Recall of certain US tissue products

There is negligible health risk associated with this issue.

Bone graft material is used as filler material in orthopaedic surgery, for example in hip replacement operations or surgery on the jawbone.  Donated human bone is commonly used as a raw material for such products. 

In October 2005, the USA's Food and Drug Administration (FDA) issued a recall notice, advising clinicians in the USA to consider testing patients who had received affected tissues for certain diseases that should have been addressed by donor screening (including HIV, hepatitis and syphilis).  This advice was given in relation to the wide range of tissues sourced by BioMedical Tissue Services, many of which were distributed through tissue banks in the USA.  The FDA could not be sure that all the tissues supplied had undergone rigorous sterilization processes. 

For many tissues obtained for transplant, donor screening is an important way of ensuring that the risk to recipients from infectious diseases in minimised.  This is particularly important when tissues are used without processing, such as for heart transplants.  A wide range of tissues can be removed from deceased donors and the reliance on donor screening as a way of ensuring that risks are low varies considerably, depending on the tissue involved and how it is processed.

Production of bone graft material involves rigorous processing and sterilization, which removes potential sources of allergy or infection.  Thus the risk of infection from this product is no different from that of any other surgical implant, ie negligible.

The supplier of Bone Allograft, Plus Orthopaedics, and the tissue processor, Regeneration Technology Industries, have verified that all appropriate screening and processing steps were carried out with respect to bone sourced from BioMedical Tissue Services, thus confirming that the risk  is negligible.

The FDA’s advice had been passed on to affected hospitals by Plus Orthopaedics.  In order to clarify the actual risk associated with bone graft material, the MHRA and the National Assembly for Wales wrote to medical directors and chief executives of all trusts and private hospitals in England and Wales which had received notification from Plus Orthopaedics.  The purpose of this letter was to clarify the risk assessment and point out that screening for infectious diseases was unnecessary in the UK, so that clinicians could decide what advice they should give to their patients.

A copy of the MHRA letters and a list of hospitals contacted is at Annex A (122Kb).

The MHRA will continue to monitor the situation closely and provide a further update should additional health implications come to light.