§ Mr. RedmondTo ask the Secretary of State for Health what reviews or legislation he is undertaking to ensure that sphygmomanometers satisfy the accuracy requirements of international recommendation No. 16—manometers for instruments for measuring blood pressure (sphygmomanometers); and if he will make a statement.
§ Mr. DorrellA recent limited local survey suggested a high risk of inaccuracy beyond the standard laid down in the OIML international recommendation 16. The Department has asked for details of the survey to be provided and we look forward to receiving them. On the evidence currently available, however, we believe that the inaccuracies reported by the survey are more likely to arise from user error or misuse, or from inadequate maintenance or recalibration, than from faulty design or manufacture. The Department is therefore planning to update and reissue standing guidelines on use and 41W maintenance of sphygmomanometers. In addition, the British standards for mercury and aneroid instruments have recently been updated as a further point of reference and now reflect the international recommendation. EC directives are planned for implementation from January 1993 which will set minimum standards of essential requirements for marketing medical devices of this kind within the single European market.