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.
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.” A CE mark shows that a product conforms with European directives.
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.”
How the British bureaucracy works
Whenever I catch a spokesman on the radio whose salary comes out of the “public purse”, ie my wallet and yours, and who is defending a controversial decision to pay the new “Head of Talk” or “Head of BBC Trust” (or whatever it is they call the Director-General now) a high-Roman opulence of salary and perks, his reasoning is always the same.
Staggering salaries are a necessary evil at the BBC (or at Ofqual or Ofsted, or anywhere else in the public sector) because these humongously well-paid public servants would earn much, much more if they worked in the private sector. Sometimes, as the defender of the day goes on and on, defending the indefensible decision of the day, I catch myself thinking: “Ooh, I wish I worked in the private sector…”
Until I remember that I do; and always have, throughout my life, except for one short stint when I left a posh glossy for the Radio Times simply because the BBC literally doubled my salary. When I opened the letter that said “You got the job”, I fell on the floor laughing hysterically. It wasn’t a job – it was a six-month contract – but I was paid my erstwhile annual salary for the six months. And the next six! And the next! I only stayed a year and a half because I didn’t like all the low-level corruption and petty expenses-fiddling. (If you can’t add up it’s hard to fiddle expenses. Still, it makes you jolly cross when others blatantly do.)
Weirdly, Jeremy (public servant) Hunt’s attempt to explain his doctors’ (public servants) competency checks on the wireless yesterday sounded so creepily simplistic that it baffled me. “Every doctor in the country, and that includes foreign doctors who have come to practise in the UK, will have to undergo an annual appraisal,” he said, while I shouted “How much will that cost?” “and those appraisals will be reviewed every five years and then the GMC, which is the regulator of the medical profession, will decide whether there are concerns, and where there are concerns, there’s a process” – Me: “How much?” – “that doctors will go through. It’s really designed to pick up any problems before they happen.”
On and on he went, about giving doctors a chance to bring their skills up to speed (presumably by retraining them at public expense? Before making them redundant, also at public expense?): “And at the end of the day, if they’re not able to do that, the end of the road would be that they’re prevented from practising.” By the GMC? Isn’t that a publicly funded body? It is. And in 2010, its “staff costs” for 605 people were £34 million. Lord, are we going to have to quintuple the annual emoluments and packages?
What concerns me is that if there is going to be revalidation of doctors, surely there will be a need for a publicly funded regulatory body – let’s call it Ofdoc – to oversee the process of revalidation and check that the annual checks on competence have been competently carried out? And the regulatory body will need someone to head it, most likely a female, because there is always pressure to feminise this overwhelmingly male Government (more power to their blokey elbow, say I). Let’s call her Cynthia – in fact, let’s call her Dame Cynthia because if not now then soon such a high honour must be due – who will be expensively procured (these things take time, especially if you’re a public-sector headhunter), and bountifully paid.
I’d imagine there would be an unimaginably large (to most people) package of, say, £400,000 a year, a) because she will need to be “lured” with a fat wodge from her current job, and, b) because she could easily earn that much or scads more in the private sector. And let’s not forget that at every new layer of bureaucracy, somebody – and isn’t it most likely to be McKinsey? – will need to get their consultancy fees. I think we can agree that consultancy fees are always a given in the public sector.
Bad behaviour is no bar to sixth–form study in Britain
Grammar school must offer its unruly pupil a place … it’s exam results that count, says the Government’s admission code.
Leading schools are being told not to bar badly behaved teenagers from taking up sixth–form places. Schools can only prevent pupils from progressing onto A–level–style courses at 16 if they fail their GCSEs – but not for disciplinary reasons, it was revealed.
Under the Government’s admissions code, schools are told that progression into the sixth form must not be dependent on attitude, attendance or behaviour records. The ruling emerged as a grammar school was reprimanded by the local government watchdog for refusing to offer an A–level place to an unruly teenager.
The Latymer School, in Enfield, north London, was ordered to allow the boy into the sixth form because he met strict academic criteria, despite concerns over his attitude.
Jane Martin, the Local Government Ombudsman, said: “The Government’s school admissions code specifically prohibits the school from selecting sixthform pupils based on their behaviour records. As the boy had satisfied the academic requirements to join the sixth form, he should have been admitted.”
It was revealed that the school could only prevent the pupil from taking up a sixth–form place if he had been expelled during his GCSEs.
Brian Lightman, general secretary of the Association of School and College Leaders, said: “A school should not be forced to have a disruptive pupil in the sixth form or any other part of the school. If any schools have concerns in this way, they should use full exclusion procedures.”
The Latymer School selects 11–year-olds on the basis of academic ability. It said that admission to its sixth form was dependent on pupils having the necessary GCSE results along with acting in an “evidently self–disciplined” manner, including abiding by attendance, punctuality and uniform rules.
It emerged that an unnamed boy – already at the school – was denied entry to the sixth form this year because of poor behaviour in the previous academic year that resulted in him being suspended.
The school insisted it should be able to turn down pupils for the sixth form if “admission would prejudice the school’s ability to provide an efficient education”.
But the ombudsman insisted that the ruling contravened the 2010 admissions code introduced by Labour to dictate entry to English state schools, which said that places “must not be dependent on attendance, behaviour record, or perceptions of attitude or motivation”. The 2010 code has been replaced for admissions in 2013. The Department for Education said the updated document still carries similar rules that would have bound the school in the same way.
A spokesman said: “If a pupil’s behaviour falls below the school’s expected standard, it should take the appropriate action. A school can exclude a pupil permanently in response to a serious breach, or persistent breaches, of the school’s behaviour policy.”