water treatment by peter eldridge
TRANSCRIPT
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
Page 1
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.
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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
8
• 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+
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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
11
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
12
MX Eco RO System
�Relevant Standards
�Test Points
�Raw Water Analysis
�Prefiltration
�RO Unit
�Distribution Loop
�Summary
�ISO Statements
Agenda
13
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.
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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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