Partecipants Rivara C. Asl Torino 4 - Italy Zamboni G. C. U.O.S. Endoscopia Digestiva Policlinico "G.B. Rossi" - A.O.U.I. Verona Italy Dallevacche A. (Endoscopia Digestiva P.O. Ravenna) Italy Steelco S.p.A Menin Ostani M. 3M Abbate G. Title EVIDENCES ON ENDOSCOPES MANUAL CLEANING AUTOMATION Introduction/Background Prove that Endoscopes Manual Cleaning Automation with Steelco EPW 100 system provide the same results as Manual Cleaning Procedures according to Italian National GI Reprocessing Guidelines ANOTE-ANIGEA update 2011. Endoscopes Full Manual Cleaning automation means process traceability, brushless step and less endoscope handling improving HCWs and patients safety This is the very first objective scientific approach comparing data between manual and automated cleaning procedures. Aims/Objectives The purpose of this research is to create scientific evidences on Endoscopes Manual Cleaning Automation. A pool of 400 endoscopes (200 Experimental Group treated only with EPW 100 system without brushing step using a dedicated and validated single shot detergent SteelcoXide DT & 200 Control Group with National Manual Cleaning Procedures and in use enzymatic concentrated detergent) has been sampled internal channels and external surface - using 3M Clean-Trace Hygiene Monitoring System + 3M Capitale sociale Euro 3.000.000,00 i.v. C.F., P.IVA e Numero Registro Imprese di Treviso: 04311220265 REA TV 339832 1/9
Clean-Trace Water and 3M Clean-Trace Surface. Samples were measured in RLU (Relative Light Unit). The assumption was to find better or equal RLU units number in the Experimental Group. ANOTE-ANIGEA fixed a good manual cleaning procedure under 100 RLU units (cfr Clinical trial of ATP usage for endoscope manual washing validation 2015). The 3M Clean Trace Hygiene Monitoring System used in conjunction with Clean- Trace Water and 3M Clean-Trace Surface was used to measure levels of contamination on endoscope surfaces and in channels water samples. The technology is Adenosine Triphosphate (ATP) present in all animal and vegetable matter, including most food debris, bacteria, fungi and other micro organisms. Measurement of ATP was performed using an enzyme reaction Luciferin/Luciferase (firefly reagent) + ATP = Light. The light emitted is in proportion to the amount of ATP. The intensity of the light emitted from a sample is measured by the 3M Clean Trace Hygiene Monitoring System and is displayed in Relative Light Units (RLU). (Research) Methods Case Control Study: comparing a case series to a matched control series The aim of the research has been achieved involving two GI Labs running a huge number of different procedures per year (>9.000). GI Labs have been equipped with Steelco EPW 100, 3M Clean-Trace Hygiene Monitoring System + 3M Clean-Trace Water and 3M Clean-Trace Surface. The Experimental Protocol was written in cooperation and acknowledged by ANOTE-ANIGEA. After the treatment in the Steelco EPW 100 system and Manual Cleaning Procedures (according to Italian National GI Reprocessing Guidelines ANOTE-ANIGEA update 2011) the 400 endoscopes have been sampled following this protocol steps: 3M Clean-Trace Hygiene Monitoring System daily check with 3M Clean- Trace Water pen, green light if the RLU values are <20; Prepare the endoscope on a dedicated surface avoiding overlapping, dry the final part of the distal tip with medical air. Pass the 3M Clean-Trace Surface pen Capitale sociale Euro 3.000.000,00 i.v. C.F., P.IVA e Numero Registro Imprese di Treviso: 04311220265 REA TV 339832 2/9
around the final part of the distal tip (last 10 cm) and measure RLU results with the 3M Clean Trace Hygiene Monitoring System; Record RLU surface values in a defined Experimental protocol database; Position the channel separator to open endoscope channels; Connect the endoscope suction valve to the sterile solution 0,9% through a dedicated silicon connector changed every time according to the endoscope application (Upper GI or Lower GI procedures); Flush channels with the sterile solution and collect the liquid going out from the distal tip (approximately 50 ml) in a sterile container; Take a sample of water from the sterile container by the 3M Clean-Trace Water pen and measured RLU results with the 3M Clean Trace Hygiene Monitoring System; Record RLU water values in a defined Experimental protocol database. If the endoscope was part of the Experimental Group treated with Steelco EPW 100 system after the sampling procedures HCWs have to brush it before the reprocessing in the AER. Statistical or interpretative analysis software programs used to record data are 3M Clean-Trace Data Trending Software and excel database. Findings/Results Table 1 1. Hospitals 1 (Osp1) and Hospital 2 (Osp2) RLU represented in logarithmics values to be better represented in the graphic scale. In the graph value 1,0 corresponds to 10 RLU; value 2,0 to 100 RLU; 3,0 to 1.000 RLU etc; 2. The blu line identify 2,30 Log corresponding to 200 RLU 3. The first 106 values (half chart) represents Osp1, the others Osp2 4. Between Hospitals the endoscopes were ranked in the following way: Colonscopes Others (Echoendoscopes e Duodenoscopes) Gastroscopes 5. RLU values increase from Colonoscopes to Gastroscopes Capitale sociale Euro 3.000.000,00 i.v. C.F., P.IVA e Numero Registro Imprese di Treviso: 04311220265 REA TV 339832 3/9
6. Colonscopes are easier to clean than Gastroscopes Table 1 Table 2 1. In the first 4 raws of the table are showed the RLUs mean values of both Hospitals (D). Values enclosed every kind of endoscopes tested in the 4 different categories (B). 2. Mean RLUs values are very similar (D) 3. Max RLUs values reached considering the 95% of the endoscopes tested (G). This value is interesting separating Coloscopes from Gastroscopes (raws from 5 to 8) and Osp1 from Osp2 (raws H and I) 4. Coloscopes passed and failed RLUs values are around 100 in the 95% cases while Gastroscopes shows 200 RLUs (compared to Clinical trial of ATP usage for endoscope manual washing validation 2015) 5. Osp1 has a better performance than Osp2 with Gastroscopes RLUs values similar to Colonoscopes referred to internal channels cleaning but has a worst performance in external surface cleaning Capitale sociale Euro 3.000.000,00 i.v. C.F., P.IVA e Numero Registro Imprese di Treviso: 04311220265 REA TV 339832 4/9
Table 2 Tables 3 RLUs internal channels values Osp1 is always under 100 RLUs threshold in both Experimental and Control group (in 106 endoscopes only 5 values are out of the mean). This shows a well standardized cleaning process. Graphic vertical size is smaller in the left side rather than in the right one. Osp2 has highest and less recurring values with under control values over 327 and 427 RLUs. Capitale sociale Euro 3.000.000,00 i.v. C.F., P.IVA e Numero Registro Imprese di Treviso: 04311220265 REA TV 339832 5/9
Tables 3 Capitale sociale Euro 3.000.000,00 i.v. C.F., P.IVA e Numero Registro Imprese di Treviso: 04311220265 REA TV 339832 6/9
Tables 4 RLUs surfaces values In Control group we see the same performance difference between the two Hospitals with some under control values. Better surface RLUs values are referred to Osp2. The assumption is that less attention has been provided in both groups during manual surface cleaning maybe because there were no variables to be investigated. Tables 4 Capitale sociale Euro 3.000.000,00 i.v. C.F., P.IVA e Numero Registro Imprese di Treviso: 04311220265 REA TV 339832 7/9
Summary and Discussion This firs pool of RLU data show values alignment between Manual Cleaning Automation with Steelco EPW 100 system and Manual Cleaning Procedures - according to Italian National GI Reprocessing Guidelines ANOTE-ANIGEA update 2011. Routinary controls are still strongly reccomended as a Best Pratice in monitoring cleaning efficacy both in manual and automated cleaning processes in order to guarantee patients safety. Conclusion Additional investigations will be ran in order to be able to claim and endorse the full automation of the manual cleaning step such as: Revision of the Experimental Protocol in conjunction with the ANOTE/ANIGEA President and Regional Referents Collect almost 3.000 RLUs samples from different GI Labs (1.500 CONTROL & 1.500 EXPERIMENTAL) + 1.500 microbiological cultures for channels cleaning efficacy (750 CONTROL & 750 EXPERIMENTAL) Detergent standartization in both groups (CONTROL & EXPERIMENTAL) avoiding a potential BIAS Trace the kind of the exame performed with the endoscope (diagnostic or operative) Learning outcomes + Relevance to Nursing Practice In GI Labs Endoscopes Manual Cleaning Automation with EPW 100 will improve safety for: HCWs à less chemicals handling and exposure, full traceability of this critical step, less injuries and more time for other tasks; Patients à guarantee of the same treatment without human risk, new fresh chemical used for each cycle and cross contamination reduction; Capitale sociale Euro 3.000.000,00 i.v. C.F., P.IVA e Numero Registro Imprese di Treviso: 04311220265 REA TV 339832 8/9
Endoscopes à less handling and maintenance (better integrity of internal channels without brushing), documented evidences of liquid pressure and flow inside channels providing alarms in case of obstruction. The introduction of 3M Clean Trace Hygiene Monitoring System can help to control endoscopes channels and surfaces cleanliness driving the GI Lab to take corrective actions in case of RLU values higher than 100. Bibliography 1) The repeatability of hygiene test systems in measurement of low levels of ATP. W.J. Simpson, C.J.Giles, H.A. Flockhart. Cara Technology Limited, Leatherhead Enterprise Centre, Randalls Road, Leatherhead, Surrey, KT227Ry, UK Report 30606, 27 July 2006 2) Monitoring the disinfection of flexible endoscopes using ATP bioluminescence (Biotrace international); 3) Assessment of the hygienic status of hand-contact surface on a busy general hospital ward in the UK (Nerys Bennion, Peter Obee); 4) C J Griffith, R A Cooper, J Gilmore, C Davies, M Lewis. An evaluation of hospital cleaning regimes and standard. Journal of Hospital Infection 2000;45:19-28. 5) EN 13549:2003 Cleaning services - Basic requirements and recommendations for quality measuring systems 6) Italian GI Guidelines ANOTE/ANIGEA update 2011 Capitale sociale Euro 3.000.000,00 i.v. C.F., P.IVA e Numero Registro Imprese di Treviso: 04311220265 REA TV 339832 9/9