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We did warn you

Posted by Richard Wednesday, January 18, 2012


Reported today by The Independent, Brian Toft, professor of patient safety at Coventry University, warned ministers last July that the CE mark which certifies that a product such as a hip joint or breast implant reaches the European quality standard was seriously flawed and did not protect patients.

There were 113 alerts issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) about medical devices last year, ranging from hip joints to surgical instruments, but the agency has no power to check devices until a failure is reported. And that is effectively what we were saying last week on the blog, as repeated by the Booker column on Sunday.

Notably absent from the Independent piece, though, are the words "European Union" and "Single Market", with a similar absence noted when the BBC's Today programme ran the story this morning, until Toft came on. But that is what we are dealing with.

However, the situation is worse than stated. It is not that the MHRA has "no power" to check devices until a failure is reported. A fundamental characteristic of CE marking is that national regulatory agencies are specifically prohibited from carrying out routine checks on devices, that replicate the checks supposedly done by the certifying agency.

Such routine checks are deemed to be "additional controls", having the effect of non-tariff barriers, and have been addressed by a range of ECJ judgements going back to 1979 and the Cassis de Dijon case. Thus, the legislation setting out the rules for market surveillance (Regulation EC No 765/2008 of 9 July 2008) sternly warns that:
It is necessary to ensure that products benefiting from the free movement of goods within the Community fulfil requirements providing a high level of protection of public interests such as health and safety in general, health and safety at the workplace, protection of consumers, protection of the environment and security, while ensuring that the free movement of products is not restricted to any extent greater than that which is allowed under Community harmonisation legislation or any other relevant Community rules.
CE marking is a paper-based system and thus the regulations require that, "Where economic operators present test reports or certificates attesting conformity issued by an accredited conformity assessment body, market surveillance authorities shall take due account of such reports or certificates".

In other words, as long as the paperwork is in order, extra physical checks are not allowed – and therein lies the danger. If the background checks are not being properly done – or done at all – faulty products (as in breast implants) can slip through the cracks.

Effectively confirming this in a meeting with Simon Burns, the Health minister, on 13 September, Toft said CE marks were allocated to medical devices on the basis of "design specifications" without checks on whether the devices were "being made in the way they should be made".

In July, in a presentation to the Committee on the Safety of Devices, revealed by The Lancet, he warned that the CE mark "provides a smokescreen for faulty and dangerous devices that place patients at risk".

This is not an academic issue. Apart from the breast implants scandal, the Failygraph was recently reporting: "Deaths and serious injuries involving medical devices up 29 percent", with "The number of patients killed or seriously injured by medical devices rose by almost a third last year, according to official figures".

Yet CE marking is so central to Community trade that the Single Market could not operate without it. Hence we get the silence of ministers and Tory politicians, all of whom adore the Single Market and prattle endlessly about its benefits. By any measure, though, CE marking is not fit for purpose - right across the board. Like the EU itself, it is fundamentally flawed ... and killing people.

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