Report on the Rapid Alert system for human Tissues and Cells 2010 – 2012
The Rapid Alert system for human Tissues and Cells (RATC) was initiated to provide the Member States Competent Authorities for Tissues and Cells and the European Commission with an effective and secure tool for the exchange of information and urgent measures related to human tissues or cells transferred across borders for patients undergoing transplantation and medical procedures involving such products.
This system is used in parallel with national vigilance systems which collect and manage alerts on human tissues and cells donated and used within a Member State.
RATC system does not include rapid alerts for human or veterinary medicinal products, blood and blood components, human organs intended for transplantation, or medical devices. However, where precautionary/corrective actions taken in these sectors are relevant also to the tissues and cells intended for human application or vice versa, an exchange of information with the national and European regulatory authorities responsible for these sectors should be ensured.
The RATC system was developed in December 2009 with the designation of the national representatives/contact points of Competent Authorities and the drafting of the RATC Standard Operating Procedures (SOP). In early 2010 a pilot phase followed with a series of case studies to test the functionality and reliability of the system. The latter step included an evaluation phase in which the procedures and templates were improved according to the users' feedback.
The RATC system was officially launched after the meeting of the Competent Authorities for Tissues and Cells in July 2010.
It was established earlier by the Member States and the European Commission that any rapid alert encoded in the RATC system should fulfill the following criteria:
- requires immediate/urgent consideration or follow up measures in two or more Member States
- Risk: a known or potential risk to patients;
- Severity: issues (quality and safety defects, illegal and fraudulent activities, notifications from other sectors, outbreaks of communicable diseases) of a serious or potentially serious nature;
- Public health implications: may constitute a public health risk to other countries
Four types of rapid alerts were defined:
- Quality and Safety Defects: alerts requiring field corrective actions: of the concerned human tissues/cells potentially impacting patient safety in other Member States.
- Information Notices: alerts related to field corrective actions performed by the medical device sector, medicinal products sector or other relevant sector(s).
- Illegal and fraudulent activities: alerts used to notify Member States and the Commission of the possible presence in the distribution network of tissues or cells resulting from illegal and fraudulent activities
- Epidemiological Notices: alerts related to the development of significant epidemiological situations (e.g. disease outbreaks) which may have cross-border implications in the field of tissues and cells intended for human application.
Rapid alerts reported in 2010-2012
Between 2006 and July 2010, there have been 11 rapid alerts related to tissues and cells, of which 6 related to quality and safety defects and 5 referred to outbreaks of communicable diseases
Between July 2010, and until 31 December 2012, there were 19 rapid alerts uploaded into the system:
- 7 Quality and Safety Defects
- 4 Information Notices related to medical devices
- 2 Communications regarding illegal and fraudulent activities
- 6 Epidemiological Notices
The alerts led to the following types of preventive/corrective actions:
- Quarantine and/or recall of tissues and cells with quality and/or safety defects;
- Recall or replacement of medical devices
- Raising awareness about potential illegal and fraudulent activities in this sector.
- Risk analysis and appropriate recommendations for donors travelling from/residing in the regions where outbreaks of communicable diseases were reported.
For more information:
http://ec.europa.eu/health/blood_tissues_organs/docs/ratc_report_2008_2012_en.pdf
