Olympus, Fujifilm and Pentax Warned by FDA for Compliance Failures

By MedTech Intelligence Staff

The duodenoscope manufacturers didn’t comply with requirements to conduct postmarket surveillance studies assessing reprocessing effectiveness.

Last week FDA issued warning letters to three duodenoscope manufacturers for failure to comply with the requirement of conducting postmarket surveillance studies to evaluate the effectiveness of device reprocessing. In 2015 FDA ordered Olympus, Fujifilm and Pentax to conduct a postmarket surveillance study to assess whether healthcare facilities were properly cleaning and disinfecting the duodenoscopes. The study involved sampling and culturing reprocessed duodenoscopes in clinical use to get more information about what contributed to contamination; it also involved a human factors study to examine how well trained hospital personnel were following the reprocessing instructions.

According to a release FDA issued on Friday, Olympus failed to start data collection, and Pentax and Fujifilm did not provide sufficient data related to sampling and culturing the reprocessed duodenoscopes. In addition, Olympus and Pentax haven’t complied with the human factors study requirements.

“We expect these device manufacturers to meet their study obligations to ensure patient safety.” – Jeff Shuren, M.D., CDRH

By March 24 FDA expects Olympus, Fujifilm and Pentax to submit a plan outlining how study milestones will be achieved. The agency expects that 50% of the samples for the sampling and culturing study to be processed by August 31 and 100% of the samples by the end of the year. FDA also expects 50% of the testing for the human factors study to be completed by Olympus and Pentax by May 31 and 100% by June 30. “If the companies fail to adequately respond to the warning letter, the FDA may take additional action such as seizure, injunction and civil money penalties,” FDA stated.

Pentax Medical Recalls Certain Duodenoscopes


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