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FALL 2009  

CLEANR Study Identifies Inconsistencies in Endoscope Reprocessing

The results of a new observational study, Clinical Evaluation and Assessment of Endoscope Reprocessing (CLEANR), found that while participating facilities have written endoscope reprocessing guidelines in place, there were significant variations in manual reprocessing techniques. These inconsistent practices could expose patients and staff to risks associated with hospital-acquired infections (HAIs). The results were presented in May 2009 at the Society of Gastroenterology Nurses and Associates (SGNA) Conference in St. Louis.

The CLEANR study was sponsored by ASP and led by Cori Ofstead, MSPH, of Ofstead & Associates, an independent healthcare research firm. It was conducted from October 2008-April 2009 at five U.S. sites, including two multi-specialty hospitals, two gastroenterology centers, and one outpatient surgery center. The volume of endoscopy procedures at each site ranged from 10 to 250 per week.

Reprocessing Practices Evaulated
The study was designed to evaluate reprocessing methods (manual, partially automated, and more fully automated cleaning and high-level disinfection, such as ASP’s EVOTECH
® Endoscope Cleaner and Reprocessor) in diverse clinical settings by looking at processes, time, reprocessing effectiveness, procedural delays, and staff opinions about various methods.

Managers also were interviewed, and reprocessing personnel were surveyed in endoscope reprocessing centers. Participants stated that proper cleaning and disinfection are vital and that reprocessing policies were in place to help ensure patient and staff safety. Managers at facilities using automated systems such as the EVOTECH® System said they provided increased consistency and better documentation than manual processing. 

CLEANR Results
The study found that more than half of endoscopes reprocessed with traditional methods (manual and partially automated) were not reprocessed in accordance with existing guidelines.  It also found that sites with consistent flush times were using automated channel irrigators.  Inconsistencies in reprocessing practices included:

  • Brush times ranging from 10 seconds to 2:30 minutes
  • Detergent flush times ranging from 18 seconds to 2:45 minutes
  • Rinse times ranging from 1:16 to 3:20 minutes
  • Alcohol flushes were done in only 39.5% of instances
  • Forced air was used in 81.5% of instances 

Other key employee-related findings included:

  • More than half of the employees experienced discomfort associated with reprocessing (a direct association was made between time spent reprocessing and physical discomfort)
  • 70% of staff members felt pressure to work quickly
  • Reprocessing employees disliked several tasks required by guidelines 

Adherence to endoscope reprocessing guidelines is essential to ensure patient safety and protect employees. According to SGNA 2008 Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes, “Flexible endoscope reprocessing has been shown to have a narrow margin of safety. Any slight deviation from recommended reprocessing protocol can lead to the survival of microorganisms and an increased risk of infection.”

While the participating sites had a variety of written procedures in place, less than optimal manual reprocessing techniques continued to occur. In this multi-site study, automated reprocessing was shown to improve consistency and employee satisfaction. EVOTECH® System users reported that the technology was easy to use and reprocessed endoscopes quickly enough to keep up with demand, while providing consistent documentation.

Click here to view the poster presentation containing additional study details.

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New CDC Guideline for Disinfection & Sterilization

In November 2008, the Centers for Disease Control and Prevention (CDC) released a new “Guideline for Disinfection and Sterilization in Healthcare Facilities.” This 158-page document replaces the relevant portions of the 1985 CDC guideline and was the culmination of a rigorous process that involved reviewing 1,035 scientific articles. It was developed by Drs. William Rutala and David Weber in collaboration with the Healthcare Infection Control Practices Advisory Committee (HICPAC).

New sections of the guideline include:

  • Inactivation of emerging pathogens/bioterrorist agents/antibiotic-resistant bacteria
  • New sterilization processes such as hydrogen peroxide gas plasma and liquid peracetic acid
  • Toxicologic, environmental, and occupational concerns associated with disinfection and sterilization processes
  • Disinfection of medical instruments (endoscopes, probes)
  • Inactivation of Creutzfeldt-Jakob disease agent

A key part of the guideline is information about the disinfection and sterilization of patient care items and equipment.  For semi-critical items, such as flexible endoscopes, the guideline outlines factors that impact infection risk, details the requirements for effective endoscope reprocessing, discusses the advantages of automated endoscope reprocessors (AERs), and compares disinfectants, among other important topics.  Highlights are outlined below.

Endoscope Contamination & Infection Risk
According to the guideline, factors related to infection risk include initial cleaning of the device, its physical complexity, and biofilms and microbial load, among others.  It also cites inadequate cleaning, using the wrong disinfectant, and failure to follow procedures as the primary reasons for infection transmission.  To address these issues, the guideline provides detailed requirements for effective cleaning and disinfection. 

In addition, it discusses the difficulty of reprocessing endoscopes, stating that: “Flexible endoscopes are particularly difficult to disinfect and easy to damage because of their intricate design and delicate materials.  Meticulous cleaning must precede any sterilization or high-level disinfection of these instruments.”

As a result, the guideline recommends that reprocessing personnel adhere to nearly 20 procedures in order to ensure adequate cleaning and disinfection (see Table 1). 

Endoscopes & AERs 
According to the guideline, automated reprocessors offer several advantages over manual reprocessing of flexible endoscopes.  By automating and standardizing several important reprocessing steps, there is less of a chance that critical steps will be missed or inadequately performed.  In addition, chemical exposure for personnel is reduced when using an AER. 

Endoscopes & Chemical Disinfectants 
The guideline also compares the advantages and disadvantages of several high-level disinfectants, including ortho-phthalaldehyde, peracetic acid, and glutaraldehyde.  According to the guideline, there are several advantages of using ortho-phthalaldehyde, such as excellent stability over a wide pH range, a barely perceptible odor, and excellent materials compatibility. 

The guideline states that:
“Ortho-phthalaldehyde has begun to replace glutaraldehyde in many health-care facilities because it has several potential advantages over glutaraldehyde: it is not known to irritate the eyes and nasal passages, does not require activation or exposure monitoring, and has a 12-minute high-level disinfection claim in the United States.”

For More Information
The updated CDC guideline focuses on the proper cleaning and high-level disinfection or sterilization of endoscopes in order to prevent the spread of hospital-acquired infections.  Click here to view “2008 Centers for Disease Control and Prevention (CDC): Guideline for Disinfection and Sterilization,” a four-page summary of the new guideline as it applies to endoscope reprocessing, or click here to view the full CDC document.  White papers providing additional information about CIDEX® OPA Concentrate Solution and the EVOTECH® Endoscope Cleaner and Reprocessor also are available for download.

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