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Archive for category: E-News

E-News

dark_field x-ray

New dark-field X-ray technology improves diagnosis of pulmonary disease

, 4 November 2021/in E-News /by panglobal

dark-field X-ray

 

For the first time, researchers at the Technical University of Munich (TUM) have successfully used a new X-ray method for respiratory diagnostics with patients. Dark-field X-rays visualize early changes in the alveolar structure caused by the lung disease COPD and require only one fiftieth of the radiation dose typically applied in X-ray computed tomography. This permits broad medical application in early detection and treatment follow-up of respiratory ailments.

There are millions of cases in which serious respiratory system illnesses place limitations on quality of life. Every year more than four million people die of serious respiratory ailments worldwide. Partially destroyed alveoli and an over-inflation of the lungs (emphysema) are typical of the life-threatening ailment Chronic Obstructive Pulmonary Disease (COPD).

However, the fine distinctions between healthy and diseased tissue are barely visible on conventional chest X-rays. Detailed diagnostic information is only available using three-dimensional computed tomography approaches, in which the computer assembles many individual images. Until now there has been no fast and cost-effective option for early detection and follow-up examinations with a low radiation exposure as used in plain chest X-rays.

A procedure developed at the Technical University of Munich could now fill this gap: dark-field chest X-rays. In the November 1, 2021 issue of The Lancet Digital Health a research team led by Franz Pfeiffer, Professor for Biomedical Physics and Director of the Munich Institute of Biomedical Engineering at TUM, present the results of an initial clinical patient study, which used the new X-ray technology for the diagnosis of the lung disease COPD.

The wave character of X-rays is the key

Conventional X-ray imaging is based on the attenuation of X-rays on their way through the tissue. Dark-field technology on the other hand use the wave nature of X-ray light, which is discarded in conventional X-ray imaging.

The new method thus uses the physical phenomenon of scattering in a manner similar to the long-known principle of dark-field microscopy with visible light. This allows to visualize the structure of objects that are for the most part transparent. These structures appear in the microscope as bright images on a dark background, which has given the method its name.

“The X-ray dark-field signal is particularly strong for interfaces between air and tissue,” Prof. Pfeiffer points out. “This makes it possible for a dark-field X-ray image of the lung to clearly distinguish between intact alveoli, i.e. those filled with air, and regions in which less intact alveoli exist.”

dark-field x-ray

The dark field X-ray method visualizes early changes in the alveolar structure as a result of the lung disease COPD. Franz Pfeiffer, Professor for Biomedical Physics, hopes that this will significantly improve the early detection of lung diseases.

Lower radiation dose

In addition, an examination using dark-field chest X-ray technology involves a significantly lower radiation dose than presently used computed tomography. This is because dark-field chest X-rays require only one exposure per patient, as compared to the large number of individual images taken from different directions which are necessary in computed tomography.

“We expect the radiation exposure to be reduced by a factor of fifty,” says Prof. Pfeiffer. Furthermore, the first clinical results have confirmed that the dark-field X-rays provide additional image information on the underlying microstructure of the lung.

“Given the close connection between the alveolar structure and the functional condition of the lung, this ability is of great significance for pulmonary medicine,” explains Dr. Alexander Fingerle, senior physician at TUM’s university hospital Klinikum rechts der Isar’s Department of Diagnostic and Interventional Radiology. “In the future dark-field X-rays could help improve early detection of COPD and other respiratory ailments.”

Better X-ray equipment for early detection

Prof. Pfeiffer hopes these initial clinical results with patients will accelerate the execution of further clinical studies and the development of marketable devices that use the dark-field method.

“Dark-field chest X-rays are currently giving us a chance to significantly improve the early detection of lung diseases and at the same time to implement it on a wider basis than before,” Prof Pfeiffer notes.

Since dark-field imaging is not limited to COPD, further translational studies with other pulmonary pathologies such as pulmonary fibrosis, pneumothorax, lung cancer and pneumonia, including COVID-19, are of great interest.

Reference:

K. Willer, et. al. X-ray dark-field chest imaging for detection and quantification of emphysema in patients with chronic obstructive pulmonary disease: a diagnostic accuracy study. The Lancet Digital Health. November 1, 2021. doi: https://doi.org/10.1016/S2589-7500(21)00146-1

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IHF and AHF join forces

, 4 November 2021/in E-News /by panglobal

The International Hospital Federation (IHF) and Africa Healthcare Federation (AHF) have entered into a partnership to increase the participation of healthcare leaders from African countries in the IHF and other global hospital and healthcare initiatives.

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Owlstone Medical secures $58 million to advance breath biopsy

, 4 November 2021/in E-News /by panglobal

Owlstone Medical, a global leader in breath biopsy for applications in early disease detection and precision medicine, closed its Series D financing round after securing $58 million in funding, exceeding its $50 million target after it was over subscribed. This brings the total raised by the company to more than $150 million since founding in […]

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SAFIRA regional anaesthesia device awarded HSJ Patient Safety Innovation of the Year

, 4 November 2021/in E-News /by panglobal

A ground-breaking regional anaesthesia device, invented by clinicians at The Queen Elizabeth Hospital King’s Lynn NHS Foundation Trust (QEH) and developed in conjunction with medical device company Medovate, has been awarded ‘Patient Safety Innovation of the Year’ at this year’s HSJ Patient Safety Awards.

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Brooks Automation, Cleveland Clinic open biobanking facility

, 4 November 2021/in E-News /by panglobal

Brooks Automation and Cleveland Clinic have opened a new 22,000-square-foot biospecimen sample management and repository facility on Cleveland Clinic’s main campus in Cleveland, Ohio. The two-story biorepository is managed by Azenta Life Sciences, Brooks’ recently re-branded life sciences division, and includes ultra-cold and cryogenic storage. The new facility increases biobanking capacity at Cleveland Clinic and […]

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DNV and CareCom launch CareIndexing: a new company shaping up disorderly clinical data with artificial intelligence

, 4 November 2021/in E-News /by panglobal

Healthcare professionals create and update hundreds of thousands of patient notes, diagnostic reports, lab analyses, and other clinical records every day. Yet 80% of the data included in them is unstructured. Information about clinical diagnoses is reported using different expressions, terms, acronyms and even languages, making records impossible to consolidate, analyse and report on at […]

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Hologic to acquire Bolder Surgical for $160 million

, 4 November 2021/in E-News /by panglobal

Hologic, a global leader in women’s health, will acquire Bolder Surgical, a privately held, U.S.-based company that provides advanced energy vessel sealing surgical devices, for approximately $160 million, subject to working capital and other customary closing adjustments.

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New study finds facemask ventilation of patients for surgery does not increase the risk of spread of COVID-19

, 27 October 2021/in Corona News, E-News /by panglobal

 

Study that included introducing deliberate mask ‘leak’ shows this procedure is low risk and should not be used as a reason to delay or slow down surgery 

 

New research published in Anaesthesia [1] says that the use of facemask ventilation during routine surgery should not be classed as an aerosol-generating procedure and does not increase the risk of COVID-19 transmission compared with normal breathing/coughing of patients.

Thus this procedure is not high risk and can be performed confidently for both routine surgery and emergency airway management. Its use should neither slow down operations or necessitate the use of extra personal protective equipment for medical teams.

Designation as ‘aerosol-generating procedure’

Facemask ventilation is an essential intervention used by anaesthetists as part of the ‘life support’ of most anaesthetised patients having surgery. Its designation as an ‘aerosol-generating procedure’ (AGP) by the World Health Organization has had a major impact on operating theatre efficiency and processes. However, there is no direct evidence to indicate whether facemask ventilation is a high-risk procedure for aerosol generation.  No study to date has measured the aerosol generated during facemask ventilation and the evidence for its AGP classification is based largely on one study of infections in anaesthetists dating back to the previous SARS-1 epidemic in 2003.

As a result of this AGP designation, current guidance dictates that anaesthetists performing facemask ventilation in a patient at risk of having COVID-19 would have to wear a respirator mask, eye protection and additional personal protective equipment. This would also apply to nearby theatre staff.  In addition, extra time (up to half an hour per case) had to be added to each operation to allow sufficient air changes in theatre to remove any of the presumed infectious aerosol.  This greatly reduces the number of cases that can be done each day, especially for urgent or emergency surgery, and is contributing to the backlog in the healthcare system.

The study

In this new study, the authors conducted aerosol monitoring in anaesthetised patients during standard facemask ventilation, and facemask ventilation with an intentionally generated air leak – to mimic the worst-case scenario where aerosol might spread into the air. Recordings were made in ultraclean operating theatres (at Southmead Hospital, North Bristol NHS Trust, UK) and compared against the aerosol generated by each patient’s normal breathing and coughing.

Respiratory aerosol from normal breathing was reliably detected above the very low background particle concentrations with median aerosol concentration of 191 particles per litre. The average aerosol concentration detected during facemask ventilation without a leak (3 particles per litre) was 64-times less than that for breathing. When an intentional leak was introduced the aerosol count was 17 times lower than breathing (11 particles per litre).

When looking at peak particle concentrations the team found that a patient coughing produced a spike of 1260 particles per litre, compared to the peak of 60 per litre (20 times lower) for regular facemask ventilation and 120 per litre with an intentional leak introduced (10 times lower).

Dr Andrew Shrimpton, the lead author of the study, commented: “This study demonstrates that facemask ventilation, even when performed with an intentional leak, does not generate high levels of bioaerosol.”

The authors add: “The low concentration of aerosol detected during facemask ventilation even with an intentional leak is also reassuring given that this represents a worst-case scenario. Both normal breathing and a voluntary cough generate many-fold higher quantities of aerosol than facemask ventilation. On this basis, we believe facemask ventilation should not be considered an aerosol-generating procedure. Accumulating evidence demonstrates many procedures currently defined as aerosol-generating are not intrinsically high risk for generating aerosol, and that natural patient respiratory events often generate far higher amounts.”

Clinical guidance

They conclude: “The emerging evidence from quantitative clinical aerosol studies is yet to be incorporated into clinical guidance for aerosol-generating procedures and we believe this needs urgent reassessment. Declassification of some of these anaesthesia-related procedures as aerosol-generating would seem appropriate due to their lack of aerosol generation. Our findings also raise the broader question of whether the term ‘aerosol-generating procedure’ is still a useful concept for anaesthetic airway management practice in the prevention of SARS-CoV-2 or other airborne pathogens.”

Dr Mike Nathanson, President of the Association of Anaesthetists said: “This important work will allow clinicians to better understand the risks of general anaesthesia in patients with Covid. As we enter another winter, and with a high prevalence of Covid, the backlog of surgical cases is increasing. Anaesthetists will wish to carry on working for as many of their patients as possible. As the authors suggest, this research will inform the debate on how we can work safely.”

This study is the result of a collaboration between Anaesthetic and Aerosol research groups based in Bristol, UK and Melbourne, Australia as part of the NIHR funded AERATOR study.  The results reinforce the findings of similar studies performed by the AERATOR group demonstrating many anaesthetic procedures are not high risk for aerosol generation.

Reference:

[1] Quantitative evaluation of aerosol generation during manual facemask ventilation. A. J. Shrimpton, et al. Anaesthesia. 26 October 2021. doi: https://doi.org/10.1111/anae.15599

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EU Medical Device Regulations: RQM+ shares free Search and Filter tool

, 26 October 2021/in E-News /by panglobal

RQM+ shares free Search and Filter tool for EU Medical Device Regulations

Most regulatory and quality professionals can think of a time when they struggled to find a specific requirement in the EU Medical Device Regulation (MDR). Finding all the instances where a particular compliance theme is mentioned can be painstaking and time-consuming. To allow easier navigation of the MDR, RQM+ has created a tool that allows users to search the legislation for specific subject areas.

The company’s internal specialists, as well as regulatory professionals within client companies, now save considerable administrative time every day by using the tool to consult the regulation.  The tool enables quick searches by topic, chapter, article, and search term. Rather than highlighting or sticky noting a paper copy, users can save notes on company interpretations of MDR sections and even individual sentences in the tool itself.

The regulatory and quality consulting firm has already shared an IVDR filtering tool, to support manufacturers working towards the EU’s upcoming In Vitro Diagnostic Regulation (IVDR). Both the IVDR and MDR tools are now freely available for medical device professionals to download and consult for their daily work.

Dr. Jaishankar Kutty, Vice President of Clinical Services at RQM+, said: “I was recently introduced to this tool after joining RQM+ this February, and my first reaction was: it would’ve been wonderful to have this tool when we waded into the initial MDR reviews at BSI! More than any other stakeholder, Notified Bodies need to know the regulation inside-out, and this tool makes it so easy to double check requirements. It’s now sitting on my desktop for easy access and it has been an extremely useful and welcome support so far.”

Nancy Morrison, Executive Director, Regulatory & Quality Consulting Services, initially developed these tools to support the RQM+ team. “We refer to regulation on a daily basis so we’re well aware of the frustrations of trying to find specific details or to gather all the sections referring to an area of compliance. We help our clients to put in place clear and organized processes to facilitate both short- and long-term compliance, and I hope that these tools will also make the work of regulatory professionals a little more straightforward.”

How does it work?

A demo of the RQM+ MDR Filtering Tool is available to watch here:
https://hubs.ly/H0XfKWW0

Download the tools

Download the RQM+ MDR Filtering Tool here:
https://hubs.ly/H0XfKWW0

Download the RQM+ IVDR Filtering Tool here:
https://hubs.ly/H0QNrQ_0

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When will pandemic end? WHO Director-General provides answers at World Health Summit

, 25 October 2021/in E-News /by panglobal

Tedros address World Health Summit 2021

 

Dr Tedros Adhanom Ghebreyesus, addressed the World Health Summit in Berlin on 24 October. This is what he had to say:

More than a decade ago, I was invited to be part of a group with an exciting new idea – an idea to bring together leaders from research, medicine, government, industry and global health, to ask the big questions and, hopefully, to make some progress towards big answers.

That first World Health Summit, in 2009, was held in the immediate aftermath of the global financial crisis, and in the shadow of the H1N1 pandemic.

In the 12 years since then, the World Health Summit has become a landmark on the global health calendar.

That’s why, together with Professor Axel Pries, we have decided to join forces to organize a joint World Health Summit in October 2022, to engage an even broader group of actors, committed to multilateral action for global health.

12 years since the first World Health Summit, we meet once again in the shadow of a pandemic.

And we are faced once again with some very big questions: some of the same ones we were asking in 2009 that remain unanswered, and some new ones.  

When will the pandemic end?

One of the questions I am asked most often is: when will the pandemic end?

My answer is that the pandemic will end when the world chooses to end it. It’s in our hands.

We have all the tools we need: effective public health tools, and effective medical tools.

But the world has not used those tools well.

With almost 50 thousand deaths a week, the pandemic is far from over – and that’s just the reported deaths.

As you know, we have set a target to vaccinate 40% of the population of every country by the end of this year.

That target is reachable, but only if the countries and companies that control supply match their statements with actions – right now.

The barrier is not production. The barriers are politics and profit.

It’s clear what needs to happen:

The countries that have already reached the 40% target – including all G20 countries – must give their place in the vaccine delivery queue to COVAX and the African Vaccines Acquisition Trust, or AVAT;

The G20 countries must fulfil their dose-sharing commitments immediately;

Manufacturers must prioritize and fulfil their contracts with COVAX and AVAT as a matter of urgency, and be far more transparent about what is going where.

And they must share know-how, technology and licences, and waive intellectual property rights.

We’re not asking for charity; we’re calling for a common-sense investment in the global recovery.

How will we prevent this happening again?

The second major question the pandemic is asking us is, how will we prevent this happening again? How do we make the world safer?

In its first report in 2019, the Global Preparedness Monitoring Board warned that the world was unprepared for a pandemic, just months before COVID-19 struck.

We welcome the GPMB’s latest report, which will be launched on Tuesday, and its recommendations.

Allow me to offer four answers; four areas in which the global health architecture must be strengthened.

First, governance

For the past 20 years, the response to every crisis or health threat has been to create a new institution or mechanism, with new governance structures, and new funding needs.

The result is a global health architecture that is complex and fragmented.

That’s why we believe the time has come for a legally-binding international agreement on pandemic preparedness and response, which will be the focus of next month’s Special Session of the World Health Assembly.

Second, financing

Cycles of panic and neglect have created a financing ecosystem that is insufficient, inefficient and inequitable.

It’s clear that we need a substantial increase in funding for national and global preparedness and response.

Crucially, any new financing facilities must be built using existing financial institutions, rather than creating new ones that further fragment the global health architecture.

More broadly, it’s clear that we need a new narrative for the way health is financed, which is why earlier this year we established the Council on the Economics of Health for All, led by Professor Mariana Mazzucato. We look forward to the launch of its second policy brief on Tuesday.

Third, systems and tools

COVID-19 has exposed serious gaps in the global ability to prepare for, prevent, detect and respond rapidly to outbreaks with epidemic and pandemic potential.

We need new tools, across the One Health spectrum.

WHO has already taken steps to build some of those tools, including the new Hub for Epidemic and Pandemic Intelligence here in Berlin, which I had the honour to open with Chancellor Merkel last month.

Last month, I also had the honour of joining President Macron to break ground on the new WHO Academy in Lyon, which will be a state-of-the-art school, using cutting edge technologies to support lifelong learning for health workers and public health professionals around the world.

Other initiatives are in development.

And fourth, WHO itself

Beyond the response to COVID-19, WHO continues to respond to dozens of other emergencies around the world, to support countries to address the burden of communicable and noncommunicable diseases, and to address the social, economic and environmental determinants of health.

Earlier this month, we recommended broad use of the world’s first malaria vaccine, a new tool against an old disease that could save millions of lives;

On polio, only two cases have been reported in Afghanistan and Pakistan so far this year, the lowest in history, and no case has been reported for nine months.

Last month, I had the opportunity to visit Afghanistan, and I’m pleased that house-to-house vaccination will shortly resume for the first time in three years, bringing us closer than ever to our dream of a polio-free world.

On NCDs, in 2019, we reached agreement with 11 of the world’s biggest food companies to eliminate industrially produced trans-fats from the global food supply by 2023, and most companies say they have already achieved this goal. We have also launched a programme to certify countries that have eliminated trans fats from their national food supply.

On childhood cancer, we are now actively supporting 50 countries, providing medicines in conflict settings like Yemen and Syria, almost doubling the health workforce in some countries, supporting the construction of new cancer centres and the development of legislation to guarantee access to care for children with cancer throughout their lifetime.

On climate change, we’re supporting 14 countries, especially small island developing states, with investments at country level for climate-resilient and environmentally sustainable health facilities.

And day by day, we continue to support countries to strengthen their health systems, especially primary health care, on their journey towards universal health coverage.

This is the unglamorous but indispensable work that only WHO can do.

It has often been said that if WHO didn’t exist, it would have to be created.

A unique global mandate

With 194 Member States and 152 country offices, WHO has a unique global mandate, unique global reach and unique global legitimacy.

But over several decades, it has been progressively weakened by a debilitating imbalance between assessed contributions, which currently account for just 16% of our budget, and voluntary, earmarked contributions, which now account for 84%.

This imbalance distorts our budget and constrains our ability to deliver what our Member States expect of us. Redressing it is vital if WHO is to be the independent and authoritative global health leader the world needs it to be.

Frankly, the world doesn’t need another structure or institution;

It needs a strengthened, empowered and sustainably financed WHO at the centre of the global health architecture.

Let leave you with three specific requests:

First, we must end this pandemic, by pulling out all the stops to reach our target of vaccinating 40% of the population of every country by the end of this year.

Second, we must prevent the next pandemic, with better governance, financing, systems and tools, and by strengthening WHO.

And third, all countries must invest in primary health care as the foundation of universal health coverage.

The pandemic has demonstrated beyond doubt that health is not a luxury for the rich, or simply an outcome of development; it’s a fundamental human right, and the basis of social, economic and political stability.

There’s only one way to achieve these three things – and that’s together.

No country can end the pandemic in isolation from the rest of the world;

And no country can protect the health of its own people without working to protect the health of all people.

It takes some tough negotiations and some tough decisions. But the reward is a world that is healthier, safer and fairer for all of us.

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