January 18, 2012
The scandal of substandard breast implants placed in thousands of British women is symptomatic of a wider regulatory failure affecting all medical devices, an expert on patient safety said yesterday.
Brian Toft, professor of patient safety at Coventry University, warned ministers last July that the CE mark which certifies that a product such as a hip joint or breast implant reaches the European quality standard was seriously flawed and did not protect patients.
There were 113 alerts issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) about medical devices last year, ranging from hip joints to surgical instruments, but the agency has no power to check devices until a failure is reported.
In a meeting with Simon Burns, the Health minister, on 13 September, Professor Toft said CE marks were allocated to medical devices on the basis of “design specifications” without checks on whether the devices were “being made in the way they should be made”.