The Pulse | Thursday, January 2, 2020
Risk Assessments: Make Your Hard Work Easier
As flexible endoscopes are associated with more outbreaks of infections than any other reusable medical device in healthcare, it is imperative that facilities conduct a risk assessment for reprocessing steps 1-3. Specific to endoscope reprocessing, a risk assessment is a systematic process that examines all reprocessing components to identify gaps that may pose potential harm to patients, as well as staff.
Current literature has been focused on reducing the margin of safety for endoscope reprocessing, whether through validated manufacturer reprocessing guidelines, evidenced-based reprocessing guidelines or the re-classification from high level disinfection to sterilization, as well as new technology to support potential changes4. Historically, outbreaks associated with endoscopes were due to non-compliance of reprocessing step. Although recent endoscope related outbreaks revealed no reprocessing breaches, a continued focus on reprocessing steps is still needed in order to reduce the potential for patient harm5.
Identify the Right Tools
In performing a risk assessment, it is important to identify an assessment tool that encompasses all categories of reprocessing, such as: pre-cleaning, leak testing, manual cleaning, visual inspection, disinfection or sterilization, drying, storage, transport, documentation, personal protective equipment, education/competency, quality assurance process, safety, solutions and supplies. Each category should have multiple line items that review the category components to assess the overall risk for each category. For instance, the pre-cleaning category should assess items such as, “Is appropriate personal protective equipment worn when performing preclearing? Is gross soil removed with enzymatic detergent at point of care?” and so on. Ideally, the more comprehensive the assessment tool is, the better the risk assessment.
Find Your A-Team
Once the assessment tool is identified, identify the audit team that will perform the risk assessment, such as infection prevention and gastroenterology staff. In performing the risk assessment, set aside ample time. If this is not possible, perform the review in smaller sessions, ensuring you are thorough and objective.
Once the risk assessment is complete, review the assessment results with the audit team, determine a goal for each non-compliant component and create measurable objectives to meet each goal. Identify a timeframe for completion, too, including a responsible person(s) for each goal. Essentially, you are creating an action plan to correct the non-compliant results of the risk assessment.
Evaluation and Follow-Ups Are Key
Once the correction plan has been created, an evaluation method must be established, such as intermittent observations or audits. Most importantly, check points or subsequent reprocessing audits must be scheduled with pertinent staff members. This will ensure that progress continues, compliance increases and patient risk is mitigated.
Share Your Hard Work
After all the hard work is completed, be sure to communicate results effectively, whether to senior management or in committee meetings. This is not a “one and done” assessment. Since every department goes through staffing changes and new equipment, it is important that risk assessments are performed annually at a minimum and more often if concerns are identified.
1. Kovaleva J, Peters FT, van derMei HC, Degener JE. Transmission of infection by flexible gastrointestinal endoscopy and bronchoscopy. Clin Microbiol Rev 2013;26:231-54.
2. Murray P. Preventable tragedies: superbugs and how ineffective monitoring of medical device safety fails patients. Available from: https://www.help.senate.gov/imo/media/doc/Duodenoscope%20Investigation%20FINAL%20Report.pdf
3. Rubin ZA, Kim S, Thaker AM, Muthusamy VR. Safely reprocessing duodenoscopes: current evidence and future directions. Lancet Gastroenterol Hepatol 2018;3:499-508.
4. What’s new in reprocessing endoscopes: Are we going to ensure “the needs of the patient come first” by shifting from disinfection to sterilization? William A. Rutala PhD, MPH, CIC a,*, Hajime Kanamori MD, PhD, MPHc, Emily E. Sickbert-Bennett PhD, MSa,b, David J. Weber MD, MPHa
5. Reported gastrointestinal endoscope reprocessing lapses: The tip of the iceberg Alexandra M. Dirlam Langlay PhD a, Cori L. Ofstead MSPHa,*, Natalie J. Mueller MPHa, Pritish K. Tosh MDb, Todd H. Baron MDc, Harry P. Wetzler MD, MSPHa