPIC

Phenelle Segal, RN, CIC, FAPIC, is the founder and president of Infection Control Consulting Services LLC (ICCS). Phenelle has more than 30 years' experience providing customized comprehensive infection control and prevention services to healthcare facilities nationwide. Her services focus on assisting hospitals, ambulatory surgery centers, dental office and oral surgery practices, doctor's offices, nursing homes and other organizations with implementing and maintaining an infection control program that: complies with The Joint Commission, AAAHC, Centers for Medicaid and Medicare Services (CMS) and other regulatory agencies; respond to situations of noncompliance; and improve the processes for reducing risk.