Recall of Certain US Tissue Products

On 26 October 2005, it came to light that a tissue procurement company - BioMedical Tissue Services - in the United States had failed to adequately screen and document human cadaveric tissue donors. Affected tissue was recalled but a small number of the products had been exported to a recognised and respected UK supplier and implanted into a small number of patients, all of whom were traceable.

The suppliers of the products within the UK verified that all appropriate screening and processing steps were carried out with respect to tissue sourced from BioMedical Tissue Services. Since this includes validated viral inactivation and sterilization processes, there is negligible risk of infection with the conditions normally addressed by the donor screening programme.  

The technique used in preparing bone samples for grafting destroys bacteria and viruses making the risk of infection from the grafts extremely low and of a similar magnitude to those normally supplied.

In Wales, the tissue product concerned (Bone grafts) was used by three hospitals, University Hospital of Wales and Llandough hospital within Cardiff and Vale NHS Trust and BUPA Cardiff. We understand that up to 15 patients are involved in Wales.

In light of the Food and Drugs Administration in America (FDA) guidance in October 2005, the Welsh Assembly Government together with Medicines and Healthcare products Regulatory Authority (MHRA) wrote to Medical Directors and Chief Executives of all trusts and private hospitals that received affected tissue to clarify the risk assessment so that clinicians could make a clinical judgement what advice they should give to their patients.

Initial press interest in this issue was rekindled when it was found that one of the bodies used by Biomedical Tissue Services was that of the former BBC correspondent Alistair Cooke. On 13 July 2006, MHRA received an FOI request from the BBC seeking the names of trusts and private hospitals that received this material in the UK, this information was released on 20 September 2006.

The supply of tissues and cells is heavily regulated within the UK through the EU Tissues and Cells Directive and the Human Tissue Act 2004 which both came into force this year. Within the next few months, the Human Tissue Authority will be issuing a Code of Practice which will set out practical guidance for establishments importing and exporting human bodies, body parts and tissue, including those storing tissue for transplantation (human application).

This matter is subject to a criminal investigation in America and the FDA announced in August the formation of a multidisciplinary task force on human cell and tissue safety. There is no evidence that the tissue received by patients in the UK is directly linked to the criminal investigation but rather was supplied by the American company which is subject to investigation.