Issued 10 October 2008
Sent to all establishments licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007.
This alert is being issued by the Human Tissue Authority (HTA) in its role as Competent Authority under the European Union Tissues and Cells Directives. The Directives have now been implemented into UK law via the Human Tissue (Quality and Safety for Human Application) Regulations 2007.
The HTA has received a rapid alert from the European Commission (EC) advising of two patients with West Nile Virus (WNV) infection in the Bologna and Ferrara districts of Italy in the past few days. Both patients developed meningoencephalitis. Infections had previously been noted in horses, cows and magpies in the area (see Eurosurveillance, Volume 13, Issue 39, 25 September 2008; and Volume 13, Issue 41, 09 October 2008).
The Italian authorities have introduced control measures for all potential donors of organs, tissues and cells from the affected areas, including precautionary screening to exclude infection.
There is no evidence of the virus in the UK (surveillance in humans, birds and mosquitoes is ongoing) although antibodies have been detected in migratory birds.
This alert is to ensure that all establishments:
are aware of the recent reports of West Nile Virus and can update their donor selection and evaluation criteria accordingly;
are aware of their obligations to ensure appropriate donor selection criteria are in place;
are aware of their obligations to report Serious Adverse Events and Serious Adverse Reactions to the HTA.
Action taken by the HTA
The HTA has issued this alert to all establishments that handle human tissues and cells intended for human application in the UK.
Actions for establishments licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007
Any establishment procuring allogeneic tissue is advised that donor history enquiries include any overnight stays in the Italian provinces of Bologna and/or Ferrara during the previous 28 days. Where there is information that a potential donor has visited one of these districts, further testing for WNV should be carried out, or the donation deferred for 28 days.
Establishments importing tissue and / or cells from Italy should exercise vigilance with regards donor information and test results, although control measures have been brought into force.
Affected donors and any recipients should be identified and any subsequent suspected serious adverse events or reactions reported to the HTA.
This alert will remain in force from 10 October 2008. Establishments should refer to the HTA website for updates.
Ongoing advice and guidance
Establishments are reminded that under HTA Directions 001/2006 (Annex A):
- Selection criteria for donors are based on an analysis of the risks related to the application of the specific cells / tissues. Indicators of these risks must be identified by physical examination, review of the medical and behavioural history, biological testing, post-mortem examination (for deceased donors) and any other appropriate investigation.
- Donors must be excluded from donation if there is evidence of any risk factors for transmissible diseases on the basis of a risk assessment, taking into consideration donor travel and exposure history and local infectious disease prevalence.
- The same exclusion criteria for allogeneic living donors must be applied as for deceased donors.
Please contact the HTA on 020 7269 1900 or email firstname.lastname@example.org if you would like any further advice on any of the above points or you are storing tissue which you think may be affected.
Further guidance in relation to your obligations under the European Union Tissues and Cells Directives as implemented by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 can be found by referring to HTA Directions 001/2006, 002/2007 and 004/2007.
We issued an update on this alert in our April 2009 e-newsletter:
Update on HTA regulatory alert 003/2008 on West Nile Virus
We previously issued a regulatory alert (003/2008) to inform human application establishments of an outbreak of West Nile Virus in Italy. With the decrease of mosquito activity in the winter months, the risk of human exposure to mosquito bites is very low and precautionary measures have been reduced by the Italian authorities. More information about this issue is available on this website.