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Patients are let down by poor device regulation, warn surgeons

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7221 (Published 25 October 2012) Cite this as: BMJ 2012;345:e7221
  1. Deborah Cohen
  1. 1BMJ

Patients are being “failed” by the poor regulation of hip prostheses and other medical devices, which is potentially allowing dangerous products onto the European market, the Royal College of Surgeons warns today.

In a letter to the Daily Telegraph the college and the British Orthopaedic Association warn that revelations in a joint BMJ and Daily Telegraph investigation about the system are a “stark reminder” of the “urgent need to address the regulatory flaws.”

The investigation today discloses that the regulation of European medical products is also being “sub contracted” to Asian firms.1

One of the firms (ITC), based in Seoul, said that it had a 100% success rate and “there was no case . . . which [is] rejected.”

Executives at the firm, the official Asian representative of a Czech notified body, said that companies should apply for European market access as it was far easier to gain entry than into other countries, such as the United States, South Korea, and Japan.

Asked by undercover journalists why his firm’s services should be used, the company executive rubbed his fingers together and said “money…the profit.”

Another …

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