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DURALOCK C
CatheterLock
Solution
medCOMP
![Page 2: DURALOCK C Catheter Lock Solution med COMP. Duralock C med COMP protects against catheter related infection](https://reader033.vdocuments.site/reader033/viewer/2022061500/56649c855503460f9493c2f0/html5/thumbnails/2.jpg)
Duralock C
medCOMP
• protects against catheter related infection
![Page 3: DURALOCK C Catheter Lock Solution med COMP. Duralock C med COMP protects against catheter related infection](https://reader033.vdocuments.site/reader033/viewer/2022061500/56649c855503460f9493c2f0/html5/thumbnails/3.jpg)
Duralock C
medCOMP
• protects against catheter related infection• prevents the formation of biofilm
![Page 4: DURALOCK C Catheter Lock Solution med COMP. Duralock C med COMP protects against catheter related infection](https://reader033.vdocuments.site/reader033/viewer/2022061500/56649c855503460f9493c2f0/html5/thumbnails/4.jpg)
Duralock C
medCOMP
• protects against catheter related infection• prevents the formation of biofilm• prevents catheter clotting use of thrombolytic agents
![Page 5: DURALOCK C Catheter Lock Solution med COMP. Duralock C med COMP protects against catheter related infection](https://reader033.vdocuments.site/reader033/viewer/2022061500/56649c855503460f9493c2f0/html5/thumbnails/5.jpg)
Duralock C
medCOMP
• protects against catheter related infection
Literature shows catheter related bacteremia incidence of
3,0 – 7,0 episodes/1.000 cath.days
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Duralock C
medCOMP
• protects against catheter related infection
Literature shows catheter related bacteremia incidence of
3,0 – 7,0 episodes/1.000 cath.days
Tunneled Non tunneled
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Duralock C
medCOMP
• protects against catheter related infection
Most cultured microbes:
• S. aureus • Coagulase negative s. aureus• S epidermidis• Candida albicans• E. Agglomerans• P. aeruginosa• Enterococcus faecalis
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Duralock C
medCOMP
• protects against catheter related infection
Consequenses of CRB: • Serious complications in the use of catheters
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Duralock C
medCOMP
• protects against catheter related infection
Consequenses of CRB: • Serious complications in the use of catheters• High cost treatment:
- catheter exchange- hospitalization (for example for IV treatment with antibiotics
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Duralock C
medCOMP
• protects against catheter related infection
Consequenses of CRB: • Serious complications in the use of catheters• High cost treatment:
- catheter exchange- hospitalization (for example for IV treatment with antibiotics
• Interruption of treatment
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Duralock C
medCOMP
• protects against catheter related infection
Consequenses of CRB: • Serious complications in the use of catheters• High cost treatment:
- catheter exchange- hospitalization (for example for IV treatment with antibiotics
• Interruption of treatment• Increasing problem of antibiotic resistance
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Power of Duralock C
medCOMP
• protects against catheter related infection
![Page 13: DURALOCK C Catheter Lock Solution med COMP. Duralock C med COMP protects against catheter related infection](https://reader033.vdocuments.site/reader033/viewer/2022061500/56649c855503460f9493c2f0/html5/thumbnails/13.jpg)
Power of Duralock C
medCOMP
• protects against catheter related infection
Concentrated Sodium Citrate (23%) for Catheter Lock Stephen R. Ash et al, Hemodialysis International 4:22-31, 2000
Protocol:• 40 patients followed for several catheter locking solutions:
1/98-8/98: heparin 5000 units or 10 000 units 9/98-11/98: 10% sodium citrate (pH 6.5) with 3 mg/mL gentamicin 12/98-3/99: 20% sodium citrate with 3 mg/mL gentamicin 4/99-6/99: 46,7% sodium citrate 7/99-10/99: heparin 5000 or 10 000 units 11/99-3/00: 23% sodium citrate
Study endpoints:• The incidence of symptomatic bactaeremia (calculated as the number of episodes per 3000 patient-days)• Use of urokinase
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Power of Duralock C
medCOMP
• protects against catheter related infection
Infection Rate
![Page 15: DURALOCK C Catheter Lock Solution med COMP. Duralock C med COMP protects against catheter related infection](https://reader033.vdocuments.site/reader033/viewer/2022061500/56649c855503460f9493c2f0/html5/thumbnails/15.jpg)
Power of Duralock C
medCOMP
• protects against catheter related infection
Heparin 5000 IU/mlTrisodium citrate 30%
Nephrol Dial Transplant (2002) 17: 2189–2195
M.C. Weijmer, Y.J. Debets-Ossenkopp, F.J. van de Vondervoort and P.M. ter Wee
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Power of Duralock C
medCOMP
• protects against catheter related infection
Nephrol Dial Transplant (2002) 17: 2189–2195
M.C. Weijmer, Y.J. Debets-Ossenkopp, F.J. van de Vondervoort and P.M. ter Wee
0
5
10
15
20
25
30
35
40
Heparine Trisodiumcitrate2.2%
Trisodiumcitrate7.5%
Trisodiumcitrate15%
Trisodiumcitrate30%
Trisodiumcitrate7.5%/ gentamicin
1mg/ml
mmS. aureus
E. coli
S. epidermidis
P. aeruginosa
C. albicans
Disk Diffusion Susceptibility Test
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Power of Duralock C
medCOMP
• protects against catheter related infection
Heparin 5000 IU/ml
Nephrol Dial Transplant (2002) 17: 2189–2195
M.C. Weijmer, Y.J. Debets-Ossenkopp, F.J. van de Vondervoort and P.M. ter Wee
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Primary endpoint:Catheter survival
Secondary endpoints - infection - bacteremia
- exit site infection
- thrombosis - flow problems- use of urokinase
- side effects - bleeding- thrombocytopenia- systemic reactions after locking
Study design
Interimanalysis(200 catheters)
bacteremia
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291 hemodialysis catheters
citrate 30% heparin total
Catheters tunneled cuffed
jugular
subclavian
femoral
untunneled
jugular
subclavian
femoral
148 50
49
1
0
98
77
1
20
143 48
48
0
0
95
69
2
24
291 98
97
1
0
193
146
3
48
Catheter days 8431 8116 16547
Days per catheter tunneled cuffed
untunneled
57.0 97.1
36.5
56.8 94.2
37.8
56.9 95.7
37.1
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Power of Duralock C
medCOMP
Why protects a citrate solution against catheter related infections?
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Power of Duralock C
medCOMP
Why protects a citrate solution against catheter related infections?
Citrate =
combined with
citric acid = C3H5O(COO)33−
binds
double positive ionized molecules: Ca++ / Mg++
Na3C6H5O7
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Power of Duralock C
medCOMP
Apart from Mg++ binding, removal of Ca++ fromthe surrounding milieu can be an explanation for theantimicrobial properties of TSC. Ca++ may regulateseveral genes responsible for growth and survival ofmicrobes. Holland et al. [19] demonstrated that celldivision in E.coli in particular appears to be verysensitive to the level of cellular Ca++.
Weijmer MC, Debets-Ossenkopp YJ, Van de VondervoortFJ, ter Wee PM: Superior antimicrobial activity of trisodiumcitrate over heparin for catheter locking. Nephrol DialTransplant 17: 2189–2195, 2002
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Power of Duralock C
medCOMP
• protects against catheter related infection
Nephrol Dial Transplant (2002) 17: 2189–2195
M.C. Weijmer, Y.J. Debets-Ossenkopp, F.J. van de Vondervoort and P.M. ter Wee
“We conclude that in our in vitro study using standardized antimicrobial susceptibility tests we demonstrated that TSC 30% was the most potent antimicrobial locking solution and that its hyperosmolality was of minor importance to explain the inhibitory effects of TSC on microbial growth.”
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Power of Duralock C
medCOMP
• protects against catheter related infection
Randomized, Clinical Trial Comparison of Trisodium Citrate 30% and Heparin as Catheter-Locking Solution inHemodialysis PatientsMarcel C. Weijmer, Marinus A. van den Dorpel, Peter J.G. Van de Ven, Pieter M. ter Wee, Jos A.C.A. van Geelen, Johannes O. Groeneveld, Brigitte C. van Jaarsveld, Marjon G. Koopmans, Caatje Y. le Poole, Anita M. Schrander-Van der Meer, Carl E.H. Siegert, Koen J.F. Stas; for the CITRATE Study Group
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Catheter survival
46
28
0
5
10
15
20
25
30
35
40
45
50
% catheterspreliminary removed
heparin
citrate 30%
heparin
TSC
P=0.014
days in place
18%
medCOMP
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Bacteremia free survival
33
9
0
5
10
15
20
25
30
35
total episodesbacteremia
heparin
citrate 30%
P=0.0002
heparin
TSC
days in place
73%
medCOMP
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P=0.002
21
6
0
5
10
15
20
25
30
admissions dueto infections
P=0.001
245
440
25
50
75
100
125
150
175
200
225
250
hospital days due toinfections
heparine
citraat 30%
Infection related admissions
medCOMP
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P=0.35
Mortality
18
13
0
2
4
6
8
10
12
14
16
18
20
overall
0
P=0.022
5
Bacteremia related
heparin
citrate 30%
medCOMP
![Page 29: DURALOCK C Catheter Lock Solution med COMP. Duralock C med COMP protects against catheter related infection](https://reader033.vdocuments.site/reader033/viewer/2022061500/56649c855503460f9493c2f0/html5/thumbnails/29.jpg)
medCOMP
• Prevents formation of biofilm
Duralock C
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medCOMP
• Prevents formation of biofilm
Duralock C
Micro organisms
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medCOMP
• Prevents formation of biofilm
Duralock C
Biofilm grows under the influence of poly sacharides, produced by micro organisms.
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medCOMP
• Prevents formation of biofilm
Duralock C
Biofilm grows under the influence of poly sacharides, produced by micro organisms.
Heparin is a poly sacharide combined with an anti thrombin
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medCOMP
• Prevents formation of biofilm
Duralock C
Biofilm grows under the influence of poly sacharides, produced by micro organisms.
Heparin is a poly sacharide combined with an anti thrombin
Heparin induces the growth of biofilm
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Method:…examined 42 arterial and 26 central venous catheters that had been in place in ICU patients between 1 and 14 days for the presence of bacterial biofilms by scanning electron microscopy, transmission electron microscopy, and a special scraping/sonication bacterial recovery technique.
Crit Care Med. 1992 May;20(5):665-73.
Biofilms on indwelling vascular catheters, Passerini. L, Lam K, Costerton JW, King EG
medCOMP
Duralock C
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medCOMP
• Prevents formation of biofilm
Duralock C
Crit Care Med. 1992 May;20(5):665-73.
Biofilms on indwelling vascular catheters, Passerini. L, Lam K, Costerton JW, King EG
Conclusion: 1. Extensive biofilm formation on all 42 arterial and 26 central
venous catheters. 2. Bacteria within the biofilms on 69% (29/42) of the arterial and
88% (23/26) of the central venous catheters.
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medCOMP
• Prevents formation of biofilm
Catheter lock solutions influence staphylococcal biofilm formation on abiotic surfaces
Robert M. Q. Shanks1, Jennifer L. Sargent1, Raquel M. Martinez1, Martha L. Graber2 and George A. O’Toole11Department of Microbiology and Immunology, Dartmouth Medical School, Hanover, NH 03755 and 2Department of Medicine, Section of Hypertension and Nephrology, Dartmouth Hitchcock Medical Center, Lebanon, NH 03766, USA
Nephrol Dial Transplant (2006) 1 of 9doi:10.1093/ndt/gfl170
Power of Duralock C
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medCOMP
• Prevents formation of biofilm
Catheter lock solutions influence staphylococcal biofilm formation on abiotic surfaces
Nephrol Dial Transplant (2006) 1 of 9doi:10.1093/ndt/gfl170
This in vitro study demonstrates that heparin alternatives, sodium citrate and sodiumEDTA, can prevent the formation of S. aureus biofilms, suggesting that they may reduce the risk of biofilm-associated complications in indwelling catheters.
Power of Duralock C
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medCOMP
• prevents catheter clotting use of thrombolytic agents
Duralock C
Catheter related thrombosis is often the cause of low catheter blood flows.
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medCOMP
• prevents catheter clotting use of thrombolytic agents
Duralock C
Catheter related thrombosis is often the cause of low catheter blood flows.
Low blood flow inefficient treatment low Kt/V
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medCOMP
• prevents catheter clotting use of thrombolytic agents
Duralock C
Catheter related thrombosis is often the cause of low catheter blood flows.
Low blood flow inefficient treatment low Kt/V
Treatment: Expensive thrombolitic agents (TpA, Urokinase, Streptokinase)
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medCOMP
• prevents catheter clotting use of thrombolytic agents
Power of Duralock C
Under influence ofCa++
So...
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medCOMP
• prevents catheter clotting use of thrombolytic agents
Power of Duralock C
Under influence ofCa++
So...
Binding Ca++ inthe catheter environment,stops the proces of clotting
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Flow problems
getunneld = ongetunneld
20 18
0
5
10
15
20
25
30
% removed forflow problem
heparin
citrate 30%
heparin
TSCP=0.754
days in place
medCOMP
![Page 44: DURALOCK C Catheter Lock Solution med COMP. Duralock C med COMP protects against catheter related infection](https://reader033.vdocuments.site/reader033/viewer/2022061500/56649c855503460f9493c2f0/html5/thumbnails/44.jpg)
Power of Duralock C
medCOMP Ash SR, et al. ASN 1999 A1375
• prevents catheter clotting use of thrombolytic agents
![Page 45: DURALOCK C Catheter Lock Solution med COMP. Duralock C med COMP protects against catheter related infection](https://reader033.vdocuments.site/reader033/viewer/2022061500/56649c855503460f9493c2f0/html5/thumbnails/45.jpg)
Leakage lock solution
Bayes B et al, Nephrol Dial Transpl 1999; 14; 2532
Bleeding complications
medCOMP
Duralock C
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Power of Duralock C
medCOMP
• protects against catheter related infection
Sodium citrate for filling haemodialysis catheters
“We recommend filling the catheter with sodium citrate 46,7%
Bayes B et al, Nephrol Dial Transpl 1999; 14; 2532
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medCOMP
Duralock C
Bleeding complications
Risk of heparin lock-related bleeding when using indwelling venous catheters in haemodialysis, Hüseyin Karaaslan et al, Service de Néphrologie CHU Dupuytren, Limoges, FranceNephrol Dial Transpant, (2001) 16: 2072-2074
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Bleeding complications during citrate-trial
P=0.005
19
6
0
2
4
6
8
10
12
14
16
18
20
After insertion
P=0.01
16
5
During follow up
heparin
citrate 30%
Consequences of leakage lock solution
medCOMP
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Cornelius J. Doorenbos, Marjo Van den Elsen-Hutten, Margret J. M. Heuven and Jan Hessels, Estimation of trisodium citrate (Citra-LockTM) remaining in centralvenous catheters after the interdialytic interval, Nephrology Dialysis Transplantation 2006 21(2):543-545
“The injected concentration Citra-Locktm decreases 30% in the inter dialytic periodein jugular and subclavian catheters. Femoral catheters show a decrease of 90%.
DURALOCK C
medCOMP
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30%
46,7%
30%Anti microbial protection, Weijmer)
DURALOCK C
medCOMP
“The injected concentration Citra-Locktm decreases 30% in the inter dialytic periodin jugular and subclavian catheters. Femoral catheters show a decrease of 90%.
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Literature reviews:1. Beathard GA: Management of bacteremia associated with tunneled-cuffed hemodialysis catheters. J Am Soc Nephrol 10: 1045–1049,
19992. Weijmer MC, ter Wee PM: Temporary vascular access for hemodialysis treatment. Current guidelines and future directions. Contrib
Nephrol 137: 38–45, 20023. Costerton JW, Stewart PS, Greenberg EP: Bacterial biofilms: A common cause of persistent infections. Science 284:1318–1322, 19994. Raad I: Intravascular-catheter-related infections. Lancet 351: 893–898, 19985. Bayes B, Bonal J, Romero R: Sodium citrate for filling haemodialysis catheters. Nephrol Dial Transplant 14: 2532–2533, 19996. Karaaslan H, Peyronnet P, Benevent D, Lagarde C, Rince M, Leroux-Robert C: Risk of heparin lock-related bleeding when using
indwelling venous catheter in haemodialysis. Nephrol Dial Transplant 16: 2072–2074, 20017. Dogra GK, Herson H, Hutchison B, Irish AB, Heath CH, Golledge C, Luxton G, Moody H: Prevention of tunneledhemodialysis catheter-related infections using catheter-restricted filling with gentamicin and citrate: A randomizedcontrolled study. J Am Soc Nephrol 13: 2133–2139, 20028. Weijmer MC, Debets-Ossenkopp YJ, Van de Vondervoort FJ, ter Wee PM: Superior antimicrobial activity of trisodium citrate over
heparin for catheter locking. Nephrol Dial Transplant 17: 2189–2195, 20029. Ash SR, Mankus RA, Sutton JM, Criswell ER, Crull CC, Velasquez KA, Smeltzer BD, Ing TS: Concentrated sodium citrate (23%) for
catheter lock. Hemodial Int 4: 22–31, 200010. Stas KJ, Vanwalleghem J, Moor BD, Keuleers H: Trisodium citrate 30% vs heparin 5% as catheter lock in the interdialytic period in
twin- or double-lumen dialysis catheters for intermittent haemodialysis. Nephrol Dial Transplant 16:1521–1522, 200111. Twardowski ZJ: High-dose intradialytic urokinase to restore the patency of permanent central vein hemodialysiscatheters. Am J Kidney Dis 31: 841–847, 199812. Buturovic J, Ponikvar R, Kandus A, Boh M, Klinkmann J, Ivanovich P: Filling hemodialysis catheters in the interdialytic period: Heparin
versus citrate versus polygeline: Aprospective randomized study. Artif Organs 22: 945–947,199813. Betjes MG, Van Agteren M: Prevention of dialysis catheterrelatedsepsis with a citrate-taurolidine-containing lock solution. Nephrol Dial
Transplant 19: 1546–1551, 200414. De Wachter DS, Weijmer MC, Kausylas M, Verdonck PR: Do catheter side holes provide better blood flows? Hemodial Int 6: 40–46,
200215. Twardowski ZJ: The clotted central vein catheter for haemodialysis. Nephrol Dial Transplant 13: 2203–2206, 199816. FDA Issues Warning on triCitrasol® Dialysis Catheter Anticoagulant.FDA Talk Paper T00-16, Rockville, MD, US Food and Drug
Administration, 2000
medCOMP
Duralock C
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Heparin– Anticoagulant
– Systemic effect
– Generates bleeding risks
– Promotes bacterial growth, poly sacharide is feed for micro organisms
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Duralock C
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Heparin– Anticoagulant
– Systemic effect
– Generates bleeding risks
– Promotes bacterial growth, poly sacharide is feed for micro organisms
– Promotes formation of biofilm
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Duralock C
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Conclusions:
medCOMP
Power of Duralock C
1. Trisodium citrate, in a concentration of at least 30% shows an antimicrobial effect (Weijmer et al)
2. Trisodium citrate 30% shows a decrease of CRB of 75% in a randomized controlled multi centre trial (Weijmer et al).
3. Trisodium citrate 30% doesn’t effect positively on blood flow and use of thrombolytic agents (Weijmer et al)
4. Trisodium citrate 46,7% does show in In vivo studies a decrease in CRB and use of thrombolytic agents like Urokinase.
5. There is leakage of catheter lock solutions in the inter dialytic period, resulting in hight ATTP results, constantly measurable gentamycin levels or decreased trisodium citrate levels.
6. Catheter lock solutions based on antibiotics promote the risk of anti biotic resistance.
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medCOMP
DURALOCK C• No formation of biofilm• Anti microbial effect without anti biotics • No drug-resistant bacterial strains• No bleeding complications• Proven anticoagulant• Bio-compatible without systemic effects
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Action plan- february1-5.2 8-12.2 15-19.2 22.26.2
פגישות עם מנהלי מחלקות
הנפרולוגיה
פגישות עם מנהלי מחלקות הנפרולוגיה
הצגת הדורה לוק בישיבות הצוות של
המחלקות
ליווי אבלואציות במחלקות הנפרולוגיה
הצגת הדורה לוק בישיבות הצוות של
המחלקות
התחלת אבלואציות במחלקות הנפרולוגיה
המשך צפייה בפרוצדורות
המחלקות האנגיו- 14:00-17:00שעות
המשך צפייה בפרוצדורות
המחלקות האנגיו- 14:00-17:00שעות
המשך צפייה בפרוצדורות המחלקות
-14:00האנגיו- שעות 17:00
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Action plan- january
.118-22 25-29.1
22.1.09 מצגת דורה לוק- 26.1.09מצגת קטטרים לטווח קצר-
המשך צפייה בפרוצדורות -8:00המחלקות האנגיו- שעות
12:00
26.1.09הצגת דף הסבר דורה לוק-
תיאום פגישות עם הרופאים הרלוונטים- 29.1
המשך צפייה בפרוצדורות המחלקות 8:00-12:00האנגיו- שעות
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Action plan- march1-5.3 8-12.3 15-19.3 22.26.3
ליווי אבלואציות במחלקות הנפרולוגיה
ליווי אבלואציות במחלקות הנפרולוגיה
ליווי אבלואציות במחלקות הנפרולוגיה
הוצאת דרישות למוצר מול
מחלקות הרכש
הנפקת הצעות מחיר למנהלי מחלקות
הנפרולוגיה
הנפקת הצעות מחיר למנהלי מחלקות
הנפרולוגיה
מעקב אחר הזמנות למוצר מול
מחלקות הרכש
הוצאת דרישות למוצר מול מחלקות
הרכש
השתלבות במחלקות האנגיו
הרלוונטיות וחפיפה על הלקוח+
היכרויות עם מנהלי היחידות.
השתלבות במחלקות האנגיו הרלוונטיות וחפיפה על הלקוח+ היכרויות עם מנהלי
היחידות. השתלבות במחלקות האנגיו הרלוונטיות וחפיפה על הלקוח+ היכרויות עם מנהלי
היחידות.
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medCOMP
Q & A
DURALOCK C