2009 - Annual Haemovigilance report

Afssaps

Description

Blood and blood products
12/04/2011

Informations

• Publié par: ansm-blood-and-blood-products
• Publié le: 12 avril 2011
• Nombre de lectures: 18
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, pas de modification
• Langue: English

Extrait

Haemovigilance report 2009 2/82







CONTENTS



CONTENTS......................................................................................................................................................................................2
FOREWORD.............................................................5
SPEECH BY MR. JEAN MARIMBERT, DIRECTOR GENERAL OF AFSSAPS..............................................................................6
1. Introduction..............................................................................................................................................................................9
1.1. News in 2009...............................................9
1.2. The new texts published in 2009..................................................................................................................................10
1.2.1. The principal European texts...............................................................................................................................10
1.2.2. The principal national texts...............................10
ORDERS ........................................................................................................................................................................................10
DECREES ......................................................................................................................................................................................10
DECISIONS by the Director General of Afssaps, listed in chronological order..............................................................................10
1.3. Organisation of haemovigilance ...................................................................................................................................11
1.4. The process..................................................................................................................................................................12
1.4.1. Reporting.............................................................................................................................................................12
1.4.2. Declaration......................................12
1.4.3. Declaration deadlines..........................................................................................................................................12
1.4.4. Traceability.......................................13
1.4.5. Annual report.......................................................................................................................................................14
2. 2009 data.........................................................15
2.1. Methodological reminder ..............................................................................................................................................15
2.1.1. Data sources .......................................................................................................................................................15
- RARs: declarations submitted by HVCs, HFs and BE via the “e-FIT” database..........................................................................15
2.1.2. Validation of the data...........................................................................................................................................16
1. RAR declaration via e-FIT ..........................................................................................................................................................16
Diagram 5. Logical diagram of the saving of RARs in e-FIT from creation to closure....................................................................16
2. Paper declaration (SAEF, PDI, DSARF) ....................................................................................................................................17
2.2. Transfusion activity: general data.................................................................................................................................17
2.2.1. Number of patients transfused ............................................................................................................................17
2.2.2. donors and donations ........................................................................................................................18
2.2.3. Release/issue of labile blood products (LBPs)....................................................................................................19
2.2.4. LBPs transiting through Hospital Blood Bank (HBB)...........................................................................................20
Table 8. Distribution of the number of LBPs dispensed by HBBs according to their type* in 2009................................................20
2.2.5. LBPs traceability..................................................................................................................................................20
2.3. Recipient adverse reaction (RAR)................................................................................................................................21
2.3.1. The number of declarations and their frequency.................................................................................................21
2.3.2. Confirmed cases of imputability 2 to 4 ................................................................................................................21
Diagram 6 – Confirmed RARs: imputability 2 to 4..........................................................................................................................22
Table 10. Distribution per diagnosis of adverse events of imputability 2 to 4 in 2009....................................................................22
Figure 5. Distribution of confirmed RARs of imputability 2 to 4 per sex and age ...........................................................................24
Table 16. Distribution of the 8 deaths according to the type of LBPs distributed...........................................................................27
2.4. Serious adverse events (SAE) .....................................................................................................................................30
2.4.1. SAEs with transfusion of LBP declared on the AR as grade 0 without clinical or biological manifestation.........30
2.4.2. iusion of LBP that caused an RAE of a grade higher than or equal to 1 ...................................31
2.4.3. SAEs without transfusion of LBP.........................................................................................................................31
2.5. Serious adverse reactions in donors (DSAR)...............................................................................................................32
2.5.1. The number of declarations and their frequency.................................................................................................32
Table 22. Distribution of DSARs per grade and per imputability*...................................................................................................32
Diagram 7. DSARs according to collection method (all grades and per imputability) ....................................................................33
2.5.2. The principal characteristics of the DSARs of imputability NE and 1 to 3...........................................................33
Table 29. Generalised clinical manifestations according to the type of donation...........................................................................36
2.6. Post-donation information (PDI)...................................36
3. Changes from 2000-2009......................................................................................................................................................37
3.1. Transfusion activity.......................................................................................................................................................37
3.1.1. Number of patients transfused ............................................................................................................................37
Sources: EFS, CTSA and RHC Activity Report..............................................................................................................................37
3.1.2. donors and donations ........................................................................................................................37
Sources: EFS and CTSA................................................................................................................................................................38
3.1.3. LBP distribution/issue.................................38
3.2. Recipient adverse reactions (RAR) ..............................................................................................................................38
3.2.1. Reminder of the principal modifications made to the RAR declaration form since 2001.....................................38
3.2.2. The number of reportings and their frequency ..............................................................................................