28 September 2012

The European Union (EU) has announced it wants to improve the rules regarding the safety of medical devices. The organisation made the announcement following the issues that occurred regarding breast implants last year. It emerged safety regulators had failed to stop substandard silicone breast implants manufactured by French firm Poly Implant Prothese being used on women, Reuters reports.It was discovered that poor EU regulations were partly to blame for the scandal and tougher controls on medical devices are now being called for to prevent anything similar from happening again. Products that will be affected by the changes include contact lenses, pregnancy testing kits, life support machines, pacemakers and implants, among many others. Currently, controls on medical devices are overseen by a network of 80 national assessment agencies, but as part of the proposals a new panel would be introduced to monitor these agencies. EU health commissioner John Dalli said at a news conference: They (the panel) would have the possibility to pick out medical devices on certain risk-based criteria to decide whether to go into an in-depth analysis of the processes. Among other main changes proposed is an extension of the current legal definition of medical devices to include breast and other aesthetic implants. Independent assessment agencies will be given greater powers to monitor device manufacturers, including unannounced factory inspections and regular product testing, while EU governments will be obliged to improve their supervision of the agencies. Better product traceability systems will also be introduced so that people can be rapidly alerted to safety concerns surrounding a particular device. The legislation must be jointly approved by EU governments and lawmakers, which could take up to two years. It is hoped this will be a positive step and ensure the safety of patients. Read the full story here: