Volume 1: Findings and Conclusions
7. Medicines and cosmetics
Medical devices

865 Devices such as heart valves and pericardium patches were not covered by the Medicines Act. When BSE emerged, they were the responsibility of the Procurement Directorate (PD) of the National Health Service (NHS), which operated a voluntary registration scheme for manufacturers. The purchasing power of the NHS gave it considerable leverage over manufacturers. The need to consider this type of product in relation to BSE was not recognised until February 1989. Thereafter officials in PD lost no time in issuing guidelines that paralleled those issued to manufacturers of human and veterinary medicines (see below). Volume 7 recounts the actions they took on the products thought to carry risk. The last two such products were dealt with in early 1990 - one company had come into line with the guidelines by January 1990, while the other, after unsuccessfully attempting to find alternative material, ceased production of its device in April and recalled stocks. The response of PD was prompt and adequate.