§ Mr. Austin Mitchell
To ask the Secretary of State for Health when the class I recall, issued in the United States of America on the Edwards-Duromedics heart valve, 413W reached his Department; what action was taken as a result; and when and what warnings were issued to general practitioners about the hazards of the valve.
§ Mr. Freeman
The Department became aware on 17 May 1988 that the manufacturer had arranged a voluntary recall in the USA. Urgent arrangements were made for a meeting in this country on 19 May 1988 between the manufacturer and the Department of Health medical and technical staff. This led to agreement to the company issuing a letter on 25 May 1988 to all implanting centres and known United Kingdom purchasers of the specified heart valves with instructions to inform appropriate medical staff of the need to discontinue use for new patients and ensure very careful monitoring of patients currently using them. Guidance was also given on diagnosis and treatment. After further independent evaluation of various types of valve in Sheffield the Department subsequently issued a "Dear Doctor" letter on 19 August 1988 to all consultant cardiothoracic surgeons and cardiologists in the United Kingdom, covering the question of valve failure. Since 1986 the Department has been funding a heart valve registry based at the Hammersmith hospital to monitor usage and failures in use in the United Kingdom.