Monitoring Flexible Endoscope Channels to Assure Cleaning

Transcription

1 Monitoring Flexible Endoscope Channels to Assure Cleaning Dr. Michelle J. Alfa, Ph.D., FCCM Medical Director, Clinical Microbiology, Diagnostic Services of Manitoba, Winnipeg, Canada

2 Disclaimers: Dr. M. Alfa - Sponsored to give invited presentations at various National and International conferences by; STERIS, 3M, J&J, Healthmark, Virox, Medisafe, Ontario Hospital Association, CHICA, and multiple conference associations. - The University of Manitoba has licensed my patent for Artificial Test Soil to Healthmark. - Research projects for STERIS, 3M, J&J, Novaflux, Virox, Olympus, Medisafe, Case Medical (no funds from these research projects comes to me personally it is all handled by the St. Boniface Research Centre). - Three day educational workshop on Microbiology for 3M - On advisory panels and/or provided consulting advice for STERIS, Getinge, 3M, J&J, and Novaflux.

3 Objectives: Overview of Endoscope cleaning issues: - staff training - shortcuts in reprocessing Monitoring efficacy of manual cleaning: - ATP - Organic residuals - Bioburden Role of monitoring manual endoscope cleaning Copyright Dr. Michelle Alfa

4 Flexible Endoscopes: Complex Narrow lumens Staff may not know which channels require cleaning Copyright Dr. Michelle Alfa

5 Endoscope issues: Manual Cleaning Staff training: - often done verbally, - may not be updated for new scopes - yearly competency assessment needed Shortcuts: - pressure to rush - often problems related to shortcuts in cleaning How to ensure adequate cleaning? - visible inspection inadequate for endoscope lumens - cleaning monitors needed to evaluate lumens

6 Endoscope Reprocessing: Bedside flush with water or detergent Transport to reprocessing area (< 1 Hr) Leak test (immersed) Clean: enzymatic detergent, brush, copious flushing (at least 90 mls) Rinse: Tap water copious flushing (at least 90 mls) HLD: immersion Rinse: bacteria-free rinse water

7 Endoscope Reprocessing: It is NOT a Race!! Short-cuts: Duodenoscope: - Research cleaning: 17 mins - Avg clinical cleaning (20 scopes): 6.5 mins Bronchoscope: - Research cleaning: 14 mins - Avg clinical cleaning (20 scopes): 5 mins Pumps to facilitate flushing: Ensure correct fluid volumes flushed Standardize volume used for flushing Copyright Dr. Michelle Alfa

8 log10 cfu/ml log10 cfu/ml Survival of bacteria in enzymatic detergent at use-dilution Enterococcus faecalis Bacteriostatic effect of Pentazyme - Enterococcus faecalis Time (hours) PBS PBS 9 Pentazyme enzyme (1:128) Pseudomonas aeruginosa Bacteriostatic effect of Pentazyme - Pseudomonas aeruginosa PBS enzyme PBS Pentazyme (1:128) Alfa MJ, et al Am J Infect Control 2006; 34: Time (hours) Soaking overnight at room temperature in enzymatic detergent will lead to biofilm formation!! Copyright Dr. Michelle Alfa

9 Endoscope Cleaning Monitors for Lumens: Automated Washers HealthMark USA, Medisafe UK, Steris/Browne UK, SteriTec, USA Flexi check: Endoscope lumen Medisafe Lumen check: Laparoscopic device lumen TOSI Lumchek Steritec Lumen Wash-Checks These monitors assess how effective the washer function is: ISO committee working to standardize washer cleaning monitoring These monitors do not provide an indication of how well the manual cleaning is being done by staff These represent some examples it is NOT an all-inclusive list Pictures from company websites Copyright Dr. Michelle Alfa

10 Endoscope Lumens: Manual Cleaning Monitors Channel Sample Channel Chek: Healthmark Clean-trace: 3M Carbohydrate, protein, hemoglobin Detects ATP Tests assess how well the manual cleaning is being done by staff Pictures from company websites Copyright Dr. Michelle Alfa

11 ATP monitoring of Endoscope Channel Cleaning ATP is present in living cells: both human and bacterial cells ATP measured by assay that detects relative light units or RLUs Human White cell Bacteria Low level of RLUs Pictures from Google Images High level of RLUs Copyright Dr. Michelle Alfa

12 ATP Assay Is not a linear correlation with microbial numbers [~10 3 cfu/ml to be detected] Reflects total human cellular and bacterial cellular residuals Protein, carbohydrate in pure form (i.e. not in a living cell) will NOT show any RLUs when tested by the ATP assay.

13 Simulated-use testing Artificial Test Soil (containing 10 6 cfu/ml P.aeruginosa, E.faecalis) All channels inoculated (entire channel) Inoculated scope held 1 Hr at Room Temp No Bedside flush

14 RLUs/test Protein ug/cm2 Log10 cfu/cm2 Simulated-use Evaluation Neg control Protein Residuals Pos Control Partial Clean Total Clean CLEAN Benchmarks: Duodenoscope: triplicate testing Protein: < 6.4 ug/cm 2 Bioburden: < 4 Log 10 /cm 2 Sterile RO water to collect sample L1: Suction/biopsy channel (40 ml) L2: Air/water channel (20 ml) Protein: Bioburden: E.faecalis - Total clean: range ug/cm Partial clean: range ug/cm 2 Bioburden: 4 L1 - Total clean: range L2 2 3 Log 10 /cm 2 - Partial clean: range Log 10 /cm ATP: - Total clean: range RLUs - Partial clean: range 8,000 46,000 RLUs Neg control Neg control Pos Control ATP Assay Pos Control Partial Clean Partial Clean Total Clean Total Clean L1 L2 L1 L2

15 Clinical Study: ATP Clean-trace Validation for monitoring manual cleaning of flexible endoscopes Duodenoscopes: Colonoscopes: 10 pre-clean 30 post-clean ATP test Samples collected from surface and channels [flush sterile RO water from umbilical to distal end] - S1: 1cm 2 - L1 (Suction/biopsy): 40 ml - L2 (Air/water): 20 ml - L3 (Aux): 10 ml - L4 (Elevator wire): 5 ml Bioburden Organic: Protein

16 Clinical Study: Duodenoscopes & Colonoscopes Benchmarks for Clean: protein: < 6.4 ug/cm 2 bioburden: < 4 log/cm 2 10 patient-used endoscopes; - bedside flush, no manual clean 20 patient-used endoscopes; -bedside flush, manual cleaning

17 RLUs ug/cm2 Site Log 10 cfu/cm2 Clinical Study Colonoscopes: 5 pre-clean, 20 post-clean Protein Bioburden S1 L1 L2 L3 Site Pre-clean Post-clean S1 L1 L2 L3 Site Pre-clean Post-clean CLEAN Benchmarks: Protein: < 6.4 ug/cm 2 Bioburden: < 4 Log 10 /cm 2 L1: Suction/biopsy channel L2: Air/water channel L3: Auxillary water channel ATP Assay S1 L1 L2 L3 Pre-clean Post-clean Site

18 RLUs Log 10 cfu/cm2 ug/cm2 Clinical Study Duodenoscopes: 5 pre-clean, 20 post-clean Duodenoscopes Bioburden more difficult to clean than Colonoscopes Protein Duodenoscopes Post manual cleaning: S1: 10% 1 > 200 RLUs (all Pre-clean < 750 RLUs) L1: 0.5 0% > 200 RLUs Post-clean L2: 0% 0 > 200 RLUs S1 L1 L2 L4 L4: 20% > 200 RLUs (all < 700 RLUs) Site S1 L1 L2 L4 Site Pre-clean Post-clean CLEAN Benchmarks: Protein: < 6.4 ug/cm 2 Bioburden: < 4 Log 10 /cm 2 L1: Suction/biopsy channel L2: Air/water channel L4: Elevator wire channel ATP Assay S1 L1 L2 L4 Pre-clean Post-clean Site

19 Summary: ATP Assay Validation ATP Assay: < 200 RLUs ensures channel is clean (< 6.4 ug/cm 2 & < 4 Log 10 cfu/cm 2 ) ATP Assay: - rapid, easy to perform - not affected by enzymatic detergent - not applicable after HLD

20 SUMMARY: Flexible endoscopes: Complex, narrow lumens Difficult to ensure manual cleaning Channel tests for cleaning: ATP Residual organics; protein Bioburden Quality Program: Staff training Monitoring of manual cleaning of scopes Copyright Dr. Michelle Alfa

21 What can Users do?? ENSURE STAFF ARE PROPERLY TRAINED Monitor lumens to ensure proper manual cleaning as part of overall Quality Assurance Program Copyright Dr. Michelle Alfa

22 References General Reprocessing AAMI TIR12:2004 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers, 2ed Red brochure: Proper Maintenance of Instruments, 8ed. Spaulding EH. Chemical disinfection of medical and surgical materials [Chapter 32]. In: Lawrence CA, Block SS, eds. Disinfection, sterilization and preservation. Philadelphia, PA: Lea & Febiger, 1968: Provincial Infectious Diseases Advisory Committee (PIDAC) MOHLTC Best Practice Practices for Cleaning, Disinfection and Sterilization In all Health Care Settings (April 30, 2006) CDC (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 ISO :2006. Washer disinfectors, Part 1: General requirements, definitions and tests. Copyright Dr. Michelle Alfa

23 References Reprocessing Instructions & Methods AAMI TIR12:2004 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers, 2ed ANSI/AAMI ST81:2004 Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices ANSI/AAMI ST79:2006 Comprehensive guide to steam sterilization and sterility assurance in health care facilities Cleaning AAMI TIR34:2008 Water for reprocessing medical devices AAMI TIR30:2003 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices ISO/TS :2005 Washer-disinfectors Part 5:Test soils and methods for demonstrating cleaning efficacy of washer disinfectors Copyright Dr. Michelle Alfa