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M.Senn, Swissmedlab Okt. 2004 Hemovigilance in Switzerland Marianne Senn, ART (CSMLS) Head of Hemovigilance Swissmedic / Swiss Agency for Therapeutic Products.

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Presentation on theme: "M.Senn, Swissmedlab Okt. 2004 Hemovigilance in Switzerland Marianne Senn, ART (CSMLS) Head of Hemovigilance Swissmedic / Swiss Agency for Therapeutic Products."— Presentation transcript:

1 M.Senn, Swissmedlab Okt. 2004 Hemovigilance in Switzerland Marianne Senn, ART (CSMLS) Head of Hemovigilance Swissmedic / Swiss Agency for Therapeutic Products marianne.senn@swissmedic.ch www.swissmedic.ch/haemo.asp

2 M.Senn, Swissmedlab Okt. 2004

3 Topics Hemovigilance Transfusion Risks First Data Recommendations

4 M.Senn, Swissmedlab Okt. 2004 Hemovigilance Systematic surveillance of adverse effects of transfusion Gaining complete picture of transfusion hazards Recommendations based on evidence Contribute to allocation of resources D. Stainsby; Hematology Journal (2004) 5

5 M.Senn, Swissmedlab Okt. 2004 Safety in Transfusion Therapy Safe Product Blood Administration Processes Production Processes

6 M.Senn, Swissmedlab Okt. 2004 Safety and the Blood Administration Process Safe Product Prescription by M.D. Patient Sample Transfusion service laboratory Blood Administration Preparation

7 M.Senn, Swissmedlab Okt. 2004 Risks of Transfusion Transfusion transmitted infection Immune complications Cardiovascular and metabolic complications Errors and Near Misses Unknown risks

8 M.Senn, Swissmedlab Okt. 2004 Infectious Transfusion Risks AuBuchon and Vamvakas; Transfusion 44, Sept.04

9 M.Senn, Swissmedlab Okt. 2004 Immune Complications adapted. B. Mansouri 26.8.2004

10 M.Senn, Swissmedlab Okt. 2004 Cardiovascular and Metabolic Complications TACO (transfusion related ciculatory overload) Hypocalcemia Hyperkalemia Hypothermia Hemosiderosis

11 M.Senn, Swissmedlab Okt. 2004 Errors and Near-Misses IBPT incorrect blood product transfused Near - Misses Learn from errors Eliminate root cause of errors

12 M.Senn, Swissmedlab Okt. 2004 Effectiveness of the Hemovigilance System Recognition + Dokumentation + Reporting Prerequisit : Reporting of all adverse events and proper investigations Analysis and feedback to everybody involved in transfusion medicine. adapted. B. Mansouri 26..8.2004

13 M.Senn, Swissmedlab Okt. 2004 Fever > 38°C, at least 1°C  DAT, Group and Screen Culture of Product and Patient neg AHTRAAHTR AHTR Fever, chills, nausea, vomiting, chest or back pain, dyspnea, hypotension,  DIC and renal failure POS AHTRAAHTR Bacterial Contamination Fever > 39° C rise > 2° C Chills, hypotension often within 15 Min. NEG POS FNHTR

14 M.Senn, Swissmedlab Okt. 2004 Bacterial Contamination Segments are not representative. Culture of product always from bag content. Keep bag for 24 hours after transfusion at 4°C.

15 M.Senn, Swissmedlab Okt. 2004 Allergic-Anaphylactic TR Mild allergic Not reportable Moderate Anaphlactic IgA and Anti-IgA analysis Urticaria <2/3 only symptom >2/3 body surface affected, nausea, chest pain, dyspnea Airway obstruction, bronchospasm, hypotension, vascular collapse

16 M.Senn, Swissmedlab Okt. 2004 Dyspnea,  O 2 Sats, SOB Hypertension heart pain, distended neck veins Hypotension Sometimes hypertension Fever Pulmonary edema Chest X Ray (if medical Indication) If pulmonary infiltrates, test donors for granulocyte antibodies TACO Within several hours of transfusion TRALI usually 1-2 up to 6 hours after transfusion

17 M.Senn, Swissmedlab Okt. 2004 No Blame Culture “Errors are excusable; ignoring them is not” L.L. Leape 2000

18 M.Senn, Swissmedlab Okt. 2004 Population:approx. 7 millionPopulation:approx. 7 million Issued by BTS SRCIssued by BTS SRC –Red cells: 292’000 units –Platelets: 80’000 units, (90% Apheresis) –FFPq and SD- Plasma: 80’000 Approx. 200 Hospitals transfuse Blood ComponentsApprox. 200 Hospitals transfuse Blood Components Select Swiss Figures

19 M.Senn, Swissmedlab Okt. 2004 Distribution by blood component 2002/2003

20 M.Senn, Swissmedlab Okt. 2004 Reports Received

21 M.Senn, Swissmedlab Okt. 2004 Products and Events

22 M.Senn, Swissmedlab Okt. 2004 8 Reported Deaths in 2002 and 2003 4x TACO, (3x probable, 1x possible) 1x Bact. Contamination (lab. work-up on product not performed, typical clinical course) 3x Heart Failure,(3x causality with blood component transfusion unlikely)

23 M.Senn, Swissmedlab Okt. 2004 32 Life-Threatening TR in 2002 and 2003 5x TACO 3x TRALI 3x IBCT (A-B-O incompatible transfusion) 2x HTR (1x Anti-Jk(a) and 1x Anti-Fy(a) 15 x Anaphylactic Reactions 4x most likely medication administered simultaneously cause of event

24 M.Senn, Swissmedlab Okt. 2004 Future Tasks 1.Open communication with responsible person for hemovigilance in hospitals 2.Establishment of an advisory group 3.Recommendations based on hemovigilance data

25 M.Senn, Swissmedlab Okt. 2004 Safe Product Prescription by M.D. Patient Sample Hospital Transfusions Service Blood Administration Safety in Transfusion Therapy Donor Selection Testing and Preparation Material and Reagents

26 M.Senn, Swissmedlab Okt. 2004 www.swissmedic.ch/ haemo.asp Swissmedlab ppt and doc (full text)

27 M.Senn, Swissmedlab Okt. 2004

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