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Over the last decade, incidences of outbreaks from infections that can be attributed to poorly disinfected endoscopes have been showing up in the news regularly. So much so that regulatory bodies from the US Congress to the FDA have been increasing their scrutiny of these extremely useful, yet sometimes problematic reusable medical instruments.

Many different groups have taken on the mantle to help hospitals learn from each other to institute best practices for effective reprocessing of endoscopes. One such group recently presented their findings at the Global Surgical Conference & Expo 2019. Presenters Daniel Fedderson, BSN, RN, MAJ, AN and Kenneth Romito, MSN, RN, MAJ, AN explained how they have taken their perioperative team to a 96%+ compliance rate for reprocessing. Their article in The Periop Life captured the main takeaways of their presentation:

“The intricate design of flexible endoscopes and multiple steps required for cleaning and high-level disinfection (HLD) make the process vulnerable to human error.

As perioperative nurses, we know that missing just one step or failure to complete any phase in endoscope reprocessing can result in patient exposure to harmful contaminants that can lead to infections, increased hospital stays, increased medical costs, and even death.

Auditing the Process

We recommended applying an evidence-based approach to improving standardization around reprocessing flexible endoscopes within our organization, and implemented audits conducted at three-month intervals with feedback to stakeholders to establish a standardized approach.

These four practices were key to effectively and successfully implement the audits:

• Use an audit quality feedback loop administered at regular intervals consistently over time.
• Measure clinical practice against well-established standards and/or evidence-based practice.
• Incorporate a multidisciplinary approach with an established leader or facilitator to conduct and analyze the audits.
• Assess leadership, education, training, and competency in addition to clinical practices as part of the auditing process.

Achieving Compliance

Robust leadership buy-in proved invaluable in implementing these audit best-practices by driving the changes in clinical performance and standardization of policies and equipment. However, building a structure around auditing best practices for safe endoscope reprocessing was a first step. Next, we needed a way to address ongoing process compliance.

To achieve buy-in among every team member, we focused on establishing a culture supporting the Highly Reliable Organization (HRO) goals of quality, safety, and continuous process improvement around endoscope reprocessing.

Three specific principles of high reliability in particular made the difference:

• Preoccupation with failure—To prevent process failures, each audit focused on quality loop iteration, diminishing gaps between observed practices, evidence-based practice recommendations by professional organizations, and manufacturer IFUs.
• Deference to expertise—By applying the HRO principle of deference to expertise, we established a task force with subject matter experts empowered to transform HLD practices within the framework of our evidence-based audit process.
• Commitment to resilience—The HLD task force became a fully chartered HLD committee with a full-time employee hired as committee chair to support the organization’s commitment to the HRO goals of quality, safety, and continuous process improvement related to HLD.

These efforts continue to prove successful. After our fourth audit of established processes in September 2018, which included 65 steps across five clinics, our team achieved a 96.9% compliance rate. Today the work of the HLD task force continues, as do our measured successes in safer endoscope reprocessing.”

Read the entire article here: Achieving High Reliability in Flexible Endoscope High-Level Disinfection

As the article notes, an effective way to improve endoscope disinfection efficacy is to introduce strong standards and perform occasional audits to make sure employees are following protocols closely. But what happens when no one is watching? Do you trust that all of your employees, when no one is looking over their shoulder, will reprocess scopes properly and never skip any steps? Most facilities still have staff go through their HLD routines based on memorization, but recent technology products have been introduced in recent years to ensure staff follow the same process each and every time – even when no one is watching.

One such product is iRIScope from Mobile Aspects. The way that iRIScope and other systems like it work is to walk staff through the HLD process for each scope in a workflow that matches the hospital’s existing standard operating procedures. By using a combination of RFID technology and touchscreen kiosks, staff are guided through the HLD process and are required to log all steps as completed before they can move on to the next step. If a step is missed, a reminder to complete that step is displayed and the missed step is logged in the system. This ensures that no scopes are missing any of the key steps in the HLD process. It also allows managers to properly train their employees by highlighting the employees that are most prone to skipping steps. Using this data helps managers train up their staff efficiently based on analytics coming out of the system, rather than observations noticed only during audits.

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The US Government is continuing its scrutiny of Olympus and the other major endoscope manufacturers following several reports of infections related to duodenoscopes in recent years. The latest chapter includes a letter written by a US Senator asking for additional information regarding duodenoscope investigations.

Sen. Patty Murray (D-WA) wrote a letter to the three major duodenoscope manufacturers requesting additional information about what the companies are doing to mitigate the existing dangers posed by their equipment. As this article by Ana Mulero in Regulatory Focus continues:

“I am writing today to understand how your company plans to respond to these troubling findings and what changes may be necessary going forward to ensure patient safety,” Murray said. She referred to the preliminary results of the postmarket surveillance studies that the US Food and Drug Administration (FDA) imposed as requirements on all three manufacturers—Olympus, Pentax and Fujifilm—marketing duodenoscopes in the US market.

FDA’s update last month on the mandated studies reported rates of contamination that were even higher than those reported as of March 2018. Culturing results showed up to 5.4% of properly collected samples testing positive for high-concern organisms such as E. coli as of March, according to FDA. The new preliminary results marked a 3% spike in the contamination rate versus 2018 for such organisms.

The results, which remain preliminary as they are based on a portion of FDA-mandated samples, came after FDA sent warning letters to the duodenoscope manufacturers over inadequate study progress. At the time, Olympus spokesperson Mark Miller told Focus that the firm “takes this matter very seriously.”

The progress on human factors studies, required for postmarket surveillance, are now marked as adequate for each of the three duodenoscope manufacturers. But each sampling and culturing study remains in a noncompliant status. FDA also observed an uptick in the total number of medical device reports (MDRs) on patient infections and device contamination after the agency had reported an observed “steady decline.” The agency said last month that it had received 205 MDRs between 15 October 2018 through 31 March after declining to less than 100 MDRs in 2017.

Final results on the sampling and culturing studies are expected this year, FDA reported last December.

Murray recognized “important steps have been taken to reduce outbreaks.” But “it is unacceptable that one in 20 patients who undergo a procedure using a duodenoscope may acquire an infection as a result of that procedure—even when hospitals have followed cleaning instructions properly.” Murray made note of a 2016 report issued to highlight challenges in identifying and responding to such safety issues.

The letter gives the firms until 23 May to respond to seven questions. Questions range from the firms’ projected timeline for completing both postmarket surveillance studies to whether the firms have plans for device redesigns.

“I remain concerned about the risk of infection posed by these devices and committed to ensuring rigorous oversight of the safety of Olympus medical devices,” said Murray of each of the duodenoscope makers.”

Read the entire article here: Updated: Murray Questions Devicemakers on Contaminated Duodenoscopes

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. Sen. Murray rightly points out that even by following proper reprocessing techniques, duodenoscopes can still show infection rates of over 5%. To minimize risk, 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 automatically. 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.

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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.

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