Human Tissue Authority

The regulator for human tissue and organs

Regulatory alert 001/2015 - West Nile Virus

7 December 2015 update: The French Competent Authority issued an update to itsalert. The update noted that additional precautions taken in France following detection of this case of West Nile Virus in October 2015 were no longer in force.

Issued 27 November 2015

Notice for 

•    Designated Individuals in the Human Application sector 
•    Licence contacts in the Organ Donation and Transplantation sector 

regarding Rapid Alert on Substances of Human Origin, related to diagnosis of West Nile Virus in an individual in an area of mainland France, issued by the French Competent Authority.

Scope

This alert is being issued by the Human Tissue Authority (HTA) as designated Competent Authority for the purposes of the European Union Tissue and Cells Directives (2004/23/EC, 2006/17/EC and 2006/86/EC), brought into law by The Human Tissue (Quality and Safety for Human Application) Regulations 2007 and the European Union Organ Donation Directive (2012/53/EC), brought into law by the Quality and Safety of Organs Intended for Transplantation Regulations 2012 (as amended). Please circulate this information to staff within your establishment undertaking activities which may be affected by this notice.

Issue

The French Health Ministry created an alert on the EU Rapid Alert on Substances of Human Origin platform on 11 November 2015 advising that an individual has been diagnosed as infected with West Nile Virus (WNV) in the city of Nimes, department of Gard, Languedoc-Rousillon region of France.

Action taken by the HTA

The HTA has issued this alert to all UK establishments that handle human tissues and cells for human application, and retrieve or implant solid organs for transplantation, to raise awareness of potential WNV transmission from donors to recipients.

Actions for establishments

The HTA has previously issued guidance about WNV following an earlier regulatory alert in 2008. The Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) has also produced a position statement on WNV and solid organ transplantation.

Establishments in the human application and organ transplantation sectors are advised to continue to exercise vigilance for donors who have returned from travel in a WNV risk area during the summer months. Human application establishments should also be vigilant when importing tissues and cells from WNV risk areas.

Please contact the HTA on 020 7269 1900 or email us if you would like any further advice on any of the above points or you are processing tissues and cells which you think may be affected.

 

Audience: