the documentation

 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
MD 04#07 Rev.05 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™
Steelco S.p.a. -­‐ VIA BALEGANTE, 27 – 31039 RIESE PIO X (TV) Tel. 0039 0423 7561 Fax 0039 0423 755528 www.steelcospa.com e-­‐mail: [email protected] 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 CleanTrace™ 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
MD 04#07 Rev.05 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™ CleanTrace™ 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
Steelco S.p.a. -­‐ VIA BALEGANTE, 27 – 31039 RIESE PIO X (TV) Tel. 0039 0423 7561 Fax 0039 0423 755528 www.steelcospa.com e-­‐mail: [email protected] 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
MD 04#07 Rev.05 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
Steelco S.p.a. -­‐ VIA BALEGANTE, 27 – 31039 RIESE PIO X (TV) Tel. 0039 0423 7561 Fax 0039 0423 755528 www.steelcospa.com e-­‐mail: [email protected] 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
MD 04#07 Rev.05 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
Steelco S.p.a. -­‐ VIA BALEGANTE, 27 – 31039 RIESE PIO X (TV) Tel. 0039 0423 7561 Fax 0039 0423 755528 www.steelcospa.com e-­‐mail: [email protected] 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
MD 04#07 Rev.05 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.
Steelco S.p.a. -­‐ VIA BALEGANTE, 27 – 31039 RIESE PIO X (TV) Tel. 0039 0423 7561 Fax 0039 0423 755528 www.steelcospa.com e-­‐mail: [email protected] 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 MD 04#07 Rev.05 Tables 3
Steelco S.p.a. -­‐ VIA BALEGANTE, 27 – 31039 RIESE PIO X (TV) Tel. 0039 0423 7561 Fax 0039 0423 755528 www.steelcospa.com e-­‐mail: [email protected] 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.
MD 04#07 Rev.05 Tables 4
Steelco S.p.a. -­‐ VIA BALEGANTE, 27 – 31039 RIESE PIO X (TV) Tel. 0039 0423 7561 Fax 0039 0423 755528 www.steelcospa.com e-­‐mail: [email protected] 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:
MD 04#07 Rev.05 • 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;
Steelco S.p.a. -­‐ VIA BALEGANTE, 27 – 31039 RIESE PIO X (TV) Tel. 0039 0423 7561 Fax 0039 0423 755528 www.steelcospa.com e-­‐mail: [email protected] 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
MD 04#07 Rev.05 6) Italian GI Guidelines ANOTE/ANIGEA update 2011
Steelco S.p.a. -­‐ VIA BALEGANTE, 27 – 31039 RIESE PIO X (TV) Tel. 0039 0423 7561 Fax 0039 0423 755528 www.steelcospa.com e-­‐mail: [email protected] 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