Dialysis system and its cleaning methods in Japan

Dialysis system and ít cleaning methods in JapanDialysis system and ít cleaning methods in JapanDialysis system and ít cleaning methods in JapanDialysis system and ít cleaning methods in JapanDialysis system and ít cleaning methods in JapanDialysis system and ít cleaning methods in JapanDialysis system and ít cleaning methods in JapanDialysis system and ít cleaning methods in JapanDialysis system and ít cleaning methods in Japan

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DIALYSIS SYSTEM AND ITS CLEANING METHODS IN JAPAN

HAICBIFS BMY ATLBKOCORAMCAA

What is the purpose of the dialysate cleaning’?

* Restraint of an acute reaction during the dialysis treatment When Endotoxin (ET) and the fragment included in dialysate invade blood after passing through a dialysis membrane, it can cause fever and blood pressure drop during dialysis treatment as a result of deriving cytokine production

* The prevention of complications in the chronic dialysis

treatment

When chronic stimulation with cytokine is repeated for a long term, it may be causing dialysis amyloidosis (DRA), nutritional disorder, chronic feeble inflammation, an arteriosclerotic (MIA syndrome) immunoecompetence drop, the osteopathy

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The clinical manifestations that is expected by improvement of dialysate cleaning

¢ Drop (production restraint) of the serum & 2-MG density

¢ The onset and progress restraint of Carpal tunnel syndrome and DRA

* Improvement of chronic feeble inflammation (CRP drop ,

IL-6 drop)

* Improvement of anemia(reaction improvement for the ESA,

improvement of the red blood cell life)

¢ Protein metabolism, imorovement of the nutritional

disorder (improvement of the liver albumin synthetic drop)

* Improvement of the oxidation stress (oxidation LDL drop)

* Improvement of the cellular immunocompetence * Prevention of arteriosclerosis

Clinical Engineering Vol.i9NO.8 2008 894p

Standard of the dialysis water cleaning

Dialysis fluid cleaning Ty ISO23500 JSDT live bacteria ET live bacteria ET live bacteria ET

<(CFU/mì <(EU/m) <(CFU/m) <(EU/m)) <(CFU/m) <(EU/m) 0.01 100 Dialysis nọ 0.25 400 0.05 water Target 1 Target Action level 0.001 50 100 Dialysis fluid Action level 05 100 0.05 50 0.1 0.01 Ultrapure dialysis fluid 0.1 0.03 0.1 0.001 Manage it by the clinical use 7 - There do not 10¢ 0.001 gs appropriately in safety A 0.03 Substitution management Committee of ¬ pe 8 vế cteria undetectable guarantee ultrapure "—

Dialysis fluid cleaning Ver2.00 + + * Japan Association for Clinical Engineers standard JSDT +» + * Japan Society for Dialysis Therapy standard

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Representative of the water generator system in Japan Water softening Activated device charcoal Raw water Pre filter Check filter Ultraviolet germicidal lamp = 7a tT ETRF 3e#4eawsm~

RO tank “RO module

From dialysate cleaning guidelines Ver2.0

A role of each system , and caution points

System Role Important point

Filter It remove impurities(fine particles, | Confirm pressure in filter inlet and outlet insoluble oxide) of raw water The | Because a pressure difference occurs if blocking pore size of the 1st filter are happens in a filter, assume it an aim of the filter 10-30 um, the 2nd filter are exchange

5-10um

Water softening It substitute a hardness Monitor an exchange rate of the ion regularly (soft device ingredient of raw water with a Na | water uses a judgment indicator), and exchange

ion and make soft water, and or reproduction of the resin is necessary if ability prevent the deterioration of RO for exchange seems to cut 30%

membrane hardness after processing is less than 10

Activated charcoal | It eliminate mainly free chlorine Be careful that is preventive to propagate with

filter device (chloramine) bacteria after the device , because of adsorbing free chlorine sterilizing raw water

RO module It give high pressure of 10-30 Watch the fact that the permeation water which kg/cm2 to raw water through RO | passed through RO module is in 50-75% membrane and remove many (recovery rate) of raw water In the case of less ions, bacteria, endotoxin Cesium | than 50%, because a solute (scale) which does and the radioactive material are not pass through a membrane accumulates on eliminated, too the RO membrane surface, exchange is necessary

When using groundwater, be careful because chloramine may be produced , ammonia of groundwater and chlorine for sterilization react

RO tank The tank which performs storing | confirm the UV light(ultraviolet rays sterilization) water so that RO water is regularly, and change it

supplied stably because the tank is becoming the hotbeds of the bacteria breeding, ultraviolet rays germicidal light is established

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Daily checking points for water generator system (on the date of HD session)

Inspection item tolerance Permeable water temperature(‘C) 25~38 Inlet pressure of Pre filter (Mpa)

Outlet pressure of Pre filter (Mpa) Differential pressure(In—Out) (Mpa) Inlet pressure of Check filter (Mpa) Outlet pressure of Check filter (Mpa) Differential pressure(In—Out) (Mpa) Inlet pressure of RO module (Mpa) Outlet pressure of RO module (Mpa) Differential pressure(In—Out) (Mpa)

The quality of permeable water (us/cem) 20 below

The quantity of permeable water (£/min)

The draining quantity of concentrated water (£/min) The quantity of returning water (£/min)

Supply pump pressure (Mpa)

The water leak Good or NG Abnormal! point Good or NG Speed of pump rotation (for water making)

The piping and dialysis device cleaning method with

chemical liquid of Surugadai nihon university hospital

From RO tank throughout to the piping of dialysis machine on each patients, we perform cleaning with chemical liquid

¢ Short time chemical liquid enclosure method(Once every 3 months) We supply it to a pipe after making sodium hypochlorite solution of

1000ppm in RO tank We perform flushing enough water after having enclosed it in the pipe and single patient dialysis machine

inside for 30 minutes

* The low-concentrated chemical liquid automatic filling Method (daily)

We make sodium hypochlorite solution of 1p om in RO tank and wash

with water after having enclosed it in the piping for approximately 6 hours

* The washing of the ion-exchange resin reoroduction and the RO module in the water processing device perform by automatic program twice a week

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Example of independent patient dialysis machine cleaning in Surugadai nihon university hospital

We carry out cleaning with the chemical liquid in independent patient dialysis machine, using wash program of the machine

(Method and schedule]

We carry out cleaning by a single pass method with sodium

hypochlorite (BOOppm) and acetic acid(1%) The acetic acid washing

once a week (for removing calcium carbonate purpose in a machine)

Week Mon, Tue ,Wedl ,Thu ,Sat

Process | flushing sodium flushing | Preset | Pre hypochlorite flushing Time(min) 30 30 40 = 3O Week

Process Flushing sodium Flushing | acetic | Flushing | Preset Pre hypochlorite acid flushing Time(min) 30 30 30 30 40 = 30 Sampling unit (TORAY Medical product)

SUS* body for @GTube SUS* body for Large bore pipe

SUS* : Stainless steel

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Representative sampling point(Japanese style) —⁄ RO treated water erator Dialysis solution Dialysate @ Sampling point ¬= lncebendent patient dialysis machine Checking item and method on regular service () Checking item Dirt in dialysate circuit Method

Viewing including the adhesion of protein and the rust in the silicon tube

Judgment °«_ tolerance Use of the rust

preventing agent and

exchange of the silicon tube

Leak in dialysate circuit Viewing the leak from a

tube joint and an electromagnetic valve, a

pump

Exchange of the leak part

Dialysate temperature Measuring dialysis fluid outlet temperature with thermometer

<+O8C

Dialysate flow quantity When QD 500ml/min,

true flow quantity with measuring cylinder

<+10%

Remove water control

Testing using sham circuit with water

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Checking item and method on regular service @)

Checking item Method Judgment °¢ tolerance Blood leakage detection Checking movement The cleaning in the sensor and the detection analyzer and voltage

voltage in calibration adjustment

filter

Blood pump flow quantity When QB 200mI/min, =+10% true flow quantity with

measuring cylinder

Pressure gauge (V pressure, | measuring the error <S+10% dialysate pressure) with standard pressure

gauge

Infusion pumb Measuring the true =+10% quantity

Air bubbles detection Operation check at the | Adjustment of the sensor time of the micro air detective sensitivity

bubbles mixture

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Duties of the clinical engineer

Duties for the operation of the life support management device and maintenance

(checking) of it

(Effective date of the Clinical Engineers Act, April 1988)

Relation for Blood purification therapy Relation for Extracorporeal Relation for respiratory circulation therapy

Duties contents of clinical engineer

(CE) in the hospital

Clinical duties

Medical instrument maintenance duties Article management duties

The education/training duties in hospital staff

Medical safety management duties

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General duties of CE by the dialysis treatment

Before a dialysis treatment start

¢ We check dialysis device and blood circuits , and record it

* Weconfirm dialysis device and its operating instruction , moreover confirm the instruction of requisite drug for a device and a circuit (together dialysate and replacement

solution)

* Preparations of device and circuit (including the filling solution) necessary as dialysis treatment

* The assembling of blood circuit necessary for dialysis device , and priming (filling) process of the circuit

* Preparations of drug and treatment materials necessary for the operation of dialysis device (together the density control of dialysate and replacement solution)

* Opening check of dialysis device

General duties of CE by the dialysis treatment

From start to finish ,in a dialysis treatment@

* Puncture and withdrawal to vascular access of the puncture needle

* The connection of the blood circuit( the catheter) to Blood access attaching to a body, and the removal * The setting of the operating conditions (treatment time,

blood flow quantity, remove water control ) of dialysis device ,and make a change in monitoring requirement * The setting of the dose of blood, replacement liquid, a

supplementary liquid , and make a change in it

* Monitoring of the monitoring device necessary for the operation of dialysis device

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General duties of CE by the dialysis treatment

From start to finish ,in a dialysis treatment@

¢ Drawing blood from a blood circuit necessary for the

operation of dialysis device

¢ Drawing blood from indwelling catheter

¢ Record about the dialysis device operating condition ,

a patient condition, the monitoring item

General duties of CE by the dialysis treatment

After the dialysis treatment finish

¢ The sterilization of dialysis device and washing it

Others

° In the case of connection and removal of the blood circuit, giving treatment of sterilization and the

hemostasis

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Duties of CE except clinical duties

in dialysis treatment

¢ Duties in relation to dialysate cleaning

¢ Duties in relation to the maintenance of the dialysis device

¢ Duties in relation to patient data accumulation ¢ Duties in relation to management of dialysis treatment materials Dialysis duties as the team medical care Dr CE Nrs

Cooperation of duties is important surpassing

the type of job in dialysis treatment ! !