2008 - Annual Haemovigilance report

Afssaps

Description

Blood and blood products
04/01/2010

Informations

• Publié par: ansm-blood-and-blood-products
• Publié le: 04 janvier 2010
• Nombre de lectures: 11
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, pas de modification
• Langue: English

Extrait

Haemovigilance report 2008 Table of contents
Haemovigilance report 2008 Table of contents ......................................................................... 2
Foreword ................................................................................................................................... 4
1. Introduction........................................................................................................................ 6
1.1. The new texts published in 2008................................................................................ 6
1.2. News in 2008.............................................................................................................. 6
1.3. Organisation of haemovigilance................................................................................. 6
1.3.1. Actors.................................................................................................................7
1.3.2. Regulatory roles of each actor............................................................................ 7
1.3.3. Other actions of the network .............................................................................. 9
1.4. Process........................................................................................................................ 9
1.4.1. Notifications.......................................................................................................9
1.4.2. Notifications deadlines.....................................................................................10
1.4.3. Traceability11
1.4.4. Annual report....................................................................................................12
2. 2008 data....... 13
2.1. Methodology reminder.............................................................................................13
2.1.1. Data sources.....................................................................................................
2.1.2. Validation of the data ....................................................................................... 14
2.2. Transfusion activity: general information ................................................................ 15
2.2.1. Number of patients........................................................................................... 15
2.2.2. Number of donors and donations ..................................................................... 16
2.2.3. Number of labile blood products distributed (LBP)......................................... 16
2.2.4. LBP transiting through the hospital blood banks............................................. 17
2.2.5. Traceability of LBP..........................................................................................17
2.3. Recipient adverse reactions (RAR) .......................................................................... 18
2.3.1. Definitions and number of notifications........................................................... 18
2.3.2. Grades 3 to 4 RAR 18
2.3.3. Grades 1 and 2 RAR......................................................................................... 21
2.3.4. Global analysis per diagnosis of imputability 2 to 4 RAR............................... 21
2.3.5. Diagnoses per type of product 23
2.4. Serious adverse event of the transfusion chain (SAE) ............................................. 24
2.4.1. SAE with or without transfused LBP............................................................... 24
2.4.2. SAE with transfusion of LBP without RAR .................................................... 25
2.4.3. SAE with transfusion of LBP that caused a RAR (grade higher than or equal to
1) 26
2.4.4. SAE without transfusion of LBP...................................................................... 26
2.5. Donor serious adverse reactions (DSAR) ................................................................ 26
2.6. Post-donation information (PDI).............................................................................. 27
3. Evolutions......................................................................................................................... 28
3.1. Reminder of the main modifications that appeared on the RAR notification form
since 2001:............................................................................................................................ 28
3.2. LBP consumption.....................................................................................................28
3.3. Recipients................................................................................................................. 29
3.4. RAR.......................................................................................................................... 29
3.4.1. The most serious and most certain RAR.......................................................... 31
3.4.2. Grades 1 and 2 RAR......................................................................................... 32
3.5. Other events.............................................................................................................. 33
3.5.1. SAE with transfusion of LBP without RAR .................................................... 33
Haemovigilance report 2008 Page 2 of 56 3.5.2. SAE with transfusion of LBP that caused a RAR (grade higher than or equal to
1) 34
3.5.3. SAE without transfusion of LBP...................................................................... 34
3.5.4. DSAR...............................................................................................................35
3.5.5. PDI...................................................................................................................35
4. Work carried out in 2008 ................................................................................................. 36
4.1. Participation in the elaboration of legislative and regulatory texts.......................... 36
4.2. National haemovigilance commission and work groups.......................................... 36
4.3. The haemovigilance portal project of the Afssaps site (www.afssaps.fr)................ 39
4.4. Communications and publications ........................................................................... 39
4.4.1. Communications in congresses........................................................................39
4.4.2. Publications......................................................................................................
4.5. Other communications or studies............................................................................. 40
4.5.1. INTS/UNCAM survey.....................................................................................40
4.5.2. Health information technology.........................................................................
4.5.3. International cooperation..................................................................................40
5. Actions carried out and improvement proposals.............................................................. 41
5.1. Evolution of e-fit 41
5.2. Organisation of a “Review of traceability directives” sub-group ............................ 41
5.3. Other actions to be carried out ................................................................................. 41
6. Evaluation of actions carried out previously and follow-up of measures ........................ 42
6.1. Training on the e-fit tool .......................................................................................... 42
6.2. The exploration of cases of allergy with methylene blue treated plasma transfusions
(MB-VIP) ............................................................................................................................. 42
6.3. The other recommendations in 2008........................................................................ 43
7. Summary and conclusion ................................................................................................. 44
7.1. Highlights of the year 2008...................................................................................... 44
7.2. Major tendencies......................................................................................................45
7.3. Conclusion................................................................................................................ 46
8. Annexes............................................................................................................................ 48
8.1. Key values 48
8.1.1. General comments:...........................................................................................48
8.1.2. Distribution of RAR per products and product family..................................... 49
8.1.3. Organisational data per inter-region................................................................. 50
8.2. List of centralised strains since 2003 ....................................................................... 51
8.3. Definitions................................................................................................................ 51
8.3.1. Adverse reaction, serious adverse reaction, incident and serious adverse event
51
8.3.2. Severity levels..................................................................................................51
8.3.3. Imputability levels............................................................................................52
8.3.4. RARF inves