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FDA warns duodenoscope manufacturers to comply with postmarket studies

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The FDA announced it has issued warning letters to three duodenoscope manufacturers — Pentax, Olympus and Fujifilm — for failing to comply with a federal order to conduct postmarket surveillance studies of reprocessing procedures.

In 2015, the FDA ordered the companies to conduct studies to determine whether health care facilities could properly clean and disinfect the devices. According to the FDA, Olympus has not begun data collection, and Pentax and Fujifilm have not yet provided sufficient data. Olympus and Pentax allegedly have not complied with requirements for human factor studies that asses how well hospital staff are following reprocessing instructions for the devices. Fujifilm has been meeting the requirements for the human factor study, according to the FDA.

“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,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health said in an FDA news release. “We expect these device manufacturers to meet their study obligations to ensure patient safety.”

In an email to Healio Gastroenterology and Liver Disease, Olympus said it is reviewing the warning letter so they can directly respond to the FDA in a timely manner.

"Olympus takes this matter very seriously. We are committed to addressing the issues identified in the letter and are working diligently to provide the requested information," the company said in the statement. "As always, patient safety remains our top priority. We are committed to developing solutions for healthcare professionals that help improve clinical outcomes and enhance quality of life for patients."

Fujifilm offered the following statement in an email to Healio Gastroenterology and Liver Disease:

"The health and safety of patients are Fujifilm's number one priority, and we continually work with the FDA to ensure that our products and processes meet FDA requirements. Fujifilm is actively engaged in a 522 postmarket surveillance study and while certain milestones have been attained, on March 9, 2018, the FDA issued a Warning Letter noting failure to provide sufficient data and comply with requirements of certain aspects of the study. The FDA has not objected to the continued marketing of our products in the United States and we will continue to work to meet FDA requirements."

Pentax is also reviewing its letter and will respond to the FDA's timeline, the company said in a statement to Healio Gastroenterology and Liver Disease.

"Pentax Medical has been working closely with the FDA in developing the study plans and is committed to continuing to work with FDA to resolve the outstanding issues and complete the postmarket surveillance studies," the statement said.

Following the discovery of a potential link between multi-drug resistant bacteria and duodenoscopes in 2013, the FDA found that the cases were occurring even though users were following the correct manufacturer sterilization instructions.

In warning letters sent in August 2015, the FDA alleged that Pentax and Olympus failed to report knowledge that their duodenoscopes “may have caused or contributed to a death or serious injury” to the FDA within 30 days of receiving the information. Letters sent to Pentax and Fujifilm also said the companies failed to validate their reprocessing instructions.

The FDA has been working with the manufacturers to review reprocessing instructions, as well as remove and replace models that might have had faulty designs that made them difficult to clean.

The FDA expects Olympus, Fujifilm and Pentax to submit plans by March 24, 2018 that outline how they will achieve study milestones. In the sampling and culturing study, the FDA expects 50% of samples collected in the study to be processed by August 31, 2018 and 100% by the end of the year. For Olympus’s and Pentax’s human factor studies, the agency expects the companies to complete 50% of testing by May 31, 2018 and 100% by June 30, 2018. If the companies fail to adequately respond to the warning letter, the FDA said it may take additional action such as seizure, injunction and civil money penalties. - by Alex Young

References:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm600388.htm

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm458510.htm

Disclosure: Shuren is employed by the FDA.