Faulty Medical Implants Investigation: Patients Failed by Poor Implant Regulation, Say Surgeons
Patients are being "failed" by the poor regulation of artificial hips and other medical devices, which is potentially allowing dangerous products to be used in Britain, the Royal College of Surgeons warns.
In a letter to The Daily Telegraph, the Royal College and the British Orthopaedic Association (BOA) warn that this week's revelations about the system are a "stark reminder" of the "urgent need to address the regulatory flaws".
A joint investigation by this newspaper and the British Medical Journal discloses that the regulation of European medical products is also being "sub-contracted" to questionable Asian firms.When asked by undercover journalists why the European Union certification system was so attractive, an executive at one firm, based in Seoul. rubbed his fingers together and said "money". Another representative of the Slovakian regulatory body in Hong Kong also boasted that he had never had an application for a medical device rejected.
In a letter to today's Daily Telegraph, the Royal College and BOA demand urgent regulation to stop the unacceptable practices. "Your investigation into the regulation of medical devices is a stark reminder that the governance of these medical implants continues to fail patients," they said. "New surgical devices, and the techniques required to implant them, must be regulated so that they can be safely introduced into our health care system and monitored in the long term.
"Jeremy Hunt [the Health Secretary] is right to highlight the urgent need to address the current regulatory flaws so we can protect patients."
The institutions said that "as a minimum" a mandatory database showing which surgical implants have been licensed for use, and on what basis, should be introduced. Currently, it is impossible to find which regulatory body has licensed a medical device for use.
The European Commission also admitted last night that there are "weaknesses" in the regulatory system, but that tightening the rules may take "some time".
Yesterday, Mr Hunt said that there was a "worrying and completely unacceptable weakness in the regulatory system" and ordered officials to introduce British safeguards.
This newspaper launched the joint-investigation into the pan-European system of licensing artificial hips and other medical devices amid widespread fears that the procedure is open to abuse.
Earlier this week, it was disclosed that British patients' health is being put at risk because some European regulators were prepared to license potentially dangerous medical implants.
Official regulatory bodies in Slovakia and the Czech Republic were prepared to approve a "toxic" hip replacement which means it could be sold to the NHS and legally used in unsuspecting British patients, the investigation found.
Hungarian regulators were exposed offering advice on how to re-label potentially dangerous devices made in China so that patients thought they were manufactured in the EU.
It can now be disclosed that the South Korean office of a Czech regulator is offering expensive "consultancy" services, while also assessing whether products are safe to be licensed, to medical firms seeking approval. EU rules ban regulators from offering both services.
"We only focus on how to help our clients," said one executive at ITC in Seoul. It was also uncovered that 3eC, an official regulatory organisation in Slovakia, recommended that representatives of a fictitious Chinese manufacturer contact their "partner" in Asia.
When undercover reporters spoke to him, Vidyyut Kr Bera from BS Certification Services, which is based in Hong Kong, he said that he would assess the company's application before passing it on to Slovakia for final approval. He said that the "advantage" of using his services was that there were "high chances that the file will pass in one attempt".
The practices were condemned by experts and the European Commission last night. Peter McCulloch, a clinical reader in surgery at Oxford University, said that regulators offering consultancy services is "clearly a blatant conflict of interest, and it is difficult to see how it could be ethically justified".
The European Commission said it was against the rules for regulators to work as consultants because they should be "independent and impartial".
Throughout Europe, more than 70 notified bodies, private firms charged with authorising medical devices, are competing for business leading to fears that sub-standard products are being authorised.
A spokesman for the commission said: "The commission recognises that there are some weaknesses in the current regulatory framework and, of course, anything which jeopardises patients' health or safety is unacceptable."
Holly Watt and Claire Newell - telegraph.co.uk
