m~ blood canadienne services du sang ca n a d ia n s o … · 2/14 1. introduction cbs are changing...

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m~ " CA . . . N .. A . D ... IA ... N S ... O ... C . I . .ETE' BLOOD CANADIENNE SERVICES DU SANG REPORT BC- 062, Final report Buffy Coat Project: Compatibility of transfusion sets with component bags used by the CBS ~ Version: 2.3 Date: 2007-01-05 , ~

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Page 1: m~ BLOOD CANADIENNE SERVICES DU SANG CA N A D IA N S O … · 2/14 1. INTRODUCTION CBS are changing the methods by which it produces blood components. The changes include the introduction

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BLOOD CANADIENNESERVICES DU SANG

REPORT

BC- 062, Final reportBuffy Coat Project:

Compatibility of transfusion sets with component bags used by the CBS

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Version: 2.3 Date: 2007-01-05

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1. INTRODUCTION

CBS are changing the methods by which it produces blood components. The changesinclude the introduction of new equipment (i.e. Compomat G4 and the Compodock) andthe production of a pooled platelet concentrate using the manufacturing technique knownas the buffy coat-method. In addition, bags from two, for Canada, new manufacturers willbe used: Baxter and MacoPharma.

Upon implementation of the new blood bags (MacoPharma) in Edmonton in October2005, hospitals reported difficulties when inserting and removing the spike from thespike port on the red blood cell (RBC) bag. The difficulties seemed to be more prominentin trauma situations where rapid spiking and un-spiking of blood bags were required.Difficulties with spiking the pooled platelets bags were not reported.

During the selection process of the blood bags, the bags were requested to be compliantwith ISO 3826. It was felt by the selection committee that the application of this standardwould ensure compatibility with CBS and hospital systems. These standards include,amongst other items, the specifications for infusion ports. The standard states (point4.8.1): ... "The port(s) which shall have a puncturable, non-resealable closure shall allowconnection of a transfusion set having a closure-piercing device in accordance with ISO1135-4 without leakage on insertion or during conditions of use, including emptyingunder pressure (See 4.3). Before the closure ispierced by the point of the closure-piercing device, the out-let port(s) shall be tightly occluded by the closure-piercingdevice." Thus, as long as the port meets the criteria of sealing the port with the spike(closure-piercing device) before piercing the closure, there are no requirements forspecific dimensions or design of the port it self. ISO 1135-4, as referred to in the text,defines the dimensions of the spike to be used. See Figure 1. It has now become clear thatunlike in Europe, the ISO standard is not implemented by all transfusion set or bagmanufacturers in Canada. For example, the ports on the bag currently used (Pall Medsep)are not manufactured according to ISO standards and hence the manufacturers of hospitaltransfusion sets have never had to meet this specification.

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05.6"

ISO 1135-4

(Ch. 5.4)

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28 " 1

+0.105.2- 0.2

Figure 1. Dimensions of the ISO-spike (closure-piercing device).From ISO 1135-4:2004(E).

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In addition, the ports on the new blood bags (Baxter and MacoPharma) require a differentinsertion and removal method compared with the bags used previously (Pall) due to aslightly different design. It is recommended to insert the spike in the port until the tip is incontact with the septum of the port. Then the spike is inserted through the septum using atwisting motion. When the spike is removed, the same twisting motion, in the oppositedirection, is used.

This report is a summary of a two part study performed by the CBS. The first part wasreported in "BC-062, Compatibility of infusion sets with components bags used by theCBS, rev 1.1 (2006-05-04)". In the first part bags from Baxter, MacoPharma and Pallwere studied. In the second study, in addition to the mentioned bags, a bag fromMacoPharma with a modified, slightly wider, port size was tested, as well as a newgeneration of Pall bags, currently used in Europe.

2. PURPOSE

The purpose of this study was to assess the compatibility of commonly used transfusionsets with bags currently used or bags to be introduced in Canada.

3. SPECIFICATION OF BAGS

The following bag sets were used in this study:

MacoPharma ref#: LQT7290LX and DQE729lLXMacoPharma, modified, ref#: 14964Baxter ref#: CGR8448B and CGR8496B

Baxter ref #:CGR 7042, platelet pooling bagPall Medical, CBS bags, ref#: RLB434CBPall Medical, European bags, ref #: not applicable

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For dimensions of the ports, see Table 1. It was confirmed from all vendors that for theirrespective bag set, the ports on all bags were the same.

Table I. Length and inner diameter of outlet ports on bags. TBD: to be completed with data frommanufacturers. * Straight design = sides of port are parallel. ** Tapered design = sides of port arewider at the top, tapering in towards the septum.

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Manufacturer Port lenf!:th Port lenf!:thto septum Port inner diameter Port desif!:nBaxter 30-32 mm 15 mm 4.9-5.0 mm Straight*MacoPharma 32 mm 15mm 4.8 mm StraightMacoPharma, modified 32 mm 15mm 5.0 mm StraightPall Medical, CBS 26 mm 13 mm 5.18-5.33 mm StraightPall Medical, European TBD 16mm 0.48 top, 0.52 bottom Tapered**

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4. SPECIFICA nON OF TRANSFUSION SETS

A representative sample of transfusion sets was obtained from transfusion setmanufactures/distributors. The following transfusion sets were tested:

* It was confinned from the vendor that the same type of spike was used on all the listed partnumbers, if several are listed.

In addition, the microaggregate filters SQ40S and SQ40SE (Pall) were tested. The spikeis manufactured according to ISO standards but with a slightly different configuration ofthe point. The SQ40S has a side point whereas the SQ40SE has the point in the center ofthe spike.

Dimensions of the spikes can be found in Table 2. The dimensions were obtained bymeasuring the spikes using a digital caliper (Samona, MEl122) with a resolution of 0.01mm. Measurements were done by two independent persons and according to Figure 2.

Full length

Length to bevel

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W

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Outer diameter at base

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Figure 2. Definitions of lengths and diameters for measuring spikes.

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Manufacturer Product code *Baxter J/C7627 Y-type, JC6723 Y-type, JC2038 straightSmiths Industries D-50Smiths Industries D-100Smiths Industries DI-50

Cardinal Health (formerly Alaris) 2477, 79980E, 72980E, and 2177-0000

Cardinal Health (formerly Alaris) 28080ETerumo TY*A2005020

Hospira (formerly Abbott) F668-12, 11994, 11994-48Benson Medical (Arizant) 24360, Ranger system spike setsBBraun NF5145Deltec 21-0425-01

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Table 2. Manufacturing standards and dimensions of spikes used in the study. All measurements are in mm.nd = not done.

4. OVERVIEW OF STUDY PLAN:

Baxter

bag

Bags held at roomtemperature until

testin

MacoPharma

bag

MacoPharma

bag,modified

Pall

CBS bagPlatelet storage bag

Bags held at 4° until testing

~ ~ ~ ~ ~Success of spiking was measured and each set was rated for ease of inserting and removing spike.

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5. STAFF PERFORMING TESTS:

The staff performing the study was trained in spiking and un-spiking by a representativefrom MacoPharma. The training was completed the day before or the same day as thefirst tests were performed. Five staff members from CBS performed the study.

6. METHODS:

Preparation

To blind the staff performing the study, all bags and sets were color coded. Bagsdesigned for cold storage were held at 4QCuntil testing and platelet pooling bags at roomtemperature.

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Length, Length, Outer Outer Difference inbase to tip base to diameter diameter at diameter

Manufacturer bevel at bevel base base - bevelBaxter 24.1 17.5 5.1 5.7 0.53Smiths Industries, D-50 25.4 18.8 5.1 5.6 0.53Smiths Industries, D-I 00 29.2 21.0 5.2 5.7 0.51Smiths Industries, DJ-50 27.2 18.7 5.0 5.6 0.52Cardinal Health 79980E 20.8 12.6 5.0 5.7 0.69Cardinal Health 28080E 26.9 18.9 5.0 5.6 0.54Terumo 27.1 14.5 5.3 5.8 0.46Hospira (formerly Abbott) 25.4 14.2 5.2 5.8 0.64Arizant 25.3 17.8 5.1 5.7 0.52BBraun 23.4 15.5 5.1 5.5 0.43Deltec 19.9 10.7 5.1 5.9 0.82Pall, SQ40SE 20.8 12.6 5.6 5.0 0.69Pall, SQ40S nd nd nd nd nd

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Procedure

After uncovering the opening of the spike port on the bag, the spike was inserted into thespike port according to instructions. To test the accurate insertion of the spike, water waspushed through the line into the bag using a syringe. If the water entered the bag, thespiking was successful. The result was recorded Yes/No on the report form.

The ease of spiking was rated using a scale of 1-4, where 1=very difficult, 2=difficult,3=easy, 4=very easy. The spike was then removed from the spike port and the ease ofremoval was rated using the same scale as above.

Each person tested all types of transfusion sets with the Baxter, MacoPharma and PallCBS bags. The modified MacoPharma bag was tested by 1-3 staff(2-6 spikings) and thePall European bag by 2 staff. See Table 3a for details. To test for intra-test variability,each combination was performed twice at separate times. As no complaints had beenexperienced using the platelet pooling set (Baxter ref#:CGR7042) this set was onlytested once by one person.

The same spike was used by one person for testing all the bags/testing session. Eachspike was used three times. To alleviate the potential influence on performance and easeof use of multiple use of the spike, the order the bags were spiked in was randomized.Thus, the bag from one manufacturer was not always spiked first. We did not find that therating of spiking and un-spiking changed with usage.

7. DATA ANALYSIS AND STATISTICAL METHODS

The data was analyzed using median and range.

8. RESULTS~

Success of spikingOut of 438 spikings performed, 410 (94%) were successful. Success was defined asobtaining flow of fluid through the spike into the bag. There were 28 instances where thespike could not be inserted correctly to achieve immediate flow of fluid. In the some ofthese instances, flow could be achieved by applying additional force (5/28).

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Using Baxter bags there were a total of 10/116 (9%) spikings that were not successfuland using MacoPharma bags 16/126 (13%) spikings failed. The modified MacoPharmabag, with a slightly larger port dimension, failed in 2/40 spikings (5%). Out of thefailures, 6 failures using Baxter bags and 8 using MacoPharma bags were experiencedusing the Pall SQ40S and SQ40SE filters. Table 3a and b.

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Excluding the SQ40 filter from the analysis, the failure rate using Baxter bags was 4%(4/100) and for MacoPharma 7% (8/110). The modified MacoPharma bag was not testedwith the SQ40 filters. There were no failures using Pall bags or the platelet pooling bag.Table 3a and b.

The SQ40S and SQ40SE filters (Pall) had the highest number (6/18 and 8/24 failures,respectively) and the highest percent failures (30 and 33%, respectively), followed by theBaxter sets (7/40, 17%), Arizant (2/36,6%) and Smiths D-IOO(2/36, 6%). There were nofailures using the Smiths DI50, Hospira (Abbott), Deltec or Cardinal Health (Alaris) sets.Table 3a and b.

There were no failures when spiking the platelet storage bag using sets from Baxter,Cardinal Health (Alaris), Arizant, Smiths (D-50) and Hospira (Abbott).

Five out of5 staff had failures. The failure rates were (by tester): 8/69 (12%), 3/118(3%),2/93 (2%), 7/79 (9%) and 3/79 (4%).

Sets Failures/Total # of s ikin sBaxter 0/10 0/4Smiths Industries, D-50 0/2 0/10 0/4Smiths Industries, D-I 00 0/2 0/10 0/4Smiths Industries, DI-50 0/10 0/6 0/10 0/4Cardinal Health 79980£ 0/10 0/2 0/10 0/4Cardinal Health 28080£ 0/10 0/6 0/10 0/4Terumo 0/10 0/2 0/10 0/4Hos ira form. Abbott) :. 0/10 0/6 0/10 0/4Arizant 0/10 Nd 0/10 0/4BBraun Nd 0/6 0/10 0/4Deltec 0/10 0/10 0/2 0/2 0/4Total 100 110 40 102 44# failures 4 8 2 0 0% failures 4% 7% 5% 0% 0%

Table3a. Successin achievingfree flow of fluid after spikingwas ratedY (success)or N (failure).In 5/14instancesflow couldbe achievedafter applyingadditionalforceor re-positioningthe spike.Nd=notdone.The combinationswherefailuresoccurredare markedin grey.

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BC-O62, Final Report, version 2.3

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Table 3b. Success and failures in spiking bags using the SQ40S and SQ40SE microaggregate filter (Pall).The modified MacoPharma bag was not used in this test.

SpikingThe ease of spiking was rated from I to 4, where I was very difficult and 4 very easy.Each tester perfonned the test twice using different bags from the same manufacturer. Atotal of21O pairs of tests were done. In 127 out of21O (60%) pair of tests there was nodiscrepancy between the ratings, 78 (37%) and 6 (3%) pairs had one or two steps betweenthe ratings, respectively. In only one case (0.5%) was there a difference ofthree steps.

The spiking of Baxter bags was rated from "Difficult" (median rating: 2) to "Easy"(median rating: 3.5) using transfusion sets from all manufacturers. Sets from Deltec(median rating: 2) and Smiths D-I 00 (median rating: 2.5) rated the lowest, whereas allthe other sets were rated "Easy" (median range of 3-3.5). The median rates using theMacoPhanna bags rated from "Difficult" (2) to "Easy" (3) on the scale. Fivelll setstested were rated as "Difficult" (2) using this bag. The modified MacoPhanna bags ratedsomewhat better (median range: 2 - 3.5) and only 2/9 tested sets were rated as"Difficult". Pall bags were rated as the easiest: median ranges of 3- 4 and had a moreconsistent perfonnance compared with the Baxter and MacoPharma bags (range 3-4 foreach set for Pall; 1-4,2-4,2-3 and 3-4 for Baxter, and 1-4, 1-3,2-3,2-4 and 3-4 forMacoPhanna). Table 4. The spiking of the platelet pooling set was rated as 4.

The spiking of the Baxter ba-gand the MacoPhanna bag with the Pall SQ40S andSQ40SE filters were rated as "Very difficult" and "Difficult" (1.5 and 2 on the scale,respectively), and with the Pall bag as "Easy" (3, range 2-4).

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SQ40S SQ40SETotal # of # of % Total # of # of %

Ba2s spikings failures failures spikings failures failuresBaxter 6 3 50 10 3 30Macophanna 6 3 50 10 5 50Pall, CBS 6 0 0 nd nd ndPall, European nd nd nd 4 0 0Total 18 6 30% 24 8 33%

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3 33-4 2-33.5 33-4 3-43 2.5

2-3 2-33 3.5

3-4 3-43 3

3-4 3-43.5 3.53-4 3-43 4

2-4 3-44 4

3-4 4-43 3

3-4 3-43 3 3

2-3 3-4 2-32 3 3.5 3.5

Deltec 2- 3 3- 3 3- 4 3- 4Table 4. Spiking: Compatibility between transfusion sets and bags using a scale of 1-4 where I=very

difficult, 2=difficult, 3=easy and 4=very easy. The results are expressed as median and range. Nd= not

done. Combinations with any ratingof "Very difficult"are marked ingrey.

Sets

Baxter

Smiths Industries, D-50

Smiths Industries,D-l 00

Smiths Industries, DI-50

Cardinal Health 79980E

Cardinal Health 28080E

Terumo

Hospira (form. Abbott

Arizant

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Un-spikingThe ease of un-spiking was rated using the same scale as described above. Out of213pairs tested using the same spike in bags from the same manufacturer, 59% (126/213) hadno discrepancies between the ratings, 36% (77) had 1 step difference, 4% (8) and 1% (2)had 2 and 3 steps differences, respectively.

The un-spiking of all bags was over all rated as "Easy" or "Very easy" (range: 3 - 4)using all transfusion sets. However, there was a larger variability in the ranges using theBaxter and MacoPharma bags compared with the Pall bags. Table 5.

The variability using the Pall SQ40S and SQ40SE filters was large using the Baxter andMacoPharma bags, with a median rating of "Difficult" (SQ40S: 2, range 1-4; SQ40SE: 2,range 1-3) for Baxter and "Easy" to "Difficult" (SQ40S: 3, range: 1-3; SQ40SE: 2, range

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1-3) for MacoPharma bags. The SQ40S was tested with the Pall CBS bag and rated"Easy" (3, range: 2-4) and the SQ40SE tested with the Pall European bag also rated"Easy" (3, range: 3-4).

4 3.53-4 3-4

4 3.53-4 3-4

3 33-4 3-4

4 33-4 3-4

4 33-4 3-43.5 3.5

3-4 3-44 4

3-4 4-44 4

3-4 4-44 3.5

3-4 3-43 4 4

3-4 3 - 4 4 - 43.5 3.5 4

Deltec;' 3 - 4 3 - 4 3 - 4Table 5. Unspiking: Compatibility between transfusion sets and bags using a scale of 1-4 where 1=verydifficult, 2=difficult, 3=easy and 4=very easy. The results are expressed as median and range. Nd=not done.Combinations with any rating of "Very difficult" are marked in grey.

Sets

Baxter

Smiths Industries, D-503

2-43

2-33

2-43

3-43

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3-43

3-4Nd

Smiths Industries, D-l 00

Smiths Industries, DI-50

Cardinal Health 79980£

Cardinal Health 28080£

Terumo

Hospira (form. Abbott

Arizant

BBraun

32-4

32-4

32-3

33-4

32-4

32-4

33-4

33-4

33-4

32-4

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32-33.5

3-43

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3-43.5

3-43

3-44

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9. CONCLUSIONS

The tested transfusion sets from Hospira (Abbott), Cardinal Health (Alaris), Smiths DI-50 and Deltec did not fail with any of the bags at any time. The sets from Hospira,Cardinal Health and Smiths DI-50 were all rated as "Easy", whereas the sets from Deltec,while not failing, were still rated as "Difficult" for the Baxter and MacoPharma bags.Transfusion sets from Baxter, Smiths (D-50 and D-100), Terumo, Arizant and BBraunfailed with the MacoPharma bag and sets from Baxter and Smiths (D-lOO) sets failed

BC-062, Final Report, version 2.3

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with bags from Baxter. The modified bags from MacoPharma failed with sets fromBaxter. Bags from Pall did not fail at any time. Transfusion sets from Baxter had thehighest failure rate (17%) and were the only sets that failed with Baxter bags,MacoPharma bags and modified MacoPharma bags. The combination Baxter set-Baxterbag failed 3/10 times but despite this failure rate the spiking was rated as "Easy"(median: 3, range 1-4). One reason for this could be variability in the subjective rating ofthe performance of the spiking/un-spiking. On the other hand, it may also reflectvariability in the ports of the bags.

Transfusion sets are usually sterilized either by gas (Ethyleneoxide) or by irradiation.This typically does not change the dimensions of molded parts of hard plastic, such asspikes. Blood bags, and ports, are manufactured of soft pvc. As blood bags are sterilizedby steam, some shrinkage in the plastic occurs. This could cause variability in the portsize affecting the compatibility. As the bag designed for platelet storage used in this studywas sterilized by irradiation, this could also explain the ease of use and success withspiking/unspiking of this bag.

The Pall SQ40S and SQ40SE filters had the most failures (30% and 33%) and the lowestrating of all sets tested. These are micro-aggregate filters designed to be used duringtransfusion of red cells. Micro-aggregates consist of granulocytes, platelets and fibrinstrands and are formed during storage. As leuko-depletion removes the majority of thegranulocytes and platelets pre-storage, very few micro-aggregates are formed. Still, usingthe PRP-method there is a risk of micro-aggregate formation, as a relatively large volumeof plasma is left in the red cell unit. When the buffy coat method is implemented acrossthe country, all red cell units will contain a minimum amount of plasma, reducing thepossibility of micro-aggregate formation to a minimum. Thus, the need for this filtershould be re-assessed.

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To complement this qualitative study, a quantitative study on the same bag and setcombinations was performed by M Nightingale, (See: M Nightingale Report:Quantitative study of compatibility between transfusion sets and blood bags used by theCanadian Blood Service. Version 1.0, 29thof June 2006). The study was done using atechnique previously reported (M Nightingale. Improving compatibility between bloodpacks and transfusion sets. Transfusion Medicine 2006; 16:11-5). A summary of theresults can be found in Appendix 1. Even though the definitions of "Success" aredifferent in the quantitative and qualitative studies (fully spiked and flow of fluid,respectively) the results are over all consistent. Unfortunately, the Baxter sets with ISOspikes were not available for the qualitative study, thus a comparison of the performanceof this set could not be done. The major difference in result between the studies wasfound using the Deltec spike where the qualitative study had 100% success but thequantitative study only had 60%. This could be due to the fact that this is a short spikeand could not be inserted according to the definition for success in the quantitative study.However, in the qualitative study flow of fluid was achieved even though the septumpotentially was not fully perforated.

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In conclusion, we found a larger variability in spiking and un-spiking Baxter andMacoPharma bags, compared with Pall bags. The ease of use of spiking andcompatibility of the MacoPharma bag was somewhat lower compared with the Baxterbag. The MacoPharma bag had a rating of "Difficult" (2) for 6/11 transfusion sets, andfor both the Baxter bag and the modified MacoPharma bag 2/10 sets rated "Difficult" (2- 2.5). Both the Pall bags were rated "Easy" to "Very Easy" (3-4) with all transfusionsets, except Smiths D-lOOwhere the European bag rated 2.5.

In the study, there were four transfusion sets with no failures and high compatibility:Hospira (Abbott), Cardinal Health 79980E (Alaris), Cardinal Health 28080E (Alaris) andSmiths ISO set (DI50).

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Appendix 1

Summary of results from M Nightingale Report: Quantitative study of compatibility betweentransfusion sets and blood bags used by the Canadian Blood Service. Version 1.0, 29thof June2006. An additional column has been added for ease of comparison of the two studies.

Analysis of successful' spikings' by bag code

Bag code No of 'spikings' No. % % successfulattempted successful successful in Qualitative study

(Inc!. SQ40SE)

Pink, Baxter 37 27 73 94

Green, MacoPharma 37 30 81 89

Yellow, Modified 37 37 100 95MacoPharma

White, Pall CBS 37 37 100 100

Orange, Pall 37 37 100 100European

Analysis of successful' spikings' by spike code

Spike code No. % % successfulsuccessful successful in Qualitative study

A, Baxter Universal 9 60 83

B, Smiths D50 15 15 I 100 I I 97

C, SmithsD100 15 12 I 80 I I 94

D, SmithsDI50 15 I 15 I 100 I I 100

E, Alaris 28080E 15 I 15 I 100 I I 100:,

F, Terumo 15 I 15 I 100 I I 97

G, BaxterISO 15 I 15 I 100 I I Nd

H, Abbott 15 I 15 I 100 I I 100

I, Arizant 15 I 15 I 100 I I 94

K, BBraun 15 I 15 I 100 I I 97

L, Deltec

I

15

I

9 60

H100

M, SQ40SE 5 3 60 67

IP, Alaris 79980E

I

15 15I

100 U 100I

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Date: _d<J()7-01-0'6

tlC-O62, Final I a:poTt, vers!on 2.3

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Prepared by:

t4tar4b/ (J~Elissbdb Sem eDevelopment Scientist,

R&D

Date: acol~O/-Og

I4J 002/002

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