§ Mr. AshleyTo ask the Secretary of State for Health what procedures are in place to co-ordinate warnings to(a) cardiac specialists, (b) district general hospitals, (c) general practitioners and (d) patients fitted with suspect valves in cases where a fault is identified in a specific make of valve.
§ Mr. DorrellHospitals and manufacturers of such devices are required to report incidents involving defective or potentially defective devices to the Department's national defect reporting centre for investigation by appropriate technical experts. Where a risk to patients or staff is identified, appropriate advice is issued and other action taken if required. The basis of circulation of such advice is considered in each particular case, on its merits.
§ Mr. AshleyTo ask the Secretary of State for Health what controls there are over the range of heart valves which may be purchased by the National Health Service.
§ Mr. DorrellThis is a matter for the health authority concerned. The Department advises authorities to purchase from manufacturers registered under its manufacturer registration scheme or equivalent scheme of manufacturing quality assurance.
§ Mr. AshleyTo ask the Secretary of State for Health how many companies supply artificial heart valves to the National Health Service; and in which countries these companies are based.
§ Mr. DorrellCurrently nine companies supply heart valves to the United Kingdom National Health Service. Their manufacturing sites are based in the USA, Switzerland, Puerto Rico, Canada, Italy and the United Kingdom.
§ Mr. AshleyTo ask the Secretary of State for Health (1) if he will request the Medicines Commission urgently to establish a licensing system for artificial heart valves and other specialised devices used for medical purposes;
(2) if the Medicines Commission has considered the need to license and monitor the use of artificial heart valves.
§ Mrs. Virginia BottomleyUse of heart valves in the United Kingdom is monitored since 1986 by the national heart valve registry at Hammersmith hospital. The Medicines Commission has expressed concern about certain products, including critical medical devices such as heart valves, but accepts that adequate provision for the necessary controls should be pursued through the current European Commission initiatives for the harmonisation of regulation of these devices.
§ Mr. AshleyTo ask the Secretary of State for Health if any heart valves which have been refused licences in the United States of America have been used by the national health service.
§ Mr. DorrellWe are aware of two United States manufactured heart valves used in the National Health Service where marketing approval in the United States of America was withheld, pending receipt of further clinical data.
§ Mr. AshleyTo ask the Secretary of State for Health in the last year for which figures are available how many yellow cards were received reporting failures of artificial heart valves.
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§ Mr. DorrellMedical devices such as heart valves are not included in the "yellow card" reporting system. However, the Department's national defect reporting centre for medical device incidents has received four reports of mechanical failure of heart valves in the last 12 months.
§ Mr. AshleyTo ask the Secretary of State for Health how many British heart patients died because of a faulty artificial heart valve in the last five years for which figures are available.
§ Mr. DorrellWe are aware of 15 deaths in the United Kingdom in the last five years due to mechanical failure of implanted valves. All were implanted prior to the setting up of the United Kingdom heart valve registry in January 1986.
§ Mr. AshleyTo ask the Secretary of State for Health if the European Economic community has put forward any proposals to control the use of artificial heart valves.
§ Mr. DorrellAn EC working document is in preparation which is intended to lead to a directive to harmonise the regulation of all non-powered medical devices, including heart valves.
§ Mr. AshleyTo ask the Secretary of State for Health approximately how many artificial heart valves are fitted annually; and what is the estimated percentage that are successful.
§ Mr. DorrellAbout 5,000 artificial heart valves are implanted annually in the United Kingdom, 94 per cent. of these patients survive surgery and leave hospital.