Device licensing bodies sometimes put business before safety, an investigation findsBMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7138 (Published 25 October 2012) Cite this as: BMJ 2012;345:e7138
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 rates and to have released metal ions into patients’ blood. Reporters took a glossy brochure on the hip implant to 14 notified bodies in five countries and applied to get quotations for CE certification.
The investigation found that the notified bodies competed with each other on price and speed of certification, were prepared to accept low levels of evidence on the effectiveness of high risk devices, offered advice on how to get approval, and in some cases offered near guarantees of success. Some were happy to assess the hip despite having no experience with similar products.
One official told reporters that his body was “on the side of manufacturer and their products, not on the side of patients.”
Six of the bodies returned quotations ranging from €2750 (£2240; $3575) to €50 000 to process documents, and none said that they would not be prepared to approve the fake device. Only four raised any concerns that it was a hip implant, saying that these posed difficulties for the regulators.
The evidence that notified bodies required on the device varied, as did their post-marketing surveillance strategies and how factories are checked. Some said they could omit the biocompatibility tests, which assess how safe the materials are once inserted into the body. Others said that clinical investigations were not necessary, despite it being a high risk implant.
One official admitted that applications “don’t really fail”; another boasted that his body had “a 100% success rate.”
And despite EU legislation banning bodies from advising manufacturers how to get approval, the investigation found evidence that some do just that.
England’s health secretary, Jeremy Hunt, said that it was “completely unacceptable” that patients’ safety could be at risk from potentially dangerous implants. He said he would ask the UK Medicines and Healthcare Products Regulatory Agency and the British Orthopaedic Association to ensure that patients get the highest quality devices.
In an editorial accompanying the BMJ investigative feature, Peter McCulloch, reader in surgery at the University of Oxford, described the current EU rules for licensing medical devices as “fragmented, privatised, and largely opaque; safety is dealt with in an unsatisfactory way and efficacy not at all.”2
He said that the notified bodies “lie at the heart of the problems with the current system.”
McCulloch called for patient safety, not trade, to be at the centre of the system to regulate medical devices.
To achieve this, “agreement is needed on a universal set of clear and well understood standards of clinical evidence for regulators to apply,” he added. “Evidence should also be open to public scrutiny, in contrast to the current situation.” He said that devices—like drugs—should require evidence of efficacy as well as safety before being given a licence. Patients should be given new devices only as part of clinical trials. And like drugs, devices should have patent protection, which would serve two purposes: “to reduce the problem of poorly researched ‘me too’ devices seen in several areas while increasing the profitability of devices with good evidence of safety and efficacy.”
Cite this as: BMJ 2012;345:e7138