Key Benefits:
The Director General of the French Health Products Safety Agency,
Having regard to Directive 2002/98/EC of the European Parliament and the Council of 27 January 2003 establishing quality and safety standards for the collection, control, processing, conservation and distribution of human blood and blood components, and amending Directive 2001/83/EC;
Vu le Public Health Codeincluding articles L. 1221-13 and R. 1221-22 to R. 1221-52, and D. 1221-53;
In view of the decision of 24 December 2009 setting out the form and content of the annual state of activity of the blood transfusion institutions provided for in theArticle R. 1223-8 of the Public Health Code ;
Considering the opinion of the President of the French Blood Institution of 30 April 2010;
Considering the opinion of the Director of the Blood Transfusion Centre of the Armed Forces dated 29 April 2010,
Decides:
The reporting and reporting of a serious adverse effect on a blood donor is set out in Appendix I to this decision.
The list of adverse effects with appreciation of their severity grades based on their symptomatology is set out in Appendix II to this decision.
The form and content of the severe adverse reaction reporting form in a blood donor is set out in Appendix III to this decision.
The decision of May 7, 2007 setting out the form, content and modalities for the transmission of the severe adverse reaction reporting form in a blood donor is repealed.
The Director of the Evaluation of Medicines and Biologics is responsible for the execution of this decision, which will be published in the Official Journal of the French Republic.
A N N E X E S
A N N E X E I
MODALITIES OF SIGNALEMENT AND DECLARATION OF AN INDUSTRYABLE EFFECT SURVENTORS
1. Finality of reporting
and the declaration of an adverse effect
An adverse effect in a blood donor is defined as the nocive reaction in a blood donor and related to or likely to be related to blood removal.
A serious adverse effect is an adverse effect that leads to death or endangering life, causing disability or disability, or causing or prolonging hospitalization or any other morbid state. In particular, an adverse effect will be considered severe when it requires or should have required medical care.
The drafting of the adverse reaction reporting form is mandatory for serious adverse effects in a blood donor as defined in Chapter 2: " Contents of the adverse reaction reporting form". Its purpose is to identify the serious adverse effect and to analyse its imputability, with the aim of knowing the cause and preventing its repetition.
The occurrence of a serious adverse effect can lead to an assessment of the organization and operation of blood collection and blood components and, more broadly, safety in the various stages of the transfusion chain that may have consequences on the donor.
Investigations necessary for the evaluation of a serious adverse effect are carried out by the blood transfusion institution's hemovigilance correspondent in which the product was taken.
2. Contents of the sheet
serious adverse reaction reporting
The serious adverse reaction reporting form in a donor includes all the entries listed in Appendix III to this decision. These are related to the immediate serious adverse effects that occurred during the donation process and subsequent serious adverse effects.
For each serious adverse effect in a blood donor, severity grades and imputability levels must be indicated on the file.
2.1. Grades of severity:
they are listed in Appendix II to this decision
Grade 1: small.
Grade 2: moderate.
Grade 3: Severe.
Grade 4: death of the donor within seven days of the donation.
Only grades 2, 3 and 4 must be declared.
2.2. For each serious adverse reaction statement in connection with an aesthetic procedure, the medical devices used are specified in the adverse reaction report sheet
2.3. Imputability levels
For each serious adverse reaction statement, an analysis will be required to establish the causal link between blood or blood sample and the occurrence of severe adverse reaction. Imputability levels are classified according to the following criteria:
Imputability 0. ― Excludes or improbable: when the evidence cannot be questioned and allows to assign the adverse effect to other causes than the donation of blood or blood components or when the available appreciation elements clearly encourage the attribution of the adverse effect to causes other than the donation of blood or blood components.
Imputability 1. ― Possible: where the available assessment elements do not allow for a clear attribution of the adverse effect or the donation of blood or blood component or other causes.
Accountability 2. ― Probable: when the available appreciation elements clearly encourage the allocation of the unwanted effect to the donation of blood or blood component.
Accountability 3. ― Certain: where evidence cannot be questioned and allow the adverse effect to be attributed to blood donation or blood component.
Imputability NE. ― Unevaluable: when data are insufficient to assess accountability.
The specified imputability concerns only the adverse effect itself, and does not apply to the aftermath or complications of it.
3. Reporting and reporting modalities
3.1. Reporting procedure
A health professional who notices or is aware of the occurrence of a serious adverse reaction in a blood donor shall report it without delay and no later than eight hours to the blood transfusion institution's hemovigilance correspondent or to the person authorized by the blood transfusion institution on the site attached to the blood transfusion institution in which the donor candidate has presented himself.
This information can be done by all available means locally.
3.2. Modalities of declaration
3.2.1. Habitual
The "e-FIT" tele-reporting application for transfusional adverse reactions, regularly updated by the French Health Products Safety Agency, represents the usual reporting modality of severe adverse reactions in blood donors. It is used by the hemovigilance correspondents of blood transfusion institutions and by the regional hemovigilance coordinators for, each with regard to it, to provide the report sheet, to approve it, to acknowledge receipt and to target information regarding the serious adverse effect.
The French Health Products Safety Agency and the Regional Hemovigilance Coordinator are simultaneously provided with all serious adverse event reports from a blood donor as soon as it is created within the "e-FIT" application. The French Blood Institution and the Blood Transfusion Centre of the Armed Forces are each recipient of the report cards concerning them.
In the event of problems that may involve transfusion security, the regional coordinator of hemovigilance is informed, as soon as possible, by the hemovigilance correspondent of the blood transfusion establishment concerned. In application of theArticle R. 1221-32 of the Public Health Code, the regional coordinator of hemovigilance seizes the Director General of the Regional Health Agency and the Director General of the French Health Product Safety Agency.
Any modification of a record made necessary by the results of the investigation on the case or its evolution is immediately forwarded to the above-mentioned recipients, as long as it is carried out within the "e-FIT" application.
3.2.2. Degraded
In the event of the unavailability of the "e-FIT" telecommunication system, a degraded procedure is put in place with the use of paper forms, as follows:
The hemovigilance correspondent of the transfusion establishment in which the donation originated from the serious adverse reaction fills the paper form according to the model in Appendix III to this decision, the date and the sign.
The Regional Hemovigilance Coordinator and the French Health Products Agency are to be provided with any grade 2 to 4 adverse event sheets by any means available (fax, email, postal mail), within the time limits specified in 3.3.3 below. The French Blood Institution and the Blood Transfusion Centre of the Armed Forces are the recipients of the cards that concern them.
The Regional Hemovigilance Coordinator ensures that degraded procedures for the transmission of adverse event sheets exist locally.
The integration, in the "e-FIT" application, of data collected during degraded procedures is carried out by the blood transfusion institution's hemovigilance correspondent as soon as the computer input becomes possible.
3.3.3. Time limits
The hemovigilance correspondent of the blood transfusion establishment where the donation at the origin of the occurrence of a serious grade 2 or 3 adverse event takes place has a maximum period of fifteen days to complete the investigations and enter the report form in the "e-FIT" application of the teledeclaration of transfusional adverse effects.
The statement takes place without delay in the "e-FIT" tele-reporting of transfusional adverse reactions in the event of death or endangering the donor's vital prognosis, as well as in each case where the serious adverse effect would be made public or when the blood transfusion establishment's hemovigilance correspondent considers it necessary.
4. Retention of severe donor adverse event sheet
The serious donor adverse event sheet is retained, in paper or electronic form, in accordance with existing legislation:
- by the blood transfusion institution's hemovigilance correspondent and by the person authorized by the blood transfusion institution on the site attached to the blood transfusion institution in which the donor candidate has presented himself;
― by the regional coordinator of hemovigilance;
- by the French Blood Establishment or, as the case may be, the Blood Transfusion Centre of the Armed Forces;
― by the French Health Products Safety Agency.
In addition, the blood transfusion facility keeps data in the donor's folder, allowing the identification of the donor's severe adverse event card for access to the file via "e-FIT".
5. Supplementary report
When additional clarifications, other than those already included in the severe adverse event sheet, are required for the analysis of the serious adverse reaction, a supplementary report, prepared in consultation between the blood transfusion facility's hemovigilance correspondent and the regional hemovigilance coordinator, is transmitted to the French Health Product Safety Agency and the French Bloodshed Centre, or, as the case may be, to the French Health Products Agency Any supplementary report shall be retained as described in Chapter 4.
If a serious incident within the meaning ofArticle R. 1221-23 of the Public Health Code is associated with the occurrence of the severe adverse reaction, a serious incident record will be completed, and retained with the severe adverse event sheet as described in Chapter 4.
6. Annual report
The "e-FIT" application allows the French Health Product Safety Agency to establish automatically and as necessary an assessment of the serious adverse effects of blood donors in each blood transfusion institution. In addition, a summary of the annual report is provided each year as part of the annual state of activity of blood transfusion establishments defined by the Order of December 24, 2009, setting out the form and content of the annual activity status of blood transfusion establishments provided for in the Order of December 24, 2009Article R. 1223-8 of the Public Health Code.
A N N E X E I
INDEPENDENT EFFECTS AND THEIR GRADES
SELON LA SYMPTOMATOLOGY CONSTATEMENT
Grades 1 are set for information purposes.
Only grades 2, 3 and 4 must be declared, grade 4 corresponding to death.
| 1. Local adverse effects related to needle insertion | | | |
| 1.1. Vascular injury 1.1.1. Hematoma | Size less than 4 cm in diameter than its constitution, local treatment | Size greater than 4 cm in diameter than its constitution, local treatment | Specialised opinion |
| 1.1.2. Arterial punishment | NP (*) | Local salary | Specialised opinion |
| 1.1.3. Thrombophlebite | NP (*) | NP (*) | Specialised opinion |
| 1.2. Nervous injury 1.2.1. Directed by the needle | Symptomatology (pain, paresthesia) regressive in less than 2 weeks | Symptomatology (pain, paresthesia) regressive in 2 weeks to 1 year | Persistent symptoms after 1 year or requiring medical treatment |
| 1.2.2. Indirected by hematome | Symptomatology (pain, paresthesia) regressive in less than 2 weeks | Symptomatology (pain, paresthesia) regressive in 2 weeks to 1 year | Persistent symptoms after 1 year or requiring medical treatment |
| 1.3. Other local reactions related to needle insertion 1.3.1. Tender injury | No consequence | NP (*) | Medical treatment/specialized advice |
| 1.3.2. Local allergic reaction | No consequence | NP (*) | Medical treatment/specialized advice |
| 1.3.3. Local infection | No consequence | NP (*) | medical treatment/specialized advice |
| 1.3.4. Local pain | No consequence | NP (*) | Medical treatment/specialized advice |
| 2. General adverse effects | | | |
| 2.1. Disease 2.1.1. Immediate (on the donation site) | subjective symptoms only (fatigue, anxiety, unease, vertigo) | Short loss of knowledge, +/– accompanied (vomitments, loss of urine, convulsions) | Medical treatment/specialized advice |
| 2.1.2. Delayed (within 24 hours after donation, excluding donation site) | subjective symptoms only (fatigue, anxiety, unease, vertigo) | Short loss of knowledge, +/– accompanied (vomitments, loss of urine, convulsions) | Medical treatment/specialized advice |
| 2.2. Effects related to vascular injury 2.2.1. Pseudo-anévrysm of the Brachial artery | NP (*) | NP (*) | Medical treatment/specialized advice |
| 2.2.2. Arterial/venous | NP (*) | NP (*) | medical treatment/specialized advice |
| 2.2.3. Loge syndrome | NP (*) | NP (*) | medical treatment/specialized advice |
| 2.2.4. Thrombosis of the axillary vein | NP (*) | NP (*) | Medical treatment/specialized advice |
| 2.2.5. Deep vein thrombosis | NP (*) | NP (*) | Medical treatment/specialized advice |
| 2.3. Cardiovascular impairment occurring within 24 hours of the donation: Note. ― In the case that the ETS is informed of a cardiovascular attack that occurred beyond 24 hours, but has evidence of an accountability analysis, a statement will be made. 2.3.1. Chest angle | NP (*) | NP (*) | medical treatment/specialized advice |
| 2.3.2. Myocardial infarction | NP (*) | NP (*) | Medical treatment/specialized advice |
| 2.2.3. Brain vascular accident | NP (*) | NP (*) | Medical treatment/specialized advice |
| 3. Adverse effects related to the aesthetic procedure | | | |
| 3.1. diffuse allergic reaction | NP (*) | NP (*) | medical treatment/specialized advice |
| 3.2. Anaphylaxis | NP (*) | NP (*) | Medical treatment/specialized advice |
| 3.3. Hémolyse | NP (*) | NP (*) | Medical treatment/specialized advice |
| 3.4. Lung | NP (*) | NP (*) | Medical treatment/specialized advice |
| 3.5. Citrate response | Isolated paresthesia (one zone) and spontaneously regressive | Paresthesia interesting several zones OR regressing only after decrease in return speed of plasma | Intravenous medical treatment/specialized advice |
| 4. Other effects | | | |
| (*) Not relevant. | |||
You can consult the table in the
JOn° 180 of 06/08/2010 text number 40
You can consult the table in the
JOn° 180 of 06/08/2010 text number 40
Done at Saint-Denis on 1 June 2010.
J. Marimbert
