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FDA Issues Warning Letter to Duodenoscope Manufacturers

Terri Ackerman

Last updated: October 20, 2016 7:23 pm

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On August 12, 2015, the U.S. Food and Drug Administration (FDA) sent warning letters to three duodenoscope manufacturers who distribute products in the United States. The manufacturers are Olympus, Fujifilm and Hoya Corporation (Pentax Life Care Division). 1

The FDA conducted inspections at the facilities of the three duodenoscope manufacturers and found that each had violated FDA good manufacturing practice requirements or otherwise deviated from FDA requirements.

Olympus Duodenoscope

Violations for Olympus were noted regarding the Olympus TJF Type Q-180V duodenovideoscope, and included failing to report to the FDA within 30 days after receiving or becoming aware of information suggesting a device it markets “may have caused or contributed to a death or serious injury…” According to the FDA, Olympus knew in May, 2012 that “16 patients contracted a Pseudomonas aeruginosa infection . . . which [in] some [cases] resulted in abscesses” after the use of its duodenoscope, but didn’t notify the FDA about the infections until 2015. 2

Fujifilm Duodenoscope

FDA inspectors found that some of the company’s devices were “adulterated” insofar as “the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements.”  The FDA noted Fujifilm had failed to “establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met” and failed to “establish and maintain procedures for implementing corrective and preventive action…” among other problems. 3

Hoya Corporation (Pentax Life Care Division) Duodenoscope

According to the FDA, after inspection of several of its facilities, the Pentax Life Care Division of Hoya Corporation was also found to have devices adulterated within the meaning of good manufacturing practice requirements. For example, the company “received complaints regarding foreign objects lodged in the channel of duodenoscopes after manual cleaning and reprocessing…” Though the company identified this hazard as “critical” it “did not address how mechanical obstructions should be handled by the user.” The company also failed to report to the FDA within 30 days regarding several antibiotic-resistant infections that occurred after use of its duodenoscopes. 4

FDA Continues to Investigate the Safety of Reprocessed Duodenoscopes

According to the FDA, the complex design of endoscopic retrograde cholangiopancreatography (ERCP) “endoscopes (also called duodenoscopes) may impede effective reprocessing . . . a detailed, multistep process to clean and disinfect or sterilize reusable devices 5.”

The FDA noted that recent reports have linked “multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly.” 6

The FDA is closely monitoring the association between reprocessed duodenoscopes and “the transmission of infectious agents.” In the meantime, the agency has advised personnel who oversee the reprocessing of duodenoscopes to do the following: 7

  1. “Meticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using AER [an automated endoscope reprocessor]. Raise and lower the elevator throughout the manual cleaning process to allow brushing of both sides.”
  2. “Implement a comprehensive quality control program for reprocessing duodenoscopes.”

Specialized Endoscopic Procedure Used to Diagnose and Treat Digestive Tract Conditions

Each year, more than 500,000 ERCP procedures using duodenoscopes are conducted in the United States. 8 An ERCP procedure is considered the least invasive method of “draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions.” 9

Duodenoscopes are a specific type of endoscope. During an ERCP procedure, these “flexible, lighted tubes . . . are threaded through the mouth, throat, stomach, and into the top of the small intestine (the duodenum).” 10

Unlike many other types of endoscopes, however, duodenoscopes “have a movable ‘elevator’ mechanism at the tip” that can be angled in different ways. 11

Complex Design of Duodenoscopes Associated with Transmission of Serious Infections

Although the intricacy of duodenoscopes “improves the efficiency and effectiveness” of ERCP procedures, it poses “challenges for cleaning and high-level disinfection. Some parts of the scopes may be extremely difficult to access, and effective cleaning of all areas of the duodenoscope may not be possible.” 12

It is possible that “residual bacteria from one patient may remain in device crevices of a duodenoscope, exposing subsequent patients to risk of infection.” The “complex design of ERCP endoscopes…may impede effective reprocessing.” 13

  1. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm458510.htm; http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm458453.htm; http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm458487.htm 

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

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

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

  5. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm 

  6. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm 

  7. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm; http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm454766.htm 

  8. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm 

  9. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm 

  10. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm 

  11. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm 

  12. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm; http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm454766.htm 

  13. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm; http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm434922.htm