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Device licensing bodies sometimes put business before safety, an investigation finds

BMJ 2012; 345 doi: https://doi.org/10.1136/bmj.e7138 (Published 25 October 2012) Cite this as: BMJ 2012;345:e7138
  1. Zosia Kmietowicz1,
  2. Deborah Cohen2
  1. 1London
  2. 2BMJ

Some of the 76 “notified bodies” that are charged with evaluating the safety and reliability of clinical devices for use in the European Union have been exposed as being more interested in attracting business than guarding the safety of patients.

The BMJ and the Daily Telegraph conducted a “secret shopper” exercise to test the processes that notified bodies use for assessing devices on behalf of national and EU regulators.1 These are commercial enterprises and issue CE certificates (signifying compliance with European standards) for toys and toasters as well as medical devices.

For the exercise the BMJ and the Daily Telegraph created an imaginary, large diameter metal on metal hip prosthesis similar to an implant that was recalled after it was found to have unacceptably high failure …

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