Patients are let down by poor device regulation, warn surgeons

BMJ 2012; 345 doi: (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 representative of a Slovakian notified body in Hong Kong also said that he had never had an application for a medical device rejected.

The Royal College of Surgeons and the British Orthopaedic Association have said there should be an urgent crackdown on 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 healthcare 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.”

They said that “as a minimum” a mandatory database showing which surgical implants have been licensed for use—and on what basis—should be introduced. It is currently impossible to discover which regulatory body has certified a medical device for use.

The European Commission also admitted on 24 October that there were “weaknesses” in the regulatory system—but that tightening the rules might take “some time.”

The health secretary said that there was a “worrying and completely unacceptable weakness in the regulatory system” and ordered officials to introduce new safeguards.

The Daily Telegraph and BMJ launched a joint investigation into the pan-European system of licensing artificial hips and other medical devices amid widespread fears that the system was open to abuse.

Earlier this week, it was revealed that a notified body in Slovakia was prepared to approve a dangerous hip prosthesis, which means it could be sold across Europe.1

During the investigation notified bodies from Slovakia and Hungary were seen offering advice on how to market a device to make it more appealing to purchasers. They told undercover reporters to relabel non-EU products as made in Europe as it was better from a “marketing point of view.”2

The investigation also found that the South Korean office of a European notified body was offering expensive “consultancy” services—while also assessing whether products are safe to be licensed—to medical firms seeking approval. EU legislation bans notified bodies from offering both services.

“We only focus on how to help our clients,” said one executive at ITC in Seoul.

The executives added the company could offer a “one stop shop” and helped clients “increase profit.”

He said that although employees of the US Food and Drug Administration, who are government officials, often rejected products and were not keen to help manufacturers with their applications—private European notified body workers were keen to help.

Asked if European regulatory organisations wanted to help the medical companies, Lee from ITC replied: “Oh, yes, yes, yes.”

One executive also disclosed that the same people were working for the regulatory and consulting arms of the companies.

3eC, the official regulatory organisation in Slovakia, recommended that representatives of a fictitious Chinese manufacturer contact their “partner” in Asia. When reporters spoke to Vidduyt Bera from BS Services, which is based in Hong Kong, he said that he would assess the company’s application. He would then pass it to the office in Slovakia for final approval.

The client would pay him directly and then he would pay the regulator.

The “advantage” of using his services, instead of dealing with 3eC directly, was that the client “will come to know a lot of things in advance before it is done a final review” and therefore 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 was “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 employees of notified bodies to work as consultants because they should be “independent and impartial.”

The disclosures will add to concerns that the system of approving medical devices is lax and fails to protect patients adequately. Across 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 European Commission said: “The commission recognises that there are some weaknesses in the current regulatory framework and of course anything that jeopardises patients’ health or safety is unacceptable.”


Cite this as: BMJ 2012;345:e7221