As the European Commission's proposed measures for new medical device regulations go through the European Parliament, a sting operation engineered by the Telegraph and British Medical Journal has put the spotlight on "unscrupulous EU regulators" and "loopholes in the woeful EU system to approve devices." The undercover investigation involved submitting a formal application to Notified Bodies in Slovakia and the Czech Republic for a hip implant modelled after a metal-on-metal device banned in the United Kingdom. The Slovakian organisation was prepared to offer provisional approval for the design, while the body in the Czech Republic was considering licensing the product, reports the newspaper.
The hip implant was designed by medical experts for the purposes of the investigation, writes the Telegraph, with specifications similar to the Depuy ASR XL Acetabular System, which was recalled in 2010. Reporters submitting the technical dossier posed as representatives of a Chinese company seeking to market the implant on the EU market. A representative of the Slovakian NB reportedly told them that the organisation could not give "exact advice" but would just "cross the line and say just do this and it will be OK. Therefore we have so high rate of successful certification [sic]." A representative of the Czech NB is said to have told reporters that it would not put obstacles in the way and that it was "on the side of the manufacturer . . . not the patient."
Metal-on-metal implants have been shown to produce microscopic metal debris that can lead to soft tissue and bone damage around the hip joint, sometimes requiring revision surgery. In March 2012, British experts at the world's biggest artificial joint registry said doctors should stop using metal-on-metal hip replacements.
Commenting to EMDT on the sting operation, medico-legal specialist Erik Vollebregt says, "this is exactly what the European Commission asked the member states to look at a year ago in [former Commissioner of Health] Dalli's action plan. To me this is proof that the Commission's planned shake-out of bad NBs is necessary (the good NBs are also convinced of this), but that the member states must play their role and take responsibility and monitor the NBs they accreditate much more closely."
The new medical device regulations that are now going through Parliament include stricter control of Notified Bodies and a number of other measures that tighten regulatory requirements, notably a much-debated scrutiny procedure that much of industry opposes. Some of those measures were introduced to assuage public concerns arising from the Pip implant scandal that erupted earlier this year.
What impact will this new scandal have on the regulation? Tell us what you think.