Higher Than Expected Contamination Rates Found With Duodenoscopes After Reprocessing, FDA Warns

Megan Brooks


December 11, 2018

Preliminary results from the US Food and Drug Administration's (FDA's) mandated postmarket surveillance studies of duodenoscopes show "higher-than-expected" contamination rates after reprocessing.

In a safety communication issued December 10, the FDA said 3% of properly collected samples tested positive for more than 100 colony-forming units of "low-concern" organisms that are unlikely to cause serious infections but are, nevertheless, an indication of a "reprocessing failure."

Moreover, an additional 3% of properly collected samples tested positive for "high-concern" bacteria that are more often associated with disease, such as Escherichia coli or Staphylococcus aureus.

In 2013, the FDA first became aware of a potential association between multi‒drug resistant bacteria and reprocessed duodenoscopes. In 2015, as part of ongoing efforts to prevent patient infections associated with the transmission of bacteria from contaminated duodenoscopes, the FDA ordered duodenoscope makers Olympus, Fujifilm, and Pentax to determine whether healthcare facilities were able to properly clean and disinfect the devices.

The companies were required to conduct two separate studies: one study to sample and culture reprocessed duodenoscopes to learn more about issues that contribute to contamination; and one "human factors" study to assess how well trained hospital staff are in following the reprocessing instructions.

Last spring, the FDA sent warning letters to all three companies citing their failure to carry out the required studies, as reported by Medscape Medical News.

All three manufacturers have since started collecting the required data. As of November, testing for the initial human factors study has been completed, and at least 10% of the samples have been collected for the sampling and culturing study.

Preliminary findings from the human factors study indicate that reprocessing instructions in current user manuals are hard for reprocessing staff to comprehend and follow, the FDA said.

For example, some reprocessing staff missed one or more steps in the process and needed additional training to complete the process properly. The study showed that the descriptions of some of the processing steps in the user manuals are unclear. The FDA is working with the duodenoscope manufacturers to revise and clarify the user materials to improve comprehension and adherence to reprocessing instructions.

In addition, manufacturers are now conducting "root cause" analyses to better understand the "higher-than-expected" contamination rates seen in the sampling and culture interim study. Some factors that may contribute to device contamination after reprocessing include device damage and errors in reprocessing, the FDA said.

The FDA emphasized that the current results are preliminary and that final results are expected next year.

Best Practices

For now, the FDA recommends that healthcare facilities that use duodenoscopes meticulously follow manufacturer reprocessing instructions and consider implementing supplemental reprocessing measures to reduce the risk for infection transmission, such as microbiologic culturing, sterilization, use of a liquid chemical sterilant processing system, and repeat high-level disinfection.

The FDA recommends that facilities strictly adhere to these "best practices":

  • Meticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using automated endoscope reprocessors. Raise and lower the elevator throughout the manual cleaning process to allow brushing and flushing of both sides. After cleaning, carefully inspect the elevator recess and repeat cleaning if any soil or debris is visible.

  • Implement a comprehensive quality control program for reprocessing duodenoscopes. This reprocessing program should include written procedures for monitoring training and adherence to the program, and documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure.

  • Follow the duodenoscope manufacturer's recommendations for inspection, leak testing, and maintenance of the duodenoscope.

  • Prior to each use, closely inspect and remove from service for assessment, and repair or replace any duodenoscope that shows visible signs of damage, as recommended in the duodenoscope instruction manuals. Examples of damage may include loose parts; protrusions or abnormal bulging from the endoscope; kinks or bends in tubing; cracks and gaps in the adhesive that seals the device's distal cap; or other signs of wear or damage.

  • During each reprocessing cycle, conduct leak testing and remove from service for assessment, and repair or replace any duodenoscope that shows signs of leakage. Follow the duodenoscope manufacturer's leak testing instructions for angulating the bending section and elevator during leak testing.

  • As recommended in the duodenoscope instruction manuals, return the duodenoscope to the duodenoscope manufacturer for inspection, servicing, and maintenance of the device at least once per year.

In a statement, Jeff Shuren, MD, director of the Center for Devices and Radiological Health at the FDA, acknowledged that following the manufacturer's reprocessing and maintenance instructions, "while critical, is not sufficient" to avoid all infections associated with the use of duodenoscopes. Therefore, the agency is working with developers on new product designs, including disposable components, to curb infection risk.

Olympus Fined for Failure to Report Infections

Shuren also noted that the agency relies on manufacturers to report infections associated with duodenoscopes in a timely manner — generally within 30 days of learning about the event.

When this does not happen, the agency has pledged to take action. In that regard, the FDA's Office of Criminal Investigations, working with the US Department of Justice (DOJ), recently brought criminal action against Olympus for failing to adequately file adverse event reports involving infections that occurred in Europe in 2012 and 2013. These infections were associated with their TJF-Q180V duodenoscope.

After pleading guilty to three counts of distributing misbranded devices in interstate commerce, the company was fined $80,000,000 and ordered to forfeit $5,000,000. As part of its plea agreement with the DOJ, Olympus is also required to undertake enhanced compliance measures.

Shuren emphasized that an individual patient's risk of acquiring infection from an inadequately reprocessed medical device remains "relatively low," given the large number of such devices in use. There has also been a "steady decline" in infections following implementation of new safety measures to improve reprocessing techniques.

A recent analysis indicates that the number of reports associated with patient infections peaked in 2015 at 250 and has declined 62% to fewer than 100 reports per year in 2017 and 2018. "We are hopeful that this decline is the result of a successful effort on the part of health care facilities to implement our enhanced safety measures," said Shuren.

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