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13th November 2024
The remanufacturing of single-use medical devices has the potential to significantly reduce greenhouse gas emissions from health systems, and while there are impressive examples of best practice, there is still a long way to go across much of Europe. Here, Bob Unwin and Josselin Duchateau share an overview of remanufacturing and describe how the practice works at Stepping Hill Hospital, part of Stockport NHS Foundation Trust, UK, and efforts to get programmes started in France.
A growing body of evidence finds that when it comes to harmful greenhouse gas emissions, hospitals are part of the problem.
Health systems generate nearly 5% of all global greenhouse gas emissions and a staggering 71% of these emissions come from the supply chain. In a study looking at emissions from the UK’s NHS, single-use medical devices were found to have an outsized impact on the NHS carbon footprint.
A regulatory framework for commercial remanufacturing of medical devices labelled for ‘single use’, also known as SUDS, began in the United States in 1998, and Germany followed in 2002. Commercial remanufacturers – meaning the work is done by private industry outside of the clinical setting – are regulated under the EU Medical Device Regulation (MDR) 2017/245 in force since May 2021. Today, over 11,900 hospitals and surgical centres use reprocessed devices globally.
Remanufactured SUDs must be compliant with the MDR under Article 17. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) guideline regulated the remanufacturing of SUDs from 2016. CE marked remanufactured devices must obtain the same levels of cleanliness, sterility and functionality as required of a virgin device.
Remanufactured SUDs cost at least 30-50% less than the virgin devices, according to the Association of Medical Device Reprocessors (AMDR). They also reduce waste, greenhouse gas emissions, and reliance on the international supply chain that hospitals found to be vulnerable during the Covid-19 pandemic.
Commercial remanufacturers collect devices, decontaminate, function test, clean, repackage, sterilise and return the SUDs for reuse by hospitals and clinics. Thus, remanufacturing creates a circular economy.
Peer-reviewed life cycle assessments are a well-established resource for comparing environmental impact across numerous categories to examine the cradle-to-grave impact on air, water and land for choices between two or more products.
A research team from Fraunhofer – the prestigious German research society – confirmed through a well-designed life cycle assessment that a remanufactured electrophysiology catheter resulted in a 50% reduction in greenhouse gas emissions compared to its virgin alternative when shipped from the UK to Germany where the devices were remanufactured and returned to the UK. Numerous additional peer reviewed life cycle assessments confirm substantial CO2 reductions at an average of 41% from the use of remanufactured SUDs.
In 2022, Stockport NHS Foundation Trust staff initiated a Green Plan, which included targets such as reducing greenhouse emissions by 85% by 2032, a 75% cut in business travel emissions by 2030, and achieving a ‘net zero’ carbon footprint by 2040 in line with wider NHS ambitions.
Supply chain leadership had become aware that an inordinate amount of greenhouse gas emissions from hospitals resulted from the supply chain. They sought to implement initiatives proven to reduce greenhouse gas emissions.
The leadership team’s research included review of NHS support for SUD remanufacturing including NHS-funded research and the NHS ‘Device Remanufacture “How to” Guide’ for the use of commercially remanufactured devices that documented substantial savings and emissions benefits at other hospitals.
The remanufacturing programme launched at Stockport NHS Foundation Trust in July 2022 significantly reduced Stepping Hill Hospital’s waste stream and greenhouse gas emissions. The Trust generated savings of approximately £33,000 during the fiscal year 2022/23 and received an additional £350 through a collections agreement with their remanufacturing partner.
While switching products can be difficult, as surgeons always have preferred medical devices, they had no difficulties using the remanufactured products because they were using the same product make and model. In the fiscal year 2023/24, the programme saved £40,763.52. By replacing 183 virgin surgical Harmonic Scissors (devices) with their reprocessed counterparts, Stepping Hill eliminated the use of the equivalent of 209 kg of CO2.
The Stockport programme underscores the UK’s leadership in circular innovation in healthcare, standing out as a key example.
Taking this further, in October 2024, the UK’s Department of Health announced ‘a major crackdown on waste’ in an effort to save millions of pounds a year, helping to divert more resources to frontline NHS care. The ‘Design for Life roadmap’ strategy is a full-throttle approach to driving a circular economy. A commitment to use remanufactured SUDs plays a leading role, with plans to radically cut the number of SUDs in the health service and reduce its reliance on foreign imports.
Many European nations, such as Belgium, Germany, and Spain, have also embraced remanufactured devices. However, in the EU, the MDR only allows remanufacturing when permitted by national law within individual Member States, with the requirement to notify the European Commission of their regulations.
This ‘opt-in’ model does not incentivise countries to adopt the practice and adds extra regulatory hurdles before they may do so. As a result, in some European countries, concerned healthcare providers and other industry stakeholders must often raise their voices to advocate change in linear, outdated, or stagnant national policies. An illustrative example of this is France.
Outside of the hospital, France has long been a leader in the promotion of a circular economy – a 2023 policy saw the French Government pay people to repair old clothes rather than throw them away, for example. But French hospitals are given no such treatment, and the use of remanufactured devices has been banned in France.
This ban has been a thorn in the side of environmentally minded French clinicians and healthcare staff. In December 2022, a position paper published in Le Monde signed by representatives of different medical and pharmaceutical scientific societies called for a lift of this ban.
At the April 2023 European Heart Rhythm Association Congress in Barcelona, Spain, numerous French clinicians and researchers spoke forcefully in favour of the use of remanufactured devices. Then, in March 2024, a group of more than 20 doctors from the French Society of Cardiology published a position paper that similarly endorsed remanufacturing and advocated wider regulatory and professional acceptance of remanufactured devices across the continent.
Thankfully, French authorities appear to have seen the writing on the wall: in the Social Security Financing Bill for 2024, the Government included an article finally authorising the use of remanufactured devices as part of a two-year experiment.
In a recent report detailing how the experiment could work, the General Inspectorate of Social Affairs (IGAS) and the General Inspectorate of the Environment and Sustainable Development (IGEDD) situated the potential adoption of device remanufacturing as part of France’s broader efforts to reduce its healthcare sector’s environmental footprint.
According to the report, the experiment will examine commercial remanufacturing of SUDs for four French healthcare establishments. As France lacks any existing infrastructure for a medical device remanufacturing industry, the report further encourages working with an experienced commercial remanufacturing partner.
In its own report commenting on the experiment, the French National Academies of Medicine, Pharmacy and Surgery highlighted that stakeholders across the board support the idea, provided that safety, technical and regulatory standards are maintained.
It would seem, at last, that the regulatory and medical communities in France are on the same page about this critical issue. The success of this experiment could pave the way for more sustainable practices, aligning with France’s aspirations to be a leader in the sustainable transition of healthcare. All eyes will be on this two-year trial as it explores the safety, cost-effectiveness and sustainability of remanufacturing medical devices in one of Europe’s largest healthcare sectors.
While a firm date for the commencement of the programme has not been set, the Directorate General of Health has stated that the decrees implementing the experiment should be finalised by the end of 2024. The current working draft proposes to evaluate both CE and CS remanufacturing routes, therefore allowing the experiment to cover a wide number of devices.
The experimentation phase should last two years, and the evaluation of the experiment will result in either a prolongation of the ban, or a modification of the law legalising remanufacturing of SUDs in France.
In addition to the UK successes and the French experiment, remanufacturing of SUDs is currently permitted in Belgium, Croatia, Germany, Ireland, the Netherlands, Spain, Portugal, Sweden and Israel. Globally, commercial, regulated remanufacturing of SUDs also takes place in the US, Canada, Japan, Israel and Australia.
The AMDR – the nonprofit trade association representing the remanufacturers – hopes to remove the ‘opt-in’ language in the EU MDR in a move that will make it easier for more countries in Europe to benefit from this sustainable option and reduce greenhouse gas emissions within their health systems.
Authors
Bob Unwin, registered nurse, directorate manager, theatre and critical care at Stepping Hill Hospital, Stockport NHS Foundation Trust, UK
Josselin Duchateau, clinical electrophysiologist, University Hospital of Bordeaux, France
5th November 2024
The Government has introduced ‘historic’ legislation to phase out smoking among young people, extend the smoking ban to outdoor spaces, and clamp down on vaping.
The Tobacco and Vapes Bill, introduced in Parliament, will ‘create a smokefree generation’ by banning the sale of tobacco products across the UK to anyone aged 15 or younger this year.
Legislation for this same ban was first introduced under the previous Conservative Government but did not progress after the election was called, with the new Labour Government confirming over the summer that it will proceed with similar laws including new additions to strengthen the bill.
As part of the new bill, the Government will ‘be given powers’ to extend the current indoor smoking ban to specified outdoor spaces, which could include children’s playgrounds and outside schools and hospitals, subject to consultation.
However, the announcement confirmed that the Government has decided against pursuing plans floated earlier this year to ban smoking in outdoor hospitality areas including nightclubs and sports venues,
To tackle vaping, the new legislation will ban advertising and sponsorship of vape products, and give the Government powers to ‘restrict flavours, display and packaging’.
This follows a recently-announced ban on disposable vapes, which will come into force from June next year under separate laws.
The Government is particularly focused on preventing youth vaping, with the Department of Health and Social Care (DHSC) citing figures showing that a quarter of 11- to 15-year-olds tried vaping in 2023.
Current restrictions on smoke-free areas may also be extended to become ‘vape free’, with a focus on areas where there are children and young adults.
The new legislation will allow the Government to introduce a licensing scheme to sell tobacco, vape and nicotine products in England, Wales and Northern Ireland, as well as ‘on the spot fines’ of £200 for retailers found to be selling these products to people underage.
Health secretary Wes Streeting said the Government is taking ‘bold action’ to create a smoke free generation, to ‘clamp down’ on vaping, and to protect children from the ‘harms of second-hand smoke’.
He added: ‘This historic legislation will save thousands of lives and protect the NHS. By building a healthy society, we will also help to build a healthy economy, with fewer people off work sick.’
Chief medical officer Professor Chris Whitty said that a ‘smokefree country’ would prevent disease, disability and premature deaths for future generations.
He continued: ‘The rising numbers of children vaping is a major concern and the Tobacco and Vapes Bill will help prevent marketing vapes to children, which is utterly unacceptable.
‘This is a major piece of legislation which if passed will have a positive and lasting impact on the health of the nation.’
The BMA ‘welcomed’ the new measures on smoking and vaping, in response to the bill’s introduction in Parliament, following its calls for a ban on disposable and non-tobacco flavoured vapes in August.
Chair of the union’s Board of Science Professor David Strain said the new measures are a ‘significant step forward’ to creating healthier environments for the populations while also reducing the burden on the NHS.
He added: ‘But we also need to see the detail of the Government’s consultations on these measures to make sure they can, in reality, deliver what Ministers are promising they can and alongside these new measures, there is an urgent need for investment in the smoking cessation services to help smokers quit.
‘Bringing in more stringent rules to stop people smoking and vaping will lead to a healthier population but for those who are still smoking, many will need support to stop and that means greater investment in the services and staff to give that support.’
Professor Lion Shahab, director of the University College London tobacco and alcohol research group, said the bill includes ‘a number of world-leading measures’, highlighting in particular the ban on smoking for future generations.
‘If parliament passes this new bill, it would put the UK at the very forefront of the fight to eradicate one of the most harmful inventions of modern times and protect the future of the next generation to allow them to live a full life, unencumbered by entirely preventable cancer, cardiovascular and pulmonary disease,’ he said.
But on vaping, he said that ‘legislation to protect youth has to be balanced with the need to support smokers to quit, including with e-cigarettes’, and that the Government must ‘monitor unintended consequences’ of the bill.
A version of this article was originally published by our sister publication Pulse.
25th September 2024
The Government will target areas with the ‘highest numbers of people off work sick’ for a new initiative to get hospitals running like a ‘Formula 1 pit stop’, according to health secretary Wes Streeting.
Speaking at the Labour Party conference, Mr Streeting announced plans for ‘crack teams of top clinicians’ to go into hospitals and roll out reforms in operating theatres.
The new ways of working have been developed by surgeons and can deliver ‘up to four times more operations than normal’, according to Labour.
This model is based on operating theatres at Guys and St Thomas’ in London, which Labour said ‘run like a Formula 1 pit stop to cut time between procedures’.
Mr Streeting said the initial focus on 20 hospital trusts in areas with the ‘biggest rates of economic inactivity’ is based on the Government’s commitment to ‘moving the dial’ on its ‘growth mission’.
In January, a census report found that over half of the UK surgical workforce faced problems accessing theatres, which was contributing to long waiting times for hospital treatment and excessive workloads.
And the following month, the Times Health Commission called for high-intensity theatre lists to be launched once a month in 50 hospitals to get through a week’s worth of planned operations in a day and create seven-day surgical hubs.
During his Labour Party conference speech, the health secretary also promised to maintain the NHS as a service which is free at the point of use, claiming that the ‘crisis’ left by the Conservatives means that ‘seven in 10 people now expect charges for NHS care to be introduced’.
‘I’ve said it before, I’ll say it again: over my dead body. We will always defend our NHS as a public service free at the point of use, so that whenever you fall ill, you never have to worry about the bill,’ Mr Streeting told the conference.
As well as the focus on areas of high ‘economic activity’, the health secretary also indicated that Government initiatives will be targeted at ‘disadvantaged areas’.
He argued that patient ‘choice’ should not ‘just be the preserve of the wealthy’, and that ‘power should be ‘in the hands of the many’.
‘So, starting in the most disadvantaged areas, we will ensure patients’ right to choose where they are treated, and we will build up local health services so it’s a genuine choice,’ Mr Streeting added.
Earlier this month, ahead of the publication of the Darzi review, the health secretary set out three ‘strategic shifts’ for the NHS’ which included moving care from ‘hospital to community’.
A version of this article was originally published by our sister publication Pulse.
19th July 2024
The UK is set to become the first country in the world to have a national vaccination programme to protect both newborns and older adults against respiratory syncytial virus (RSV).
The vaccination rollout – which will start from 1 September 2024 in England, Wales and Northern Ireland, and from 12 August 2024 in Scotland – includes a vaccine for pregnant women over 28 weeks to help protect their newborn babies, and a routine programme for those aged over 75, which includes a one-off campaign for people aged 75 to 79.
These are the groups at the greatest risk from RSV, based on advice from the Joint Committee on Vaccination and Immunisation (JCVI) from June 2023.
The vaccination programme announcement follows the publication of an open letter in March 2024 signed by over 2,000 paediatricians and healthcare professionals from around the UK calling on the Government to act on the JCVI advice as soon as possible.
Commenting on the latest announcement, Dr Mike McKean, vice president for policy at the Royal College of Paediatrics and Child Health, which led the campaign, said: ‘We’re delighted that the calls of thousands of paediatricians and health professionals for a much-needed RSV programme have been heard. Campaigning for an RSV vaccine has been a key issue for the College for many years now and today’s announcement represents a huge step forward for child health and the paediatric workforce in England and Scotland.’
All adults turning 75 years of age on or after 1 September 2024 will be eligible for the routine programme and should be offered a single dose of the RSV vaccine on or after their 75th birthday.
A one-off catch-up campaign for those aged 75 to 79 years old as of 1 September 2024 will aim to complete the majority by 31 August 2025.
In line with JCVI guidance, individuals will remain eligible until the day before their 80th birthday, with the exception of people who turn 80 in the first year who have until 31 August 2025 to get vaccinated.
All women who are at least 28 weeks pregnant on 1 September 2024, will be offered a single dose of the RSV vaccine. After that, pregnant women will become eligible as they reach 28 weeks gestation and remain eligible up to birth.
Maternal RSV vaccination reduces the risk of the virus leading to severe bronchiolitis by 70% in the first six months of life, after which the risk of severe infection is much lower.
The UK’s RSV vaccination programme will use the same vaccine to protect both newborns and older adults against RSV, which is Pfizer’s bivalent recombinant vaccine called Abrysvo, was licensed by the Medicines and Healthcare products Regulatory Agency in November last year.
In one trial published in the New England Journal of Medicine, the Pfizer RSV vaccine given during pregnancy was shown to be effective against severe RSV-associated lower respiratory tract illness in infants up to six months old.
A second trial showed the vaccine prevented RSV-associated lower respiratory tract illness and RSV-associated acute respiratory illness in adults over 60 years of age.
NHS England data show RSV accounts for around 33,000 NHS hospitalisations in children aged under five in the UK each year, and is responsible for 20-30 infant deaths, posing a significant challenge to child health services each winter. It also causes around 9,000 hospital admissions in those aged over 75.
It is hoped the new vaccination programme will mitigate these risks, free up thousands of hospital bed days and help avoid hundreds of deaths each year.
Minister for public health and prevention, Andrew Gwynne, said he had seen the devastating effects of RSV firsthand.
‘My own grandson contracted RSV when he was just days old, leading to weeks in intensive care and a lifelong impact on his health. I don’t want anyone to go through what he went through.
‘Not only will this vaccine save lives and protect the most vulnerable, it will help ease pressure on our broken NHS, freeing up thousands of hospital beds as we head into winter.’
Dr McKean, added: ‘This newly announced programme has the potential to transform child health services during the winter months by reducing hospital admissions and could even save young lives. A reduction in RSV cases annually would allow us to focus on the many other children and young people requiring emergency care over winter months.
‘Vaccinations play a crucial role in protecting child health, but we are seeing a worrying decline in uptake across many routine childhood immunisations. As paediatricians, we want to continue to champion the use of vaccinations to win the battle against these dangerous and preventable infections.’
Dr Adrian Boyle, president of the Royal College of Emergency Medicine also welcomed the announcement, saying: ‘We greatly welcome the introduction of a national RSV vaccination programme to reduce the risk to children and ease the spike in seasonal pressure experienced by already overstretched [Emergency] Departments.
‘RSV is a nasty and potentially very serious illness which each year sees tens of thousands of poorly children brought into Emergency Departments by worried parents.
‘We commend the excellent work done by the Royal College of Paediatrics and Child Health in calling for the implementation of this vaccination programme and we look forward to seeing the positive impact felt by families and medical staff in the coming winter as a result.’
Dr Christopher Johnson, head of vaccine preventable disease programme at Public Health Wales said: ‘The RSV vaccine has the potential to save 1,000 young children every year in Wales from hospitalisation and could save the lives of over 125 older people each year.
‘It is a game-changing new vaccination programme that will protect thousands of our most vulnerable from getting ill in the first place, or significantly reducing the likelihood of severe infection, keeping people out of hospital and from needing to see a GP, and enabling more people to benefit from NHS services.’
9th February 2024
There is insufficient evidence to recommend the use of novel nicotine and tobacco products as a ‘harm reduction’ strategy to reduce smoking and aid quitting.
This is according to an updated position statement from the European Respiratory Society (ERS), which states that such harm reduction claims are ‘simply exploited by the tobacco industry for financial gain’.
Since its previous statement on this topic was issued in 2019, evidence has increasingly shown legitimate concern around the long-term health risks of novel products such as electronic cigarettes, heated tobacco products and nicotine pouches, the ERS said.
‘ERS maintains a firm position that all nicotine and tobacco products are highly addictive and harmful, and that quitting smoking entirely is still the best option,’ it added.
Across eight position statements, the ERS details this increasing evidence and suggests that novel tobacco and nicotine products do not help existing smokers to quit, are harmful to public health and constitute gateways towards nicotine addiction and the initiation of smoking among youth.
This can lead to much greater negative effect on a population level, it said.
And it encouraged the use of evidence-based interventions, such as nicotine replacement therapy or tobacco cessation medications when cessation aids are required.
‘Reducing tobacco use and protecting youth from addiction to emerging products that may normalise tobacco use should be a top priority,’ the ERS concluded.
Referring to the EU’s priority of a tobacco-free generation by 2040, the ERS added that it ‘does not recommend any lung-damaging products and cannot recommend harm reduction as a population-based strategy to reduce smoking and aid quitting’.
Commenting on the revised position statement, Dr Filippos Filippidis, chair of the ERS Tobacco Control Committee, said: ‘The argument that novel tobacco products contribute to “harm reduction” lacks sufficient independent evidence. Their potential lung damaging effects, and uptake amongst young people, means that ERS cannot support novel tobacco products and “harm reduction” as a population-based strategy.’
This updated ERS position statement on novel tobacco and nicotine products comes as the UK Government announced disposable vapes and alternatives such as nicotine pouches are to be banned.
The planned measures follow a consultation on smoking and vaping launched in October 2023, and are designed to ‘tackle the rise in youth vaping and protect children’s health’.
As part of the package announced by Prime Minister Rishi Sunak, new powers will be introduced to restrict flavours specifically marketed at children and to ensure that manufacturers produce plain and less visually appealing packaging.
These powers will also allow the Government to change how vapes are displayed in shops, moving them out of sight of children and away from products that appeal to them, such as sweets.
Furthermore, the crackdown on underage sales will see the introduction of a new set of fines to shops in England and Wales selling vapes illegally to children, and trading standards officers will be empowered to act ‘on the spot’ to tackle underage sales.
The number of children using vapes in the UK in the past three years has tripled. Use among younger children is also rising, according to the figures, with 9% of 11- to 15-year-olds now using vapes.
Commenting that ‘marketing vapes to children is not acceptable‘, Mr Sunak said: ‘Alongside our commitment to stop children who turn 15 this year or younger from ever legally being sold cigarettes, these changes will leave a lasting legacy by protecting our children’s health for the long term.’
19th December 2023
The UK’s devolved nations could detect greater numbers of lung cancer cases with improved screening programmes, new analyses by Cancer Research UK have found as the charity calls for governments to ’urgently implement’ such programmes.
Lung cancer is the leading cause of cancer death in England, Scotland, Wales and Northern Ireland and smokers and former smokers aged 55-74 are at greatest risk.
In November 2022, the National Screening Committee (NSC) recommended that everyone in this group be screened but, to date, only England has initiated a screening programme on this advice.
Almost 900,000 people were invited for checks during the pilot stages in England. Of the 200,000 scans carried out, more than 2,000 people were detected as having lung cancer, and 76% of those were identified at an earlier stage (stage 1 or 2) compared to 29% identified outside of the pilot programme in 2019.
Cancer Research UK’s latest analyses suggests that equivalent lung cancer screening programmes in the devolved nations could diagnose around 4,000 more lung cancer patients in Scotland at an early stage over the next decade, as well as 2,400 more people in Wales and 1,400 in Northern Ireland.
If just 50% of eligible people took part in screening, earlier lung cancer diagnosis could save 2,300 lives in Scotland, 1,000 lives in Wales and 600 lives in Northern Ireland over the next 10 years, Cancer Research UK said.
Professor David Weller, professor of general practice at the University of Edinburgh, believes a nationwide screening programme ’has the potential to be a game changer when it comes to reducing the burden of lung cancer in Scotland’.
He said: ’For too long, lung cancer has been perceived as a disease you can’t do anything about, but we know that diagnosis at an early stage really can make a difference.
’Major trials of targeted lung cancer screening show significant reductions in mortality from lung cancer. Pilot studies in the UK and internationally consistently show people being diagnosed with lung cancer at an earlier stage.’
In Scotland, a pilot project called LUNGSCOT – of which Professor Weller is the principal investigator – is exploring the challenges for local lung cancer screening. It is running in Lothian with funding released for Grampian, Greater Glasgow and Clyde, and the Highlands and Islands.
A pilot is also running in Cwm Taf Morgannwg in Wales, where charities including Cancer Research UK are running a public petition in the hopes of raising the issue in the Senedd.
In Northern Ireland, there are no plans or pilots to report due to the lack of a Northern Irish Executive following the 2022 elections. That said, authors of the Northern Ireland Cancer Strategy 2022-2032 have said they intend to implement all NSC recommendations.
Debbie King, Cancer Research UK’s senior external affairs manager in the devolved nations, said: ’Lung screening matters because it means more people can be diagnosed at an earlier stage, when treatment is more likely to be successful.
’A fully-funded national targeted lung cancer screening programme in Northern Ireland, Scotland and Wales is a real chance to reduce the toll of this disease.
’There have been big improvements in how we diagnose and treat other forms of cancer, but long-term lung cancer survival in the UK isn’t much higher than it was 50 years ago. This is unacceptable when evidence shows that earlier diagnosis through targeted lung cancer screening can potentially help thousands of people live longer healthier lives.’
These latest analyses were published shortly after Cancer Research UK released its manifesto for reducing cancer deaths by 20,000 a year by 2040.
While overall cancer deaths have halved over the last 50 years, progress is at risk of stalling in the UK, the charity said.
As part of the manifesto, Cancer Research UK has called on the next UK Government to address variation in treatment across different geographical areas, which includes optimising cancer screening programmes and accelerating the roll-out of the lung cancer screening programme in England.
On the manifesto, former national cancer director at the Department of Health and chair of the National Screening Committee, Professor Sir Mike Richards, said: ’Cancer outcomes in the UK are lagging behind comparable countries like Denmark. We need consistent funding and long-term strategies to make the UK the best in the world for cancer survival.’
11th December 2023
The UK Government will lay legislation this week to allow the General Medical Council (GMC) to begin the process of regulating physician associates (PAs) and anaesthesia associates (AAs).
The legislation will be laid before Parliament via affirmative statutory instruments on Wednesday and the regulations are expected to come into force at the end of 2024.
The GMC will set standards of practice, education and training, and operate fitness to practice procedures, ensuring that PAs and AAs ‘have the same levels of regulatory oversight and accountability as doctors and other regulated healthcare professionals’, the Government said.
The legislation follows a consultation which had also suggested PAs could get prescribing rights in order to relieve pressure on doctors and services.
However, the BMA raised concerns about the legislation saying it thinks this ‘will add further, dangerous confusion’ with patients being left under the impression that they have seen a doctor when they haven’t.
‘The blurring of this distinction between doctors and non-medically qualified professionals can, and has, led to fatal consequences,’ the BMA added.
The union asked doctors to write to their MP ahead of Wednesday‘s Parliament session, so that MPs are ‘aware of this issue, oppose the legislation in Parliament and force the Government to abandon its plans’.
Health and social care secretary Victoria Atkins said: ‘Physician associates and anaesthesia associates are already making a great contribution to the NHS, supporting doctors to provide faster high quality care for patients.
‘This new legislation paves the way for these professionals to be held to the same strict standards as doctors, boosting patient safety.
‘This is part of our Long Term Workforce Plan to reform the NHS to ensure it has a workforce fit for the future.’
GMC chief executive Charlie Massey said: ‘This is a welcome and significant milestone towards bringing physician associates and anaesthesia associates into regulation.
‘We’re pleased to support the development of these valuable professionals recognising the important role they play in the medical workforce. Regulation will help increase the contribution PAs and AAs can make to UK healthcare while keeping patients safe.
‘We are working hard to design and deliver detailed regulatory processes for registration, education, standards and fitness to practise for both professions.’
Most statutory instruments (SIs) subject to the affirmative procedure are laid in the form of a draft SI and are considered by the Joint Committee on Statutory Instruments (JCSI).
Next, the SI will be automatically referred to a Delegated Legislation Committee (DLC). These committees have 16-18 members. Any MP can attend and speak but only members of the DLC can vote.
A DLC considers an SI but does not have the power to stop it. In some rare cases, the SI is not referred to a committee, but is debated in the Commons Chamber if it is of particular interest.
Once the SI has been debated by a committee, it needs final approval by the Commons before being ‘made’ (signed by the minister) and becoming law.
Health Education England (HEE) and NHS England recently warned the BMA that its stance on medical associate professionals (MAPs) is impacting NHS relationships and patient confidence.
HEE has published an open letter to the BMA in response to the union’s call to halt recruitment of MAPs until regulation is in place.
At its recent Symposium, the GMC also called on doctors to show ‘multi-disciplinary respect’ towards healthcare professional colleagues who are not doctors.
A version of this article was originally published by our sister publication Pulse.
20th October 2023
A consultation on UK-wide guidelines for the clinical treatment of harmful drinking and alcohol dependence has been launched by the Department of Health and Social Care (DHSC).
Developed in partnership with the UK‘s devolved administrations, the guidelines include advice for alcohol care in acute hospitals as well as other settings such as primary care, community health services and the criminal justice system.
‘Patients with alcohol use disorder present to acute hospitals with a wide range of primary diagnoses and the presence of alcohol use disorder may not always be obvious to the patient or to clinical staff,‘ the guidance states.
It therefore emphasises the need for hospitals to have staff with appropriate skills to identify alcohol use disorders, assess risk and provide specialist treatment interventions.
The importance of implementing a system for identifying health risk from alcohol and gauging the severity of alcohol use disorder among all hospital inpatients is also highlighted as this may impact a patient‘s treatment, recovery and risk of complications.
The guidelines also outline key factors in dealing with acute or medically assisted alcohol withdrawal, managing associated complications and treating patients with co-occurring physical and mental health conditions, including those in crisis.
The need for a seamless transition to ongoing treatment in mental health and community services when discharged is also detailed, with integrated planning identified as a priority to ensure effective wrap-around care.
According to the DHSC, the main aim of the guidelines is to develop a ‘clearer consensus’ on good practice and how to implement NICE-recommended interventions.
The consultation will be open for eight weeks, inviting views from people working in alcohol treatment, the wider health and care sector and those with lived experience of alcohol dependence across the UK.
Neil O’Brien, minister for public health, said: ’This consultation will help us develop guidance to ensure alcohol treatment services are of consistently high quality, providing stronger pathways to recovery for those in need of treatment for alcohol dependence.’
In May, ministers were accused of not taking alcohol harm seriously enough after a new report revealed that over the last two decades the number of alcohol-related deaths rose by 89% and was continuing to rise sharply since the start of the pandemic.
Despite this, the report found that a ‘staggering’ 82% of dependent drinkers were not in treatment despite success rates of 60% and evidence that treatment delivers £3 of benefit for every £1 invested.
A version of this story was originally published by our sister publication Nursing in Practice.
13th October 2023
The UK Government has launched a public consultation on its plans to create a smoke-free generation at the same time as introducing measures to tackle vaping in teenagers.
It follows proposals announced earlier this month by the Prime Minister that it will become illegal for people born in or after 2009 to buy tobacco products.
Under the plans, the law will stop children turning 14 or younger this year from ever legally being sold tobacco products, raising the smoking age by a year each year until it applies to the whole population.
Several options for cracking down on youth vaping are also included in the consultation after figures form 2023 suggest one in five children has tried it.
Measures will need to balance the need to make vapes available to current adult smokers to help them quit while reducing access and appeal for children and teenagers, the consultation document states.
Possible changes in law range from limits on how vape flavours are described to restrictions on ingredients or flavours, such as tobacco, mint or fruit flavours only.
The public is also being asked for views on regulating displays in shops to being behind the counter but on display or hidden, as with current rules on tobacco products.
Various options for branding and presentation are being considered including banning the use of cartoons, animals and other child-friendly imaging to more stringent restrictions on imagery and colouring used in the packaging.
Questions on whether disposable vapes should be banned are also included in the consultation, and views are also being sought on the cost of vapes compared to tobacco products.
Currently 12.9% of people in the UK are smokers. In setting out the proposals, the Government said no other consumer product kills up to two-thirds of users.
It added that in England, almost every minute of every day someone is admitted to hospital because of smoking, and up to 75,000 GP appointments could be attributed to smoking each month. The consultation also covers Scotland, Wales and Northern Ireland.
Last year a damning review led by Dr Javed Khan into the Government’s ambition to make England smoke-free by 2030 backed England to follow in the footsteps of New Zealand, and recommended ‘increasing the age of sale from 18, by one year, every year until no one can buy a tobacco product in this country’.
Last month, researchers declared that nicotine vaping is the most effective among widely available smoking cessation aids.
Health and social care secretary Steve Barclay said: ‘There has been a surge in vaping amongst children, which is why we’re taking action to reduce the appeal and availability of vapes. Vapes should never be used by children and we’re committed to reversing this trend.
‘We also need to take bold action to protect future generations from the harms of smoking addiction, which damages health at every stage of life and costs the economy billions.’
Professor Chris Whitty, chief medical officer for England said: ‘Ensuring people do not become addicted to smoking, and helping them overcome addiction to stop smoking are two the best interventions for health.
‘Vaping is less dangerous than smoking but still has risks and can cause addiction. Vaping can be useful for smokers to quit, but should not be marketed to non-smokers and marketing them to children is utterly unacceptable.’
Sarah Woolnough, chief executive at Asthma + Lung UK, said the charity welcomed the consultation as it is clear more must be done urgently to stop children accessing vapes.
‘Disposable vapes at their current pocket money prices, with cartoons and bubble-gum flavour options, are far too attractive and easy for children to access,’ she said.
The public consultation is open until 6 December.
A version of this story was originally published by our sister publication Pulse.
28th January 2021
The Moderna vaccine, mRNA-1273, has been shown to elicit high levels of neutralising antibody titres in clinical trials. However, with the identification of COVID-19 variants, a major concern is whether the range of vaccines available are capable of generating sufficient immunity. The UK COVID-19 variant, termed B.1.1.7, has 17 mutations, 8 of which are in the spike protein and two of which, 69-70 del and N501Y, have led to a particular concern that the variant is much more easily transmitted and potentially associated with a higher mortality. The other variant identified, B.1.351, has emerged from South Africa and as with the UK variant, evidence suggests that B.1.351 is more transmissible and produces a higher viral load among those who become infected. In fact, genomic analysis shows that mutations in the S protein are more extensive in B.1.351, with 3 of these present in the receptor binding domain, which is the target for neutralising antibodies which could affect vaccine efficacy. For this recent, but unpublished, study, researchers from Moderna, the vaccine manufacturer, sought to assess the neutralisation of sera from eight patients (aged 18 to 55) who had already received two doses of the company’s vaccine. In an effort to test the effectiveness of m-RNA-1273, the researchers created and tested pseudo viruses, that contained either a partial or a complete set of mutations present in the B.1.1.7 and B.1.351 lineages.
Findings
With respect to the B.1.1.7 lineage, both the partial and complete pseudo viruses, containing the recognised mutations, had minimal effect on the production of neutralising antibodies, i.e., the vaccine was just as effective against this variant as the original COVID-19 strain. In contrast, there was a significant decrease in neutralising titres measured against either the partial or complete mutations found within the B.1.351 variant. In fact, antibody titres were approximately 6-fold lower relative to other variants for the complete set of mutations. Nevertheless, the authors reported that the antibody titres generated against the complete B.1.351 pseudo virus, while lower than for B.1.1.7, were still generally high enough to provide protection if vaccinated with the mRNA-1273.
Citation
Wu K et al. mRNA-1273 induces neutralising antibodies against spike mutants from global SARS-CoV-2 variants. 2021 https://doi.org/10.1101/2021.01.25.427948https://doi.org/10.1101/2021.01.25.427948