The European breast implant recall raises questions about the effectiveness of the European Union's CE Mark medical device approval process say critics of the process, according to a MassDevice report.
The CE Mark is often used as an example of a faster and more efficient review process than the FDA's, but this latest medical device recall reveals flaws in the process. Brian Toft, professor of patient safety at Coventry University in the U.K., has called the CE Mark "a smokescreen for faulty and dangerous devices that place patients at risk," the report said. Physicians at the European Society of Cardiology meeting in Paris last August said the approval process was too lenient in its review of potentially dangerous products.
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The CE Mark is often used as an example of a faster and more efficient review process than the FDA's, but this latest medical device recall reveals flaws in the process. Brian Toft, professor of patient safety at Coventry University in the U.K., has called the CE Mark "a smokescreen for faulty and dangerous devices that place patients at risk," the report said. Physicians at the European Society of Cardiology meeting in Paris last August said the approval process was too lenient in its review of potentially dangerous products.
Related Articles on Medical Devices:
FDA Clears Curos Disinfecting Port Protector
Covidien Recalls Duet Stapling System After Injuries, Deaths
FDA Misses Deadline in Conflict with Medical Device Makers Over Approval Process