CLEANR Study Shows that Automation Improves Consistency in Endoscope Reprocessing
A podium presentation sponsored by ASP presented the full findings from the CLEANR (Clinical Evaluation and Assessment of Endoscope Reprocessing) study at the 2010 SGNA Annual Course. The results of the prospective, multi-site observational study found that while participating facilities have written endoscope reprocessing guidelines in place, there was great variability in reprocessing practices within and between sites, and that guideline adherence was worse when manual methods were used compared with a fully automated system.
Reprocessing Practices Evaluated
The CLEANR study was led by Cori Ofstead, MSPH, of Ofstead & Associates, an independent healthcare research firm.* It was conducted from October 2008 to 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.
Participating sites used manual cleaning followed by automated high-level disinfection (MHLD) or a fully automated system [ASP’s EVOTECH® Endoscope Cleaner and Reprocessor (ECR)]. The study evaluated employee perceptions, occupational health, reprocessing practices, and the time required to reprocess endoscopes. Data were used to evaluate adherence with six of the main steps covered in the 2009 SGNA guidelines (See Figure 1).
Figure 1: 2009 SGNA Guidelines and Study Focus
During the study, the reprocessing of 183 GI endoscopes was observed. The observers found that while the participating sites had a variety of written procedures in place, less than optimal manual reprocessing techniques continued to occur.
Results showed that only one in 69 endoscopes reprocessed with manual methods was reprocessed in accordance with existing guidelines. In 99% of cases, one or more steps were skipped or incorrectly done (See Figure 2). Multiple steps were skipped or done incorrectly for 45% of endoscopes reprocessed using MHLD. The errors included:
- 57% did not brush all channels and components
- 55% did not dry with forced air
- 22% tested for leaks using sudsy water
- 16% skipped air purge after detergent flush
- 14% did not flush with alcohol
- 10% skipped final wipe down
In comparison, 75% of endoscopes reprocessed using ECRs were completed according to guidelines. With ECR reprocessing, the only step skipped was the final wipe down, and there were no instances where multiple steps were skipped.
Figure 2: Adherence by Reprocessing Method
Additional inconsistencies in MHLD reprocessing practices included:
- Brush times ranging from 10 seconds to 2:35 minutes
- Detergent flush times ranging from 18 seconds to 2:45 minutes
- Rinse times ranging from 1:17 to 3:20 minutes
In addition to observed adherence to guidelines, interviews with management and infection control staff members were conducted. The site coordinator and reprocessing staff members also completed surveys. Participants in the study stated that proper cleaning and disinfection of endoscopes are vital and that reprocessing policies were in place to help ensure patient and staff safety.
Key employee-related findings included:
- More than half of employees experienced discomfort associated with reprocessing endoscopes (a direct association was made between time spent reprocessing and physical discomfort). The presence of physical symptoms was strongly associated with the reprocessing method, and employees who used ECRs were far less likely to report symptoms.
- 75% of staff members felt pressure to work quickly.
- 37% observed procedural delays due to a lack of clean endoscopes.
- Reprocessing employees disliked several tasks required by guidelines, including only 50% of employees stating that they “liked” manual cleaning (brushing)—a critical step in the disinfection process.
- EVOTECH® ECR users reported that the technology was easy to use and reprocessed endoscopes quickly enough to keep up with demand, while providing consistent documentation.
Adherence to endoscope reprocessing guidelines is essential to ensure patient safety and protect employees. According to the SGNA 2009 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.” Importantly, in this multi-site study, fully automated reprocessing was shown to improve consistency and adherence to reprocessing guidelines.
The researchers recommended strategies to improve compliance with guidelines, including developing new educational programs, increasing specificity of guidelines and policies, monitoring compliance, and providing feedback. They also recommended utilizing automation such as provided by the EVOTECH® ECR to ensure consistency, alleviate symptoms and time pressures associated with reprocessing endoscopes, improve accountability, and prepare documentation.
Click here to view a handout containing additional study details.
ASP-Sponsored Educational Sessions at SGNA 2010
For the fourth year in a row, ASP maintained its support of SGNA at the Platinum Level—one of only three sponsors to reach this milestone. In addition to the CLEANR Study presentation, ASP also sponsored the following educational sessions at the 2010 SGNA Annual Course:
The Nurse Manager’s Guide to Reprocessing Competency
—Jane Allaire, RN, CGRN; James Collins, BS, RN CNOR; Michelle E. Day, BSN, RN, CGRN; Cynthia M. Friis, Med BSN, RN, BC; Patricia Maher, RN, CGRN
How Do You Know the Scope You Are Using Has Been High-Level Disinfected?
—Linda L. Kelly, RN, CGRN
Infection Control Panel
—Bradley J. Catalone, PhD, MBA; Lawrence F. Muscarella, PhD; Keith Nelson; Wallace Puckett, PhD
|Breakfast Session: Go Beyond AER! New Clinical Data Reinforce Effectiveness of the EVOTECH® ECR—The First Commercially Available Endoscope Cleaner & Reprocessor
*Financial support for the CLEANR study was provided by ASP.