Transcript Plan d’action Soluscope

Introduction
To the pr EN ISO 15883-4
Project norm
Norms related to washer
disinfectors (pr EN ISO 15883)
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15883-1 : General requirements
« General requirements, definitions & tests »
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15883-2 : Requirements on WD for
surgical medical devices.
« Requirements & tests for the the WD using the thermal disinfection for the surgical
instruments, anaesthesia equipments, accessories, …»
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15883-3 : Requirements for bed pan WD
« Requirements & tests for the WD using the thermal disinfection of human waste
containers »
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15883-4 : Requirements for thermo labile
flexible endoscopes WD
« Requirements & tests for the WD using the chemical disinfection for flexible
endoscopes »
Structure of prEN 15883-4
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Introduction (Chap 1 to 3 : Scope, normative
references, terms & definitions)
Performances requirements (chap 4)
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Cycle steps
Self-disinfection
Water treatment
Process requirements (Chap 5)
Testing (Chap 6)
Documentation & information (Chap 7 to 10)
Annexes (A, B, C, D, E & ZA)
Mandatory steps in a treatment
cycle
a)
b)
c)
d)
e)
f)
Leak test
Cleaning
Rinsing (if necessary)
Disinfection
Rinsing (toxic residues elimination)
Drying (when appropriate)
Cleaning
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All inner and outer surfaces of the device have to be cleaned.
Cleaning includes a washing step that uses a detergent.
Detergent is single use.
All chemical residues and moisture are rinsed after washing.
Cleaning efficacy has to be demonstrated (cf chap 6).
Critical parameters of cleaning efficacy are : temperature,
mechanical effect (type, flow), duration, detergent (type,
concentration)
Disinfection
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Efficacy of the disinfectant (in vitro tests)
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Tests conditions with critical parameters of the WD :
temperature, concentration & contact time,
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Temperature & concentration of LD, with 5 hours of
contact time :
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6 log reduction for : bacteria, mycobacteria, yeast &
fungi
4 log reduction for : fungi spores & viruses
6 log reduction for the most resistant bacterial
endospores.
The capacity of the WD to disinfect an
endoscope is tested (see chap. 6 : evaluation of
the process)
Disinfection (2)
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NeEd to control the temperature during
all disinfection step.
Single use of the disinfectant
(recommended).
Final rinse : potable water quality, at
least. No mycobacteria, nor Legionella
Channel flush with 0,2µ filtered air
Drying
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Drying is not necessary if scope is quickly
reused.
Drying is necessary before scope storage.
Drying needs to remove all remaining humidity
(very strict tests conditions).
WD may not dry. In that case, manufacturer
has to provide manual drying instructions.
Alcohol rinse is possible to improve the drying.
Self-disinfection
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Self disinfection cycle has to be design
to remove the contamination of a WD.
Thermal process is preferred for self
disinfection cycle.
Self disinfection cycle has to be
automated.
Self disinfection cycle efficacy has to be
demonstrated (chap 6)
Water treatment
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Integrated to the WD or not.
Design to achieve the final rinse water quality.
Need to be disinfected without affecting its
efficacy :
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During the WD self-disinfection cycle
With an independent procedure, at an appropriate
frequency.
When integrated to the WD, water sampling
need to be easy.
Process requirements
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Design & materials need to be chosen to
respect endoscope integrity
Endoscope has to be protected from being
flushed with too hot fluids.
WD needs to monitor critical parameters
(temperature, contact time, concentration of
both detergent & disinfectant independently
from the controller means.
Process requirements (2)
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The WD has to control fluids flow in every
channel of the endoscope :
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WD shall detect non connected channels
WD shall detect blocked channels.
Manufacturer has to provide connecting
drawings of the WD to the different types of
scopes.
Manufacturer shall provide data related to the
type of scopes that could be reprocessed in the
WD.
Testing
Equipments & methods to use :
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Water quality (to test before installation &
every year)
Leak test
Channel blockage/disconnection
Drying
Chemical dosing tests
Thermometric tests
Testing (2)
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Cleaning efficacy
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Contamination of the surrogate and the
chamber
Launch a cycle & interrupt after cleaning
Residues detection (visible & proteins)
To perform during installation and then on
a routine base
Testing (3)
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Microbial tests
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Preliminary tests : in vitro studies
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Temperature, concentration, contact time
Bacterias, mycobacterias, viruses, yeast & fungis,
spores
Self disinfection test
Final rinse disinfection test
Load disinfection test
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Contaminated scopes with bacterias,
mycobacterias, fungis, spores, suspended in a soil
and dried.
Annex A
Final rinse microbial contamination
 Where, how & when to sample ?
 What germs :
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Aerobic mesophile flora
Environmental mycobacterias
Legionellas
Annex B
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Microbial test of the efficacy of the
chemical disinfection of the load
What strains ?
What devices ?
Evaluation of the physical elimination of
the germs (spores)
Annex C
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Summary table of tests.
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Type tests (Validation)
Plant tests (QC)
Operational tests
Performance tests
Routine tests
Annex D
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Microbial evaluation for the water treatment self
disinfection
Germ : Pseudomonas aeruginosa
Method 1 : contamination of the WD &
watertreatment, 24h incubation, automatic self
disinfection cycle and then sample
Method 2 : contamination, incubation 48h, scope
reprocessing cycle, then 24h incubation, then
standard cycle, 4 consecutive days, then 48h
incubation, then self disinfection cycle, then
sample.
Annex D
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Advises on validation of microbial
methods
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Reproductibility
Sensitivity of detection
Efficacy of samples
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Conclusions
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A very detailled norm (51 pages + 15883-1)
A very high level of expectations
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Disinfectant performances (in vitro)
Machine performances
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Channel control
Critical parameters control
Self-disinfection
Water treatment
Performances of the couple : Machine +
products
Conclusion (2)
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A real challenge for the manufacturers
A document already used for several
referentials : HTM2030 (UK), CTIN guide
(France) and buyers guide (UK & France)
A real tool for the users :
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A real standart for the choice of an
endoscope washor-disinfector.
A real progress for the infection control
in the endoscopy department
Thank you for your attention