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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

ProChem company A Wholly Owned Subsidiary of Cottrell, Ltd. 7399 South Tucson Way Englewood, CO 80112

Attention: John R. scoville, Jr.

Subject: Omnicide Liquid Disinfectant EPA Registration No. 46851-2

AUG 2 1995

Letters Dated July 10, 1995 and July 13, 1995

The container labeling and package insert labeling referred to above, submitted in connection with registration under the Federal Insecticide, Fungicide, and Rodenticide Acts, as amended, are acceptable, provided that you make the labeling changes listed below before you release the product for shipment bearing the amended label.

1. On the container Labeling:

a. The "Virucidal" claim must be keyed by a symbol to the paragraph listing the specific tested viruses.

b. Specify the major areas in which the product is recommended for use (e.g. homes, school, hospitals)-

c. Delete the term "ProCide" wherever it may appear on the label. This is not your product name.

2. According to our records, there is a contradiction concerning the name of this product. The name on file is "omnicide Liquid Disinfectant" and not "omnicide sterilization and Disinfecting Solution". Please clarify.

3. You are reminded that the container labeling must meet EPA's current labeling requirements.

::::.! .. ....-.... ............ ··1 ··_··· ... ·_··t··:·:::·:::r-..... _ ... ··, ...... _·- ._-1" ............ 1-. __ ...... _. O"TE '~ .................. ••••••••••••••••• .... ............. ................. ................. ................. • •••• ~ ........ - ................. .

OFFICIAL FILE COpy EPA Form 132()'lA (1/90) Prinltd 011 Rtcycltd Papa Ie uS GOVFHNMENT PR1NT!NG OFf It:!: I~J5 &19457

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2

A stamped copy of the labeling is enclosed for your records. submit one (1) copy of the final printed label prior to release of the product for shipment.

If you have any questions concerning this letter, please contact Martha Terry at 703-305-6982.

Enclosure

Sincerel,,--,,-v~

Marion J. Johnson, Jr. Product Manager (31) Antimicrobial Program Branch Registration Division (7505C)

+-

INTWO(o USE

Sterllllatlon: This soltl\Jon !'.hould be used lor 11m ~1r.II!if;l.liuTl 01 heal sensitive IIlcdiVlI 1'!lllIllllur.nl lOt wluch allr.rnahvc method!:. of !,1r:rili, .. tll'lt1 fife 1101 suilable. Medical r.qllipmr.ol whlth !>h(lU\fl alway!. llc SI(lli!llCd is thai winch 1<; r ... 1Irijori/~11 a!; uilir.ai (n.n • lI'icd in procedures III whir.h (.o!'llar.! will he mail!'! wilh li~5Ur. lhal is 1101111,\11'; (tlll~.nlt;lcd sl!'!!!I!!.)

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Intcllnclllitle level DlslnlettlDn: ThiS sol1ltlOn \110111111.1' 11 ... (,11 lor disinfr.clion 01 medlCil.I t'lllltflfllr.:II Illr wInch a fl~k 01 r.ro~ .. (i)ul.l!''WI:tliml I'tlsl';. Mr.l1ir.:d c(Juipmr.nl which !-',:nIlTlI ,,1 ... J.l15 lie (h<;mfr.clcd I ... Ihitl wti:ch IS 10 " .. U';f'llmllllJl':r1h11r:s talr.oollfrd as non·c.:i:, r.1I (' () w.l'd :'\ rroc:r.lfllfl'S in whir.h t:onIJr.t WI;) nn'i !,t' ·I,;l.Ill' \'Itlh ml.I(.1 "'1(1:!)

pnECAUTIO~ARY STATEMENTS IIAZARDS TO IIUf~ANS AND DOMESTIC ANIMALS

DANGER: Keep QU\ 01 Rellth of r.htldlt.l1. Dircel COIII.1cl may ~usr. eye damage ami \lun inita!ionlrullnanr.. 00 :101 (Jet iulu r.yrs. on M:in ot on clr.tltinO Wear gOOQlc$ Of lacc $!Iield ;11111 IIIhhr.1 1110'1(':<; \'Ihen h;mdbll!J ("It plltJftll!] Avnlll CIInlatninalion ("11100(1 Uo;.r. In writ \'('1IJo1Jlt:tl Jt('a in (J()~r.rl r.rJtll;:t.inr.l~

STA1[I~ENT or pnACTICAl lIlEATM[NT. In r~lSr. 01 cOlllitcl. imll1r.dl;:t.I~1y lIu~.h n)·c~. Of

sktO willi COllIOlIo; am(lunl~ or "'';Itef fnr al r.'Ol'i1 15 minutf's. For (W~s. gr.! rnr.di(:.11 <t1lE'.r.lion UfUmlul if swalJowcd Orink IfUQI'! qu;ullilir." 01 'I't~fp.r ilnd call a plrV$ltiilll immr.dlalefy

NOTE TO PIIYSIC)AH: p,ol}ablc 11lur,osi\1 (\amagc hom or.t1 ~lflOSlJrp. may r.Ohll<lirnlicalc lhe lise of ga<;.hic "v.1Qc.

STORAGE AND DISPOSAL

Slore al conlrolled fOom lr.mllCIi\lmc IS"C·JD·CIS9"·86"fj Pesticide OIspoul: 0,<,('..-:1,,1 1r.~.idu;JI",ol.'!lon in drttin. FlU5h tltnlO1tghlYVllih w,llel Container Disposal: 00 nollt::n~,e r.1ll111y r.olll.tmt:r \'1'.111 cnnl;:t.inCI al\d pulln II,,-<;f'

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Long Life Reusable Acliv;

Sterilizing and Disinfectir

Sporicidal, Virucidal, Fungici Bactericidal, Tuberculocidal

Acliv.lngredler.1 Glutaratdehyde Inert Ingredient TOTAL

2.4% 97.6%

100.0%

E P.A. RcglStration No 46851"2 E P.A Esl,lJlisllmcnT No. 37255·CA·Ol E PA Esla~I'shment No 39754·WI-1 (Sec shoulder 01 conlalner lor E PA Est No)

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AtUnUon: Ar.livalr: Ihlt ,'",(1M solution hy "c1f1in!1lhr. r.nlire r.nnlr.nl!i: of Ihr. Ar;livalnl Dollle (w!lkh Is al1:Jr;hrrlln (hr. I'rnriclc- !<.olllllnn cOItlitilltf) III the r.OIllainr.r. PfAr.r. £~p 011 r.nnl;dnel illKf !.hakr. well On ar.tlvalion Ihr. snluUon 'nllilcdi:tlcly r.lt"npes. r.olo, 10 hIm'!. Ihru~hy indir..1lil1O ~.olll'inll i!> rc,\rly Ih IISr.. Rr.r.fJld (he d,\(r. of .1r.lr/'\liou 011 Ihl' illdl(~'Ir.11 '.p,\I;r. hr.low. In a InQ honk or .1 l.1h'" :Jlliyrlilo :tny ',I'o.nnd.uy (lIul.lInN ul.rt! 1m "r.hv.,'",d !'.nIIlIUlII S"r IMrl.l!1f' ill~"11 1m ,l,Id,IIllIU/Ill5,ftllr.fmw; Jilt!

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BEST COP'{ AVA\LABLE

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. ACCEf'fIW wlth co'"

I " """""r~ :J LPA .< .. , '" Letter V'lt.d:

ill 1[: .,

Omnicide™ activated dialdehyde solution is a liquid chemical sterilant and a high or

intermediate level disinfectant when used according to the Instructions for Use.

1. Germicide Level of Activity: Omnicide™ can be used at the following gennicide

levels of activity:

Sterilallt: Omnicide™ is a sterilant when used or reused, a;;cording to the Directions

For Use, at or above its Minimum Effective Concentration (MEC) as determined by

the ProChek G Glutaraldehyde Concentration Indicator Test Strip at 68°F (20°C) with

an immersion time of ten hours for a use period not to exceed 28 days.

High Level Disinfectant: Omnicide™ is a high level disinfectant when used or

reused, according to the Directions for Use, at or above its Minimum Effective

Concentration (MEC) as determined by the ProChek G Glutaraldehyde Concentration

Indicator Test Strip at 68°F (20°C) with an immersion time of 45 minutes for a use

period not to exceed 28 days.

Intermediate Level DisilJfectanl: Omnicide™ is an intermediate level disinfectant

when used or reused, at or above itsMinimum Effective Concentration (MEC) as

determined by the ProChek G Glutaraldehyde Concentration Indicator Test Strip at

68°F (20°C) with an immersion time of ten minutes according to the Directions for

Use in Section E for a use period not to exceed 28 days.

A ten minute immersion at 68° F (20° C) will destroy all vegetative bacteria including

S. aureus, S. choleraesuis, P. aeruginosa, E. coli, all pathogenic fungi, representative

viruses and 99.99% of Mycobacterilllll strains' CQuantitaHve 1'8) as •. represei~ted by bovis and terrae.

Cottrell 510(k) K932922 Response 6/29/95

ACCEP'l'l!lO Vlith COMME~"T8

1:1 £i'.\ 4ttcr D3~

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2. Reuse Period: Omnicide 1M has demonstrated efficacy in the presence of 5 percent organic soil contamination and a simulated amount of microbiological burden during

reuse. OMNICIDETM SOLUTION MAYBE REUSED ONLY WHILE THE MINIMUM EFFECTIVE CONCENTRATION (MEC) AS DETERMINED BY THE PROCHEK G GLUTARALDEHYDE CONCENTRATION INDICATOR TEST STRIP, PH AND TEMPERATURE MEET THE REQUlREI\-IENTS BASED UPON MONITORING AS DESCRIBED IN INDICATOR DIRECTIONS

FOR USE. Efficacy of Omnicide™ solution during its use-life must be verified by the ProCheK G Glutaraldehyde Concentration Indicator Test Strip to determine that at least the MEC as determined by the ProChek G Glutaraldehyde Concentration Indicator Test Strip is present. The product must be discarded after 28 days.

3. General Information: Choose a germicide with the level of microbial activity that is appropriate for the reusable medical device or equipment surface. Follow the reusable device labeling and standard institutional practices. In the absence of complete instructions, use the following guidance:

First, for patient contacting devices, determine whether the reusable device to be processed is a critical, semi-critical, or non-critical device.

• A critical device routinely penetrates the skin or mucous membranes during use or are otherwise used in normally sterile tissues of the body.

• A semi-critical device makes contact with mucous membranes but does not ordinarily penetrate sleIile areas of the body.

• A non-critical device contacts only intact skin during routine use.

Second, determine if sterilization, high level or intermediate level disinfection is

required.

Critical device: Sterilization is required.

Semi-critical Device: Although sterilization is recommended whenever practical,

High Level Disinfection is acceptable (e.g. GI eTido'scQP¥?~:~nesthe~ia equ~tment to be used in the airway, diaphragm-fitting rings, etc.) . ~- .. ~ . i

Cottrell 510(k) K932922 Response 6/29/95

" ACCEPTfo:D l , 1'.1,'1 Com'"".".., , I;) E'>' .",.,"~

. • .. Lettcl' llalcd:.. , • :, ~ .' ,

i .~ .J

Non-critical device: Medical Equipment Surfaces: Intermediate level disinfection is recommended.

Third, determine the time required to achieve the level of disinfection or sterili1.ation required for the specified medical device.

4. The gennicidal activity of Omnicide™ was demonstI3ted using stressed solutions* in

performance, clinical and simulated use testing using the following organisms:

Organisms

Spores

• Bacillus subtilis

• Clostridium sporogenes

Vegetative Organisms

• Staphylococcus ameus

• Salmonella choleraesuis

• Pseudomonas aeruginosa

• Escherichia coli • Mycobacterium bovis

Funoi b

• Trichophyton interdigitalc

Non-lipid Small Virus

• Polio 2

Lipid Medium Virus

• Herpes simplex

• HIV-I (AIDS Virus)

Onmicide™ Disinfection Times

10 hours

45 minutes

10 minutes

10 minutes

10 minutes

60 seconds at full strength

~""'.' ..

.1 I ',.-.... "J ,-t',:U .

* Testing was performed using Omnicide 1M solution which h"d been diluted to 1':­percent using 5 percent bovine calf serum.

Cottrell 510(k) K932922 Response 7/12/95 - Correction of AIDS Claim 1",°" '\ ( 1:'> .....

, , . .. '

5. Material Compatibility: Omnicide™ solution is recGilunended for usage with

medical devices made from the materials shown below.

polypropylene

ABS

polyethylene*

polycarbonate

black oxide steel*

Mylar*

vinyl and Tygon tubing**

nickel plating"

acrylic bar*

polyethylene tubing*

PVC*

*represents four weeks of exposure

**represents 13 days of exposure

Following sterilization or disinfection, the sterilized or disinfected medical device

should be rinsed according to the Instruction for Use, Rinsing (Section E.4), and dried

according to manufacturers instructions.

6. Pre-cleaning Agent Compatibility: Omnicide™ IS compatible with enzymatic

detergents which are neutral In pH, low foaming and easily rinsed from equipment.

Detergents that are either highly acidic or alkaline are contraindicated as precleaning

agents since improper rinsing could effect the efficacy of the Omnicide ™ ~ol\ltion by

altering its pH.

B. CONTRAI~1)ICATIONS

1. Sterilant Usage: Routine biological monitoring is not possible with OlllIlicide TM

solution and therefore Omnicide™ solution should NOT be used to sterilize reusable

medical devices that are compatible with other sterilization processes that can be

biologically monitored.

Omnicide™ solution should not be used for sterili7.at;on of critical devices intended

for single usc (e.g. catheters). .. ".. - --... - .;:~." -.~~

Cottrell 51O(k) K932922 Response 6/29/~)5

. ACCEP1'Gt} With C'O!~~\JF.!\~S

in F-I'A l,.cU"r D~tClf: ' .

1::;':J I' L' •• ,... .~' t. ", i, ..• -! ::.-ic~~ k .. " I ,- ", f;'" ,

: .,'.. • . ., d·Wf.! .U(r .. , ,h.t r .... ". r -._'.I, (Ill' ~i;(> I!l· ... •.· :')0 t·,·:· .• · •.. ·.· ,,"'f> ""' •• '

. ', .. I l .• I'I.!' h. A nt1'f '1., Pane-1 if. / o· "Q. '<> .~ .. -.... ..If.~~'£L- -:l "2,g,-

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2. High Level Disinfectant Usage: Omnicide™ solution should not be used to hi~h

level disinfect a semi-critical device when sterilization is practical.

3. Endoscope Usage: Onmicide™ solution is not the method of choice for steriliz.1tion

of rigid endoscopes which the device manufacturer indicates are compatible with

steam stel ilization.

C. WARNINGS

OiviNICIDpM ACfIVATED DIALDEHYDE SOLUTION IS HAZARDOUS TO

HUMANS AND DOMESTIC ANIMALS.

DANGER: Kcep Out of Reach of Children

Contains Glutaraldehyde

1. Direct contact is corrosive to exposed tissue, causing eye damage and skin irrita­

tion/damage. Do not get into eyes, on skin or on clothing.

2. Avoid contamination of food.

3. Use ill well ventilated area in closed con:ainers,

In case of contact, immediately flush eyes or skin with copiolls amounts of water for at

least 15 minutes. For eye.s, get medical a!lention.

Harmful if swallowed. Drink large quantities of water and call a physician immediately.

Probable mucosal damage from oral exposure may contraindicate the use of gastric

lavage.

Emergency, safety,.or technical information about OIfmicide™ solution can be obtain~d

from Cottrell, Ltd. Hotline at 1-800-843-3343, or bywntacting Chcmtrac at80Q,;?;},,'i-51)53

or by contacting your local Cottrell, Ltd. representative.

Cottrell 5 :O(k) K932922 Response 6/29/95

_. _ .... -. , ACCi~pnm

wi:h COmlE~'T3 I:. E P <\ LrUor Date\!:.

'II,', .) .. ,I •• 1 ~

: ,

Page 5

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-- -------------------------------------

D. PRECAUTIONS

I. Appropri~'te hand, eye and face plOtection as well as liquid proof gowns should be

worn when cleaning and sterilizing/disinfecting soiled devices and equipment.

More detailed information regarding the handling of the products along Wilh

compatible materials is included in the MSDS sheet attached to the product container.

2. Contaminated, reusable devices MUST BE THOROUGHLY CLEANED prior to

disinfection or sterilization, since residual contamination will decrease effectiveness

of the germicide.

1 The user "'IUST adhere to the Directions for Use since any modification will afiect

the safety and effectiwness of the germicide. "'.- ..

." """

4. The reusable device manufacturer should provide the user with a validated ~ ACCBFii'iD

reprocessing procedure for that device using Omnicide™ solutiOll. bill! COi\B1E!I."l'S lil EPA Leller Datelf:

E. DIRECTIONS FOR USE

I. Activation L.,: ..... ;·:.~)~·,:·): .. ··.i;~·:'.}~ .... .: - •• ~. L· ...... i E!:l\ 1'1'" ;\.0. Lf •. , .. ,

Activate the Omnicide™ solution by addir,g the entire contents of the Acti'VfltJ:~~ (which is auached to the Omnicide™ solution container) to the container. Place cap

on container and shake well. On activa:ion, the solution immediately changes color

to bille, thereby indicating solution is ready to use. The solution should then be

immediately te~1ed with the Prochek G Glutaraldehyde Indicator Test Strip upon

activation and prior to each use to assure glutaraldehyde concentration is above the

MEC. Omnicide ™ solution is intended for us~ in manual (Lucket and tray) systems

made from polypropylene, ABS, polyethylene, glaso-filled polypropylene or specially

molded polycarbonate plastics. Record the date of activation (mixing date) and the

expiration date on the Omnicide™ solution container label in the space provided, as

well as in a log book or a label affixed to any secondary container used for the

activated solution. Omnicide™ must be discarded after 28 days, even if the

ProChek G Glutaraldehyde Indicator Test Strip indicates pass.

Cottrell 51O(k) K932922 Response 6/29/95 Page 6

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2. Cleaning/Decontamillation

Blood and other body fluids must be thoroughly cleaned from the surfaces, lwnens,

and objects before application of the disinfectant or sterilant. Blood and other body

fluids should be autoclaved and disposed of according to all applicable federal, state

and local regulations for infectious waste disposal.

For complete disinfection or sterilization of medical instruments and equipment,

thoroughly clean, rinse and rough dry objects before immersing in Omnicide™

solution. Cleanse and rinse the lumens of hollow instruments before filling with

Omnicide™ solution. Refer to the reusable device manufacturers labeling for

instructions on disassembly, decontamination, cleaning and leak testing of their

equipment.

3. Usage

It is a violation of the Federal Law to use this product in a manner inconsistent

with its labeling.

a. Sterilization (Bucket[frav Manual System)

Prior to immersing medical equipment/devices, test the solution with a ProChek G

Glutaraldehyde Indicator Test Strip to assure that the glutaraldehyde concentration

is above its MEC.

Immerse medical equipment/devices completely in Omnicide™ Solution for a

minimum of ten hours at 68°F (20°C) to eliminate all microorganisms including

Clostridium sporogenes and Bacillus subtilis spores. Remove equipment from the

solution using sterile technique and rinse thoroughly with sterile water following

the rinsing instructions below.

Cottrell 510(k) K932922 Rcsponse 6/29/95 Page 7

b. High Level Disinfection (BucketITray Manual System)

Prior to immersing medical equipment/devices, test the solution with a ProChek G

Glutaraldehyde Indicator Test Strip to assure that the glutaraldehyde concentration

is above its MEC.

Inunerse medical equipment/devices completely in Omnicide™ solution for a

minimum of 45 minutes at 68°F (20°C) to destroy all pathogenic

microorganisms, except for large numbers of bacterial endospores, but including

Mycobacterium tuberculosis (Quantitative TB Method). Remove devices and

equipment from the s0lution and rinse thoroughly follo~WlL the. rinsing inl>1mctions below.

c. Intemlediate Level Disinfectant . j ,

ACGEPTFiD with C01IME~'TS,

In :f;P 1I J,ctter Dat~ .. '.\ I" : J\til) l

Prior to immersing medical equipment/devices, test the solution with a ProChek G

Glutaraldehyde Indicator Test Strip to assure that the glutaraldehy?e.lfM~~.~~npK.;,.;.','~~;:;~~~ is above its MEC. ·U r.:"on<lc'.I, r',r "'0 i""'" id~

~ n-b4\~!:t:·.u.i uncl!..T EPA l:~g. ~';o.

1-=~~(/- ~~-Omnicide ™ is an intermediate level disinfectant when used or reused, at or above

its Minimum Effective Concentration (MEC) as determined by the ProOlek G

Glutaraldehyde Concentration Indicator Test Strip at 68°P (20°C) with an

immersion time of tcn minutes for a use period not to exceed 28 days.

4. Rinsing Instructions

Foliowing immersion in Omnicide™ solution, thoroughly rinse the equipment or

medical device by immersing in two gallons of water. Repeat this procedure a second

tillie with a fresh two gallon volume of water.

For endoscopic instmments with lumens, a rninimum of 500 ml of water should be

flushed through lumens during: each separate rinse unless otherwise noted by the

device or equipment manufacturer. Use fresh volumes of water for each rinse.

Discard the water following each rinse, Do not reuse the water for rinsing or any

other purpose as it will become contaminated with glutaraldehyde,

Refer to the reusable device/equipment manufacturers labeling for rinsing instmctions.

Cottrell 51O(k) K932922 Response 6/29/95 Page 8

J

,J-

Sterile Waler Rinse:

Critical devices which are sterilized with Omnicide 1M must be rinsed with sterile

water.

Potable Water Rinse:

A sterile water rinse is recommended when practical, for all devices. Alternatively,

a high quality potable water (one that meets Federal Clean Water Standards at point

of use) may be used.

The use of potable water for rinsing, increases the risk of contaminating the device

or medical equipment with Pseudomonades and atypical (fast growing) Mycobacteria

that are often present in potable water supplies. The devices (e.g. colonoscope) need

to be completely dried, because any moisture remaining provides an ideal situation for

rapid colonization of bacteria. Additionally, mycobacteria are highly resistant to

drying, therefore, rapid drying will avoid possible colonization but may not result in

a device free from atypical mycobacteria. A final rinse using a 70 percent isopropyl

alcohol solution should be used to speed the drying process and reduce the numbers

of any organism present as a result of rinsing with potable water.

F. REUSE

Omnicide™ solution has demonstrated efficacy in the pre.<;ence of 5 percent organic

soil contamination and a simulated amount of microbiological burden during reuse.

'I11e glutaraldehyde concentration of this product during its use-life must be verified by

the ProCheK G Glutaraldehyde Concentration Indicator Test Strip to determine the

solution is above the Minimum Effective Concentration requirement (MEC) as determined

by the ProChek G Glutaraldehyde Concentration Indicator Test Strip is present. TIlis

solution may be used and reused within the limitations indicated above for up to 28 days ,

after activation. Omnicide TM must be discarded after. 28 days •. eyeJljUll~)r.2.<;bek G .--.- .,,~~'-... _. _ ~f

Glutaldldehyde Indicator Test Strip indicates pass. . ~

.j ,

Cottrell 51O(k) K 932922 Response 6/29/95

ACCEPTF.-D with COlIMENTS

.:in EPA Letter DatEd;

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G. i\IONITORING OF GERMICIDE TO ENSURE SPECIFICATIONS ARE MET

It is recommended that the Omnicide™ solution be tested with the ProCheK G

glutaraldehyde test strip prior to each usage. This is to insure that the appropriate

concentration of ghltaraldehyde is present and to guard against a dilution which may

lower the concentration of the glutaraldehyde below its MEC. During the use of

Omnicide TM as a high level disinfectant and/or sterilant, it is also highly recommended

that a thermometer and timer be used to ensure that optimum conditions are met. The

pH of the activated solution may be periodically checked to verify that the pH of the

solution is between 8.0 and 9.0.

H. POST-PROCESSING HANDLING AND STORAGE OF REUSABLE DEVICES

Sterilized or disinfected reusable devices are either to be used immediately or stored in

a manner to minimize contamination. Refer to reusable device equipment manufacturers

labeling for additional storage and/or handling instructions.

I. STORAGE CONDITIONS AND EXPIRATION DATE

). Prior to activation, Ornnicide™ solution should be stored in its original sealed

container at controlled room temperature 15° -30° C (590 _86 0 F).

2. The expiration date of the unactivated Omnicide™ solution and activator will be found

on the side of the immediate container.

3. The use ;:>criod for activated Omnicide™ is for no longer than as indicated by

ProCheK G Glutaraldehyde Concentrdtion Indicator Test Strip or 28 days following

activation. Once activated, the solution requires no further dilution prior to its usage.

J. SAFETY INFORMATION

Emergency, safety, or technical information about Omnicide™ solution can be obtained '...... . ~

from Cottrell, Ltd. at 1-800-843-3343, Infotrac at 800-535'-5053, or.by sontactirig your

Cottrell, Ltd. representative. ,

I

Cottrell 510(k) K932922 Response 6/29/95

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K. USER TRAIN1NG

TIle user should be adequately trained in the de.contamination and disinfection or

sterilization of medical devices and the handling of liquid chemical germicides. Additional

infonnation about Omnicide™ solution can be obtained from Cottrell, Ltd. at 1-800-843-

3343, or by contacting your local Cottrell, Ltd. representative.

L. DISPOSAL INFORMATION

0.946 L (1 quart), 3785 L (I gallon), and 9462 L (2.5 gallon) size container must be triple

rinsed and disposed of in accordance with local or state regulations.

M. REORDER INFORMATION

I Reorder I Description

PCI032 0.946 L (1 quart)

PCI128 3.785 L (l gallon)

PCG660 Strips ProCheK G Concentration

r

Indicator

PCG615 ProCheK G Concentration

Cottrell 510(k) K932922 Response 6/29/95

I Case Contains

4 x 0.946 L (4 qts/case)

4 x 3785 L (4 gals/case)

, ,

";

60 strips/bottle

(6 blls/case)

15 strips/pkg

...... ~ ' ..

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Page II

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OMNICIDETM LONG LIFE ACTIVATED DIALDEHYDE SOLUTION

PACKAGE INSERT

ENDOSCOPE REPROCESSING

DRAFI' LABELING

A. INTENDED USEflNSTRUCTIONS FOR USE

Omnicide TM activated dialdehyde solution is a liquid chemical sterilant and high level

disinfectant for flexible endoscopes when used according to the Instructions for Use.

1. Germicide Level of Activity: Omnicide™ can be used at the foilowir:g germicide

levels of activity:

Flexible Endoscopes, when expected to penetrate the sldn or mucous membranes or

are used in otherwise normal!y sterile tissues of the body during use are critical

devices and therefore, are required to be sterile.

Sterilant: Omnicide ™ is a sterilant for flexible endoscopes when used or reused,

according to the Directions For Use, at or above its Minimum Effective Concentration

(MEC) as detemlined by the ProChek G Glutaraldehyde Concentration Indicator Test

Strip at 68° F (20° C) with an immersion time of ten hours for a use period not to

exceed 28 days.

Flexible Endoscopes when expected to come in contact without penetration of mucous

membranes are semi-critical devices and therefore may be high level disinfected.

High Level Disinfectant: Omnicide TM is a high level disinfectant for flexible

endoscopes when used or reused, according to the Directions for Use, at or above its

Minimum Effective Concentration (MEC) as determined by the ProChek G

Glutaraldehyde Concentration Indicator Test Strip at 68°F (20° C) with an immersion

time of 45 minutes according to the instructions for use· in Section E for a use period • . I· ~ ,

not to exceed 28 days. ; l\G('.-~i· ~·i:. v

," .. r:i cc:·r .. ~!::';~" .. ~ _ i'") 'r;~'A rr~~!.l· i\ ::.1:

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Gener'll Procedure for High Level Disinfection of Flexible Endoscopes

(This procedure is recommended in the absence of specific

directions from the device manufacturer)

Trained Personnel

• Personnel involved in the reprocessing of endoscopes should have the ability to read.

understand. and implement instructions from manufactures and regulatory agencies as they

relate to endoscopic disinfection.

• The person(s) to whom the job of reprocessing endoscope~ is given should have the

opportunity to become completely familiar with the mechanical aspects of the endoscopic

equipment.

• Training should include familiarization with OSHA regulations and in-house policies on

how to appropriately and safely handle liquid chemical germicides.

• Training should also include information on the safe handling. of im.1ruments thar'are

contaminated with body fluids after use. This should include familiarizmion with t': ~:!~r-! :":)

universal precautions.

Cleaning of flexible endoscopes

- ' .. . . . . ,"

• Cleaning at the Examination Room .: ' .. , ... ." ... . . "... i :.;' ,1.:' ~. -.:. ': .:t,,!

. j:" : .:.... .;: .... :.~ •• ::-.:-.. i:o::·g. ~~~. : ... t.;6((')/-,*

Reflux of body fluids from the patient may occur in any of the standard channels:~ eleanmg of- -4,

endoscopes and accessories should be performed promptly after removing the endoscope from

the patient to prevent drying of secretions.

1. Personnel should dpnne all personnel protective equipment.

2. Prepare an enzyme detergent (e.g_. Pro EZ or Pro EZ Plus) or one recommended by the

scope manufacturer.

Cottrell 5 lOCk) K932922 Response 6/29/95 Page 13

I

3. Gently wipe all debris from the insertion tube with a moistened gauze or the like.

4. Place the distal end of the flexible endoscope into the water and enzyme detergent

solution and aspirate through the biopsy/suction channel for 5-10 seconds or until the

solution is visibly clean. Alternate aspiration of the detergent solution and air several

times. Finish by suctioning air.

5. Flush or blowout air and water channels in accordance with the endoscope manufacturers

instructions.

6. Transport the endoscope to the reprocessing area.

Cleaning at the Reprocessing A~~'!

, , . Attach any necessary water-tight caps to the electrical portions of the umbilicus.

2. Before proceeding with any further cleaning steps, the flexible endoscope should be leak

tested. (Refer to manufacturers leakage test instructions). Follow the manufacturers

instructions if the instrument appears damaged.

3. fill a sink or basin with a freshly made enzyme (e.g., Pro EZ or Pro EZ Plus) detergent

solution.

4. Immerse the endoscope. All channels should be irrigated with copious amounts of

detergent and tap water to soften, moisten, and dilute the organic debris. All detachable

parts (e.g., hoods and suction valves) should be removed and soaked in the detergent

solution. The insertion tube should be washed with detergent solution and rinsed.

5. Use a small soft brush to scrub all detachable parts.

6. Usc a brush to clean under the suction valve, air/water valve and biopsy port openings. ' .... . ... - ~ ..... ~", •

. ... . -. .. ~ ". '-_ .... ~_.$

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;\ I c,-.. _ I, • I .,

Cottrell 5 JOCk) K932922 Response 6/29/95

7. Brush the entire suction/biopsy system including the body, the insertion tube, and the

umbilicus of the endoscope in accordance with the manufacturer's instructions.

8. Accessible channel(s) should be brushed to remove particulate matter, and the detergent

solution must be suctioned or pumped through all channels to lemove dislodged material.

Channel irrigators may be useful for this step. Fill all channels with detergent solution

and soak 2-5 minutes in accordance to the Pro EZ instructions.

Rinse after cleaning:

9. Rinse the endoscope and all detachable parts in clean water.

10. Rinse all channels well with water to remove debri3 and detergent.

11. Purge water from all channels and wipe dry the exterior of the endoscope with a soft

clean cloth to prevent dilution of the Omnicide™ disinfectant used in subsequent Sieps.

Mallual Disinfection

12. Activate the OIlUlicide™ Long Life activated dialdehyde by adding the entire content of

the Activator bottle which is attached to the OIl}nicide™ solution container. Recap the

container and shake well. On activation, the solution immediately changes color to blue,

thereby indicating the solution is ready. Use ProChek G Glutaraldehyde Concentration

Indicator Test Strips after activation to determine that the solution is above the Minimum

Effective Concentration (MEC) before use.

Test the activated Ornnicide TM solution usmg the ProChek G Glutaraldehyde

Concentration Indicator at 20'C, before each usc.

13. A ttach channel irrigators/adapters and cover the biopsy port - in -accorsl.!lnce· 'with')he .- '4 - ~ -.,--. .'. ;.

manufacturer's instructions.

14. Pour the activated Omnicide™ into an appropriate sized basin.

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15. Completely immerse the endoscope in the basin of Omnicide™. Note: in order to prevent

damage to the endoscope, DO NOT soak any other accessory equipment with the

endoscope.

16. Inject the Omnicide™ solution into all channels of the endoscope until it can be seen

exiting the opposite end of each channel. Assure that all channels are filled with

disinfectant and that no air pockets remain within the channels.

17. Cover the disinfectant soaking basin with a tight fitting lid to minimize chemical vapor

exposure.

18. Soak the endoscope for 45 minutes. Use a timer to ensure adequate soaking time.

19. Before completely removing the endoscope from the disinfectant, flush all channels with

air to remove disinfectant.

Rinse After Manual Disinfection

20. Rinse 1: Fill a basin with two gallons of water (preferably sterile water). Place the

endoscope into the basin and thoroughly rinse the exterior of the scope. Attach channel

irrigators/adapters to the endoscope and flush with 500 rn1 of water through the channel

irrigator. Empty basin.

21. Rinse 2: Fill a basin with two gallons of water (preferably sterile water). Place the

endoscope into the basin and thoroughly rinse the exterior of the scope and flush with 500

ml of water through the charmel irrigator.

22. Purge all channels with air.

23. Flush all channels with 70% alcohol until the alcohol can be seen exiting the opposite end

of each channel.

24. Purge all channels with air.

25. Remove all adapters and devices.

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26. Dry the exterior of the endoscope with a soft clean cloth. Do not attach detachable pans

to the endoscope prior to storage. Storage of endoscopes with the removable parts

detached lowers the risk of trapping liquid inside the instrument and facilitates continued

drying of the channels and channel openings. To prevent the growth of waterborne

organisms, the endoscope and all detached parts should be thoroughly dried prior to

storage.

27. Hang the endoscope vertically with the distal tip hanging freely in a well vemilated, du>t­

free cabinet.

References:

I. ASTM:F 1518-94, Standard for Cleaning and Disinfecticn of Flexible Fiberoptic and

Video Endoscopes Used in the Examination of the Hollow Visera, Currcnt edition

approved May 15, 1994, Published July 1994.

') Martin, M.A., MD, Reichelderfer, M., APIC guideline for infection prevention and control

in l1exible endoscopy, Association for Professionals in Infection Control and

Epidemiology, Inc., AJIC Am J Infect Control 1994: 22: 19-38.

3. Vesley, D. et. a!., Significant factors in the disinfection and ~terilization of flexible

endoscopes, AJIC, December 1992, pg. 292.

4. Axon, A.T.R, Bond, B., Bottrill, P.M., Cowen, A.E., Fleisher, D.E. and Tandon, RK.,

Endoscopic disinfection, Working Party Reports, Blackwell Scientific Publications, 1990,

46-50. -" '~"' ... _.

-.''''-.. , ;

.'

".-. 2 - . I • . --

Cottrell 510(k) K932922 Response 6/29/95 Page 17

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OMNICIDETM LONG LIFE ACTIVATED DlALDEHYDE SOLUTION

PACKAGE INSERT

ULTRASOUND TRANSDUCER REPROCESSING

(Endocavity, Endovaginal, Enderectal, Transesophageal, ctc)

DRAFT LABELING

(Refer to the device manufacturer's instruction for specific procedures)

A. INTENDED USE/INSTRUCTIONS FOR USE

Omnicide™ activated dialdehyde solution is a liquid chemical sterilant, high level

disinfectant and intermediate levei disinfectant for ultrasound transducers when used

according to the Instructions For Use.

1. Germicide Level of Activity: Omnicide™ can be used at the followii.3 levels of

activity:

Sterilant: Omnicide ™ is a sterilant for ultrasound transducers when used or

reused «ccording to the Dirc(;tions For Use, at or above ilS Minimum Effective

Concentration (MEC) as detennined by the ProChek G Glutaraldehyde

Concentration Indicator Test Strip at 68° F(20° C) with an immersion time of ten

hours for a u~e period not (0 exceed 28 days.

High Lcvel Disinfcdant.: Onlllicide™ is a high level disinfectant for ultrasound

transducers when used or reused, according to the Directions for Use, at or above

its Minimum Effective Concentration (MEC) a!) determined by Prochek G

Glu!araldehyde Concentration Test Strip at 68°F(20°C) with an immersion time

of 45 minutes according to the instmctions for use in Section E for a use period

not to exceed 28 days.

'~f 0:-, .. ,', .

Cottrell 51O(k) K932922 Response 6/29/95 Page 18

. .. ,

/ . ,

Intermediate Level Disillff!ctallt: Omnicide™ is an intermediate level disinfec­

tant when used or reused, according to the Directions for Use, at or above its

Minimum Effective Concentration (MEC) as determined by the Prochek G

Glutaraldehyde Concentration Indicator Strip at 68°F(20°C) with an immersion

time of 10 minutes according to the instmctions for use in Section E for a use

period not to exceed 28 days.

-... --~- ..

Cottrell 510(k) K932922 Response 6/29/95 Page 19

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Gcnc,"al Procedurc for High Level Disinfcction

of Ultrasound Transducers

(Endocavity, Endovaginal, Endorectal, Transesophageal, etc.)

(Refer to the device manufacturer's instruction for specific procedures)

Trained Personnel

• Personnel involved in the reprocessing of Ultrasound transducers should have the ability

to read, understand, and implement il.lstructions from manufactures and regulawry

agencies as they relate to transducer di5.';}fp-ction.

• The person(s) to whom the Job of rl!processing Ultrasound transducers is given should

havc the opportunity to become compleiely familiar with the mechanical aspects of the

ultrasound equipment.

• Training should include familiarization with OSHA regulations and in-house policies on

how to appropriately and safely handle liquid chemical germicides.

• Training should also include information on the safe handling of instruments that are

contaminated with body fluids aftcr use. This should include familiarization with

universal prccant ions.

Cleaning of Transducers . , , .

Cleaning of transducers and accessories should be performed promptly after patient use1~~ni~ent drying of secretions.

1. Personnel should donne all personnel protective equipment.

2. Prepare an enzyme'detergent (e.g., Pro EZ or Pro EZ Plus) or one reconunended by the

transducer manufacturer.

3. Gently wipe all debris from transducer surfaces with a moistened gauze or the like.

Cottrell 51O(k) K932922 Response 6/29{95 Page 20

6

4. Immerse the distal end of the transducer into the water and enzyme detergent solution for

2-5 mIllutes or as recommended by the device manufacturer.

NOTE: Refer to manufacturers instmctions for recommended immersion depth.

5. Rinse all surfaces with water and dry by wiping with a soft clean cloth.

Manual Disinfection

Caution: Omnicide™ may discolor the exterior of some transducers, however,

the acoustic or scanning performance is not impaired. Check with the

device manufactu rers for specific recommendations tefore proceeding.

6. Activate the Omnicide™ Long Life activated dialdehyde by adding the entire content of

the Activator bottIc which is attached to the Omnicide ™ solution container. Recap tne

container and shake well. On activation, the solution immediately changes color te blue,

thereby indicating the solution is ready. Use ProChek G Glutaraldehyde Concentration

Indicator Test Strips after activation to detelmine that the solution is above the Minimum

Effective Concentration (MEC) before use.

Test the activated Omnicide ™ solution uSlIlg the ProChek G Glmaraldehyde

Concentration Indicator at 20'C, before each use.

7. Pour the activated Omnkide™ into an appropriate sized basin.

8. Immerse the distal end of the transducer into the Omnicide™ solution. Note: Refer to

manufacturers instructions for recommended immersion depth.

9. Cover the disinfectant soaking basin to minimize chemical vapor exposure.

10. Soak the transducer for 45 minutes. Use a f ;mer to ensure adequate soaking time. ',.

.: :

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Rinse After Manual Disinfection

11. ginse 1: Fill a basin with a minimum of 1 gallon of water (preferably sterile water).

Place the transducer into the water to the recommended depth and allow to soak for 5

minutes. Remove the transducer.

12. Rinse 2: Holding the transducer over the basin, flush with fresh water (preferably sterile

water) for one minute.

13. Dry the transducer by wiping with a soft (preferably sterile) cloth.

Storage

Refer to manufacturer's recommendation.

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Page 22