Introduction To the pr EN ISO 15883-4 Project norm.
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Transcript of Introduction To the pr EN ISO 15883-4 Project norm.
Introduction To the pr EN ISO 15883-4
Project norm
Norms related to washer disinfectors (pr EN ISO 15883)
15883-1 : General requirements« General requirements, definitions & tests »
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, …»
15883-3 : Requirements for bed pan WD« Requirements & tests for the WD using the thermal disinfection of human waste containers »
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
Introduction (Chap 1 to 3 : Scope, normative references, terms & definitions)
Performances requirements (chap 4)– 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) Leak testb) Cleaningc) Rinsing (if necessary)
d) Disinfectione) Rinsing (toxic residues elimination)
f) Drying (when appropriate)
Cleaning
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
Efficacy of the disinfectant (in vitro tests)– Tests conditions with critical parameters of the WD :
temperature, concentration & contact time, 6 log reduction for : bacteria, mycobacteria, yeast & fungi 4 log reduction for : fungi spores & viruses
– Temperature & concentration of LD, with 5 hours of contact time :
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)
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
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
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
Integrated to the WD or not. Design to achieve the final rinse water
quality. Need to be disinfected without affecting its
efficacy :– 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
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)
The WD has to control fluids flow in every channel of the endoscope :– 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 :– Water quality (to test before installation &
every year)– Leak test– Channel blockage/disconnection– Drying– Chemical dosing tests– Thermometric tests
Testing (2)
Cleaning efficacy– 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)
Microbial tests– Preliminary tests : in vitro studies
Temperature, concentration, contact time Bacterias, mycobacterias, viruses, yeast & fungis,
spores– Self disinfection test– Final rinse disinfection test– Load disinfection test
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 :
– Aerobic mesophile flora– Environmental mycobacterias– Legionellas
Annex B
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
Summary table of tests.– Type tests (Validation)– Plant tests (QC)– Operational tests– Performance tests– Routine tests
Annex D
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
Advises on validation of microbial methods– Reproductibility– Sensitivity of detection– Efficacy of samples– …
Conclusions
A very detailled norm (51 pages + 15883-1)
A very high level of expectations– Disinfectant performances (in vitro)– Machine performances
Channel control Critical parameters control Self-disinfection Water treatment
– Performances of the couple : Machine + products
Conclusion (2)
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 :– 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