§ Mr. Alan Howarth
To ask the Secretary of State for Health what(a) agency and (b) department was responsible for the purchase by the national health service of Bjork Shiley heart valves between 1979 and 1986; where these valves were delivered and centrally stored when imported; what records were kept detailing serial numbers of the valves and to which hospital batches of valves were despatched; what procedures, including record keeping were followed by them on the occasions when the manufacturers or distributors recalled certain valves; and what is his policy for making this information available to next of kin or other relatives of national health service patients who received an implanted Bjork Shiley heart valve in this period and subsequently died. 479W
§ Mr. Horam
Responsibility for the purchase of medical devices, including heart valves, rested with local health authorities and hospitals. The delivery and storage of imported valves was a matter for the United Kingdom sales office of the manufacturer, Shiley Inc, and information is not available centrally. Responsibility for keeping records of valves delivered to hospitals, and for implementing appropriate recall procedures rests with the manufacturer involved. As part of Shiley's recall of Bjork-Shiley convexo-concave heart valves, they provided advice to relevant cardiothoracic surgeons and cardiologists, which included list of serial numbers for valves delivered to their hospitals. The Department provided further independent advice to health service professionals across the UK to assist them in making informed decisions about patient management. Our policy remains that clinicians are in the best place to provide advice to individual patients and their next of kin, in the light of personal circumstances.