Medical device regulation – an explainer

[UPDATE: The Independent adds some detail on the lack of data held the MHRA: “it did not have accurate data for the total number of implants inserted, making it impossible to calculate the true rupture rate.”]

Sarah Boseley provides some background to the PIP breast implants saga with a very informative piece on how implants and other medical devices are regulated.

The top angle is that these devices only require the same certification as toys, but there’s much more below that which is of particular use to anyone wanting to investigate medical devices or piggyback on the PIP story to look for similar problems. Continue reading

Question: How many walk-in centres are being closed?

The Yorkshire Post reports on the closure of an NHS walk-in centre in Leeds with a brief mention of wider plans.

“NHS Leeds said the Department of Health did not intend to continue delivering services from commuter walk-in centres and this means the Leeds centre will close. Centres in Manchester, Newcastle and London have already been axed.

“It will shutdown on November 30 and is the latest service in West Yorkshire to be hit by cuts. Already opening hours have been cut at other centres in Halifax, Todmorden and Dewsbury.”

A quick search finds walk-in centres also closing in Nottinghamshire.

An FOI to the Department of Health asking for a list of planned walk-in closures with dates and full addresses may help paint a national pattern. However, the decision to close lies with Primary Care Trusts (PCTs) and many appear to have held or be holding consultations, so it would be worth also looking into how many consultations are still being held. This advanced search gives some clues.

Are you investigating this? Let us know how we can help.

Link: “Evidence” of NHS privatisation plans

Channel 4 news reports on documents which GPs say represent “firm evidence that the government is planning to privatise the National Health Service as part of its reforms.”:

“Richard Vautrey, deputy chair of the British Medical Association’s (BMA) GP committee, said that the document was quite explicit in suggesting that the government was going to create a market for private companies to come in and take over these services and that commissioning groups would be too small do without support. Continue reading

Link: NHS watchdog faces investigation

From The Guardian:

“The watchdog responsible for overseeing NHS hospitals and care homes is being urgently investigated by the Department of Health over a series of alleged failures that could have risked patient care.

“The [Care Quality Commission]’s chief executive, Cynthia Bower, spent last Thursday morning being questioned by Una O’Brien, the health department’s permanent secretary, before a team of Whitehall officials descended on the watchdog’s headquarters in the City that afternoon.

“The inquiry coincides with investigations by the National Audit Office and the Commons public accounts committee.”

And background:

“The Guardian has established that:

“• The CQC misled parliament in its annual report, overstating the number of inspections and reviews of the NHS, independent healthcare and adult social care sectors it carried out. Rather than the 15,220 “inspections and reviews” it claimed to have undertaken in the year ending March 2011, it has now admitted to the DoH that the correct figure is 7,368.

“• There has been rising disquiet over the CQC’s “light touch” regulation. Until May 2011, when BBC’s Panorama exposed the scandal of abuse at Winterbourne View, a private hospital for people with learning disabilities, the CQC had launched just one investigation. By contrast, its predecessor, the Healthcare Commission, completed 16 investigations in five years. After the BBC’s story the regulator launched two investigations into NHS hospital trusts.”

Links: Andrew Lansley ordered to reveal NHS reforms risks report

The Health Department has been ordered by the Information Commissioner to make public a report into the risks raised by NHS reforms.

Officials had previously refused FOI requests to supply the report because it “jeopardised the success of [government] policy”.

The Evening Standard, which asked for a review of the department’s refusal, reports on the decision:

“The document is expected to reveal the risks to patient safety, finances and the very workings of the NHS from the unprecedented reshaping of the health service.

“… In his ruling, [Information Commissioner Christopher]  Graham said: “Disclosure would significantly aid public understanding of risks related to the proposed reforms and it would also inform participation in the debate about the reforms.””

Links: NHS payoffs and middle class drinking

“The use of “interim” management in the NHS was justified by several of the organisations as solving specific short-term problems while long term plans were drawn up.

“But many of the arrangements uncovered by The Sunday Telegraphlasted for more than a year, despite the rocketing bills.”

“The report, by 2020 Health, a centre-right think tank, says many middle class drinkers are not aware of the risks of their evening tipple, with couples who share a bottle of wine over dinner most evenings unwittingly increasing their chances of cancer and strokes.”