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BMJ and Daily Telegraph's fake hip exposes failing European device regulation
Date:10/25/2012

A joint investigation by the BMJ and Daily Telegraph has exposed the major flaws in the current EU system used for regulating medical devices, such as hip replacements and breast implants.

It reveals that some "notified bodies" (the agencies charged with assessing how safe medical devices are before they are sold) are more interested in attracting business than safeguarding patients.

Undercover reports created a fake large diameter metal on metal total hipcalled the Changi TMH (Total Metal Hip)that was based on a device which has been recalled globally for safety reason. .

The hip was presented to 14 notified bodies in five countries and undercover reporters applied to get quotations for CE certification.

The dossier created for the Changi TMH said that tests had shown it produced potentially toxic levels of metal ions in the bodyhowever; it was passed as having an acceptable design for use in patients across Europe.

The investigation found some notified bodies are more concerned with repeat business and making profits than the safety of their patients. In fact, an official from ITC, one of the notified bodies in the Czech Republic, admitted that it is "one the side of [the] manufacturer and their products, not on the side of patients" but when later questioned said it was "in full accordance with the law".

It was also discovered that agencies compete for business based on price, speed and promised rates of successful certification. Prices for a coveted CE certificate cost between 2,750 and 50,000 and there are further costs charged for annual checks. With over 500,000 medical devices on the market, competition is therefore rife.

An employee of a Turkish notified body said it is a "money making business" with notified bodies dropping their standards to attract further work. Hip implants are classed as one of the most high risk devices and should therefore be subject to the most rigorous p
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Contact: Stephanie Burns
sburns@bmjgroup.com
44-020-738-36920
BMJ-British Medical Journal
Source:Eurekalert

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