Thursday, 1 March 2012

One member of staff sacked and another reprimanded after data breaches at Northampton General Hospital

One member of staff sacked and another reprimanded after data breaches at Northampton General Hospital:

ONE member of staff was sacked and another severely reprimanded for accessing details of Northampton General Hospital patients they were not treating, a new report reveals. Northampton Chronicle and Echo

Why we need a national framework for patient experience | Jocelyn Cornwell

Why we need a national framework for patient experience | Jocelyn Cornwell: Why do we need a national framework for patient experience? And, why do we need one now? (Blog, 29 Feb 2012) Kings Fund

Rationing health care: is it time to set out more clearly what is funded by the NHS?

Rationing health care: is it time to set out more clearly what is funded by the NHS?:

It draws on the experience of countries that have sought to explicitly define the health care benefits that their publicly-funded health systems will pay for. It outlines the current system in which decisions for determining which treatments are funded by the NHS are arrived at implicitly and makes several recommendations for how the system could be improved. More ….

Metal hip patients 'need annual checks'

Metal hip patients 'need annual checks':

Patients with a common type of metal hip implant should have annual health checks for life, according to the UK body for regulating medical devices. The all-metal devices have been found to wear down at an accelerated rate in some patients, potentially causing damage and deterioration in the bone and tissue around the hip. There are also concerns that they could leak traces of metal into the bloodstream, which the annual medical checks will monitor.

Hours before critical coverage from the British Medical Journal and the BBC, the Medicines and Healthcare products Regulatory Agency (MHRA) issued new guidelines on larger forms of ‘metal-on-metal’ (MoM) hip implants. Advice on smaller metal devices or those featuring a plastic or ceramic heads has not changed. Previously, guidelines suggested larger MoM implants should only be checked annually for five years after surgery. The agency now says the annual check-ups should be continued for the life of the implant. Check-ups, they say, are a precautionary measure to reduce the “small risk” of complications and the need for further surgery.

Together with the recent controversy over PIP breast implants, the news has caused some medical quarters to call for tighter regulation of medical devices, perhaps bringing the approval process into line with that of medicines, which must undergo several years of laboratory, animal and human testing before being approved for wider use.

What types of implants are involved?

There are numerous designs and materials used to make hip implants. In recent days the MHRA has issued major updates to its advice on a type of metal-on-metal (MoM) hip replacement. As the name implies, MoM implants feature a joint made of two metal surfaces -- a metal ‘ball’ that replaces the ball found at the top of the thigh bone (femur) and a metal ‘cup’ that acts like the socket found in the pelvis.

The MHRA’s updated advice concerns the type of MoM implant in which the head of the femur is 36mm or greater. This is often referred to as a ‘large head’ implant. The agency now says that patients fitted with this type of implant should be monitored annually for the life of the implant, and that they should also have tests to measure levels of metal particles (ions) in their blood. Patients with these implants who have symptoms should also have MRI or ultrasound scans, and patients without symptoms should have a scan if their blood levels of metal ions are rising. The previous guidance on this type of hip implant, issued in April 2010, advised that patients should be monitored annually for no fewer than five years.

What about other types of hip implants?

Advice on monitoring patients with other types of hip implants remains the same, and guidance has not changed on:

  • MoM hip resurfacing implants – where the socket and ball of the hip bone has a metal surface applied to it rather than being totally replaced.

  • Total MoM implants where the replacement ball is less than 36mm wide.

  • A particular range of hip replacements called DePuy ASR – these hip replacements were recalled by their manufacturer, DePuy, in 2010 because of high failure rates. The company made three types of ASR implant.

  • Implants featuring plastic or ceramic heads.

How many people are affected?

It is estimated that, in total, 49,000 people in the UK have been given metal-on-metal implants with a width of 36mm or above. This represents a minority of the patients given hip replacements, who mostly have devices featuring plastic, ceramics or smaller metal heads.

In 2010 there were 76,759 hip replacements, and that approximately 5% of these surgeries used an MoM implant sized 36mm or above.

What exactly is the problem with MoM implants?

All hip implants will wear down over time as the ball and cup slide against each other during walking and running. Although many people live the rest of their lives without needing their implant to be replaced, any implant may eventually need surgery to remove or replace its components. Surgery to remove or replace part of the implant is known as ‘revision’ and, of the 76,759 procedures performed in 2010, some 7,852 were revision surgeries.

However, data now suggest that large head MoM hip implants (those with a width of 36mm or greater) wear down at a faster rate than other types of implants. As friction acts upon their surfaces it can cause tiny metal particles (medically referred to as ‘debris’) to break off and enter the space around the implant. Individuals are thought to react differently to the presence of these metal particles, but, in some people, they can trigger inflammation and discomfort in the area around the implant. Over time this can cause damage and deterioration in the bone and tissue surrounding the implant and joint. This, in turn, may cause the implant to become loose and cause painful symptoms, meaning that further surgery is required.

News coverage has also focussed on the MHRA’s recommendation to check for the presence of metal ions in the bloodstream, potentially released either from debris or the implant itself. Ions are electrically charged molecules. Levels of ions in the bloodstream, particularly of the cobalt and chromium used in the surface of the implants, may, therefore, indicate how much wear there is to the artificial hip.

There has been no definitive link between ions from MoM implants and illness, although there has been a small number of cases in which high levels of metal ions in the bloodstream have been associated with symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system and thyroid gland.

The MHRA points out that most patients with MoM implants have well functioning hips and are thought to be at low risk of developing serious problems. However, a small number of patients with these hip implants develop soft tissue reactions to the “wear debris” associated with some MoM implants.

How are medical devices regulated?

In the UK, the MHRA is the government agency responsible for ensuring that medical devices work and are safe. The MHRA audits the performance of private sector organisations (called notified bodies) that assess and approve medical devices. Once a product is on the market and in use, the MHRA has a system for receiving reports of problems with these products, and will issue warnings if these problems are confirmed through their investigations. It also inspects companies that manufacture products to ensure they comply with regulations.

This system differs greatly from that for testing and approving drugs. Drugs require several years of research testing and trials before they can be approved for clinical use.

What action have regulators taken?

The MHRA has convened an expert advisory group to look at the problems associated with MoM implants, meeting regularly to assess new scientific evidence and reports from doctors and medical staff treating patients. The agency says it is continuing to monitor closely all the latest evidence about these devices and may issue further advice in the future.

In the US, the Food and Drug Administration (FDA) says it is gathering additional information about adverse events in patients with MoM implants. In the meantime, it advises patients with MoM hip implants who have no symptoms to attend follow-up appointments as normal with their surgeon. Patients who develop symptoms should see their surgeon promptly for further evaluation.

What actions have critics called for?

In light of the PIP breast implant controversy and this new information on hip implants, there is currently intense scrutiny on the way medical devices are regulated in the UK and Europe, with patient groups and the media arguing that medical devices should be regulated in a similar way to medicines.

Clearing a medicine for use in the UK is a lengthy process involving several stages of laboratory and animal testing, and then carefully controlled and monitored tests in humans. Only once there is enough evidence to suggest that a medicine is reasonably safe that it can enter clinical use, and even then patients will be monitored to look at the longer-term effects of the drug.

However, medical devices are not required to go through human trials before entering use, and can currently be approved on the basis of mechanical tests and animal research. While certain devices, such as hip implants, have been monitored through systems such as the National Joint Registry, in light of the recent health concerns over PIP breast implant patient groups are calling for more testing before devices are allowed into clinical use, and closer, mandatory monitoring schemes to ensure their safety once they enter the market.

Links To The Headlines

Annual blood tests for hip patients over poison fears. The Daily Telegraph, February 29 2012

Hip replacement toxic risk could affect 50000. The Independent, February 29 2012

MHRA: Metal hip implant patients need life-long checks. BBC News, February 29 2012

Metal scare over hip replacement joints. The Guardian, February 29 2012

Toxic metal hip implants 'could affect thousands more people than PIP breast scandal. Daily Mail, February 29 2012

VIDEO: Metal hip implants need life-long checks

VIDEO: Metal hip implants need life-long checks: The government's health regulator has advised that patients who have undergone large head metal-on-metal hip replacements should be monitored annually for life. Deborah Cohen reports. BBC News

Funding gap risks derailing four-year GP training plan, warns GPC

Funding gap risks derailing four-year GP training plan, warns GPC: Plans to extend GP training to four years have 'no sound financial footing' and risk backfiring on the profession, the GPC has said. GP Online

Call to 'join patients online'

Call to 'join patients online': Doctors have an "ethical duty" to use the communication channels their patients use to communicate with them, provide them with good medical advice, and influence their lifestyle choices. E-Health Insider

Consultation on the United Kingdom Plan for rare diseases

Consultation on the United Kingdom Plan for rare diseases:

Earlier diagnosis of a rare condition and better co-ordinated care will help improve the quality of life for people with rare diseases and their families, according to this plan on rare diseases. Comments must be submitted by 25th May 2012.

Health concentrates on achieving cures more for less outlay

Health concentrates on achieving cures more for less outlay:

Geoff Mulgan suggests six areas where the healthcare sector can innovate and increase productivity

Data from OECD countries shows a roughly inverse correlation between spending on health and mortality and a roughly inverse correlation between growth in spending on health and improvements in mortality (the correlations hold even if the US is excluded).

These glaring facts are likely to force ever more attention on to health productivity, health innovation and the adoption of models from elsewhere that can demonstrably achieve more for less.

But what kinds of innovation will achieve the most impact? Huge sums are invested globally in medical research and development – and with good reason. Yet less than 0.5% addresses the behavioural and social factors that explain well over 50% of mortality (and most of that 0.5% focuses on compliance – getting patients to take their drugs). Declining productivity of research and development in fields such as pharmaceuticals means that attention is bound to turn elsewhere.

Here are six places to look for innovations that can have a big impact on productivity:

• More effective use of existing institutions. The methods used by Narayana Hrudalya in India show just how much impact approaches taken in other industries can have on health – with more intensive measurement, specialisation and peer review. Big gains are also possible in primary care – a theme of Nesta's work with GPs and others on "people powered health".

• We should expect more use of ubiquitous cheap technologies rather than costly and often over-engineered telecare and telemedicine, whether to monitor blood pressures or other vital signs, to provide e-tutorials on self-care or to provide real-time advice.

• To drive productivity improvements, some of the patterns already seen in business services are likely to be used more widely: breaking down "service journeys" into modular elements and then recombining them using web and other technologies; managing pricing and loading dynamically in response to demand; mobilising resources globally, such as call centres, and using intensive "customer relationship management" tools to personalise what services are offered; and concentrating specialist advice such as a team of doctors and nurses in a clinic and call centre focused on just one condition, such as diabetes or multiple sclerosis.

• We should expect more innovations that make the most of society's capacity. Sweden's patient hotels are situated next to hospitals and provide a pleasant environment for the patient and an extra bed for a spouse or parent: although they involve greater capital cost, they achieve better clinical outcomes, mobilising a social capacity – the love and care of the family – to support healing. Another example is Canada's Tyze which organises an online network of support for isolated older people, allowing friends, family members and professionals to co-ordinate their care: they will visit to cook a meal, remind the older person about prescriptions or do their shopping.

• We should expect to see more innovation in finance: social impact bonds in the UK, social benefit bonds (Australia) and pay-for-success bonds (US) are all pointers. Already health insurers can give incentives to their customers to change their diet or join gyms (for example, cutting their premiums if they can show improvements in their body mass index), and municipalities can reward social housing providers who do better in supporting older people at home, thus reducing the pressure on hospitals or residential care homes.

• The end of life is likely to be an important focus for innovation. Most people die in hospitals, tied up with tubes and with their bodies pumped full of drugs. Yet most would rather die at home and with more control over the timing and manner of their death. Across the world, many models are being tested – such as home hospices.

The bulk of money and power remains tied up in institutions dedicated to the fields of innovation that delivered so much in the second half of the 20th century: pharmaceuticals, medical instruments and clinical procedures. But in a time of fiscal austerity, governments and publics won't for long accept that it's inevitable that more money doesn't translate into better outcomes.

• Geoff Mulgan is speaking at the Nuffield Trust Health Policy Summit in Surrey today; the Guardian healthcare network will be covering the two-day event on the site and on Twitter. Follow us @gdnhealthcare. To hear more about the Health Policy Summit and other healthcare news, sign up here to receive our weekly email.

Guardian Professional.

NHS reforms return to Lords as Lansley works with Lib Dems on amendments

NHS reforms return to Lords as Lansley works with Lib Dems on amendments:

Lords debate sections on psychiatric care and public health amid increasing unhappiness over the bill among GPs and Lib Dems

The health and social care bill is returning to the House of Lords amid increasing unhappiness about the proposed reforms among GPs and Liberal Democrat activists.

Peers will debate amendments to the bill around public heath and psychiatric care on Wednesday – the controversial third part of the bill dealing with competition has now been moved to next Tuesday.

The health secretary, Andrew Lansley, is working with the Liberal Democrats on further amendments to the bill to provide the final reassurance Nick Clegg believes is needed to see off a damaging backlash by activists at the party's spring conference next week.

He told the BBC on Tuesday that the legislation would ensure "competition is a means to an end, not an end in itself".

Lansley's bill suffered another setback when a key group of GPs withdrew their support before the latest debates in the House of Lords.

The Tower Hamlets Clinical Commissioning Group wrote to David Cameron, urging him to ditch the legislation and echoing the concerns over its impact on services expressed by professional bodies including the British Medical Association and the Royal College of GPs.

The east London group is the first clinical commissioning group to go public with a call for the bill to be scrapped. Its chairman, Dr Sam Everington, was formerly an adviser to the health secretary. The group said the goal of improving services to patients through clinically led commissioning could be achieved without the extra bureaucracy the bill would create. The restructuring of the NHS being conducted by Lansley was getting in the way of GPs' work, they said.

They told Cameron he was wrong to claim repeatedly that GPs' willingness to participate in preparations for the new arrangements meant they supported the bill.

Lansley told the BBC: "What [Dr Everington] and his colleagues don't yet appreciate is that the only way in which they actually will have something which is sustained into the future and enables them to develop all the opportunities that they have is if we get rid of two tiers of bureaucracy in the process."

Asked why the GPs might not have taken his arguments on board, he said: "It's probably because the BMA and a lot of other organisations are constantly telling people things that are not in the legislation."

He said he did not worry that he might not be the right person to take the government's NHS reforms forward. "Do you know why I don't do that?" he added. "Because I do know a lot of people across the NHS and I visit them all the time, and I've done so for years, and I know absolutely where they are."

With the bill due to continue on its way through the Lords until at least the middle of March, it may be some days before a long list of amendments being tabled by peers is discussed. The Guardian

Stroke victims at highest death risk

Stroke victims at highest death risk: Stroke victims admitted to hospital in an emergency are four times more likely to die than those admitted following a heart attack, according to NHS figures. The Daily Telegraph

Lib Dems hope to finally kill health reforms

Lib Dems hope to finally kill health reforms:
Liberal Democrat activists will defy Nick Clegg over the Government's controversial health reforms by seeking to "kill" them at a party policy-making conference next week. The Independent

Heart attack patients: emergency hospital admissions drop by a quarter while death rate nearly halves in a decade

Heart attack patients: emergency hospital admissions drop by a quarter while death rate nearly halves in a decade: Hospitals in England have seen the annual number of emergency admissions for heart attacks among patients aged 35 to 74 drop by more than a quarter in... NHS Information Centre