§ Mr. CousinsTo ask the Secretary of State for Health what steps she is taking to improve the quality of radiotherapy equipment.
§ Mr. SackvilleThe performance of radiotherapy equipment should be defined, as part of the specification, when the equipment is purchased from the manufacturers. It is the user's responsibility to ensure that performance is maintained to meet current treatment requirements.
All medical devices should be purchased from manufacturers who manufacture to a recognised quality assurance system. Such QA systems include those which comply with BS 5750, ISO 9000, BS EN 29000. The Department's medical devices directorate operates a manufacturers registration scheme to register manufacturers whose QA systems have been audited by MDD.
198WThe Department recommends that all medical devices are managed according to the principles of the document Health Equipment Information 98 "Management of medical equipment and devices", November 1990. This gives advice on, selection, acceptance testing, training, servicing and replacement, amongst other things. Copies will be placed in the Library.
From 1 January 1995, the medical devices directive takes effect for new medical devices placed on the market. All medical devices covered by the directive will need to carry a CE mark to denote compliance with the essential requirements as defined in the directive by 1997.