The Blog

The United States Food and Drug Administration (FDA) has released another update regarding its research into the safety and contamination risks associated with the use of duodenoscopes. After receiving further research results, the FDA is reiterating its previous recommendations regarding the proper handling and reprocessing of duodenoscopes that it released in a Safety Communication in December 2018.

The FDA has reviewed data from the major endoscope manufacturers regarding the contamination rates they are finding in post-market surveillance studies. The FDA has also reviewed medical device reports regarding real-world infections and deaths attributed to duodenoscopes. The data reviews have shown that there is still a lot of room for improvement when it comes to the safety of duodenoscopes. The FDA’s Safety Communication notes:

“On October 5, 2015, the FDA ordered all three manufacturers (Fujifilm Medical Systems USA, Inc, Olympus Medical Systems Corporation, Pentax of America) who make duodenoscopes sold in the U.S. to conduct postmarket surveillance studies so the FDA can better understand how duodenoscopes are reprocessed in real-world settings.

As of March 2019, the manufacturers continue to collect samples for the Sampling and Culturing Study.

The study was designed to evaluate the percentage of clinically used duodenoscopes which remain contaminated with viable microorganisms after use of labeled reprocessing instructions. The studies were designed assuming less than a 0.4% contamination rate. The preliminary results as of March 2019 indicate higher than expected levels of contamination:

• For low to moderate concern organisms with >100 CFU, updated culturing results continue to indicate a higher-than-expected contamination rate after reprocessing, with up to 3.6% of properly collected samples testing positive.
• For high concern organisms, defined as organisms that are more often associated with disease, such as E. coli, and Pseudomonas aeruginosa, updated culturing results appear to show that up to 5.4% of properly collected samples test positive, which is an increase from the 3% contamination rate that was previously reported.

Root cause analyses are currently underway to better understand these culturing results. Some factors that may contribute to device contamination after reprocessing include device damage and errors in reprocessing. These results remain preliminary because they are based on the collection of only a portion of the samples that the FDA has mandated be collected and tested. Each manufacturer must still submit to the FDA culturing results for the total number of samples required in each approved study plan.

The numbers of samples collected and the contamination results to date, along with summary descriptions of the FDA-approved study plans, are available on the respective FDA 522 Postmarket Surveillance Studies webpage for each manufacturer: Fujifilm, Pentax, and Olympus.

Update: Medical Device Reporting for Duodenoscopes

As announced in December 2018, the FDA has observed a decline in the number of medical device reports associated with patient infections after safety measures to improve reprocessing techniques were implemented, beginning in 2015. Our analysis of medical device reports associated with patient infections for duodenoscope indicates that the number of medical device reports peaked in 2015 at 250 reports and declined 62% to fewer than 100 reports per year in 2017.

However, late in 2018 we received additional medical device reports of patient infections and device contamination. Our analysis of 205 medical device reports received from October 15, 2018 through March 31, 2019 includes 45 reports of patient infection, one (1) report of patient exposure, and 159 reports of device contamination. In 2018, 3 deaths were reported in the US related to duodenoscopes. These reports indicate that although the number of reports has declined, there continues to be a need for improvement of the safety of reprocessed duodenoscopes.

Recommendations for Facilities and Staff that Reprocess Duodenoscopes

The FDA recommendations have not changed. Facilities and staff are reminded of the importance of strictly adhering to the manufacturer’s reprocessing and maintenance instructions and following these best practices:

• Meticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using an automated endoscope reprocessor (AER). 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. Your reprocessing program should include written procedures to monitor 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 and 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.

• Be aware that FDA has previously issued a Safety Communication and provided a detailed list of supplemental duodenoscope reprocessing measures that can be implemented to reduce the risk of infection transmission, such as: microbiological culturing, sterilization, use of a liquid chemical sterilant processing system and repeat high-level disinfection. Hospitals and health care facilities that utilize duodenoscopes can, in addition to meticulously following manufacturer reprocessing instructions, take one or more of these additional steps to further reduce the risk of infection and increase the safety of these medical devices.”

Read the entire letter here: The FDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions: FDA Safety Communication

As evidence continues to mount about the potential dangers of duodenoscopes, hospitals must ensure that they’re doing everything they can to protect themselves and their patients from harm. The FDA rightly points out that a major risk factor of using duodenoscopes stems from issues with reprocessing. Make sure that your staff is following the proper processes and protocols each and every time a duodenoscope is reprocessed. Systems such as iRIScope can display the proper workflow for reprocessing duodenoscopes and document the process in real-time. Any breaches of protocol can be alerted in real-time to protect patients and identify which staff members need additional training on reprocessing techniques. You owe it to your staff and your patients to offer everyone the peace of mind that duodenoscopes and all other flexible endoscopes are being properly reprocessed every single time.

Read More

Contrary to recent claims by Olympus regarding the safety of its duodenoscopes, the United States Food and Drug Administration (FDA) has put out a statement regarding the dangers of using duodenoscopes. Duodenoscopes have been in the spotlight over the past several years due to a large number of patient safety incidents reported around the world.

In a letter penned by Jeff Shuren, MD, the Director of the Center for Devices and Radiologic Health at the FDA, Dr. Shuren warned of the continued danger of using duodenoscopes on patients. Dr. Shuren referenced preliminary findings from surveillance studies being conducted by the FDA and duodenoscope manufacturers in response to the high number of patient safety issues reported in recent years:

“Today, we are issuing a safety communication reporting on these preliminary findings and providing important information for hospitals and health care providers who use and reprocess these devices. Interim results from the sampling studies indicate higher-than-expected contamination rates after reprocessing, with up to 3 percent of properly collected samples testing positive for more than 100 colony forming units of low concern organisms that are unlikely to cause serious infections (but an indication of a reprocessing failure) and an additional 3 percent of properly collected samples testing positive for “high concern” organisms. These are bacteria more often associated with disease, such as E. coli or Staphylococcus aureus (staph).

The manufacturers are currently conducting root cause analyses to better understand these preliminary culturing results. Some factors that may contribute to device contamination include device damage and errors in reprocessing. Because of the higher-than-expected contamination rates and to help protect patients from bacterial infections associated with the use of duodenoscopes, we have included in today’s safety communication updated recommendations regarding steps that health care providers can take to enhance duodenoscope reprocessing.

Hospital and health care facilities that use duodenoscopes should meticulously follow manufacturer reprocessing instructions. In addition, health care facilities should consider implementing supplemental reprocessing measures to reduce the risk of infection transmission, such as microbiological culturing, sterilization, use of a liquid chemical sterilant processing system and repeat high-level disinfection. The FDA previously issued a safety communication recommending these additional reprocessing steps to further reduce the risk of infection and increase the safety of these medical devices.

In today’s safety communication, in addition to supplemental reprocessing measures, we are also recommending that hospital staff carefully inspect a component of the duodenoscope that is difficult to clean, called the elevator recess, and to repeat cleaning if any soil or debris is visible. We are also emphasizing that users follow the manufacturer’s recommendations for inspection, leak testing and maintenance of the duodenoscope and return the duodenoscope to the manufacturer, at least once a year, for inspection, servicing and maintenance. We also strongly encourage health care providers to participate in the manufacturers’ sampling and culturing studies, and consider initiating their own duodenoscope surveillance sampling and culturing to reduce the risks of infection.

However, it has become clear that following the manufacturer’s reprocessing and maintenance instructions, while critical, is not sufficient to avoid all infections associated with the use of duodenoscopes. That is why the FDA has also been working with developers on new product designs, including disposable components. Technological advances in product design hold promise to reduce the risk of contamination and enhance patient safety.

Finally, we rely on manufacturers to report infections associated with duodenoscopes, as well as other adverse events caused by medical devices, to the FDA in a timely manner – generally within 30 days of learning about the event. When this does not occur, patients’ safety and sometimes their lives may be put at risk. When this happens, the agency can and does take action. The FDA’s Office of Criminal Investigations recently worked with the U.S. Department of Justice to bring criminal action against Olympus for failing to adequately file adverse event reports involving infections that occurred in Europe in 2012 and 2013 that were associated with their TJF-Q180V duodenoscope. After pleading guilty to three counts of distributing misbranding 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 Justice Department, Olympus is also required to undertake enhanced compliance measures.

I want to emphasize 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. We have also seen a steady decline in medical device reports associated with patient infections after the FDA implemented safety measures to improve reprocessing techniques including issuing recommendations to health care providers to enhance their cleaning and high-level disinfection of these devices, working with duodenoscope manufacturers as they reviewed and modified their instructions for manual reprocessing and reviewing validated instructions for manufacturers of automated endoscope reprocessors that are used to reprocess duodenoscopes. A recent analysis of medical device reports indicates that the number of reports associated with patient infections peaked in 2015 at 250 reports and has declined 62 percent 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.

Reducing patient exposure to infections in health care settings remains a national priority involving multiple stakeholders with overlapping responsibilities. The FDA’s foremost concern is patient safety and we are committed to enhancing the safety margin of procedures with reprocessed medical devices, which include duodenoscopes and other endoscopes. As part of our larger efforts outlined in our Medical Device Safety Action Plan, our goal is to protect patients and spur innovation of new products that are safer, more effective, and address unmet medical needs.”

Read the entire letter here: Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data

As evidence continues to mount about the potential dangers of duodenoscopes, hospitals must ensure that they’re doing everything they can to protect themselves and their patients from harm. The FDA rightly points out that a major risk factor of using duodenoscopes stems from issues with reprocessing. Make sure that your staff is following the proper processes and protocols each and every time a duodenoscope is reprocessed. Systems such as iRIScope can display the proper workflow for reprocessing duodenoscopes and document the process in real-time. Any breaches of protocol can be alerted in real-time to protect patients and identify which staff members need additional training on reprocessing techniques. You owe it to your staff and your patients to offer everyone the peace of mind that duodenoscopes and all other flexible endoscopes are being properly reprocessed every single time.

Read More