In March 2018, the FDA sent warning letters to the leading manufacturers of duodenoscopes: Olympus Corp., Fujifilm Medical Systems, and Pentax of America. In each case, the FDA said the companies had failed to comply with requirements under section 522 of the Federal Food, Drug and Cosmetic Act and Title 21 of the Code of Federal Regulations (CFR) Part 822. The FDA told the manufacturers that they had not conducted postmarket surveillance on their duodenoscopes. The surveillance order was needed “because failure of these devices would be reasonably likely to cause infection and possibly death in patients undergoing endoscopic retrograde cholangiopancreatography procedures,” the letters said. The companies were told to take specific steps to correct the noted violations, document those corrective actions, and send information to the FDA. Learn more by reading our online coverage at: http://bit.ly/2pxWWPk.
Agency told three leading manufacturers that they had not conducted postmarket surveillance on their duodenoscopes. The companies were told to take specific steps to correct the noted violations, document those corrective actions, and send information to the FDA.
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