August 21, 2015
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FDA issues warning letters to duodenoscope manufacturers following 'superbug' outbreaks

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The FDA sent warning letters on August 12 to Pentax, Olympus and Fujifilm following inspections of their facilities which were prompted by the recent outbreaks of infections linked to duodenoscopes manufactured by the companies.

The warning letters issued to Pentax and Olympus said the companies 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. According to the letters, Pentax failed to submit reports for patients who developed carbapenem-resistant Enterobacteriaceae infections linked to their duodenoscopes (rather, their importer reported the information), and Olympus “became aware of [16 patients contracting Pseudomonas aeruginosa infections linked to their duodenoscopes] on May 16, 2012,” but failed to report the event until 2015.

The warning letters to Pentax and Fujifilm also said the companies failed to validate their reprocessing instructions.

In a separate letter, the FDA told Fujifilm “that a new 510(k) submission is required for the ED-530XT duodenoscope,” citing that “significant differences” from the ED-450XT5 duodenoscope invalidates the company’s determination that clearance from the latter model also applies to the former. The FDA sent a similar letter to Pentax regarding their ED-3670TK and ED-3490TK duodenoscopes.

The FDA asked the companies for a response within 15 business days detailing corrective actions and plans for preventing future violations.

“The FDA takes these violations very seriously and will continue to monitor these firms to ensure they take appropriate corrective action,” an FDA spokeswoman said in an email. “However, currently available information indicates that the benefits of these devices continue to outweigh the risks in appropriately selected patients.” 

References:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm458453.htm

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm458487.htm

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

http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM458554.pdf

http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM458552.pdf

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