FDA Updates Recommendations for Duodenoscope Reprocessing

The U.S. Food and Drug Administration (FDA) has issued a safety communication drawing attention to the ongoing challenge of effective cleaning and disinfection of duodenoscopes between their uses.

The safety communication shares the results of preliminary surveillance studies performed by the three U.S. duodenoscope manufacturers: Olympus, Fujifilm and Pentax. The studies — one to sample and culture reprocessed duodenoscopes in clinical use to characterize contamination rates and learn more about issues that contribute to contamination (sampling study) and one to assess how effectively the trained hospital staff follow the manufacturer reprocessing instructions (human factors study) — are intended to determine whether healthcare facilities are able to properly clean and disinfect the devices.

Concerning the preliminary findings of the sampling studies, FDA states:

"Interim results from these studies indicate higher-than-expected contamination rates after reprocessing, with up to 3% of properly collected samples testing positive for enough low concern organisms to indicate a reprocessing failure and up to 3% of properly collected samples testing positive for high concern organisms. High concern organisms are defined as organisms that are more often associated with disease, such as E. coli, and Pseudomonas aeruginosa. 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."

Concerning the preliminary findings of the human factors studies, FDA states:

"… results indicate that reprocessing instructions in current user manuals are difficult for reprocessing staff to comprehend and follow. For example, some reprocessing staff missed one or more steps in the process and needed additional training to complete the process properly. The study revealed that the descriptions of some of the processing steps in the user manuals were unclear. As a result, the FDA is working with the duodenoscope manufacturers to revise and clarify the user materials to improve comprehension and adherence to reprocessing instructions."

Revised Duodenoscope Recommendations

Since the study results revealed unexpectedly higher contamination rates, FDA provided updated recommendations for steps healthcare providers can take to enhance duodenoscope reprocessing. They include the following:

  • Facilities and staff should strictly adhere to the manufacturer's reprocessing and maintenance instructions.

  • Meticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using an automated endoscope reprocessor. 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. Include in it 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.

    • 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.

    • Return the duodenoscope to the duodenoscope manufacturer for inspection, servicing and maintenance of the device at least once per year.

FDA also highlighted its previously issued safety communication that provides a detailed list of supplemental duodenoscope reprocessing measures (e.g., microbiological culturing, sterilization, use of a liquid chemical sterilant processing system, repeat high-level disinfection) that can be implemented to reduce the risk of infection transmission. 

In March, FDA issued warning letters to the duodenoscope manufacturers concerning their failure to fully comply with a federal order to conduct the postmarket surveillance studies.

Does Your Organization Have a 'Smart' Infection Control Policy?

Mobile technology has taken on a much greater importance in the delivery of healthcare in recent years. This surge has brought with it growing concerns about infection risks associated with smart devices, like phones and tablets, and other handheld electronics.

An article in McKnight's Long-Term Care News examines the challenge of cleaning these devices, noting that they can carry germs, such as "surface-clinging bacteria that can live for weeks if not properly treated."

This challenge is by no means exclusive to long-term care settings. Examples of mobile technology in use at many different types of healthcare organizations, such as hospitals and outpatient centers, include mobile carts that allow clinicians to access electronic health records from the patient's bedside; remote monitoring and wearable devices; apps that can help clinicians with everything from clinician-decision making to medication reconciliation to communications to training; and smartphones with music to be played in operating rooms for surgeons.

Unfortunately, numerous studies (such as this one) have found that such devices are frequently contaminated and rarely cleaned and disinfected after handling.

One critical step for organizations to take, according to the article: "… mobile electronic devices should be addressed in policy as would any other reusable equipment — such as IV poles, wheelchairs or blood pressure cuffs — or any electronic device mounted in a resident's room."

Joint Commission Issues Flu Prevention Safety Advisory

The Joint Commission has issued a new "Quick Safety" advisory concerning flu prevention in healthcare organizations.

Quick Safety 46 notes that the number of cases of influenza-associated illness that occurred last season was the highest since the 2009 H1N1 pandemic. During the 2017-2018 flu season, an estimated 48.8 million became ill with influenza. Of those, almost 23 million went to a healthcare provider, nearly a million were hospitalized and nearly 80,000 died from influenza.

While the severity of flu seasons varies, The Joint Commission states that prevention efforts are critical to avoiding contracting the flu and protecting others, including patients.

The Joint Commission shares the following recommended actions for healthcare workers:

  • Get vaccinated. Doing so annually is "the best way to prevention seasonal flu." 

  • Clean hands frequently with soap and water or alcohol-based hand rub.  

  • Avoid touching eyes, nose and mouth as they are openings for germs to enter the body after touching a contaminated surface.

  • Clean and disinfect surfaces frequently. 

  • If sick or showing flu symptoms, stay home.

  • Cover mouth and nose when coughing or sneezing.

  • Clean hands after handling tissue.

The Joint Commission also provides the following recommendations for organizations:

  • Implement supportive, non-punitive time-off policies to encourage sick employees from coming to work.

  • Make the flu vaccine available to employees working all shifts. This will encourage compliance.

  • Post signs at facility entrances to remind visitors about cough etiquette.

  • Offer tissue, masks and hand sanitizers at all entrances.

November 2018 Issue of Infection Prevention & Control Newsletter Published

The November 2018 issue of the ICCS Infection Prevention & Control Newsletter has published.

The issue identifies some of the most pertinent infection prevention and control news from November. Included in this issue are stories on changes to AORN surgical attire guidelines, importance of facial protection, hand hygiene risks linked to gloves, high-risk surfaces, troubling developments out of New Jersey and Michigan, and antibiotic resistance.

Access the issue by clicking here.

Receive the free ICCS Newsletter by signing up here.

Study: Facial Protection Helps Reduce Risk of Infection for Endoscopists

The results of a new study indicate that endoscopists and assisting staff who do not wear facial protection during procedures are at an elevated risk for exposure to blood and body fluids which could lead to infections.

The research, published in Gastrointestinal Endoscopy, was conducted over a six-month period and involved four gastroenterologists who performed 1,100 procedures in 239 endoscopy sessions. The physicians wore face shields during the sessions, with the shields swabbed before and at the end of the session to determine the number of colony-forming units (CFU). Controls included swabs of face shields placed on the endoscopy suite wall, remote patient intake bay wall and following intentional contamination with a colonoscope immediately after a colonoscopy. 

Researchers found that the CFU rate in the pre-endoscopy groups was significantly lower than the post-endoscopist face shield and endoscopy suite wall groups. They noted that "… exposure may result in transmission of infectious diseases. As such, we recommend the use of universal facial protection during GI endoscopy."

One of the researchers, Asif Khalid, MD, told Healio Gastroenterology and Liver Disease, "While endoscopy staff discard used gloves and gowns, and wash hands after performing endoscopy, we doubt colleagues that do not use face shields wash their faces in between cases. Inadvertently touching our face and then patients may serve to spread pathogenic bacteria between patients."

Access the research here.