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Water: Water: What’s What’s New New & & What What To To Do Do by
Water: Water: What’s What’s New New & &
What What To To Do Do
by by
James James Baker Baker
President President
AmeriWater, AmeriWater, Inc. Inc.
Preparing Preparing for for the the New New Medical Medical Director Director Responsibilities Responsibilities
Preparing Preparing for for the the New New Medical Medical Director Director Responsibilities Responsibilities
Disclosure Disclosure
• •
I I would would like like to to disclose disclose that that I I am am president president of of
AmeriWater AmeriWater and and receive receive an an annual annual salary salary
and and bonus bonus from from AmeriWater, AmeriWater, Inc. Inc. My My
presentation presentation does does not not endorse endorse any any
commercial commercial interest, interest, product product or or services. services.
• •
This This presentation presentation will will not not advocate advocate for for the the
off-label off-label use use of of medications. medications.
OUTLINEOUTLINE Water Water & & Water Water for for Dialysis Dialysis Standards Standards and and
OUTLINEOUTLINE
Water Water & & Water Water for for Dialysis Dialysis
Standards Standards and and Regulations Regulations
Water Water Treatment Treatment Systems Systems
Central Central Cronic Cronic
Portable Portable Acute Acute
Home Home Dialysis Dialysis
Monitoring Monitoring & & Testing Testing
Introduction Introduction To To Water Water & & Water Water for for Dialysis Dialysis
Introduction Introduction
To To
Water Water
& & Water Water for for Dialysis Dialysis
WaterWater The The Universal Universal Solvent Solvent
WaterWater
The The
Universal Universal
Solvent Solvent
Water Water & & Water Water for for Dialysis Dialysis WaterWater The The Universal Universal Solvent
WaterWater SpotSpot
WaterWater SpotSpot
Patient Patient Water Water Exposure Exposure Normal Normal person person 10 10 Liters/week Liters/week Dialysis
Patient Patient Water Water
Exposure Exposure
Normal Normal person person
10 10 Liters/week Liters/week
Dialysis Dialysis Patient Patient
350 350 Liters/week Liters/week
DialysisDialysis
DialysisDialysis
WaterWater UsageUsage
WaterWater UsageUsage
Importance Importance of of Ultra Ultra Pure Pure Water Water The The Trend Trend is
Importance Importance of of Ultra Ultra
Pure Pure Water Water
The The Trend Trend is is Toward Toward Ultra Ultra Pure Pure USP USP
Type Type
Water. Water.
The The Water Water System System Will Will Need Need to to be be
Microbiologically Microbiologically Controlled. Controlled.
AAMIAAMI WaterWater QualityQuality Four Four Groups Groups of of Contaminants Contaminants Based Based on on
AAMIAAMI WaterWater QualityQuality
Four Four Groups Groups of of
Contaminants Contaminants
Based Based on on Their Their
Effects Effects
on on Patients Patients
GroupGroup 1-Toxicity1-Toxicity TOXIC LOWEST TOXICITY CONTAMINANTS CONCENTRATION (MG/L) Aluminum 0.06 Chloramines
GroupGroup 1-Toxicity1-Toxicity
TOXIC
LOWEST TOXICITY
CONTAMINANTS
CONCENTRATION (MG/L)
Aluminum
0.06
Chloramines
0.25
Fluoride
1.0
Copper
0.49
Zinc
0.2
Nitrate
21
(as N)
Sulfate
200
Calcium/Magnesium
88
(Ca++)
Sodium
300
Microbial
--
GroupGroup 2-Drinking2-Drinking WaterWater StandardStandard Barium Barium Chromium Chromium Silver Silver Mercury
GroupGroup 2-Drinking2-Drinking WaterWater StandardStandard
Barium Barium
Chromium Chromium
Silver Silver
Mercury Mercury
AAMI AAMI is is 10% 10%
Selenium Selenium
of of Drinking Drinking Water Water
Lead Lead
Standard Standard
Cadmium Cadmium
Arsenic Arsenic
Antimony Antimony
Beryllium Beryllium
Thallium Thallium
GroupGroup 3-Physiological3-Physiological Calcium Calcium Sodium Sodium Potassium Potassium
GroupGroup 3-Physiological3-Physiological
Calcium Calcium
Sodium Sodium
Potassium Potassium
Group 4- Group 4- Microbiological Microbiological Bacteria Bacteria Endotoxin Endotoxin
Group 4-
Group 4-
Microbiological Microbiological
Bacteria Bacteria
Endotoxin Endotoxin
Bacteria/EndotoxinBacteria/Endotoxin
Bacteria/EndotoxinBacteria/Endotoxin
TheThe GoalGoal
TheThe GoalGoal
BiofilmBiofilm Bacteria Bacteria creates creates biofilm. biofilm. We We need need to to disinfect disinfect
BiofilmBiofilm
Bacteria Bacteria creates creates biofilm. biofilm.
We We need need to to disinfect disinfect enough enough to to control control
biofilm. biofilm.
Requires Requires at at least least monthly: monthly:
Disinfection Disinfection
Monitoring Monitoring (cultures (cultures & & LALs) LALs)
DialysateDialysate && WaterWater StandardsStandards Bacteria Bacteria = = 200 200 CFU, CFU, action action level
DialysateDialysate && WaterWater StandardsStandards
Bacteria Bacteria = = 200 200 CFU, CFU, action action level level 50 50 CFU CFU
Endotoxin Endotoxin = = 2 2 EU/ml, EU/ml, action action level level 1 1 EU/ml EU/ml
MONTHLY, MONTHLY, MONTHLY, MONTHLY, MONTHLY MONTHLY
DialysisDialysis StandardsStandards AAMI AAMI CMS CMS FDA FDA JCAHO JCAHO ISO ISO
DialysisDialysis StandardsStandards
AAMI AAMI
CMS CMS
FDA FDA
JCAHO JCAHO
ISO ISO
AAMIAAMI StandardsStandards RDRD 6262 RDRD 5252
AAMIAAMI StandardsStandards
RDRD 6262
RDRD 5252
Current Current AAMI AAMI Standards Standards “Voluntary” “Voluntary” industry industry water water standards
Current Current AAMI AAMI
Standards Standards
“Voluntary” “Voluntary” industry industry water water standards standards that that are are
accredited accredited through through ANSI. ANSI. However However CMS CMS
has has made made them them requirements requirements for for coverage coverage
so so they they
are are mandatory mandatory for for payment. payment.
ANSI/AAMIANSI/AAMI RD62:2006RD62:2006 Water Water Treatment Treatment Equipment Equipment for for Hemodialysis
ANSI/AAMIANSI/AAMI RD62:2006RD62:2006
Water Water Treatment Treatment Equipment Equipment for for
Hemodialysis Hemodialysis Operations Operations
The The water water treatment treatment equipment equipment
manufactures manufactures standard. standard. Revised Revised from from
the 2001 standard
the 2001
standard
Microbiological: Microbiological: Bacteria Bacteria 200 200 CFU/mL CFU/mL Max. Max. 50 50 CFU/mL CFU/mL Action
Microbiological: Microbiological:
Bacteria Bacteria 200 200 CFU/mL CFU/mL Max. Max. 50 50 CFU/mL CFU/mL Action Action
Endotoxin 2 EU/mL Max. 1 EU/mL Action
Endotoxin 2 EU/mL Max.
1 EU/mL Action
Chemical: Chemical:
Addition Addition of of Antimony, Antimony, Beryliium Beryliium and and Thalliium Thalliium
Chemical Chemical Contaminants: Contaminants: AAMI AAMI Analysis Analysis 1. 1. Contaminants Contaminants that that are
Chemical Chemical Contaminants: Contaminants:
AAMI AAMI Analysis Analysis
1. 1. Contaminants Contaminants that that are are toxic toxic
2. 2.
Contaminants Contaminants that that are are physiological physiological
3. 3.
Contaminants Contaminants from from the the USEPA USEPA Safe Safe
Drinking Drinking Water Water Act Act
NewNew AdditionsAdditions toto thethe RDRD 6262 StandardStandard The The face face of of any any
NewNew AdditionsAdditions toto thethe RDRD 6262 StandardStandard
The The face face of of any any timer timer controlling controlling a a regeneration regeneration or or
backwash backwash cycle cycle shall shall be be visible. visible.
Cartridge Cartridge filters filters shall shall be be fitted fitted with with pressure pressure gauges gauges on on
the the inlet inlet and and outlet. outlet.
Carbon Carbon Beds: Beds:
Iodine Iodine number number less less than than 900 900 in in high high organic organic waters, waters,
validated. validated.
Arrangements Arrangements of of multiple multiple beds beds in in worker/polisher worker/polisher
configurations configurations approved. approved.
RO RO lockout lockout when when backwashing. backwashing.
Addition Addition of of UV UV chlorine/chloramine chlorine/chloramine reduction. reduction.
Anion Anion resin resin systems systems as as organic organic scavenger scavenger and and pH
Anion Anion resin resin systems systems as as organic organic scavenger scavenger and and pH pH
remediation. remediation.
Chemical Chemical injection injection systems systems for for sodium sodium bisulfite bisulfite and and acid acid
injection injection with with special special control control requirements. requirements.
Storage Storage tanks tanks that that have have overflow overflow shall shall be be fitted fitted with with
means means of of preventing preventing contamination. contamination.
Endotoxin Endotoxin Filters: Filters: change change ultrafilters ultrafilters to to endotoxin endotoxin
retentive retentive filters. filters.
Hot Hot water water disinfection disinfection systems systems should should be be equipped equipped with with
a a temperature temperature monitor monitor at at the the end end of of the the loop. loop.
Ozone Ozone disinfection disinfection systems systems shall shall produce produce 0.5 0.5 ppm ppm
ozone ozone for for at at least least 10 10 minutes. minutes. Residual Residual ozone ozone should should
be be less less than than 0.1 0.1 ppm ppm before before use. use.
Direct Direct feed feed flow flow in in loop loop should should be be at at least least 1.5 1.5 feet feet per per
second. second.
Total Total chlorine chlorine “dip “dip and and read read “ “ test test strips strips may may be be used. used.
The The Physician Physician Has Has The The Ultimate Ultimate Responsibility Responsibility
The The Physician Physician
Has Has The The
Ultimate Ultimate
Responsibility Responsibility
RDRD 6262 ➜➜ RDRD 5252
RDRD 6262 ➜➜ RDRD 5252
AAMI AAMI RD52:2004 RD52:2004 “Dialysate “Dialysate for for Hemodialysis” Hemodialysis” This This is is your
AAMI AAMI RD52:2004 RD52:2004
“Dialysate “Dialysate for for Hemodialysis” Hemodialysis”
This This is is your your water water system system operation operation
standard standard
Same Same water water quality quality as as RD62:2006 RD62:2006
Monthly Monthly samples samples from from water water system system
and and at at least least from from two two dialysis dialysis machines machines
per per month month with with all all machines machines sampled sampled
per per year. year.
Important Important Note: Note: New New systems systems or or Bad Bad results results When
Important Important Note: Note:
New New systems systems or or Bad Bad results results
When When new new water water systems systems are are installed installed or or
if if results results don’t don’t meet meet standards, standards, weekly weekly
sampling sampling should should be be performed performed until until it it is is
clear clear that that the the system system is is under under control. control.
RDRD 5252 RecommendsRecommends Written Written policies policies and and procedures procedures Periodic Periodic audits
RDRD 5252 RecommendsRecommends
Written Written policies policies and and procedures procedures
Periodic Periodic audits audits of of operators operators compliance compliance
Contingency Contingency plans plans
Monthly Monthly Disinfection Disinfection
Monthly Monthly Cultures Cultures and and LALs LALs
WaterWater SystemSystem KeyKey PointsPoints MultiMedia MultiMedia measure measure differential differential pressure.
WaterWater SystemSystem KeyKey PointsPoints
MultiMedia MultiMedia measure measure differential differential pressure. pressure.
Cartridge Cartridge filters filters measure measure differential differential pressure. pressure.
Water Water softeners softeners test test hardness hardness at at end end of of day. day.
Carbon Carbon Adsorption: Adsorption:
test test total total chlorine chlorine less less than than 0.1 0.1 mg/L mg/L (ppm) (ppm)
high high pH pH water water may may interfere interfere with with carbon carbon performance performance
replace replace carbon carbon within within 72 72 hours hours on on worker worker breakthrough breakthrough
test test total total chloramine chloramine before before every every shift shift or or at at least least every every
four four hours hours
Reverse Reverse Osmosis: Osmosis: use use conductivity conductivity (or (or TDS) TDS) to to monitor
Reverse Reverse Osmosis: Osmosis:
use use conductivity conductivity (or (or TDS) TDS) to to monitor monitor RO, RO, not not % % rejection rejection
monitor monitor RO RO flows flows and and pressures pressures
AAMI AAMI chemical chemical analysis analysis when when new new membranes membranes are are
installed installed
Deionization: Deionization:
stop stop flow flow if if quality quality drops drops below below 1 1 megohm/cm megohm/cm
follow follow with with bacteria/endotoxin bacteria/endotoxin retentive retentive filter filter
replace replace worker worker tank(s) tank(s) within within 72 72 hours hours upon upon exhaustion exhaustion
Storage Storage Tank: Tank: internal internal spray spray mechanism mechanism to to wash wash down
Storage Storage Tank: Tank:
internal internal spray spray mechanism mechanism to to wash wash down down the the top top and and
facilitate facilitate disinfection disinfection
Concentrate Concentrate Preparation: Preparation:
Label Label mixing mixing tank tank with with date date and and chemical chemical
composition composition until until emptied. emptied.
Jugs Jugs labeled labeled with with contents. contents.
Permanent Permanent records; records;
concentrate concentrate formula formula
volume volume of of batch batch
lot lot numbers numbers of of powered powered concentrate concentrate
the the manufacturer manufacturer of of the the powder powder
date date and and time time of of mixing mixing test test results, results, not
date date and and time time of of mixing mixing
test test results, results, not not pH pH but but conductivity conductivity or or specific specific gravity gravity
the the person person performing performing the the mixing mixing
the the person person verifying verifying the the mixing mixing and and their their test test results results
Acid Acid concentrate concentrate additives additives
make make sure sure the the “spike” “spike” is is completely completely mixed mixed
label label container container with with final final concentration, concentration, the the date date and and
time time mixed, mixed, and and the the person person mixing mixing
log log of of mix mix in in permanent permanent record record
Distribution Distribution systems; systems; color color code code piping, piping, point point of of use
Distribution Distribution systems; systems;
color color code code piping, piping, point point of of use use and and machine machine
connection connection
Bicarb Bicarb = = Blue Blue
Acid Acid
= = Red Red
Remove Remove bicarb bicarb from from systems systems and and jugs jugs before before disinfection disinfection
You You should should have have a a copy copy of of RD RD 52 52 at at your your facility. facility.
Order Order from from www.aami.org www.aami.org / / market market place place / / dialysis dialysis equipment equipment
RDRD 5252 Brings Brings the the water water system system requirements requirements of of AAMI
RDRD 5252
Brings Brings the the water water system system requirements requirements of of AAMI AAMI
together together with with the the FDA. FDA.
“Devices “Devices used used to to purify purify water water for for hemodialysis hemodialysis are are
also also subject subject to to the the FDA FDA 510(k) 510(k) approval approval process…they process…they
must must be be approved approved by by the the FDA FDA and and users users should should
ensure ensure that that devices devices obtained obtained from from vendors vendors have have been been
approved approved by by the the FDA.” FDA.”
It’sIt’s Coming Coming CMS CMS Conditions Conditions for for Coverage Coverage of of Suppliers Suppliers
It’sIt’s Coming Coming
CMS CMS Conditions Conditions for for Coverage Coverage of of
Suppliers Suppliers of of ESRD ESRD Services. Services.
Final Final Rule Rule January January 2009 2009
Incorporates Incorporates AAMI AAMI RD52:2004 RD52:2004
Certified Certified PCT PCT required required (18 (18 months) months)
Water Water Treatment Treatment Training Training
Interpretive Interpretive Guidelines Guidelines for for Inspectors Inspectors
Water Water Treatment Treatment Systems Systems
Water Water
Treatment Treatment
Systems Systems
CentralCentral ChronicChronic WaterWater SystemSystem
CentralCentral ChronicChronic WaterWater SystemSystem
AcuteAcute andand SmallSmall WaterWater SystemSystem
AcuteAcute andand SmallSmall WaterWater SystemSystem
Portable Portable Acute Acute Water Water System System
Portable Portable Acute Acute Water Water
System System
WaterWater HeatersHeaters andand BlendBlend ValvesValves
WaterWater HeatersHeaters andand BlendBlend ValvesValves
WaterWater HeaterHeater Sizing Sizing 50-50 50-50 flow flow Cold Cold vs. vs. Hot Hot weather
WaterWater HeaterHeater
Sizing Sizing
50-50 50-50 flow flow
Cold Cold vs. vs. Hot Hot weather weather
WaterWater HeaterHeater
WaterWater HeaterHeater
BlendBlend ValveValve AssemblyAssembly
BlendBlend ValveValve AssemblyAssembly
AAMIAAMI && FDAFDA FeaturesFeatures Sized Sized to to application application Check Check Valve Valve on
AAMIAAMI && FDAFDA FeaturesFeatures
Sized Sized to to application application
Check Check Valve Valve on on hot hot and and cold cold
Monitor Monitor outlet outlet temperature temperature (LOG) (LOG)
BackflowBackflow PreventerPreventer
BackflowBackflow PreventerPreventer
BreakBreak TankTank
BreakBreak TankTank
BackflowBackflow PreventerPreventer Protects Protects potable potable water water system system Causes Causes pressure
BackflowBackflow PreventerPreventer
Protects Protects potable potable water water
system system
Causes Causes pressure pressure loss loss
Double Double check check and and dump dump
type type
Required Required by by the the Plumbing Plumbing
BoosterBooster PumpsPumps
BoosterBooster PumpsPumps
BoosterBooster Pump(s)Pump(s) Good Good practice practice Proper Proper sizing sizing needed needed to to prevent
BoosterBooster Pump(s)Pump(s)
Good Good practice practice
Proper Proper sizing sizing needed needed to to prevent prevent over over
pressure pressure
Inlet Inlet pressure pressure regulator regulator option option
By-pass By-pass for for service service
Runs Runs off off of of flow, flow, pressure pressure switch, switch, off off a a signal signal
from from the the RO RO or or pressure pressure transducer/pump transducer/pump
speed speed control. control.
SystemSystem FilterFilter Multi-Media Multi-Media type type Cartridge Cartridge type type Or Or both both
SystemSystem FilterFilter
Multi-Media Multi-Media type type
Cartridge Cartridge type type
Or Or both both
type type Cartridge Cartridge type type Or Or both both Multi-MediaMulti-Media Layers Layers of of media
Multi-MediaMulti-Media Layers Layers of of media media Backwashes Backwashes 10-20 10-20 micron micron removal removal
Multi-MediaMulti-Media
Layers Layers of of media media
Backwashes Backwashes
10-20 10-20 micron micron removal removal
Depth Depth filtration filtration
Exposed Exposed timer timer & & RO RO lockout lockout
By-pass By-pass for for service service
Monitor Monitor pressure pressure loss loss from from inlet inlet to to outlet outlet
(∆P)(LOG) (∆P)(LOG)
MultiMulti CartridgeCartridge FilterFilter
MultiMulti CartridgeCartridge FilterFilter
CartridgeCartridge FilterFilter Smaller Smaller micron micron removal removal Replaceable Replaceable cartridges
CartridgeCartridge FilterFilter
Smaller Smaller micron micron removal removal
Replaceable Replaceable cartridges cartridges
By-pass By-pass for for service service
Surface Surface filtration filtration
Polish Polish multi-media multi-media for for smaller smaller particles particles
CarbonCarbon FiltersFilters
CarbonCarbon FiltersFilters
PurposePurpose ofof CarbonCarbon To To Remove Remove Chloramines Chloramines and and Chlorine Chlorine
PurposePurpose ofof CarbonCarbon
To To Remove Remove
Chloramines Chloramines and and
Chlorine Chlorine
InsideInside thethe CarbonCarbon GranuleGranule
InsideInside thethe CarbonCarbon GranuleGranule
AAMI-Carbon AAMI-Carbon Adsorption Adsorption At At least least two two (2) (2) beds beds in
AAMI-Carbon
AAMI-Carbon
Adsorption Adsorption
At At least least two two (2) (2) beds beds in in series series
Sample Sample ports ports after after each each bed bed
Replace Replace with with new new media media within within 72 72 hours hours
Exposed Exposed timer timer & & RO RO lockout lockout
Minimum Minimum iodine iodine number number of of 900 900
12x40 12x40 mesh mesh acid acid washed washed
10 10 minute minute EBCT EBCT
Home Home and and portables portables have have new new seperate seperate
standards. standards.
(0.1 (0.1 mg/L mg/L verified verified before before each each treatment treatment
at at least least every every 4 4 hours) hours)
EBCTEBCT Empty Empty Bed Bed Contact Contact Time Time RO RO feed feed flow flow
EBCTEBCT
Empty Empty Bed Bed Contact Contact Time Time
RO RO feed feed flow flow x x 10 10 ÷ ÷ 7.48 7.48 = = total total
cubic cubic feet feet of of carbon carbon
SupplementingSupplementing CarbonCarbon Additions Additions to to carbon carbon to to improve improve performance
SupplementingSupplementing CarbonCarbon
Additions Additions to to carbon carbon to to improve improve performance performance
1. 1.
pH pH adjustment adjustment using using mineral mineral acid. acid.
2. 2.
Sodium Sodium bisulfite bisulfite feed feed . .
3. 3.
Dealkalizer Dealkalizer pre-treatment pre-treatment
4. 4.
UV UV toc toc reduction reduction light light
Backwashing Backwashing Carbon Carbon
Backwashing Backwashing
Carbon Carbon
DualDual CarbonCarbon
DualDual CarbonCarbon
SampleSample PortsPorts BetweenBetween CarbonCarbon TanksTanks
SampleSample PortsPorts BetweenBetween CarbonCarbon TanksTanks
Inside Backwash Inside Backwash Carbon Carbon
Inside Backwash
Inside Backwash
Carbon Carbon
ExchangeExchange CarbonCarbon
ExchangeExchange CarbonCarbon
ExchangeExchange CarbonCarbon Worker/polisher Worker/polisher arrangement arrangement Sample Sample ports ports PSI PSI
ExchangeExchange CarbonCarbon
Worker/polisher Worker/polisher arrangement arrangement
Sample Sample ports ports
PSI PSI gauges gauges (to (to measure measure ∆P) ∆P)
Replacement Replacement protocol protocol (less (less than than 6 6 months) months)
Easier Easier to to expand expand
Easier Easier to to change change
510K 510K service service company company is is best best
Inside Exchange Inside Exchange Carbon Carbon
Inside Exchange
Inside Exchange
Carbon Carbon
WaterWater SoftenerSoftener
WaterWater SoftenerSoftener
Two Two Ways Ways to to Protect Protect the the RO RO Membrane Membrane from
Two Two Ways Ways to to Protect Protect the the RO RO
Membrane Membrane from from Scale Scale
Salt Salt regenerated regenerated water water softener softener
Antiscalant Antiscalant chemical chemical feed feed system system
AAMI-WaterAAMI-Water SoftenerSoftener Sized Sized properly properly Timers Timers visible visible to to the the user
AAMI-WaterAAMI-Water SoftenerSoftener
Sized Sized properly properly
Timers Timers visible visible to to the the user user
Test Test for for hardness hardness at at end end of of day day
Prevent Prevent high high brine brine concentration concentration from from
entering entering the the RO RO (lockout) (lockout)
Brine Brine tank tank at at least least 1/2 1/2 full full
Water Water Softener Softener Control Control - - Fleck Fleck
Water Water Softener Softener Control Control
- - Fleck Fleck
Softener Softener Maintenance Maintenance Monitor Monitor hardness hardness with with test test strips strips at
Softener Softener
Maintenance Maintenance
Monitor Monitor hardness hardness with with test test strips strips at at the the end end of of the the day. day.
Should Should be be less less than than 1 1 grain grain per per gallon gallon (LOG). (LOG).
Use Use 99% 99% pure pure salt salt such such as as solar, solar, cubes, cubes, or or pellets. pellets.
Check Check salt salt level level daily. daily. Should Should be be at at least least 2/3 2/3 full full (LOG). (LOG).
Check Check time time of of day day daily daily (LOG). (LOG).
Monitor Monitor ∆P ∆P (LOG). (LOG).
Replace Replace resin resin periodically, periodically, usually usually between between five five and and ten ten
years. years.
Sanitize Sanitize the the brine brine tank tank every every three three to to four four months. months.
RORO Pre-filterPre-filter
RORO Pre-filterPre-filter
CartridgeCartridge FilterFilter EfficiencyEfficiency RatingRating
CartridgeCartridge FilterFilter EfficiencyEfficiency RatingRating
AAMI-SedimentAAMI-Sediment FiltersFilters Opaque Opaque housing housing Monitor Monitor the the differential
AAMI-SedimentAAMI-Sediment FiltersFilters
Opaque Opaque housing housing
Monitor Monitor the the differential differential
pressure pressure
Follow Follow the the manufacturers manufacturers
instructions instructions for for replacement replacement
RORO Pre-filterPre-filter MaintenanceMaintenance Monitor Monitor dynamic dynamic pressure pressure loss loss from from
RORO Pre-filterPre-filter MaintenanceMaintenance
Monitor Monitor dynamic dynamic pressure pressure loss loss from from inlet inlet to to
outlet outlet (∆P)(LOG) (∆P)(LOG)
Inspect Inspect for for carbon carbon fines fines at at replacement replacement
One One micron micron may may be be better better than than five five micron micron
cartridge cartridge
ReverseReverse OsmosisOsmosis The The Heart Heart of of Most Most Water Water Systems Systems Pre-treat
ReverseReverse OsmosisOsmosis
The The Heart Heart of of Most Most
Water Water Systems Systems
Pre-treat Pre-treat – – RO RO – – Post-treat Post-treat
RORO
RORO
of of Most Most Water Water Systems Systems Pre-treat Pre-treat – – RO RO – –
RORO
RORO
RORO
RORO
RO Membrane RO Membrane Function Function
RO Membrane
RO Membrane
Function Function
RORO MembraneMembrane
RORO MembraneMembrane
AAMI AAMI Reverse Reverse Osmosis Osmosis In-line In-line temperature temperature compensated compensated monitor
AAMI AAMI
Reverse Reverse Osmosis Osmosis
In-line In-line temperature temperature compensated compensated monitor monitor of of product product
conductivity. conductivity.
Conductivity Conductivity monitor monitor activates activates audible audible and and visual visual alarm alarm
in in patient patient care care area area on on high high conductivity. conductivity.
Divert Divert product product water water to to drain drain on on alarm. alarm.
Must Must meet meet AAMI AAMI RD62:2001 RD62:2001 water water quality quality
requirements requirements at at installation, installation, yearly, yearly, and and at at membrane membrane
replacement. replacement.
Monitor Monitor flow flow meters meters and and gauges. gauges.
RORO SchematicSchematic
RORO SchematicSchematic
GoodGood OperationOperation PracticesPractices Do Do not not oversize oversize Good Good pre-filter pre-filter (one (one
GoodGood OperationOperation PracticesPractices
Do Do not not oversize oversize
Good Good pre-filter pre-filter (one (one micron) micron)
Monitor Monitor conductivity conductivity for for quality quality
Monitor Monitor Pre Pre and and post post membrane membrane PSI PSI (∆P) (∆P)
Operate Operate at at pH pH of of six six to to eight eight
Do Do not not exceed exceed flux flux rate rate (4“ (4“ x x 40“ 40“ membrane membrane = = product product
flow flow of of 1.0 1.0 to to 1.3 1.3 GPM) GPM)
RORO MaintenanceMaintenance (log)(log) Daily Daily Monitor: Monitor: Conductivity, Conductivity, uS uS Inlet Inlet
RORO MaintenanceMaintenance (log)(log)
Daily Daily Monitor: Monitor:
Conductivity, Conductivity, uS uS
Inlet Inlet pressure, pressure, psi psi
Product Product flow, flow, gpm gpm
Reject Reject flow, flow, gpm gpm
Recirculation Recirculation flow, flow, gpm gpm
Membrane Membrane ∆ ∆ P, P, membrane membrane psi psi - - reject reject psi psi
Monthly: Monthly:
Disinfect Disinfect
Test Test for for bacteria bacteria and and endotoxin, endotoxin, culture culture & &
LAL LAL
Quarterly: Quarterly:
Clean Clean in in place, place, CIP CIP
Annually: Annually:
AAMI AAMI chemical chemical contaminants contaminants test test
RORO CleaningCleaning Cleaning Cleaning should should be be performed performed with with warm warm water
RORO CleaningCleaning
Cleaning Cleaning should should be be performed performed
with with warm warm water water at at
high high flow flow rate rate under under
low low pressure pressure
RORO DisinfectionDisinfection Peracetic Peracetic Acid Acid (PAA) (PAA) Injection Injection Soak Soak at at least
RORO DisinfectionDisinfection
Peracetic Peracetic Acid Acid (PAA) (PAA) Injection Injection
Soak Soak at at least least one one hour hour
Rinse Rinse and and flush flush to to remove remove endotoxin endotoxin
Verify Verify residual residual at at 1 1 ppm ppm or or less less
Storage Storage Tank Tank or or Direct Direct Feed Feed Direct Direct Feed Feed =
Storage Storage Tank Tank or or Direct Direct
Feed Feed
Direct Direct Feed Feed = = RO RO Product Product directly directly to to the the loop loop feeding feeding
dialysis dialysis machines. machines.
Indirect Indirect Feed Feed = = RO RO Product Product to to Storage Storage Tank Tank then then
pumped pumped to to the the loop loop & & dialysis dialysis machines. machines.
Which Which one one should should you you use? use?
DirectDirect FeedFeed Program Program flush flush when when not not in in use use Disinfect
DirectDirect FeedFeed
Program Program flush flush when when not not in in use use
Disinfect Disinfect Monthly Monthly (RO (RO and and loop) loop)
Use Use smallest smallest diameter diameter pipe pipe for for loop loop
Return Return product product (loop (loop flow) flow) to to RO RO feed, feed, use use
pressure pressure regulator regulator on on feed feed from from the the
pretreatment pretreatment
Plan Plan for for bulk bulk (peak) (peak) uses uses
StorageStorage TankTank
StorageStorage TankTank
AAMIAAMI StorageStorage TankTank Small Small as as practical practical Cone Cone bottom bottom No No
AAMIAAMI StorageStorage TankTank
Small Small as as practical practical
Cone Cone bottom bottom
No No overflow overflow drain drain
0.2u 0.2u vent vent filter filter (hydrophobic) (hydrophobic)
Tight Tight lid, lid, sealed sealed tank tank
“Spray “Spray ball” ball” wash wash down down mechanism mechanism for for
disinfection disinfection
Distribution Distribution Pumps Pumps and and Controls Controls Single Single Or Or Dual? Dual?
Distribution Distribution Pumps Pumps and and
Controls Controls
Single Single
Or Or
Dual? Dual?
Single Distribution Single Distribution Pump Pump
Single Distribution
Single Distribution
Pump Pump
DualDual PumpsPumps
DualDual PumpsPumps
Distribution Distribution Pump Pump Specifications Specifications Sizing Sizing of of 12 12 GPM GPM at
Distribution Distribution Pump Pump
Specifications Specifications
Sizing Sizing of of 12 12 GPM GPM at at 80 80 psi psi for for 1“ 1“ loop loop
(dynamic (dynamic pressure) pressure)
Loop Loop return return PSI PSI 20 20 to to 40 40
Justification Justification for for dual dual pumps pumps or or spare spare
single single pump pump (alternate (alternate every every 4 4 to to 6 6
hours) hours)
High High quality quality stainless stainless steel steel pump pump
Low-level Low-level shut shut down down on on storage storage tank tank
DeionizerDeionizer ExchangeExchange TanksTanks
DeionizerDeionizer ExchangeExchange TanksTanks
DeionizerDeionizer ResinResin
DeionizerDeionizer ResinResin
CationsCations andand AnionsAnions FlorideFloride
CationsCations andand AnionsAnions
FlorideFloride
DeionizationDeionization Polish Polish RO RO RO RO back-up back-up Acute Acute treatment treatment 1 1
DeionizationDeionization
Polish Polish RO RO
RO RO back-up back-up
Acute Acute treatment treatment
1 1 meg meg divert divert or or shut-off shut-off (portable (portable and and home home use use does does
not) not)
Must Must be be replaced replaced when when used used in in “off-line” “off-line” mode mode every every
three three to to six six months months
Usually Usually installed installed as as worker/polisher worker/polisher
510K 510K service service vendor vendor
Deionizer Tanks On- Deionizer Tanks On- line line
Deionizer Tanks On-
Deionizer Tanks On-
line line
DeionizerDeionizer tankstanks off-lineoff-line
DeionizerDeionizer tankstanks off-lineoff-line
AAMIAAMI DeionizationDeionization One One (1) (1) megohm/cm megohm/cm minimum minimum resistivity resistivity Audible
AAMIAAMI DeionizationDeionization
One One (1) (1) megohm/cm megohm/cm minimum minimum
resistivity resistivity
Audible Audible and and visual visual alarm alarm in in patient patient area area
Prevent Prevent less less than than one one megohm/cm megohm/cm flow flow
to to patients patients (home (home and and portable portable use use
exempt) exempt)
Pretreated Pretreated with with carbon carbon
Post Post DI DI endotoxin-retentive endotoxin-retentive filter filter
Replace Replace worker worker within within 72 72 hours hours upon upon
exhaustion exhaustion
PortablePortable RORO && DIDI forfor AcuteAcute andand HomeHome Have Have Special Special Needs Needs Micro
PortablePortable RORO && DIDI forfor AcuteAcute andand HomeHome
Have Have Special Special Needs Needs
Micro Micro Control Control is is Essential Essential
Operate Operate Under Under Different Different Regulations Regulations from from
Central Central Systems Systems
PortablePortable RORO andand DIDI Designed Designed to to be be attended attended (supervised) (supervised) No
PortablePortable RORO andand DIDI
Designed Designed to to be be attended attended (supervised) (supervised)
No No divert divert to to drain drain of of product product flow flow needed needed
Test Test for for TOTAL TOTAL chlorine chlorine before before each each
treatment treatment (use (use strips) strips)
They They have have special special microbiological microbiological needs needs
DownDown TimeTime == BugsBugs Bacteria Bacteria and and endotoxin endotoxin proliferation proliferation (caused (caused
DownDown TimeTime == BugsBugs
Bacteria Bacteria and and endotoxin endotoxin proliferation proliferation
(caused (caused by by carbon carbon and and lack lack of of use) use)
Flush Flush (carbon) (carbon) before before and and after after use use
“Pack” “Pack” with with bacteriostat bacteriostat
Disinfect Disinfect at at least least monthly monthly
TheThe Differences,Differences, RORO vs.vs. DIDI RORO DD II GrowsGrows bacteriabacteria Won’tWon’t growgrow
TheThe Differences,Differences, RORO vs.vs. DIDI
RORO
DD II
GrowsGrows bacteriabacteria
Won’tWon’t growgrow bacteriabacteria
ContinuousContinuous processprocess
RemovesRemoves microbesmicrobes
LimitedLimited outputoutput
PostPost endotoxinendotoxin filterfilter
PercentPercentPercent rejectionrejectionrejection
Pre-carbonPre-carbon filterfilter
RemovesRemoves allall ionsions
Pre-carbonPre-carbon filterfilter
Portable RO Portable RO Maintenance Maintenance Membrane Membrane life life is is one one to
Portable RO
Portable RO
Maintenance Maintenance
Membrane Membrane life life is is one one to to three three years years
Test Test bacteria bacteria and and endotoxin endotoxin before before
disinfection disinfection ( ( after after periodically) periodically)
Plan Plan to to maintain maintain the the RO RO
Log Log all all operation, operation, testing,& testing,& disinfection disinfection
Follow Follow manufacturers manufacturers instructions instructions
PortablePortable DIDI MaintenanceMaintenance Use Use worker/polisher worker/polisher configuration configuration
PortablePortable DIDI MaintenanceMaintenance
Use Use worker/polisher worker/polisher configuration configuration
Disinfect Disinfect all all filter filter housings housings & & tubing tubing monthly monthly
Exchange Exchange DI DI tanks tanks every every 3 3 months months at at least least
Test Test bacteria bacteria & & endotoxin endotoxin before before disinfect disinfect
Log Log all all replacements replacements and and disinfections disinfections
Follow Follow manufacturers manufacturers instructions instructions
AlarmAlarm SystemsSystems
AlarmAlarm SystemsSystems
AAMIAAMI -- SafetySafety Monitors Monitors cannot cannot be be disabled disabled without without notice notice
AAMIAAMI -- SafetySafety
Monitors Monitors cannot cannot be be disabled disabled without without notice notice
Remote Remote in in patient patient care care area area
Audible Audible alarm alarm at at 65 65 decibels decibels at at 3 3 meters meters
Silence Silence for for only only 180 180 seconds seconds (3 (3 minutes) minutes)
Temperature Temperature compensated compensated resistivity resistivity and and
conductivity conductivity meters meters
Include Include all all important important alarms alarms
SomeSome CommonCommon AlarmsAlarms RO RO Low Low (mid) (mid) level level tank tank DI DI
SomeSome CommonCommon AlarmsAlarms
RO RO
Low Low (mid) (mid) level level tank tank
DI DI
Bicarb Bicarb
Loop Loop conductivity conductivity
UV UV
Endotoxin Endotoxin Retentive Retentive Loop Loop Filters Filters
Endotoxin Endotoxin Retentive Retentive Loop Loop
Filters Filters
EndotoxinEndotoxin RetentiveRetentive FilterFilter Now Now required required (sub-micron (sub-micron non non endotoxin
EndotoxinEndotoxin RetentiveRetentive FilterFilter
Now Now required required (sub-micron (sub-micron non non
endotoxin endotoxin validated validated are are not not
recommended) recommended)
Disinfectant Disinfectant compatibility compatibility is is critical critical
Good Good design design and and maintenance maintenance
practices practices are are very very important important
Cross Cross flow flow vs. vs. dead dead end end design design debate! debate!
Two Two Endotoxin Endotoxin Filtration Filtration System System Designs Designs Cartridge Cartridge (dead (dead end
Two Two Endotoxin Endotoxin Filtration Filtration
System System Designs Designs
Cartridge Cartridge (dead (dead end end with with charged charged surface surface
- - validated) validated)
Cross-flow Cross-flow membrane membrane (validation (validation is is a a
problem) problem)
Cross-FlowCross-Flow UFUF MembraneMembrane
Cross-FlowCross-Flow UFUF MembraneMembrane
Cross-Flow Cross-Flow Disinfection Disinfection PAAPAA (Peracidin/Minncare)(Peracidin/Minncare) onlyonly
Cross-Flow
Cross-Flow
Disinfection Disinfection
PAAPAA (Peracidin/Minncare)(Peracidin/Minncare) onlyonly
HollowHollow FiberFiber oror MembraneMembrane CartridgeCartridge FilterFilter Endotoxin-retentiveEndotoxin-retentive
HollowHollow FiberFiber oror MembraneMembrane CartridgeCartridge FilterFilter
Endotoxin-retentiveEndotoxin-retentive FiltersFilters
CartridgeCartridge EndotoxinEndotoxin FilterFilter Cartridge Cartridge endotoxin endotoxin filters filters have have a a
CartridgeCartridge EndotoxinEndotoxin FilterFilter
Cartridge Cartridge endotoxin endotoxin filters filters have have
a a charged charged surface surface that that hold hold the the endotoxin endotoxin
fragments. fragments.
AAMI AAMI Endotoxin Endotoxin Retentive Retentive Filter Filter After After storage storage tank, tank, DI
AAMI AAMI Endotoxin Endotoxin
Retentive Retentive Filter Filter
After After storage storage tank, tank, DI DI or or UV UV
Cross-flow Cross-flow mode mode or or dead dead end end design- design-
both both need need to to be be validated validated for for endotoxin endotoxin
removal removal
Opaque Opaque housing housing to to discourage discourage algae algae and and
bacteria bacteria growth growth
DistributionDistribution LoopLoop
DistributionDistribution LoopLoop
PipePipe couplingcoupling
PipePipe couplingcoupling
PipePipe insideinside
PipePipe insideinside
Piping Piping Recommendations Recommendations No No dead dead legs legs Flow Flow velocity velocity (recirculation)
Piping Piping
Recommendations Recommendations
No No dead dead legs legs
Flow Flow velocity velocity (recirculation) (recirculation)
Ability Ability to to isolate isolate use use points points (valves) (valves)
Good Good installation installation practices practices should should be be
followed followed
LabelingLabeling
LabelingLabeling
AAMIAAMI LabelingLabeling P&ID P&ID (schematic (schematic system system drawing) drawing) Tags Tags on on
AAMIAAMI LabelingLabeling
P&ID P&ID (schematic (schematic system system drawing) drawing)
Tags Tags on on important important devices devices and and action action
points points
By-pass By-pass process process clearly clearly displayed displayed
Identified Identified water water treatment treatment components components
Descriptions Descriptions and and actions actions on on label label
510K 510K certificate certificate or or letter letter
Complete Complete manual manual
AccessoriesAccessories Wall Wall Boxes Boxes Bicarbonate Bicarbonate Concentrate Concentrate systems systems Acid Acid
AccessoriesAccessories
Wall Wall Boxes Boxes
Bicarbonate Bicarbonate Concentrate Concentrate systems systems
Acid Acid Concentrate Concentrate systems systems
DISINFECTIONDISINFECTION PreventPrevent BiofilmBiofilm
DISINFECTIONDISINFECTION
PreventPrevent BiofilmBiofilm
MicrobialMicrobial LevelsLevels The The lower lower the the bacteria bacteria and and endotoxin endotoxin level,
MicrobialMicrobial LevelsLevels
The The lower lower the the bacteria bacteria and and endotoxin endotoxin level, level, the the
healthier healthier the the patient. patient.
This This is is especially especially true true of of endotoxin, endotoxin, even even at at low low
levels. levels.
DisinfectantsDisinfectants Need Need to to destroy destroy bacteria bacteria and and endotoxin endotoxin Requires
DisinfectantsDisinfectants
Need Need to to destroy destroy bacteria bacteria and and endotoxin endotoxin
Requires Requires high high dosages dosages of of the the disinfectant disinfectant
to to “burn “burn out” out” the the endotoxin endotoxin
DisinfectantsDisinfectants Chlorine Chlorine (bleach) (bleach) PAA PAA (Peracidin/MinnCare) (Peracidin/MinnCare) Ozone
DisinfectantsDisinfectants
Chlorine Chlorine (bleach) (bleach)
PAA PAA (Peracidin/MinnCare) (Peracidin/MinnCare)
Ozone Ozone
Heat Heat
WhatWhat toto DisinfectDisinfect Reverse Reverse Osmosis Osmosis Storage Storage Tank Tank Distribution Distribution
WhatWhat toto DisinfectDisinfect
Reverse Reverse Osmosis Osmosis
Storage Storage Tank Tank
Distribution Distribution Loop Loop
Bicarb Bicarb Mixing Mixing
Bicarb Bicarb Distribution Distribution & & Loop Loop
Dialysis Dialysis Machine Machine
Reuse Reuse Machine Machine & & Rinse Rinse Station Station
PortablePortable SystemsSystems MaintenanceMaintenance Disinfect Disinfect at at least least Monthly Monthly Flush Flush
PortablePortable SystemsSystems MaintenanceMaintenance
Disinfect Disinfect at at least least Monthly Monthly
Flush Flush before before treatment treatment - - Flush Flush or or replace replace
carbon carbon after after use use
“Pack” “Pack” with with bacteriostatic bacteriostatic solution solution
Replace Replace carbon carbon regularly regularly
Water Water Testing Testing And And Monitoring Monitoring
Water Water Testing Testing
And And
Monitoring Monitoring
AAMIAAMI ChemicalChemical ContaminantsContaminants Chemical Chemical contaminants contaminants At At least least yearly
AAMIAAMI ChemicalChemical ContaminantsContaminants
Chemical Chemical contaminants contaminants
At At least least yearly yearly
Both Both the the RO RO and and the the Loop Loop
Consider Consider on on tap tap water water and and product product water water
Endotoxin Endotoxin and and Bacteria Bacteria Sample Sample Points Points End End of of recirculation
Endotoxin Endotoxin and and Bacteria Bacteria
Sample Sample Points Points
End End of of recirculation recirculation loop loop
Reuse Reuse area area
Bicarb Bicarb mix mix water water
Treatment Treatment station(s) station(s)
Reverse Reverse Osmosis Osmosis
Dialysate Dialysate
ProperProper SamplingSampling Flush Flush for for Clean Clean 1 1 to to 2 2 minutes
ProperProper SamplingSampling
Flush Flush for for
Clean Clean
1 1 to to 2 2 minutes minutes
Catch Catch
Monitoring-How Monitoring-How Often? Often? Each Each facility facility needs needs to to decide decide and
Monitoring-How Monitoring-How
Often? Often?
Each Each facility facility needs needs to to decide decide and and write write up up
a a procedure procedure for for where, where, when, when, and and how how
often often they they will will test test and and sample. sample.
AAMI AAMI - - At At least least monthly. monthly.
ChloramineChloramine Total Total chlorine chlorine test test Test Test each each patient patient shift shift
ChloramineChloramine
Total Total chlorine chlorine test test
Test Test each each patient patient shift shift or or
At At least least every every 4 4 hours hours
TheThe LogLog The The daily daily log log is is a a very very important
TheThe LogLog
The The daily daily log log is is a a very very
important important record record of of
performance performance and and testing testing
TheThe LogLog
TheThe LogLog
SummarySummary The The quality quality of of water water is is important important for for
SummarySummary
The The quality quality of of water water is is important important for for
dialysis. dialysis.
Current Current and and Future Future regulations. regulations.
Water Water systems systems and and components. components.
Testing, Testing, Monitoring Monitoring & & Logs. Logs.
DID DID WE WE ANSWER ANSWER YOUR YOUR QUESTIONS? QUESTIONS? Thank Thank You! You!
DID DID WE WE
ANSWER ANSWER YOUR YOUR
QUESTIONS? QUESTIONS?
Thank Thank You! You!