The U.S. Food and Drug Administration warned Olympus Corp., Fujifilm Holdings Corp. and Pentax Corp. for failing to undertake postmarket studies of their duodenoscopes.
The FDA said the manufacturers have yet to evaluate the risk of contamination and the effectiveness of reprocessing these devices, which are used during endoscopic retrograde cholangiopancreatography, a potentially lifesaving procedure to diagnose and treat problems in the pancreas and bile ducts.
In 2013, the FDA learned about a potential association between bacteria resistant to multiple drugs and duodenoscopes following a discovery that cases of infection were occurring despite confirmation that device users were following proper manufacturer cleaning and disinfection or sterilization instructions.
In 2015, the regulator ordered the companies to conduct a postmarket surveillance study to determine whether healthcare facilities were able to properly clean and disinfect the devices.
However, all three companies failed to provide the required data. Only Fujifilm has been meeting the requirements for its human factors study.
The FDA expects the duodenoscope manufacturers to submit a plan by March 24 that outlines how study milestones will be achieved. The FDA requires the companies to conclude the sampling and culturing study by the end of 2018. Olympus and Pentax have until June 30 to finish their human factors studies.
The agency said it may take additional action such as seizure, injunction and civil money penalties if the companies fail to adequately respond to the warning.
Although the FDA has seen a reduction in reports of patient infections related to duodenoscope use, the agency needs to verify that companies have been implementing the safety measures and if further steps are necessary, said Jeff Shuren, director of the agency's Center for Devices and Radiological Health.
