water treatment by peter eldridge

Annual Meeting of Intensive Renal Nursing

Indonesia 2012

Water Quality Monitoring in Dialysis

Fresenius Medical Care South Asia Pacific

Peter Eldridge

Manager Technical Services & Water Solutions

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MX Eco RO System

Understanding Who has Responsibility

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The requirements of this International Standard aim to

help protect haemodialysis patients from adverse

effects arising from known chemical and microbiological

contaminants that can be found in improperly

prepared dialysis fluid. However, the physician in charge

of dialysis has the ultimate responsibility for ensuring

that the dialysis fluid is correctly formulated and meets

the requirements of all applicable quality standards.

Quality of dialysis fluid for haemodialysis and related therapies ISO 11663:2009(E)

MX Eco RO System

Understanding Who has Responsibility

3Quality of dialysis fluid for haemodialysis and related therapies

ISO 11663:2009(E)

The requirements of this International Standard aim to

help protect haemodialysis patients from adverse

effects arising from known chemical and microbiological

contaminants that can be found in improperly

prepared dialysis fluid. However, the physician in charge

of dialysis has the ultimate responsibility for ensuring

that the dialysis fluid is correctly formulated and meets

the requirements of all applicable quality standards.

MX Eco RO System

Understanding Who has Responsibility

4Association for the Advancement of Medical Instrumentation

ANSI/AAMI RD52:2004

The guidance provided by this recommended practice

should help protect haemodialysis patients from adverse

effects arising from known chemical and microbial

contaminants that may be found in improperly prepared

dialysate.

However, the physician in charge of dialysis has the

ultimate responsibility for ensuring that the dialysate is

correctly formulated and meets the requirements of all

applicable quality standards.

MX Eco RO System

Understanding Who has Responsibility

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Physician in

Charge

Nurse in

Charge

Nurse Nurse Nurse Nurse

Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient Patient

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Why is it so Important

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In 3 years a patient on thrice weekly dialysis is exposed to same amount of water that is consumed in a normal life time.

MX Eco RO System

We want to Avoid these Head Lines

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• PROLOGUE: AFTER DRY SUMMER, EXTRA FLOCULATE (Aluminum

Based) WAS ADDED TO REMOVE PARTICULATES

• CHEMICAL EVENTS: NEUROLOGICAL SYMPTONS, DEATHS FROM

ENCEPHALOPATHY.

• CHEMICAL CAUSE: ALUMINUM

• CIRCUMSTANCES: CLOGGED R.O. MEMBRANES

• PATIENTS AFFECTED: 71

• NUMBER OF DEATHS: 25

MX Eco RO System

We want to Avoid these Head Lines

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• PROLOGUE: CHANGE IN ROUTING OF WATER SUPPLY TO DIALYSIS

UNIT

• CHEMICAL EVENTS: JAUNDICE, ASCITES, HIGH BP, VOMITING AND

WEIGHT LOSS

• CHEMICAL CAUSE: CYANOTOXIN OF BLUE ALGAE

• CIRCUMSTANCES: WATER DIRECTLY FROM LAKE

• PATIENTS AFFECTED: 108+

• NUMBER OF DEATHS: 60+

MX Eco RO System

We want to Avoid these Head Lines

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REPORTED CHLORAMINE-INDUCED HEMOLYSIS

OUTBREAK No. PATIENTS

TRANSFUSED

1970 ?

1974 ?

1977 ?

1981 13

1984 25

1984 10

1987 41+

1989 34

2001 14

MX Eco RO System

�Relevant Standards

�Test Points

�Raw Water Analysis

�Prefiltration

�RO Unit

�Distribution Loop

�Summary

Agenda

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MX Eco RO System

�Relevant Standards

�Test Points

�Raw Water Analysis

�Prefiltration

�RO Unit

�Distribution Loop

�Summary

Agenda

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MX Eco RO System

� Raw Water – supplied by local water supplier

– WHO – World Health Organisation Standard for Drinking Water

– Local Drinking Water Act

� Prefiltered Water– Soft Water from Prefiltration

– AAMI RD62 - 2006 Edition

– ISO 13959 - 2009 Edition (recommended by FMC)

– ISO 23500 - 2011 Edition (recommended by FMC)

� RO Water (Dialysis Water) – Treated Water from RO

– AAMI RD62 - 2006 Edition

– ISO 13959 - 2009 Edition (recommended by FMC)

Relevant Standards

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MX Eco RO System

�Relevant Standards

�Test Points

�Raw Water Analysis

�Prefiltration

�RO Unit

�Distribution Loop

�Summary

�ISO Statements

Agenda

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MX Eco RO System

Test Points

Distribution Loop

1. Cold Water Tap2. Prefiltration

3. RO Unit

4. Distribution Loop

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MX Eco RO System

�Relevant Standards

�Test Points

�Raw Water Analysis

�Prefiltration

�RO Unit

�Distribution Loop

�Summary

�ISO Statements

Agenda

15

MX Eco RO System

� Monitoring: Heavy Metal Contamination, Silt Density Index (SDI)

� Standard: WHO or Local drinking water act

� Test: Chemical analysis, SDI measure

� Sample taken: Unmixed cold water tap

� Frequency: Annually (unless changes to water supply occur)

� Risk: Damage to RO System

What if:

� Chemical analysis out of range

• Contact local water supplier & RO Supplier

� SDI higher than 5 – may lead to RO Membrane blockage & damage

• Contact RO Supplier – Prefiltration may require upgrade

1. Cold Water Tap - Raw Water Analysis

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MX Eco RO System

�Relevant Standards

�Test Points

�Raw Water Analysis

�Prefiltration

– Water Hardness Test

– Total Chlorine Test

�RO Unit

�Distribution Loop

�HD Machine

�Summary

�ISO Statements

Agenda

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MX Eco RO System

2. Prefiltration – Water Hardness Test

� Monitoring: Total Water Hardness

� Standard: ISO 23500 – 2011 Edition

� Test: Water hardness test kit

� Sample taken: After Water Softener

� Frequency: Daily – at the end of the day

� Risk: Calcification (blockage) of RO Membrane

What if: Water hardness >17 ppm of CaCO3

� Possible cause:

• Lack of salt in brine tank

• Faulty or insufficient regeneration cycle

• Exhausted resin bed in water softener

� What to do:

• Check salt level in brine tank

• Contact RO Service Team

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MX Eco RO System

2. Prefiltration – Total Chlorine Test

� Monitoring: Total Chlorine level in ppm

� Standard: ISO 13959 – 2009 Edition

� Test: Chlorine test kit – accuracy 0.1 ppm

� Sample taken: After Activated Carbon Filter 1

� Frequency: Daily before first dialysis treatment

� Risk: Patient complications / RO Membrane breakdown

What if: Chlorine level >0.1 ppm

� Possible cause:

• Faulty or insufficient backwash cycle

• Exhausted carbon media in activated carbon filter

� What to do:

• Test chlorine level after 2nd activated carbon filter

• If chlorine level still > 0.1 ppm -> discontinue treatments

• Contact RO Service Team

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MX Eco RO System

�Relevant Standards

�Test Points

�Raw Water Analysis

�Prefiltration

�RO Unit

– Chemical Analysis

– Microbial Analysis

�Distribution Loop

�Summary

�ISO Statements

Agenda

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MX Eco RO System

3.0 RO Unit – Chemical Analysis

� Monitoring: Chemical contamination

� Standard: ISO 13959 – 2009 Edition

� Test: Chemical analysis

� Sample taken: After RO Membranes

� Frequency: Annually (unless changes to RO Unit occur)

� Risk: Patient complications

What if: Ionic levels higher than recommended

� Possible cause:

• Faulty RO Membrane or O-ring

• Raw water supply may have changed (Raw water analysis)

� What to do:

• Discontinue dialysis treatment

• Contact RO Service Team

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MX Eco RO System

3.0 RO Unit – Microbial Analysis

� Monitoring: Bacterial contamination

� Standard: ISO 13959 – 2009 Edition

� Test: CFU culture & Endotoxin test (LAL)

� Sample taken: After RO Membranes

� Frequency: 3 Monthly (unless changes to RO Unit occur)

� Risk: Patient complications

Contaminant Action Level Limit level

CFU 50 CFU/ml 100 CFU/ml

Endotoxin 0.125 EU/ml 0.25 EU/ml

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MX Eco RO System

3.0 RO Unit – Microbial Analysis

What if: CFU & LAL levels higher than recommended

� Possible cause:

• Faulty RO Membrane

• Bacterial infestation

� What to do if level above Action Level

• Continue dialysis treatment

• Disinfect RO Unit a.s.a.p.

• Conduct the test again

• If test returns positive, contact RO Service Team

� What to do if level above Limit Level

• Discontinue dialysis treatment

• Disinfect RO Unit

• Conduct the test again

• If test returns positive, contact RO Service Team

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MX Eco RO System

�Relevant Standards

�Test Points

�Raw Water Analysis

�Prefiltration

�RO Unit

�Distribution Loop

�Summary

�ISO Statements

Agenda

24

MX Eco RO System

4.0 Distribution Loop – Microbial Analysis

� Monitoring: Bacterial contamination

� Standard: ISO 13959 – 2009 Edition

� Test: CFU culture & Endotoxin test (LAL)

� Sample taken: From the End of Distribution Loop

� Frequency: 3 Monthly (unless changes to Loop occur)

� Risk: Patient complications

Contaminant Action Level Limit level

CFU 50 CFU/ml 100 CFU/ml

Endotoxin 0.125 EU/ml 0.25 EU/ml

Distribution Loop

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MX Eco RO System

4.0 Distribution Loop – Microbial Analysis

What if: CFU & LAL levels higher than recommended

� Possible cause:

• Bacterial infestation

� What to do if level above Action Level

• Continue dialysis treatment

• Perform a distribution loop & storage tank disinfection a.s.a.p.

• Conduct the test again

• If test returns positive, contact RO Service Team

� What to do if level above Limit Level

• Discontinue dialysis treatment

• Perform a distribution loop & storage tank disinfection

• Conduct the test again

• If test returns positive, contact RO Service Team

Distribution Loop

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MX Eco RO System

�Relevant Standards

�Test Points

�Raw Water Analysis

�Prefiltration

�RO Unit

�Distribution Loop

�Summary

�ISO Statements

Agenda

27

MX Eco RO System

So is it Good Practice

Distribution Loop

1. Cold Water Tap2. Prefiltration

4. Distribution Loop

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TO BYPASS THE REVERSE

OSMOSIS SYSTEM.

MX Eco RO System

Remember These Head Lines

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• PROLOGUE: AFTER DRY SUMMER, EXTRA FLOCULATE (Aluminum

Based) WAS ADDED TO REMOVE PARTICULATES.

• CHEMICAL EVENTS: NEUROLOGICAL SYMPTONS, DEATHS FROM

ENCEPHALOPATHY.

• CHEMICAL CAUSE: ALUMINUM

• CIRCUMSTANCES: CLOGGED R.O. MEMBRANES.

• PATIENTS AFFECTED: 71

• NUMBER OF DEATHS: 25

MX Eco RO System

Is There a Better Option

Distribution Loop

1. Cold Water Tap2. Prefiltration

3. RO Unit

4. Distribution Loop

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Dual RO Unit

MX Eco RO System

Summary

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As health care Professionals we need to be aware of any and all updates or changes to Standards and by doing this we will ensure that our patients receive Quality Treatment.

MX Eco RO System

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MX Eco RO System

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MX Eco RO System

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MX Eco RO System

Thank you for your attention!

For detailed sampling techniques, Fresenius Medical Care is happy to provide you with

our Guideline for Routine Water Testing, which includes the Decision Flow Charts for

bacterial contamination, high chlorine level reading and hard water results. It also

includes examples of daily and 3 monthly log sheets. To receive a copy, please contact

your local Fresenius Medical Care Representative.

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