AAMI standards.pdf

ATER TECHNOLOG1

AAMI TIR34: 2014/(R)2017

mical H rum. K) Ii

A.\NII '11R34:

2014/(R)2017

AAMI'

AAMI TIR34: 2014/(R)2017

Water for the Reprocessing of Medical Devices

Association for the Advancement of Medical Instrumentation (AAMI)

This technical information report (TIR) covers the selection and maintenance of effective water quality suitable for reprocessing medical devices.

It provides guidelines for selecting the water quality necessary for the reprocessing of categories of medical devices and addresses water treatment equipment, water distribution and storage, quality control procedures for monitoring water quality, strategies for bacterial control, and environmental and personnel considerations.

TIR34 is NOT a standard and thus not subject to the same formal approval process as a standard. It is NOT mandatory. However, a TIR is approved for distribution by a technical committee and the AAMI Standards Board.

AAMI TIR34: 2014/(R)2017 Why?

The primary objective of medical device reprocessing is to ensure that a device is safe for patient use and does not cause an adverse event in the patient.

As discussed earlier, water quality can have a significant impact on medical devices and, potentially, the patient.

• Impact on Medical Devices

— Damage: pitting, corrosion 4 loss of function

— Reduction in cleaning efficacy

— Interference with disinfection/sterilization efficacy

• Impact on Patient

— Infection transmission

— Adverse reaction, inflammation, fever

AAMI TIR34: 2014/(R)2017 - Inclusions

• Covers the quality of the water used to clean, rinse, disinfect, and sterilize medical devices.

• Defines water types on the basis of hardness, pH, microorganism levels, endotoxin levels, and other characteristics. The following specific topics are covered:

a. Importance of water quality and effective water treatment

b. Categories of water quality for medical device reprocessing

c. Selection of water quality

d. Water treatment systems

e. Monitoring of water quality

f. Strategies for microorganism control

g. Personnel considerations

h. Continuous quality improvement

i. Troubleshooting water quality issues

• Provides definitions of terms and a bibliography.

• Annexes contain technical details pertaining to water treatment and monitoring for the benefit of water maintenance personnel.

AAMI TIR34: 2014/(R)2017 - Exclusions

• This TIR does not cover the water requirements for hemodialysis applications. See ANSI/AAMI/ISO 13959, ANSI/AAMI/ISO 11663, and

ANSI/AAMI RD47.

• This TIR does not address water treatment performed within medical washers, washer—disinfectors, or automated endoscope reprocessors (AERs); it covers only the water coming into such equipment. The internal filtering or other additional treatment performed within a medical washer, washer—disinfector, or AER is the responsibility of the equipment manufacturer.

• However, it is in the best interest of reprocessing personnel to be informed of the internal water treatment apparatus and of the equipment manufacturer to take into account the water quality recommendations of this document. See the ANSI/AAMI and ISO 15883 series of documents.

NOTE 1 — As defined by the Spaulding categories (CDC, 2008)

WATER TECHNOLOGIES

Categories of Medical Devices

Device Categoryl

Definition

Examples

Minimum Disinfection Level

Device that enters sterile Surgical instruments, transfer' tissue of the vascular forceps, cardiac catheters, system biopsy forceps, etc.

Sterilization

High Level Disinfection

Non-invasive, flexible Device that comes in fiberoptic endoscopes, Semi-critical contact with non-intact skin endotracheal and aspirator or mucous membranes tubes, respiratory therapy equipment, etc.

-Device that comes in Bedpans, reusable Low Level or contact with intact skin but anesthesia masks, blood Intermediate Level not mucous membranes pressure cuffs Disinfection

Ffria Winer Removal of Residua?

apkaged Pnec lo Terminal Sterilize

Lkikod dhatikiit • 4110)41ml Priif etp oike.optor • • . ifiTC 77' chrfri1 • .47 P-440 •

Dislafeciian

:R'''$ .

le"

Pad‘agmt Pnerio Tenurial plant/am Ceibes)

4'40-160 tort VS calamine}

Swila Storage

Stages of Medical Device Reprocessing (Where Water Quality Is A Consideration)

:Medical De4ida: COlicat Sernkfkkat

Cleaned by a manuel et avitarriated rnelnad atairaliig ió niahlila"elareee writhen instrignons teal

• Precise/ling enflaming lo remove gross AO'

• Cleaning le remove ser

• Flinr,irig t,s! arriova ckdorgent and kiosense iul

Daiwa imin,r e funher deceiriLqininated g try a wasear-disinledori ke/

VOQUA

MR TECHNOLOGl ES

Categories of Water Quality for Medical Device Reprocessing

AAMI TIR34: 2014/(R)2017 simplifies this into two categories:

• Utility Water — water that comes from the tap that may require further treatment

— Used for flushing, washing, rinsing

• Critical Water — water that is extensively treated to ensure microorganisms and inorganic and organic materials are removed

— Used for the final rinse or steam generation

Final Rinse2)/Stearri Water Use Fltishing/WashingfRinsing

Type of Water Utility Wateril Critical Water

Hardness 15e

Na <10 ‹io5, ofuiraL faia <2051

.Bacteria

Endotoxin <10

Specification*.

Units

Conductivity IgIC111 (rng/L = ppm) p14" 5—

Chlorides

<i00 < 10 mg/1_ <250 <

AAMI TIR34: 2014/(R)2017 Water Specs Table —Categories and recommended levels of water title* for medical :device reprocessing

NOTE 1—This is the quality of water that might come from the tap but might need ,some form of treatment to achieve these specitica

NOTE 2-11 this is the argil rinse prior to sterilization of a critical device

NOTE 3-41 hardness is greater than 150 rhy'L a water softener is recommended rinfess used for washing and the cleaning chemistry is capable of handling higher levels of lirdness.

NOTE 4—For,boller-treated steam, most boilers are treated to maintain a pH of 7.5 or 8.5. Any treatment of water that goes into boilers stisuld be in accordance with the sterilizer and boiler manufacturers written IFU.

NOTE 5—After high7leveldisinfection

Rationale / Considerations for Water Specs

• Section 5 of TIR goes into great detail about the recommendations for the water quality that should be used in various stages of medical device reprocessing, whether manual or mechanical.

• Discusses why specific contaminants need to be removed and their impact on reprocessing. Covers the following:

• Bacteria

• Endotoxins

• TOC

• pH

• Hardness

• Ionic contaminants and resistivity

• TDS

• Color

Water Quality Steam or Low-Temp Gas Table 2—Water quality tor reprocessing devices to be sterilized by steam or low-temperature gas

Stage In process Function Water quality "

1, Precleanlng Of patient used medical device

Remove gross debris and ensure that soil is not allowed to dry on the device or Inside lumens, Utility Water Is adceptable, at a temperature not exceeding 45"'C (113°F).

2.Cleaning with detergent, Remove patient organic and Inorganic material (soil) that is not removed by simple predeaning (Stage 1).

Utility Water is acceptable to dilute detergent, provided that it is compatible with the detergent to be used.

3. Initial post cleaning rinse. Remove detergent residues and any loosened soil.

Utility Water is acceptable. The water should be changed two to three times to ensure thorough rinsing. For each rinse, a sufficient volume of water should be used to completely Immerse the device; if immersion is not used, then some other means, such as the washer-disinfector manufacturer's written IFU, should be used to document that the volume of water is suffialent

4. Final post cleaning rinse, Reduce likelihood of hard Water deposits or endotoxins on device

Critical Water is preferred.2) One-final rinse is adequate If there have been two tá three changes of water during the initial post-cleaning rinse (with each rinse using sufficient water volume to completely immerse the device).

NOTE 1—Ensure that water Is compatible with the detergent martufacturer's written IFU. If the water In a specific geographic area is very hard (e_g_, 150 ppm CaCO3), it is desirable to remove solutes for all cleaning, rinsing, disinfection, and sterilization stages.

Softened water can be used to prevent or reduce Ca", Fe", Fe"",•and kig"" deposits if the removal of other ion contaminants is not needed. See Table 1.

NOTE 2—Manufacturers of ophthalmic surgical instruments recommend that devices teed for cataract surgery be thoroughly rinsed with sterile distilled water (Le., water equivalent to the Critical Water described inTable 1) before sterilization.

Water Quality — High-Level Disinfection

Table 3—Water quality for reprocessing devices to be high-level disinfected

Stage In process Function W Water quality

I, larecleaning of patient Used medical device, Renitive gross debris and ensure that soil is not allowed todry on the

-device or inside lumens, Utility Water is acceptable at a temperature not exceeding 45°C (113°F).

2: Cleaning with detergent (usually enzymatic detergent).

Remove patient organic and inorganic material (soil) that is not removed bisimple predeaning (Stage 1).

Utility Water is acceptable to dilute detergent

3.Post-cleaning rinse. Remove detergent residues and any loosened soli

Utility Water is acceptable. The water should be changed two to three times to ensure thorough rinsing. For each rinse, a sufficient volume of water should be used to completely ininierse the device; if immersion is not used, then some other means, such as the washer—disinfector Manufacturers written IFU, should document that the volume of water used is sufficient.

- - - r 4.Dilution of liquid chemical high-level disinfectant (if applicable) and liquid chemical exposure

High-level diSinfection. Utility or Critical Water may be used, provided that the manufacturer of the liquid chemical has validated its use for thIS purpose.

5. Final rinse after high-level dIsInfettion

Remove residual HLD and reduce likelihood of hard water deposits on device, For AERs, the incoming water may be Utility or Critical Water.

For manual processes, see 5:3:3.

WAT8R TECHNOLOGIES

Water Quality Liquid Chemical Sterilization

Table 4--AMMer quality for repr •cessirtg devices to receive liquid chemical sterilization

Stage in process Function Water quality

. I. Precleaning of patient used medical device, Remove gross debris and ensure that soil is not allowed to dry on the device or inside tumens.

Utility Water is acceptable, at a temperature not exceeding 45*G (113*F)..

2.Gleaning with detergent (Usually enzymatic detergent).

Remove patient organic and inorganic Material (soil) that Is not removed by simple predeaning (Stage 1)..

Utility Water Is acceptable to dilute detergent,.

3.PoSt-cleaning 'nSe... Remove detergent residues and any loosened soil, Utility Water Is acceptable. The water should be changed two VS three times to ensure thorough rinsing. For each rinse, a sufficient volume of water should be used to completely immerse the device: if immersion Is not used, then some other means, Such as the washerdisinfettor Manufacturer's written IFU, should document that the volume of water Used is sufficient.

4.Dilution of liquid chemical sterilant (if applicable) and liquid chemical exposure

Sterilization. Utility or Critical Water may be used, provided that the manufacturer of the liquid chemical has validated Its use for this purpose.

5.Final rinse after liquid chemical sterilization

Remove residual LGS and reduce likelihood of pyrogens on device.

Sterile water Is required to maintain sterility.

Water Quality Pasteurized or Thermally Disinfected

Table 5—Water quality for reprocessing devices to be Pasteurized or thermally disinfected

Stage In process , Function Water quality li

1.PrecteanIng of patient-Used medical device

Remove griosa debrie and ensure that soil is not allowed to dry on the device or Inside lumens., Utility Water Is acceptable, at a temperature not exceeding 45°C (1136F-).

2.Cleaning With detergent Remove patient organic and inorganic material (soil) that is not removed by simple precleardng (Stage 1).

Utility Water is acceptable to dilute detergent if it meets the detergent manufacturers written IFU.

3.Post -cleaning rinse, Remove detergent residues and any loosened soil

Utility Water Is acceptable_ The water should be changed two or three times to ensure thorough rinsing. For each rinse, a sufficient volume of water should be used to completely Immerse the device; If Immersion is not used, then iome other means, such as the washer—disinfector manufacturer's written IFU, shobld document that the Volume of water used Is sufficient.

-Subsequent to'preelianing, cleaning, and rinsing, ONE of two methods of heat treatment is used, 4a thermal disinfection.

. 4b Peateurizetion.

Kill microorganisms.

KIII nalcroorgarliantS.

Utility Water is acceptable if it meets the washer—disirifector manufacturer's written IFU and has:a low hardness level (430 pprn):-otherwise. Critical Water should be used.

The water used in the pasteurizer might need la be changed daily or after each load to reduce buildup and cam/over of debris. The manufacturer's written IFU should be followed.

NOTE 1—Ensure that water id compatible with,the detergent Manufacturer's Written IFU. lithe water In a specific geographidarea is very real (e.g., 150 pprn CaCO3), it Is desirable to remove solutes by DI (acceptable) or R0 (preferredVor all cleaning, rinsing, disinfection. and—steriftzation stages. Softened or.deionized water can be used to prevent or reduce , Fe"". Fe"-, and Me* depalits if rernevoi of other fern is not needed. See Table 1.

Continued on next page.

Water Quality Monitoring Table 6—Overview of water quality monitoring

Characteristic TYPe of testing Semple age Samples taken and analyzed by

Suggested frequency of ' testing

Bacteria 1-leterotrophic plate count i!,(see Annex 0)

Reprocessing area, storage tanks (If used), Immediately downstream of water treatment process

Maintenance personnel Monthly

Endotaxins

LAL lest Reprocessing area, storage tanks (if used), Immediately downstream of water treatment process

Maintenance personnel

On installation, modification, or repair of the Critical Water treatment system or when persistent Increased microbial levels are detected by heterotrophle plate count, ATP, Or TOC

Total orgaolc carbon

IOC test Reprocessing area Maintenance personnel Windily or quarterly pH pH meter

Colorimetric dipsticks

Reprocessing area •

Reprocessing area

Maintenance personnel Reprocessing personnel

Monthly

Monthly

'Water hardness

Re siAtikAty meter

Determination of ppm CaDO.;, Colorlmetric diPM..kk.S

Resistorneter

All Main water feedlines Into the faCility"

Reprocessing area

Maintenance personnel

Reprocessing personnel

Annually 2'

Annually 2)

Daily Reprocessing 'area, stoMger tanks '(If used), Immediately downstream of water treatment process

Maintenance personnel (reprocessing personnel if point-of-use water treatment is used)

Ionic contaminants

Specific tests for All Main water chloride, iron, feedllnes into the copper, facility menganese

Maintenance personnel Annually 2)

Color end turbidity

Visual inspeetion Reprocessing area, storage tanks (if used), immediately downstream of wider treatment prooeas

Maintenance personnel and reprocessing personnel

Daily ge 32 ologies

Water Quality Monitoring cont'd Table 6--Overview of water quality monitoring (confinaer#

Characteristic Type of testing Sample she

Samples taken and analyzed by

Suggested frequency at testing

Temperature Water temperature by thencuneter °I' temperature plObe

Reprocessing area Washer—disinfector:

Temperature of hot and +Cold water sources Target temperature for cold-water rinse stage, enzyme rinse stage (if 'applicable), wash stage;

and thermal rinse stage (to be confirmed by visual check of the instrument readout)

Ultrasonic cleaner.

Target temperature fOr enzyme cleaner

Manual soak:

Target temperature for detergent and all solutions used

Reprocessing personnel

Daily

Filters Pressure across membrane (to check for pressure Increases to a critical level and abrupt pressure decreases

Reprocessing area, on equipment that has internal filters (e.g.„ AEFis or POU water treatment equipment)

Reprocessing personnel (may be done In conjunction with Maintenance personnel)

Daily

NOTE1—The apecifcations presented in thia table should be tested to the parameters specified in Table 1, where applicable, NOTE 2—This characteristic should initially he monitored quarterly for one year or until there are four consecutive quarters with no out-of-Specification readings, Monitering should be ecinducted annually thereafter or as appropriate based on the assessment of the prqviousyear's validallon.

NOTE 3—The recommendations for frequency of testing in this table are the reconimerfied minimum frequency. If problems or Issues arise with the water quality, it might be necessary to increase the frequency until they are resolved.

MANUAL

Pre-cleaning and Rinsing

Cleaning

Utility Water

Utility Water

Rinsing

AUTOMATED

Enzymatic prewash

Disinfection Utility or Critical Water

Follow manufacturers' written IFU

Follow manufacturers' written IFU

Selection of Water Quality Categories Stage

Water Quality

Notes

Utility Water

Utility Water .

Utility Water

Rinse

Ultrasonic cleaner

Disinfection and sterilization

Utility or CriticaF Water

Utility Water

Critical Water:

Or critical water if devices come in contact with bloodstream or other sterile areas of the body

Depending on the terminal disinfection/sterilization

Depending on the terminal disinfection/sterilization Critical water for ophthalmic surgical instruments

Follow manufacturers' written IFU

NOTE 1 — Notes are truncated. Entire section should be read thoroughly.

Annex Notes1

:..Systems .that. include ...DI: as :a •• component should., also .• contain carbon -adsorption . and .ultrafiltration_ In such .systems, carbon is placed upstream : Of the..cleionizer to. prevent forrnation of carclridge.nic nitroSarnines,...and ultrafiltratio..n is placed :down Stream:1.0f the :deio.nithr. to remove •bacteria and :.endotoxins. The usual. a.pp.liCatIon ft:Ir....Di is as a. polisher to RU or 0%,......a. .s.anclby::.;procoss::.for use in the •.event of RO..system-failure:..11se-._Of Di '.aS,.tbe:..p.rlma.6t..meansf.Of .purffication:JS not re0OriglIended.- because ,of...tfle.._Inabillty.•Of DF:arid.:.ultrafilltration.; to r*nirAle..:Certain.•10*mtilpp0.10-weight txI, bai.Oteicat.plitidt4S, suCti:44tiproort. yi.11.11*': DelOhliatidn'ShoUid..olwayg..tio.tolb*ed .by lulti*tiltittiOiri to rentov.etiOteria•and'iendeitibAnSthat coUld-originate:in"the Dl.esin bed,.

,Detioni4ation has a finite .capaCity that, when 'exceeded, will CB Li Se product water to have dangerously high levels, of previous removed contaminants Fortunately, the .quality of product .water from Dl is readily monitored by means of resislivay rnonItOrS.:lbat,. when used as. speCified„ at .02..TeSistanCe. oi. 1 me.b.Ohrh-•Crri..(Mq-Orn).,0.r ..greater, can, prevent ..

inadvertent operation of exhausted D.1 Specifically, the .1eSiStiVity monttiiii--:4iotikt.:..be • connected to arfsaUdible,and .

viS1014.•alairlt.'fri *1.0.frOdOsoiritti:4r00,:atiri the Dl system should divOri::..oroouct.:,*.tet .10..dj*n: if an akirrri .,obhditiO11 OcOui*...i.060-0...no:o.purltsto4n6e.i.ichtioktf. pi.. be used vberf:the:..prodUOt.Water:Olte- bedTlias.ii resistivity below ,...... . . . .. • • . . . . , .:Mtlorti...! •

*2 8 ;t1ltrafiltration

Ultrafilters are rrierribtane4,based separation devices that Can be used to remove particles as Small as 1,00Q daltons:

•thus, ultrafilters :are well stilted to remove •1;i0tii: bacteria and endotoxins:.1,iltrafilteris:SbOuld ii -ploOod in water'. sliaterns.

.locallons,OcrimpoOkillof :deb:pita:00m if DI Is the ;pat process In a,Wgi.tor Iregittnent SyStern,,Or following Ultraviolet:

:JrradiatiOrri, , c...3 WterdLributicn

t. di 004E10 ittikkil*i;degpftgOreili*.a eiiriAtitriett*. lotiprid ,Oei.igliext; te? teriertite0reirefiren :RO‘ rn1rThiizbDr M Hfrñ initilittia.k. itqtrIpirinnii VoDj c 3 41 pr0420:#0 fft1060., idts.131.1*.tioe -tiffAle leap u crpoilfOldOits I tiOillic.:,.00lia001: A Itsifitista Re tent/thi pump made alinett Tuatelimists nieeded b distrifrqte the puiriied itt.olter ‘ianci.07,-Et ielteclve :thsinieetieh.

Pro.duct waier ditaibpkirei sy,sterns smquirt be. cammiructed. i rodeileis tot: do pat. oantrjbute. et.eenircals.

eloppee d, 1iOrCLenaI: crirnnanl5 6 the puritiodwLer Tht ;chic' gf ate E6rials use4i. rut gob-abet -

`distibuticio:,:syslern: :Rise deperkt: oci :the. Ofepoted. rritethod nction, :ai r distibutiee 'etviisterris diatittibeitionitared for bettetia'3in. If 4011cm:bre detexiti level

0.34,2 URtroOlolalt Irradiators

LIIIraiefolei:ErraptialorsIsitisp knoWni ao LIV kg,hts) can be Used la cdriftdlibuipslonFa:proliforatioo rr pLrifid walarslafraga arta cliskribalisa :spiral* 4IRiakhari, eitt,df., 2004). littiaiiiciletera*alarS contain a loWI*eigaira mercury lamp thatenits

'10ght at a oiave4ength o1264-,nainoineners. The lamp is conlviined inside in banspartni Onatti sieey,e Thai 15dEiarS From &act oaripticl Wirth the *aut. The dose of rod.iairi. eirierpy lird Odra by the latoo thnuld be VI:least O nifronit-ocrern2

1.11istrradiet, radiation es riot ,effecby'a .in water contraning .ire :arinnuirvis oF c‘c-garac: 3L4135:121fiCeS or colloids and, therefore. k not .,statoitkla 'fat: Use in .co,0:ltAlling bacteria in the :ptetpainient section of waler ipurlOcnion zyaieni . , iticaidataa,the le0,4 of modOtOkiri In the tloatetti vv:frretdbaciti;-6hezJid 06,freopiti lb* anitititaifill.leCi

The 'Use of :stitiOadizdl:kiias. ofriitiitliori EakidO:Iaart la the tIEVE6001111i2Oli of re!Siisiant Otains of Oactiaria: tbetakirp, litartia.rOis 410414 be iatiLip- ti...*f*Itiaxi nionelotioriadistiterSer oiu 'iaE* ilyaies4 vlle alinprit'Whaft 11:6 -lannp;stibiifikbacied.

evoQ WATER 1 FCHNOLO voh

":9

Annex Notes1

Strategies for bacterial eon:trot

•''GJaiimirtil•-:Coriiiiderittfon0..'

PiaMaps are consatirtilles Of glicraorgenisrri tthrhec bstirfaces, They rutin Itist uizihrathete that watinsierile toid ficerks, :olio a stir*e. 1;i4iorli1rn irkresses the ability aI rilicotiorganisrts la cOrtipete For hdtrpients and otier reeciteroes.. The complepily of bfririi depends, On the degree of :water or Riid movement :land .Sie nuirierria; Thicker biailni—and USLIday a greater diyersityof iricrbatgatiiernsH7will Foot islaWerleboittg waters; fri fostet-rhowing latfiens,it hattler fur iticgourganishisbi betettie 'land ternaki) adeched lo the stisilace,, sip blaBirn !iorrnation hetes lapger: i3Orgsnishits living *thin a biofilre rite shielded by En pslyrrter cirt glytiscalyx. This glyoecallyx pre-vides, the bectetki With ionic proiectitin :front tie ache!, of disinOeciants:toiln ci e3.zr thrb9gheti1 a

:water distribution s.yeserri clitceseatriblishe4 in a cii$,:tribuhurt:spbert.,bieffint can be lirfficuiktni eratticale;..)F400inelavii reP,rei trosioreael °tithe pkiis*ioLti beiOerfurp*16.1: ODW,t101. kit, :The

4iie,dersitpa of the Ivieirriestirjle *filet!, bitariiht farPied . . . in , . - :eltferfihtg egts,terini,i 414-.1t.sheittirr,bei med le tnonthly.. 11 aibfifin hrr 6ontned.:. rncon Plight, be thane teOectiNte if the pipes are tread kirlittl a ,detraling agent befiore dititt*doti lit perfumed.

wATER TECHNOLOGIES

Monitoring Water Quality & Equipment 'Nip- le Ell—Monitoring water treatment equipment

: Haig fer month:it petilitrini Mei (ore 11,22 and e.:41

Wilit ta Mormitar *aerial !Mensal . hornet interval •

I3. 4Y

Speraineation :, ' Pressure Prep less than ' itiFfr."'t'. (Abhipt , .

downward chanorsCorst:i Indicate a rt.filtilea.jil the

•Membrane.)

Press**, diger azf nee tie Mei th'it APP'icable (NO”, Cal'itd0 filter (Ore'

- A2,3 and13.3r ',-

Frees/Mr *IV:.

ocierss Oke kilit

Isi(,i Daky Pr ezeure Arno less than , kiwirotig imrw, datorrivard chanere".s Cone indicate amp tura In Ole rrielubrune.)

,Waler tonersp (see -0..2A and agl

Product water sotinesa . .

WA. Dail: end nrAi4 ftaidiress (smIclum less lion 10 pimp) ..

Water softener brine tank (see A.:24:mnd :

a Ei •

Level a Itmdissolird iait in lank

(41A

Darly- end ra (-shift

EMU sti kfFICI '

War lonelier repartee ban cycle

-(,.1?, A.,2;4•P41 RM.

Carbon adsorption iankb (Sae M2.6 nue O.7 i

Rigeoerolon cycle Orbit -seeing '

PiodOcr Water ker• chlorine or rapt' Chlorine

WA

TA

: poly, end arOitt

Daily al the beglitbittet• of each shift .. '

Er:dirtier Niger net Oa killT" " fit itaigif Iota ildeliner

'erarse osmosis. • (Mee 33.2.;A.211, ct,e)

Product Wa tor resistivity or low!

Otsioived scalds and celr.ciated rejection Product and raped flow rates and .

calculated recovery

NIA.,-

4fP.

Daly fusing:.

cenfiguousyno to

Daly (isnel • continuous nankin)

Ftejecten a 14Pd."

: Product water low rate a- MM.." pent ;1'0c:ovary 41140'

Delondeis (r,re, A 2.7 and WS)

Fetacciel Wa ler -resastivitY iltrie CatillMous - Resistivity a I 3417pro •

UltraDlets (air A..2 6 and 13.10). ••

Pressure drop ararass No flies

NM Pady 0Mipte drop leSP DU/J., 73(-11'"'' (Abrucit - Ciert'ormiard changes' conk( indicate a rupture In tire re embrace.) -

Dolltalon tserA2,9 and BM)

Produrlwa res&livity or iaial rasoMyeel sends and _ .

calcimined rejeslion Toe* EA)

141N Daly (usenet ton knuaMs manners) peleClon a 3491-1'

11*11 nil nex Page,

• NOTE -Man iimisk(CsieSircaiiriterldert but

• NOTE 2—O.:L.-tette( feWO inutile be rkiermile.o Vite obuewainutadnronteaai rqrilited.rarlUiteiiin is rete.tired'enty ti entree. wo

NOTE —It teodoirt ore rlionicrodDffade crisii,•adrierne ripricechata(ATP)asiesament tdblorlarric carbon, criOther .

-soppCsdaie karts, iitioalmin levels geed la be datetatiged wit tnoa ere sysirm is mottled. nrvdlni or Irak Intsis of viable argwrisme On not TraMntee encialeaM !emit' Inns hut or entail Oa 10 Elltri..) If imciferns we aclege6ed .ui•e c4 the egrirrdy

• linwolured WOli4 characimis*rr, alarruerri of gaireleiren leads ;might be needed as pogo( 'he ogling lmeMeratert•Paiii:ne endotrain MertimirM OnFnnE.CaiSarY

Monitoring Water Quality & Equipment (cont'd) DilitOtin Water treatment eritlipMent Ocui tinuedy

, iie - m- ,--to—m-o-Trittor • r [ .. , Witerstorage tanks (far treaied flratell

• • • • .ir;•ees Ell 2:i• and C.2)

71What -; - m- o-n-ttot

. Betterial growatand endoiniins a- Small- 1 14;:te- Ival

Weedy, unal a Pattern oF cOnsIsient, .

cOrno.Lance with intuts

.C4ri.1:.e. dgrnoisr.7abed

. Normal In.terifol

MOranly necornmended itati at least Onanierly)

Speolloaklon

Banieriret count (see 0_31

• • .litillty and Crl s.al IN atgr, 4 10 cltrinsL

• Tait, softened, .

deInnized Water; <1'00 cfn1.m1.2.73 •

. Entloianne

- OnOcal Vilter.,..< I& EUtrnil l"-

: Gestritxtbon piping :.:

system liar beaten.

,. w.ateri (see:B.:lg.:4:

Wits C.i) "

.0acterial Vawili_ gnat .indoioxitt

Week...0y, toil a pattern , tuf consistent

.compeiance with tnnts tort, b# dentonstated.

Montlylerarernended (but al letat oLMrlerly)

Bacterial connt (See CO , !Alit)* and •ciificat: i 40 crufmL .. Tap ...softened,.

deionized na*i'.", 200.

clann125

Etseeloiin Critical Woter: •f 10

Etihritl i - ' UV fight Danced tsee. _Eneroy.ctinpiat WA?: Monthly . 1 Lights have MR1.../ at4pot

Oiotte generators (see B,13.2 Ana C.1,2:3} . .

poimentation in he 'Wale/ .

ft iA Patina daub dr3ii featibri •

Diane coneentrainn she #. .

be MilL '

Hai-water nitsiniettion u-ysierns (see B.,13..).

and C:3.,..4)

Tampere lute rind One or eqtasure.of, the systetnto tint waler

N A Daring each •ondis fat rico

Ternperaluse ?., .MRL" "C..

Minhopin expos.wre trifle at ,

• 11 lernneratate.. MRL .. enin

.NOTE1-4nRke Marufnelur&s, teourbrneneted tont

NOTE 2-E[poterialleiels be [Selena-nen Merin/skean ,ree Mstriledi rim:Lied; or lepoWed_M*Scring re reOtired ally rxrbius are IctinEreiL

NOTE 3-Ftliticrolial faitsie.riYager are mutiloten by Viable count,: ATP ausetaliest TOG, or [seat n.pplieable lecta, en doimin lunras cnly need la. be detennined.nheol-te aril= .is instdied, rticdied, or repaired: (It sholid be fa:0d tha!kny levelN of crgatzinns so nut 001"&lice ens:101E1.5in levek k•=• than or eq_id.b 10 Wink.) If larldems are idernie.d in-arty .of the rcitinely ntrnitored-Water,tharoa- 'erisicar.

'astrAtane-tto ennobatin ley& nitt be needen as pert c4 lie problem inveMigu!ine.... Rubthe endoiaiM manikkilv is not necetimert.

NOTE 4.---Anintrenee in, pen sure cariketraii thui the titer is, doljEml and nee& to te-Oh. angen.":Fiefer thenaarLaer's

AAMI TIR34: 2014/(R)2017 -Conclusions

• You will need to work with the end users to determine their specific needs, their use of water or steam, and the type of equipment they are cleaning.

• Generally speaking, any active hospital will need a water system capable of producing "Critical Water".

• Maintenance and monitoring of the water system is emphasized (WaterOne, WaterComplete, WOA).

• TIR34: 2014/(R)2017 generally states that the end user should follow the medical device manufacturer's Instructions for Use (IFU).