jim baker talk - the renal network & water for dialysis standards and regulations water...
TRANSCRIPT
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Water: What’s New & What To Do
byJames Baker
PresidentAmeriWater, Inc.
Water: What’s New & What To Do
byJames Baker
PresidentAmeriWater, Inc.
Preparing for the New Medical Director Responsibilities
DisclosurePreparing for the New Medical Director Responsibilities
Disclosure
• I would like to disclose that I am president of AmeriWater and receive an annual salary and bonus from AmeriWater, Inc. My presentation does not endorse any commercial interest, product or services.
• This presentation will not advocate for the off-label use of medications.
• I would like to disclose that I am president of AmeriWater and receive an annual salary and bonus from AmeriWater, Inc. My presentation does not endorse any commercial interest, product or services.
• This presentation will not advocate for the off-label use of medications.
OUTLINEOUTLINEWater & Water for Dialysis
Standards and Regulations
Water Treatment SystemsCentral Cronic
Portable Acute
Home Dialysis
Monitoring & Testing
Water & Water for Dialysis
Standards and Regulations
Water Treatment SystemsCentral Cronic
Portable Acute
Home Dialysis
Monitoring & Testing
2
Introduction
To
Water
& Water for Dialysis
Introduction
To
Water
& Water for Dialysis
WaterWater
The UniversalSolvent
The UniversalSolvent
3
Water SpotWater Spot
Patient Water Exposure
Patient Water Exposure
Normal person 10 Liters/week
Dialysis Patient 350 Liters/week
Normal person 10 Liters/week
Dialysis Patient 350 Liters/week
DialysisDialysis
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Water UsageWater Usage
Importance of Ultra Pure Water
Importance of Ultra Pure Water
The Trend is Toward Ultra Pure USP Type Water.
The Water System Will Need to be Microbiologically Controlled.
The Trend is Toward Ultra Pure USP Type Water.
The Water System Will Need to be Microbiologically Controlled.
AAMI Water QualityAAMI Water QualityFour Groups ofContaminants
Based on Their Effects
on Patients
Four Groups ofContaminants
Based on Their Effects
on Patients
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Group 1-ToxicityGroup 1-ToxicityTOXIC
CONTAMINANTSLOWEST TOXICITY
CONCENTRATION (MG/L)Aluminum 0.06
Chloramines 0.25Fluoride 1.0Copper 0.49
Zinc 0.2Nitrate 21 (as N)Sulfate 200
Calcium/Magnesium 88 (Ca++)Sodium 300
Microbial --
Group 2-Drinking Water StandardGroup 2-Drinking Water Standard
Barium
Chromium
Silver
Mercury
Selenium
Lead
Cadmium
Arsenic
Antimony
Beryllium
Thallium
Barium
Chromium
Silver
Mercury
Selenium
Lead
Cadmium
Arsenic
Antimony
Beryllium
Thallium
AAMI is 10%of Drinking Water
Standard
AAMI is 10%of Drinking Water
Standard
Group 3-PhysiologicalGroup 3-Physiological
Calcium
Sodium
Potassium
Calcium
Sodium
Potassium
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Group 4-Microbiological
Group 4-Microbiological
BacteriaEndotoxinBacteriaEndotoxin
Bacteria/EndotoxinBacteria/Endotoxin
The GoalThe Goal
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BiofilmBiofilm
Bacteria creates biofilm.
We need to disinfect enough to control biofilm.
Requires at least monthly:Disinfection
Monitoring (cultures & LALs)
Bacteria creates biofilm.
We need to disinfect enough to control biofilm.
Requires at least monthly:Disinfection
Monitoring (cultures & LALs)
Dialysate & Water StandardsDialysate & Water Standards
Bacteria = 200 CFU, action level 50 CFU
Endotoxin = 2 EU/ml, action level 1 EU/ml
MONTHLY, MONTHLY, MONTHLY
Bacteria = 200 CFU, action level 50 CFU
Endotoxin = 2 EU/ml, action level 1 EU/ml
MONTHLY, MONTHLY, MONTHLY
Dialysis StandardsDialysis StandardsAAMI
CMS
FDA
JCAHO
ISO
AAMI
CMS
FDA
JCAHO
ISO
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AAMI StandardsAAMI StandardsRD 62RD 62 RD 52RD 52
Current AAMI Standards
Current AAMI Standards
“Voluntary” industry water standards that are accredited through ANSI. However CMS
has made them requirements for coverage so they are mandatory for payment.
“Voluntary” industry water standards that are accredited through ANSI. However CMS
has made them requirements for coverage so they are mandatory for payment.
ANSI/AAMI RD62:2006ANSI/AAMI RD62:2006
Water Treatment Equipment for Hemodialysis Operations
The water treatment equipment manufactures standard. Revised from the 2001 standard...
Water Treatment Equipment for Hemodialysis Operations
The water treatment equipment manufactures standard. Revised from the 2001 standard...
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Microbiological:Bacteria 200 CFU/mL Max. 50 CFU/mL Action
Endotoxin 2 EU/mL Max. 1 EU/mL Action
Chemical:Addition of Antimony, Beryliium and Thalliium
Microbiological:Bacteria 200 CFU/mL Max. 50 CFU/mL Action
Endotoxin 2 EU/mL Max. 1 EU/mL Action
Chemical:Addition of Antimony, Beryliium and Thalliium
1. Contaminants that are toxic2. Contaminants that are physiological 3. Contaminants from the USEPA Safe
Drinking Water Act
1. Contaminants that are toxic2. Contaminants that are physiological 3. Contaminants from the USEPA Safe
Drinking Water Act
Chemical Contaminants:AAMI Analysis
Chemical Contaminants:AAMI Analysis
New Additions to the RD 62 StandardNew Additions to the RD 62 StandardThe face of any timer controlling a regeneration or backwash cycle shall be visible.
Cartridge filters shall be fitted with pressure gauges on the inlet and outlet.
Carbon Beds:
Iodine number less than 900 in high organic waters, validated.
Arrangements of multiple beds in worker/polisher configurations approved.
RO lockout when backwashing.
Addition of UV chlorine/chloramine reduction.
The face of any timer controlling a regeneration or backwash cycle shall be visible.
Cartridge filters shall be fitted with pressure gauges on the inlet and outlet.
Carbon Beds:
Iodine number less than 900 in high organic waters, validated.
Arrangements of multiple beds in worker/polisher configurations approved.
RO lockout when backwashing.
Addition of UV chlorine/chloramine reduction.
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Anion resin systems as organic scavenger and pH remediation.
Chemical injection systems for sodium bisulfite and acid injection with special control requirements.
Storage tanks that have overflow shall be fitted with means of preventing contamination.
Endotoxin Filters: change ultrafilters to endotoxin retentive filters.
Hot water disinfection systems should be equipped with a temperature monitor at the end of the loop.
Ozone disinfection systems shall produce 0.5 ppm ozone for at least 10 minutes. Residual ozone should be less than 0.1 ppm before use.
Direct feed flow in loop should be at least 1.5 feet per second.
Total chlorine “dip and read “ test strips may be used.
Anion resin systems as organic scavenger and pH remediation.
Chemical injection systems for sodium bisulfite and acid injection with special control requirements.
Storage tanks that have overflow shall be fitted with means of preventing contamination.
Endotoxin Filters: change ultrafilters to endotoxin retentive filters.
Hot water disinfection systems should be equipped with a temperature monitor at the end of the loop.
Ozone disinfection systems shall produce 0.5 ppm ozone for at least 10 minutes. Residual ozone should be less than 0.1 ppm before use.
Direct feed flow in loop should be at least 1.5 feet per second.
Total chlorine “dip and read “ test strips may be used.
The PhysicianHas TheUltimate
Responsibility
The PhysicianHas TheUltimate
Responsibility
RD 62 ➜ RD 52RD 62 ➜ RD 52
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AAMI RD52:2004“Dialysate for Hemodialysis”
AAMI RD52:2004“Dialysate for Hemodialysis”
This is your water system operation standard
Same water quality as RD62:2006
Monthly samples from water system and at least from two dialysis machines per month with all machines sampled per year.
This is your water system operation standard
Same water quality as RD62:2006
Monthly samples from water system and at least from two dialysis machines per month with all machines sampled per year.
Important Note:New systems or Bad results
Important Note:New systems or Bad results
When new water systems are installed or if results don’t meet standards, weekly sampling should be performed until it is clear that the system is under control.
When new water systems are installed or if results don’t meet standards, weekly sampling should be performed until it is clear that the system is under control.
RD 52 RecommendsRD 52 Recommends
Written policies and procedures
Periodic audits of operators compliance
Contingency plans
Monthly Disinfection
Monthly Cultures and LALs
Written policies and procedures
Periodic audits of operators compliance
Contingency plans
Monthly Disinfection
Monthly Cultures and LALs
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Water System Key PointsWater System Key PointsMultiMedia measure differential pressure.
Cartridge filters measure differential pressure.
Water softeners test hardness at end of day.
Carbon Adsorption:
test total chlorine less than 0.1 mg/L (ppm)
high pH water may interfere with carbon performance
replace carbon within 72 hours on worker breakthrough
test total chloramine before every shift or at least every four hours
MultiMedia measure differential pressure.
Cartridge filters measure differential pressure.
Water softeners test hardness at end of day.
Carbon Adsorption:
test total chlorine less than 0.1 mg/L (ppm)
high pH water may interfere with carbon performance
replace carbon within 72 hours on worker breakthrough
test total chloramine before every shift or at least every four hours
Reverse Osmosis:
use conductivity (or TDS) to monitor RO, not % rejection
monitor RO flows and pressures
AAMI chemical analysis when new membranes are installed
Deionization:
stop flow if quality drops below 1 megohm/cm
follow with bacteria/endotoxin retentive filter
replace worker tank(s) within 72 hours upon exhaustion
Reverse Osmosis:
use conductivity (or TDS) to monitor RO, not % rejection
monitor RO flows and pressures
AAMI chemical analysis when new membranes are installed
Deionization:
stop flow if quality drops below 1 megohm/cm
follow with bacteria/endotoxin retentive filter
replace worker tank(s) within 72 hours upon exhaustion
Storage Tank:
internal spray mechanism to wash down the top and facilitate disinfection
Concentrate Preparation:
Label mixing tank with date and chemical composition until emptied.
Jugs labeled with contents.
Permanent records;
concentrate formula
volume of batch
lot numbers of powered concentrate
the manufacturer of the powder
Storage Tank:
internal spray mechanism to wash down the top and facilitate disinfection
Concentrate Preparation:
Label mixing tank with date and chemical composition until emptied.
Jugs labeled with contents.
Permanent records;
concentrate formula
volume of batch
lot numbers of powered concentrate
the manufacturer of the powder
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date and time of mixing
test results, not pH but conductivity or specific gravity
the person performing the mixing
the person verifying the mixing and their test results
Acid concentrate additives
make sure the “spike” is completely mixed
label container with final concentration, the date and time mixed, and the person mixing
log of mix in permanent record
date and time of mixing
test results, not pH but conductivity or specific gravity
the person performing the mixing
the person verifying the mixing and their test results
Acid concentrate additives
make sure the “spike” is completely mixed
label container with final concentration, the date and time mixed, and the person mixing
log of mix in permanent record
Distribution systems;
color code piping, point of use and machine connection
Bicarb = Blue
Acid = Red
Remove bicarb from systems and jugs before disinfection
You should have a copy of RD 52 at your facility.
Order from www.aami.org / market place / dialysis equipment
Distribution systems;
color code piping, point of use and machine connection
Bicarb = Blue
Acid = Red
Remove bicarb from systems and jugs before disinfection
You should have a copy of RD 52 at your facility.
Order from www.aami.org / market place / dialysis equipment
RD 52RD 52
Brings the water system requirements of AAMI together with the FDA.
“Devices used to purify water for hemodialysis are also subject to the FDA 510(k) approval process…they must be approved by the FDA and users should ensure that devices obtained from vendors have been approved by the FDA.”
Brings the water system requirements of AAMI together with the FDA.
“Devices used to purify water for hemodialysis are also subject to the FDA 510(k) approval process…they must be approved by the FDA and users should ensure that devices obtained from vendors have been approved by the FDA.”
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It’s Coming....It’s Coming....CMS Conditions for Coverage of Suppliers of ESRD Services.
Final Rule January 2009
Incorporates AAMI RD52:2004
Certified PCT required (18 months)
Water Treatment Training
Interpretive Guidelines for Inspectors
CMS Conditions for Coverage of Suppliers of ESRD Services.
Final Rule January 2009
Incorporates AAMI RD52:2004
Certified PCT required (18 months)
Water Treatment Training
Interpretive Guidelines for Inspectors
Water TreatmentSystems
Water TreatmentSystems
Central Chronic Water SystemCentral Chronic Water System
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Acute and Small Water SystemAcute and Small Water System
Portable Acute Water System
Portable Acute Water System
Water Heaters and Blend ValvesWater Heaters and Blend Valves
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Water HeaterWater Heater
Sizing50-50 flowCold vs. Hot weather
Sizing50-50 flowCold vs. Hot weather
Water HeaterWater Heater
Blend Valve AssemblyBlend Valve Assembly
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AAMI & FDA FeaturesAAMI & FDA Features
Sized to application
Check Valve on hot and cold
Monitor outlet temperature (LOG)
Sized to application
Check Valve on hot and cold
Monitor outlet temperature (LOG)
Backflow PreventerBackflow Preventer
Break TankBreak Tank
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Backflow PreventerBackflow PreventerProtects potable water systemCauses pressure lossDouble check and dump typeRequired by the Plumbing C d
Protects potable water systemCauses pressure lossDouble check and dump typeRequired by the Plumbing C d
Booster PumpsBooster Pumps
Booster Pump(s)Booster Pump(s)Good practiceProper sizing needed to prevent over pressureInlet pressure regulator optionBy-pass for serviceRuns off of flow, pressure switch, off a signal from the RO or pressure transducer/pump speed control.
Good practiceProper sizing needed to prevent over pressureInlet pressure regulator optionBy-pass for serviceRuns off of flow, pressure switch, off a signal from the RO or pressure transducer/pump speed control.
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System FilterSystem Filter
Multi-Media typeCartridge typeOr both
Multi-Media typeCartridge typeOr both
Multi-MediaMulti-MediaLayers of media
Backwashes
10-20 micron removal
Depth filtration
Exposed timer & RO lockout
By-pass for service
Monitor pressure loss from inlet to outlet (∆P)(LOG)
Layers of media
Backwashes
10-20 micron removal
Depth filtration
Exposed timer & RO lockout
By-pass for service
Monitor pressure loss from inlet to outlet (∆P)(LOG)
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Multi Cartridge FilterMulti Cartridge Filter
Cartridge FilterCartridge Filter
Smaller micron removal
Replaceable cartridges
By-pass for service
Surface filtration
Polish multi-media for smaller particles
Smaller micron removal
Replaceable cartridges
By-pass for service
Surface filtration
Polish multi-media for smaller particles
Carbon FiltersCarbon Filters
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Purpose of CarbonPurpose of Carbon
To RemoveChloramines and
Chlorine
To RemoveChloramines and
Chlorine
Inside the Carbon GranuleInside the Carbon Granule
AAMI-Carbon AdsorptionAAMI-Carbon
AdsorptionAt least two (2) beds in series
Sample ports after each bed
Replace with new media within 72 hours
Exposed timer & RO lockout
Minimum iodine number of 900
12x40 mesh acid washed
10 minute EBCT
Home and portables have new seperate standards.
(0.1 mg/L verified before each treatment at least every 4 hours)
At least two (2) beds in series
Sample ports after each bed
Replace with new media within 72 hours
Exposed timer & RO lockout
Minimum iodine number of 900
12x40 mesh acid washed
10 minute EBCT
Home and portables have new seperate standards.
(0.1 mg/L verified before each treatment at least every 4 hours)
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EBCTEBCT
Empty Bed Contact TimeRO feed flow x 10 ÷ 7.48 = total cubic feet of carbon
Empty Bed Contact TimeRO feed flow x 10 ÷ 7.48 = total cubic feet of carbon
Supplementing CarbonSupplementing Carbon
Additions to carbon to improve performance
1. pH adjustment using mineral acid. 2. Sodium bisulfite feed . 3. Dealkalizer pre-treatment4. UV toc reduction light
Additions to carbon to improve performance
1. pH adjustment using mineral acid. 2. Sodium bisulfite feed . 3. Dealkalizer pre-treatment4. UV toc reduction light
Backwashing Carbon
Backwashing Carbon
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Dual CarbonDual Carbon
Sample Ports Between Carbon TanksSample Ports Between Carbon Tanks
Inside Backwash Carbon
Inside Backwash Carbon
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Exchange CarbonExchange Carbon
Exchange CarbonExchange Carbon
Worker/polisher arrangement
Sample ports
PSI gauges (to measure ∆P)
Replacement protocol (less than 6 months)
Easier to expand
Easier to change
510K service company is best
Worker/polisher arrangement
Sample ports
PSI gauges (to measure ∆P)
Replacement protocol (less than 6 months)
Easier to expand
Easier to change
510K service company is best
Inside Exchange Carbon
Inside Exchange Carbon
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Water SoftenerWater Softener
Two Ways to Protect the ROMembrane from Scale
Two Ways to Protect the ROMembrane from Scale
Salt regenerated water softener
Antiscalant chemical feed system
Salt regenerated water softener
Antiscalant chemical feed system
AAMI-Water SoftenerAAMI-Water Softener
Sized properly
Timers visible to the user
Test for hardness at end of day
Prevent high brine concentration from entering the RO (lockout)
Brine tank at least 1/2 full
Sized properly
Timers visible to the user
Test for hardness at end of day
Prevent high brine concentration from entering the RO (lockout)
Brine tank at least 1/2 full
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Water Softener Control - Fleck
Water Softener Control - Fleck
Softener Maintenance
Softener Maintenance
Monitor hardness with test strips at the end of the day. Should be less than 1 grain per gallon (LOG).
Use 99% pure salt such as solar, cubes, or pellets.
Check salt level daily. Should be at least 2/3 full (LOG).
Check time of day daily (LOG).
Monitor ∆P (LOG).
Replace resin periodically, usually between five and ten years.
Sanitize the brine tank every three to four months.
Monitor hardness with test strips at the end of the day. Should be less than 1 grain per gallon (LOG).
Use 99% pure salt such as solar, cubes, or pellets.
Check salt level daily. Should be at least 2/3 full (LOG).
Check time of day daily (LOG).
Monitor ∆P (LOG).
Replace resin periodically, usually between five and ten years.
Sanitize the brine tank every three to four months.
RO Pre-filterRO Pre-filter
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Cartridge Filter Efficiency RatingCartridge Filter Efficiency Rating
AAMI-Sediment FiltersAAMI-Sediment Filters
Opaque housingMonitor the differential pressureFollow the manufacturers instructions for replacement
Opaque housingMonitor the differential pressureFollow the manufacturers instructions for replacement
RO Pre-filter MaintenanceRO Pre-filter Maintenance
Monitor dynamic pressure loss from inlet to outlet (∆P)(LOG)
Inspect for carbon fines at replacement
One micron may be better than five micron cartridge
Monitor dynamic pressure loss from inlet to outlet (∆P)(LOG)
Inspect for carbon fines at replacement
One micron may be better than five micron cartridge
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Reverse OsmosisReverse Osmosis
The Heart of MostWater Systems
Pre-treat – RO – Post-treat
The Heart of MostWater Systems
Pre-treat – RO – Post-treat
RORO
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RORO
RORO
RO Membrane Function
RO Membrane Function
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RO MembraneRO Membrane
AAMI Reverse Osmosis
AAMI Reverse Osmosis
In-line temperature compensated monitor of product conductivity.
Conductivity monitor activates audible and visual alarm in patient care area on high conductivity.
Divert product water to drain on alarm.
Must meet AAMI RD62:2001 water quality requirements at installation, yearly, and at membrane replacement.
Monitor flow meters and gauges.
In-line temperature compensated monitor of product conductivity.
Conductivity monitor activates audible and visual alarm in patient care area on high conductivity.
Divert product water to drain on alarm.
Must meet AAMI RD62:2001 water quality requirements at installation, yearly, and at membrane replacement.
Monitor flow meters and gauges.
RO SchematicRO Schematic
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Good Operation PracticesGood Operation Practices
Do not oversize
Good pre-filter (one micron)
Monitor conductivity for quality
Monitor Pre and post membrane PSI (∆P)
Operate at pH of six to eight
Do not exceed flux rate (4“ x 40“ membrane = product flow of 1.0 to 1.3 GPM)
Do not oversize
Good pre-filter (one micron)
Monitor conductivity for quality
Monitor Pre and post membrane PSI (∆P)
Operate at pH of six to eight
Do not exceed flux rate (4“ x 40“ membrane = product flow of 1.0 to 1.3 GPM)
RO Maintenance (log)RO Maintenance (log)Daily Monitor:
Conductivity, uSInlet pressure, psiProduct flow, gpmReject flow, gpmRecirculation flow, gpmMembrane ∆ P, membrane psi - reject psi
Monthly:Disinfect Test for bacteria and endotoxin, culture & LAL
Quarterly:Clean in place, CIP
Annually:AAMI chemical contaminants test
Daily Monitor:Conductivity, uSInlet pressure, psiProduct flow, gpmReject flow, gpmRecirculation flow, gpmMembrane ∆ P, membrane psi - reject psi
Monthly:Disinfect Test for bacteria and endotoxin, culture & LAL
Quarterly:Clean in place, CIP
Annually:AAMI chemical contaminants test
RO CleaningRO Cleaning
Cleaning should be performedwith warm water athigh flow rate under
low pressure
Cleaning should be performedwith warm water athigh flow rate under
low pressure
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RO DisinfectionRO Disinfection
Peracetic Acid (PAA) Injection
Soak at least one hour
Rinse and flush to remove endotoxin
Verify residual at 1 ppm or less
Peracetic Acid (PAA) Injection
Soak at least one hour
Rinse and flush to remove endotoxin
Verify residual at 1 ppm or less
Storage Tank or Direct Feed
Storage Tank or Direct Feed
Direct Feed = RO Product directly to the loop feeding
dialysis machines.
Indirect Feed = RO Product to Storage Tank then
pumped to the loop & dialysis machines.
Which one should you use?
Direct Feed = RO Product directly to the loop feeding
dialysis machines.
Indirect Feed = RO Product to Storage Tank then
pumped to the loop & dialysis machines.
Which one should you use?
Direct FeedDirect Feed
Program flush when not in use
Disinfect Monthly (RO and loop)
Use smallest diameter pipe for loop
Return product (loop flow) to RO feed, use pressure regulator on feed from the pretreatment
Plan for bulk (peak) uses
Program flush when not in use
Disinfect Monthly (RO and loop)
Use smallest diameter pipe for loop
Return product (loop flow) to RO feed, use pressure regulator on feed from the pretreatment
Plan for bulk (peak) uses
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Storage TankStorage Tank
AAMI Storage Tank AAMI Storage Tank Small as practical
Cone bottom
No overflow drain
0.2u vent filter (hydrophobic)
Tight lid, sealed tank
“Spray ball” wash down mechanism for disinfection
Small as practical
Cone bottom
No overflow drain
0.2u vent filter (hydrophobic)
Tight lid, sealed tank
“Spray ball” wash down mechanism for disinfection
Distribution Pumps and Controls
Distribution Pumps and Controls
Single
Or
Dual?
Single
Or
Dual?
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Single Distribution Pump
Single Distribution Pump
Dual PumpsDual Pumps
Distribution Pump Specifications
Distribution Pump Specifications
Sizing of 12 GPM at 80 psi for 1“ loop (dynamic pressure)
Loop return PSI 20 to 40
Justification for dual pumps or spare single pump (alternate every 4 to 6 hours)
High quality stainless steel pump
Low-level shut down on storage tank
Sizing of 12 GPM at 80 psi for 1“ loop (dynamic pressure)
Loop return PSI 20 to 40
Justification for dual pumps or spare single pump (alternate every 4 to 6 hours)
High quality stainless steel pump
Low-level shut down on storage tank
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Deionizer Exchange TanksDeionizer Exchange Tanks
Deionizer ResinDeionizer Resin
Cations and AnionsCations and Anions
_ Floride_ Floride
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DeionizationDeionizationPolish RO
RO back-up
Acute treatment
1 meg divert or shut-off (portable and home use does not)
Must be replaced when used in “off-line” mode every three to six months
Usually installed as worker/polisher
510K service vendor
Polish RO
RO back-up
Acute treatment
1 meg divert or shut-off (portable and home use does not)
Must be replaced when used in “off-line” mode every three to six months
Usually installed as worker/polisher
510K service vendor
Deionizer Tanks On-line
Deionizer Tanks On-line
Deionizer tanks off-lineDeionizer tanks off-line
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AAMI DeionizationAAMI DeionizationOne (1) megohm/cm minimum resistivityAudible and visual alarm in patient areaPrevent less than one megohm/cm flow to patients (home and portable use exempt)Pretreated with carbonPost DI endotoxin-retentive filterReplace worker within 72 hours upon exhaustion
One (1) megohm/cm minimum resistivityAudible and visual alarm in patient areaPrevent less than one megohm/cm flow to patients (home and portable use exempt)Pretreated with carbonPost DI endotoxin-retentive filterReplace worker within 72 hours upon exhaustion
Portable RO & DI for Acute and HomePortable RO & DI for Acute and Home
Have Special Needs
Micro Control is Essential
Operate Under Different Regulations from Central Systems
Have Special Needs
Micro Control is Essential
Operate Under Different Regulations from Central Systems
Portable RO and DIPortable RO and DI
Designed to be attended (supervised)
No divert to drain of product flow needed
Test for TOTAL chlorine before each treatment (use strips)
They have special microbiological needs
Designed to be attended (supervised)
No divert to drain of product flow needed
Test for TOTAL chlorine before each treatment (use strips)
They have special microbiological needs
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Down Time = BugsDown Time = Bugs
Bacteria and endotoxin proliferation (caused by carbon and lack of use)
Flush (carbon) before and after use
“Pack” with bacteriostat
Disinfect at least monthly
Bacteria and endotoxin proliferation (caused by carbon and lack of use)
Flush (carbon) before and after use
“Pack” with bacteriostat
Disinfect at least monthly
RORO
The Differences, RO vs. DIThe Differences, RO vs. DI
D ID I
Grows bacteriaGrows bacteria Won’t grow bacteriaWon’t grow bacteria
Continuous processContinuous process Limited outputLimited output
Removes microbesRemoves microbes Post endotoxin filterPost endotoxin filter
Percent rejectionPercent rejectionPercent rejection Removes all ionsRemoves all ions
Pre-carbon filterPre-carbon filter Pre-carbon filterPre-carbon filter
Portable RO MaintenancePortable RO Maintenance
Membrane life is one to three years
Test bacteria and endotoxin before disinfection ( after periodically)
Plan to maintain the RO
Log all operation, testing,& disinfection
Follow manufacturers instructions
Membrane life is one to three years
Test bacteria and endotoxin before disinfection ( after periodically)
Plan to maintain the RO
Log all operation, testing,& disinfection
Follow manufacturers instructions
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Portable DI MaintenancePortable DI Maintenance
Use worker/polisher configuration
Disinfect all filter housings & tubing monthly
Exchange DI tanks every 3 months at least
Test bacteria & endotoxin before disinfect
Log all replacements and disinfections
Follow manufacturers instructions
Use worker/polisher configuration
Disinfect all filter housings & tubing monthly
Exchange DI tanks every 3 months at least
Test bacteria & endotoxin before disinfect
Log all replacements and disinfections
Follow manufacturers instructions
Alarm SystemsAlarm Systems
AAMI - SafetyAAMI - SafetyMonitors cannot be disabled without noticeRemote in patient care areaAudible alarm at 65 decibels at 3 metersSilence for only 180 seconds (3 minutes)Temperature compensated resistivity and conductivity metersInclude all important alarms
Monitors cannot be disabled without noticeRemote in patient care areaAudible alarm at 65 decibels at 3 metersSilence for only 180 seconds (3 minutes)Temperature compensated resistivity and conductivity metersInclude all important alarms
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Some Common AlarmsSome Common Alarms
RO
Low (mid) level tank
DI
Bicarb
Loop conductivity
UV
RO
Low (mid) level tank
DI
Bicarb
Loop conductivity
UV
Endotoxin Retentive Loop Filters
Endotoxin Retentive Loop Filters
Now required (sub-micron non endotoxin validated are not recommended)
Disinfectant compatibility is critical
Good design and maintenance practices are very important
Cross flow vs. dead end design debate!
Now required (sub-micron non endotoxin validated are not recommended)
Disinfectant compatibility is critical
Good design and maintenance practices are very important
Cross flow vs. dead end design debate!
Endotoxin Retentive FilterEndotoxin Retentive Filter
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Two Endotoxin Filtration System Designs
Two Endotoxin Filtration System Designs
Cartridge (dead end with charged surface - validated)
Cross-flow membrane (validation is a problem)
Cartridge (dead end with charged surface - validated)
Cross-flow membrane (validation is a problem)
Cross-Flow UF MembraneCross-Flow UF Membrane
Cross-Flow DisinfectionCross-Flow Disinfection
PAA (Peracidin/Minncare) onlyPAA (Peracidin/Minncare) only
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Hollow Fiber or Membrane Cartridge FilterHollow Fiber or Membrane Cartridge Filter
Endotoxin-retentive FiltersEndotoxin-retentive Filters
Cartridge Endotoxin FilterCartridge Endotoxin Filter
Cartridge endotoxin filters have a charged surface that hold the endotoxin
fragments.
Cartridge endotoxin filters have a charged surface that hold the endotoxin
fragments.
AAMI Endotoxin Retentive FilterAAMI Endotoxin
Retentive FilterAfter storage tank, DI or UV
Cross-flow mode or dead end design-both need to be validated for endotoxin removal
Opaque housing to discourage algae and bacteria growth
After storage tank, DI or UV
Cross-flow mode or dead end design-both need to be validated for endotoxin removal
Opaque housing to discourage algae and bacteria growth
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Distribution LoopDistribution Loop
Pipe couplingPipe coupling
Pipe insidePipe inside
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Piping Recommendations
Piping Recommendations
No dead legs
Flow velocity (recirculation)
Ability to isolate use points (valves)
Good installation practices should be followed
No dead legs
Flow velocity (recirculation)
Ability to isolate use points (valves)
Good installation practices should be followed
LabelingLabeling
AAMI LabelingAAMI LabelingP&ID (schematic system drawing)
Tags on important devices and action points
By-pass process clearly displayed
Identified water treatment componentsDescriptions and actions on label
510K certificate or letter
Complete manual
P&ID (schematic system drawing)
Tags on important devices and action points
By-pass process clearly displayed
Identified water treatment componentsDescriptions and actions on label
510K certificate or letter
Complete manual
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AccessoriesAccessories
Wall Boxes
Bicarbonate Concentrate systems
Acid Concentrate systems
Wall Boxes
Bicarbonate Concentrate systems
Acid Concentrate systems
Prevent Biofilm Prevent Biofilm
DISINFECTION DISINFECTION
Microbial LevelsMicrobial Levels
The lower the bacteria and endotoxin level, the healthier the patient.
This is especially true of endotoxin, even at low levels.
The lower the bacteria and endotoxin level, the healthier the patient.
This is especially true of endotoxin, even at low levels.
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DisinfectantsDisinfectants
Need to destroy bacteria and endotoxin
Requires high dosages of the disinfectant to “burn out” the endotoxin
Need to destroy bacteria and endotoxin
Requires high dosages of the disinfectant to “burn out” the endotoxin
DisinfectantsDisinfectants
Chlorine (bleach)
PAA (Peracidin/MinnCare)
Ozone
Heat
Chlorine (bleach)
PAA (Peracidin/MinnCare)
Ozone
Heat
What to DisinfectWhat to Disinfect
Reverse OsmosisStorage TankDistribution LoopBicarb MixingBicarb Distribution & LoopDialysis MachineReuse Machine & Rinse Station
Reverse OsmosisStorage TankDistribution LoopBicarb MixingBicarb Distribution & LoopDialysis MachineReuse Machine & Rinse Station
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Portable Systems MaintenancePortable Systems Maintenance
Disinfect at least Monthly
Flush before treatment - Flush or replace carbon after use
“Pack” with bacteriostatic solution
Replace carbon regularly
Disinfect at least Monthly
Flush before treatment - Flush or replace carbon after use
“Pack” with bacteriostatic solution
Replace carbon regularly
Water TestingAnd
Monitoring
Water TestingAnd
Monitoring
AAMI Chemical ContaminantsAAMI Chemical Contaminants
Chemical contaminants
At least yearly
Both the RO and the Loop
Consider on tap water and product water
Chemical contaminants
At least yearly
Both the RO and the Loop
Consider on tap water and product water
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Endotoxin and Bacteria Sample Points
Endotoxin and Bacteria Sample Points
End of recirculation loop
Reuse area
Bicarb mix water
Treatment station(s)
Reverse Osmosis
Dialysate
End of recirculation loop
Reuse area
Bicarb mix water
Treatment station(s)
Reverse Osmosis
Dialysate
Proper SamplingProper Sampling
Flush for
1 to 2 minutes
Flush for
1 to 2 minutes Clean
Catch
Clean
Catch
Monitoring-How Often?
Monitoring-How Often?
Each facility needs to decide and write up a procedure for where, when, and how often they will test and sample.
AAMI - At least monthly.
Each facility needs to decide and write up a procedure for where, when, and how often they will test and sample.
AAMI - At least monthly.
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ChloramineChloramine
Total chlorine testTest each patient shift orAt least every 4 hours
Total chlorine testTest each patient shift orAt least every 4 hours
The LogThe Log
The daily log is a very important record of performance and testing
The daily log is a very important record of performance and testing
The LogThe Log
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SummarySummary
The quality of water is important for dialysis.
Current and Future regulations.
Water systems and components.
Testing, Monitoring & Logs.
The quality of water is important for dialysis.
Current and Future regulations.
Water systems and components.
Testing, Monitoring & Logs.
DID WEANSWER YOUR
QUESTIONS?
Thank You!
DID WEANSWER YOUR
QUESTIONS?
Thank You!