Faulty medical implants investigation: Regulators’ trail of deception has been exposed, says chairman
Andrew Miller, the chairman of a parliamentary select committee investigating the sub-standard regulation of medical devices in Britain, has said that a “trail of deception” has been exposed in the system.
9:57PM BST 23 Oct 2012
Mr Miller, the chairman of the science and technology committee, said that features of the system were “wrong” and that patients were “clearly entitled” to a process which guaranteed the safety of products being “inserted into their body”.
The committee is preparing to publish a report into the regulation of medical devices in the coming days which is expected to call for a sweeping overhaul of the system.
In the wake of The Daily Telegraph’s disclosures about loopholes in the system, dozens of patients and doctors contacted this newspaper to demand immediate reform.
Mr Miller said that the investigation had exposed behaviour that is “not within the current spirit of the regulation and my judgment of that is it is not within the legal interpretation of the regulation”.
He said that the companies which regulated the approval of medical devices should be focusing on protecting the patient.
The Labour MP said that the issue of “forum shopping” — where a manufacturer approaches multiple regulators until they achieve approval of their product — was “clearly wrong”.
He said: “It is clearly wrong that if one notified body turns down a hip replacement, then a company can go to a less reputable regulator and get the green light for CE certification.”
Mr Miller also said that the system needed more transparency so the public could make informed choices about their treatment.
“The patient is entitled to know everything possible about something that is being inserted into their body, and that it has been made in a safe environment, that it has been safely designed and is accepted by clinicians as the right thing for you.
“The way the current regulation is framed, you are, to say the least, short of information.”
Industry representatives also admitted that the system of approval needed to be reformed. Dan Jones, a spokesman for the Association of British Healthcare Industries, said: “We’ve known for some time that certain notified bodies do not operate to the same high standards as others and we’ve raised this issue with the European Commission and Medicines and Healthcare Products Regulatory Agency.
“The Telegraph article has highlighted the variation between notified bodies [which assess product standards] around Europe and we want to see this sorted out. There needs to be better control over how an organisation becomes a notified body as well as better monitoring to check the standards they are applying to manufacturers when assessing products.”
The view was shared by people who have experienced problems from the use of metal-on-metal hip implants.
Chris Morley, 65, a retired project manager from Bradford, said that the regulation system was “broken”.
Mr Morley had a metal-on-metal implant fitted in Sept 2010, but the device snapped in Jan 2012 when he was packing to go on holiday. “When you have a hip implant you expect it to last and cope with a certain amount of stress, not break so quickly,” he said.
Mr Morley said that patients needed to know what tests products had gone through and who certified them.
“As has been exposed, the notified bodies have become too close to manufacturers, they are too cosy. The problem is the process is not robust,” he said.
“When things go wrong, you need a robust process in place to investigate that cause of the failure.”
- Faulty medical implants investigation: Patients at risk from flaws in medical device rules, admit EU chiefs – Telegraph (earlsview.com)
- Dodgy medical implants getting approved – EasyBlog (earlsview.com)
- Faulty medical implants investigation: Surgeons’ letter to the Telegraph – Telegraph (earlsview.com)
- Faulty medical implants investigation: ‘We can help you label it European so China is not on packaging’ – Telegraph (earlsview.com)
- UK – Jeremy Hunt: I will not tolerate British patients being put at risk – Telegraph (earlsview.com)
- Faulty medical implants investigation: Patients at risk from flaws in medical device rules, admit EU chiefs (telegraph.co.uk)
- Faulty medical implants investigation: Patients being put at risk by implants scam, says Jeremy Hunt (telegraph.co.uk)
- Hip implant probe sparks call for better NZ system (radionz.co.nz)
- FINALLY – New rules to end secrecy over safety of medical implants – Telegraph (earlsview.com)
- Faulty medical implants investigation: Patients failed by poor implant regulation, say surgeons (telegraph.co.uk)