HC Deb 30 April 2002 vol 384 cc769-70W
Mr. Hunter

To ask the Secretary of State for Health if it is his policy that heart valve replacements which have been manufactured in the United States of America may be used by the NHS before they have been approved by the Food and Drug Administration in the USA. [51428]

Ms Blears

[holding answer 19 April 2002]: Artificial heart valves manufactured in the USA (or elsewhere) may be used by the national health service if they bear the CE marking, which indicates that they comply with European "essential requirements" for safety, quality and performance. Valves which do not bear the CE marking can also be used (on a restricted basis) as part of controlled clinical trials. Approval by the US Food and Drugs Administration is not a prerequisite for the use of artificial heart valves by the NHS, regardless of their country of origin.

Mr. Hunter

To ask the Secretary of State for Health what tests his Department carried out on the St. Jude 'Regent' range of valves prior to their use by the NHS; and when the St. Jude 'Regent' range of valves were first used by the national health service. [51430]

Ms Blears

[holding answer 19 April 2002]: My Department did not carry out any tests on the St. Jude 'Regent' range of artificial heart valves prior to their use by the national health service, because the valves were affixed with the CE marking, indicating that they complied with European "essential requirements" for safety, quality and performance. The valves received CE marking on the basis of an assessment of technical information relating to their design and safety evaluation by a Notified Body (an independent third party assessment organisation). The St. Jude 'Regent' range of artificial heart valves was first available for general use by the NHS in 1999.

Mr. Hunter

To ask the Secretary of State for Health what tests his Department carried out on the St. Jude Silzone coated mitral valve prior to its use by the NHS; and when the St. Jude Silzone coated mitral valve was first used by the national health service. [51429]

Ms Blears

[holding answer 19 April 2002]: The Department did not carry out any tests on St. Jude Silzone coated mitral artificial heart valves prior to their use by the national health service, because the valves were affixed with the CE marking, indicating that they complied with European "essential requirements" for safety, quality and performance. St. Jude Silzone coated mitral artificial heart valves were first available for general use by the NHS in 1997.