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