(2) how many CE-marked medical products have subjected by his Department to efficacy and safety validation procedures in addition to those performed by manufacturers in (a) 2007, (b) 2008 and (c) 2009 to date.
The Medicines and Healthcare products Agency (MHRA) which is the Competent Authority in the United Kingdom for medical devices does not approve medical devices designed to ensure the safety of blood before they are placed on the market. Manufacturers of such medical devices must meet the relevant essential requirements in the Medical Devices directives prior to signing a declaration of conformity and CE marking their products.
Such higher risk medical devices must obtain an EC Certificate of Conformity from a Notified Body as part of this conformity assessment process. As such MHRA has not carried out any safety or validation procedures on any CE marked medical devices in addition to those carried out by the manufacturer. Since the UK Blood Service has a legal responsibility to ensure the quality and safety of blood products, the Advisory Committee on the Microbiological Safety of Blood, Tissues and Organs (MSBTO) also recommended that clinical trials be carried out, using blood which had been subjected to prion filtration. The independent Advisory Committee on the Safety of Blood, Tissues and Organs replaced MSBTO in 2008.
The Government's independent expert scientific committee on variant Creutzfeldt-Jakob disease (and other transmissible spongiform encephalopathies), the Spongiform Encephalopathy Advisory Committee, recommended that the UK Blood Service should commission an independent validation of such products. The UK Blood Services have commissioned an independent assessment of the efficacy of the filter.
Quality studies on filtered blood are being conducted in accordance with UK Blood Service guidelines.
The need for safety studies was endorsed by the Advisory Committee on the Microbiological Safety of Blood, Tissues and Organs in 2006.