§ Mr. FlynnTo ask the Secretary of State for Health if he will introduce a mandatory pilot test over long periods for new prostheses for hip and other joint replacement prior to their general use. [31372]
§ Mr. MilburnCurrent regulations do not require mandatory clinical testing of all new joint replacements. They require that all medical devices placed on the market after 14 June 1998 should bear the CE marking demonstrating that the device in question complies with the essential requirements for safety. For all joint replacement implants, clinical data will be part of the evidence required to demonstrate compliance. This information may be generated from a clinical trial of appropriate duration or from existing data on an equivalent product.
§ Mr. FlynnTo ask the Secretary of State for Health what proposals he has to evaluate the reliability of prostheses used in hip replacements over the past 15 years. [31370]
§ Mr. MilburnThe Medical Devices Agency (MDA) collates and evaluates data on the performance of hip replacements used in the United Kingdom via its adverse incident reporting and investigating system. Users of medical devices, including hip replacements, are requested to report problems associated with the use of the devices to the MDA adverse incident centre.