Archive for category: E-News

E-News

Philips and B. Braun launch needle tip tracking for real-time ultrasound guidance for regional anesthesia

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Philips and B. Braun,  a player in regional anesthesia and pain management, recently announced the launch of Onvision, a breakthrough ultrasound guidance solution for real-time needle tip tracking in regional anesthesia. Available on the latest version of the B. Braun and Philips Xperius ultrasound system, Onvision gives anesthesiologists the confidence to accurately position the needle tip inside the body. The introduction is part of a multi-year strategic alliance between Philips and B. Braun to innovate in ultrasound-guided regional anesthesia, a rapidly growing alternative to general anesthesia.
Accurate needle placement is critical to the success of regional anesthesia procedures, such as peripheral nerve blocks, both in terms of effective pain relief and the avoidance of unintended nerve and vessel punctures or collateral damage to surrounding tissue. While real-time ultrasound imaging has proved to be a valuable tool for needle guidance, failure to optimally visualize the needle tip remains a challenge for both novice and experienced anesthetists. Currently, 10-20% of all peripheral nerve blocks are ineffective on the first attempt. By simplifying alignment between the needle and ultrasound probe, Onvision reduces the effort needed to interpret the ultrasound image. This allows the anesthesiologist to more confidently guide the tip of the needle to its target.
“Regional anesthesia is a rapidly growing alternative to general anesthesia and has the potential to improve patient outcomes as well as increase workflow efficiency in the hospital,” said Bert van Meurs, Chief Business Leader, Image Guided Therapy at Royal Philips. “By combining B. Braun’s expertise in needle design with Philips’ capabilities in real-time image guidance, we’ve created a solution to one of the biggest challenges in regional anesthesia – accurate positioning of the needle tip in the body. Our alliance with B. Braun is a strong example of our commitment to partner with industry leaders to grow our footprint in the therapy market.”
“Our customers want intuitive solutions that allow them to focus on the patient rather than the technology, so they can achieve the best outcomes. As demand for regional anesthesia grows, improved efficiency can also help reduce the pressure of an increasing workload,” said Dr. Meinrad Lugan, Member of the Board for the Hospital Care Division at B. Braun. “Onvision is a perfect example of what can be achieved through shared expertise to meet the evolving needs of our customers, bringing regional anesthesia to more patients in more hospitals worldwide.”
Together, B. Braun’s Stimuplex Onvision needles and Philips’ Onvision needle tip tracking technology indicate the position of the needle tip in relation to the ultrasound viewing plane to an accuracy of better than 3mm. A sensitive micro-sensor placed on the needle, combined with advanced signal processing and visualization techniques on the Xperius system, indicate the real-time location of the needle tip in relation to the 2D ultrasound viewing plane. The solution provides greater flexibility in needle trajectory and can reduce procedure times. The increased confidence and predictability offered by Xperius and Onvision will empower more anesthesiologists to embrace regional anesthesia as a viable and effective alternative to general anesthesia.
Regional anesthesia or analgesia involves the injection of an anesthetic in the proximity of a nerve, targeting areas of a patient’s body that are subject to surgical intervention. Regional anesthesia can have significant advantages over general anesthesia for both patients and hospitals. Patients undergoing regional anesthesia typically benefit from reduced opioid consumption and fewer side-effects, such as nausea. Moreover, regional anesthesia may lead to faster post-surgical recovery, allowing patients to ambulate or leave the hospital sooner, which benefits both patients and hospitals.
Together, Xperius and Onvision form an integrated point-of-care solution for supporting current and future needs in regional anesthesia. They are co-branded and sold via B. Braun’s global sales network, with Philips providing installation and service. Xperius is part of Philips’ portfolio of point-of-care ultrasound systems, which offers clinicians the ability to diagnose and care for their patients in any work environment. www.philips.com

The importance of ventilation to prevent spread of Covid-19

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Using laser light techniques, University of Amsterdam physicists and medical researchers have found that small cough droplets, potentially containing virus particles, can float in the air in a room for many minutes, especially when the room is poorly ventilated. Good ventilation in public spaces (e.g. public transport, nursing homes) is therefore crucial to slow down the spread of the coronavirus. The results were published in The Lancet Respiratory Medicine on 28 May 2020.
The research was carried out by physicists Daniel Bonn, Stefan Kooij and Cees van Rijn from the UvA Institute of Physics, together with medical researchers Aernout Somsen (Cardiology Centers of the Netherlands) and Reinout Bem (Amsterdam University Medical Centers).
The researchers asked healthy test persons to speak and to cough, and used laser light to analyse the droplets that were produced. Both during speech and coughing, large amounts of small droplets (between roughly 1 and 10 micrometres in size) were observed. During coughing, larger droplets (up to 1 millimeter in size) are also produced. Those droplets fall to the ground within one second, however, and therefore have a much smaller probability of transmitting viruses.
The small droplets only move very slowly to the ground due to the large amount of air drag they experience. The researchers found that such droplets can stay in the air for several minutes. After a single cough, it takes about five minutes for the number of small droplets in the air to be halved. These tiny droplets are therefore much more dangerous when it comes to possible transmission of the coronavirus.
Ventilation
When the same measurements were repeated in a well-ventilated room, the results improved dramatically. With only mechanical ventilation turned on, half of the droplets disappeared within 2.5 minutes, but in a room that also had a door and window open, the number of droplets was halved after 30 seconds – ten times faster than in the unventilated room.
The result is important for making better policies to slow down the spread of the coronavirus. Despite physical distancing, spaces like public transportation and nursing homes can still be centres for spreading the virus if insufficiently ventilated. When droplets remain in the air for a long time, proximity tracing via smartphone apps is also an insufficient precaution. The researchers therefore recommend healthcare authorities consider recommendations to ensure adequate ventilation wherever possible in public spaces
Small droplet aerosols in poorly ventilated spaces and SARS-CoV-2 transmission – The Lancet Respiratory Medicine https://doi.org/10.1016/S2213-2600(20)30245-9 Indoor environments
Meanwhile, in a similar study, scientists from Surrey’s Global Centre for Clean Air Research (GCARE), with partners from Australia’s Queensland University and Technology, argue that the lack of adequate ventilation in many indoor environments – from the workplace to the home – increases the risk of airborne transmission of Covid-19.
They note that Covid-19, like many viruses, is less than 100mn in size but expiratory droplets (from people who have coughed or sneezed) contain water, salts and other organic material, along with the virus itself. However, as the water content from the droplets evaporate, the microscopic matter becomes small and light enough to stay suspended in the air and over time the concentration of the virus will build up, increasing the risk of infection – particularly if the air is stagnant like in many indoor environments.
The study highlights improving building ventilation as a possible route to tackling indoor transmission of Covid-19.
Could fighting airborne transmission be the next line of defence against COVID-19 spread? www.sciencedirect.com/science/article/pii/S2590252020300143 Modelling
Additionally, a study carried out in March this year by four Finnish research organisations modelled the transport and spread of coronavirus through the air. They note that preliminary results indicate that aerosol particles carrying the virus can remain in the air longer than was originally thought, so it is important to avoid busy public indoor spaces. This also reduces the risk of droplet infection, which remains the main path of transmission for coronavirus.
The research has been has been submitted for peer-review and published on https://arxiv.org/abs/2005.12612. The paper details how they have modelled the airborne transport of different-sized droplets. These are emitted through coughing, so the study evaluated the quantities of particles that someone could come into contact with upon entering a supermarket or any other indoor public space.
Assistant professor at Aalto University, and project coordinator, Ville Vuorinen, says that both previous related research, and a number of well-known infection spikes, indicate a substantial risk of coronavirus through inhalation of aerosol particles, as well as direct droplet transmission and transmission from surfaces. The 3D flow simulations and analyses carried out in the project also support these ideas.
The 3D simulation shows how droplets of varying size travel in an indoor airflow https://youtu.be/f7I0O0C_eqg credit: Aalto University / Finnish Meteorological Institute / VTT / University of Helsinki / IT Center for Science CSC. Animation: Jyrki Hokkanen, CSC – IT Center for Science Ltd.

Survivors of breast cancer face increased risk of heart disease

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Thanks to advanced medical treatments, women diagnosed with breast cancer today will likely survive the disease. However, some treatment options put these women at greater risk for a number of other health problems. A new study out of Brazil shows that postmenopausal women with breast cancer are at greater risk for developing heart disease.
Cardiovascular disease remains the main cause of death in postmenopausal women, and women treated for breast cancer are at greater risk of developing heart disease than those not diagnosed with breast cancer. These cardiovascular effects may occur more than 5 years after radiation exposure, with the risk persisting for up to 30 years. The goal of the new study was to compare and evaluate risk factors for cardiovascular disease in postmenopausal women who are survivors of breast cancer and women without breast cancer. The researchers found that postmenopausal women who are survivors of breast cancer showed a markedly stronger association with metabolic syndrome, diabetes, atherosclerosis, hypertriglyceridemia, and abdominal obesity, which are major risk factors for cardiovascular disease. The risk of cardiovascular mortality similarly increased to match death rates from the cancer itself.
“Heart disease appears more commonly in women treated for breast cancer because of the toxicities of chemotherapy, radiation therapy, and use of aromatase inhibitors, which lower oestrogen. Heart-healthy lifestyle modifications will decrease both the risk of recurrent breast cancer and the risk of developing heart disease,” says Dr. JoAnn Pinkerton, NAMS executive director. “Women should schedule a cardiology consultation when breast cancer is diagnosed and continue with ongoing follow-up after cancer treatments are completed.”
The North American Menopause Society (NAMS) https://tinyurl.com/up2vyvu

Finalists of the 2019 IHF Awards unveiled

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The International Hospital Federation (IHF) announces the finalists of the 2019 IHF/Dr Kwang Tae Kim Grand Award and Excellence Awards in Corporate Social Responsibility, Leadership and Management in Healthcare, and Quality & Safety and Patient-centered Care.
Following an extensive review by the panel of judges composed of health leaders from around the world, 27 top entries from the four categories have been selected as finalists from which the Gold, Silver, Bronze and Merit Awards will be chosen.
“I am delighted and excited to see that the quality and standards of entries are very high this year”, says Dr Lawrence Lai, Chairman of the IHF Awards Committee. “With so many excellent entries, selecting the best among the best is indeed most challenging. Hence, there is no need to be disheartened even if you are not selected this time. To the Award winners, our heartiest congratulations for a job well done!”
Since the Awards was first presented in Chicago, USA in 2015, the IHF has been recognizing innovation, excellence, outstanding achievements and best practices of hospitals and healthcare organizations. Winning projects have benefitted from the IHF Awards with global recognition that inspires their teams to strengthen commitment to their causes, earns them generous donations to support their programs, as well as encourage others to aspire for improvement and eventually earn the badge for best practice.
This year’s winners will be revealed on 8 November 2019 during the 43rd World Hospital Congress at the Oman Convention and Exhibition Centre in Muscat. Gold Winners will be invited to present in a special session during the World Hospital Congress to share their winning programs and projects while Silver, Bronze Winners and Merit Awardees will be displaying posters at the Congress exhibition.

IHF Awards

New digital pills allow doctors to monitor patients at home

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There’s an app for just about everything these days. Now thanks to a new treatment option offered at the University of Minnesota, there’s now one for cancer.
These new technologies, known as digital medicines are allowing doctors to monitor their patients, even after they leave the hospital. University of Minnesota Health and Fairview Health Services are the first in the world to apply digital medicines to cancer care.
“When we give people chemotherapy in the clinic with an intravenous drug, we’re able to assess the dose and timing and make sure they’re well enough to continue getting the treatment,” said University of Minnesota Physicians oncologist/hematologist Edward Greeno, MD, a professor at the University of Minnesota Medical School’s Department of Medicine in an interview with the Washington Post. “But when you send them home with a bottle of pills, you don’t know when they’re taking them or if they’re well enough to take them.”
Dr. Greeno, who also directs the oncology service line for University of Minnesota Health, told the Star Tribune, “the technology could significantly improve cancer care because the timing and dosage of chemo-therapy is critical.”
Dr. Greeno, along with other doctors at the Masonic Cancer Clinic at the University of Minnesota Health Clinics and Surgery Center, have begun prescribing pills embedded with small, ingestible sensors. The sensors, designed by Proteus Digital Health, are only the size of a grain of sand, but can track a wealth of information that is helpful for doctors including heart rate, activity level and sleep cycle.
Once the pill is ingested, it sends the data to a small patch on the patient’s abdomen, which then connects to a mobile app that both the patient and their doctor can access.
This new technology will allow doctors to ensure patients are taking their medications as prescribed. Physicians can automatically tell how many pills a patient has left in their prescription, which helps them better manage refills and potentially save money for the patient. The technology can also give a sense of comfort to some patients, helping them take a more active role in managing their medication.
Digital medicine technology has been used to help patients manage medications for a variety of diseases, including diabetes and hypertension, but never before in cancer.

University of Minnesota https://tinyurl.com/y3tgrga4

Fujifilm Medical IT shows at HIMSS 2019 how artificial intelligence is driving the future of healthcare

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FUJIFILM is displaying its evolving portfolio of medical informatics and Enterprise Imaging innovations, by presenting REiLI, Artificial Intelligence (AI) Medical Imaging initiative at HIMSS & Health 2.0 Conference from 11th to 13th June, at Messukeskus Helsinki, Expo & Convention Centre, Helsinki, Finland.
It’s transformative time in medicine practice, and FUJIFILM is at the side of the medical world to reengineer imaging strategy. At HIMSS & Health 2.0 Conference 2019, Helsinki, Finland, discover how to design digital diagnostic data hubs delivering “total imaging care” that will benefit patients and physicians.
At the booth #6D1, our experts will show the latest innovations from our enterprise imaging portfolio and how they can help you:

  • Providing a complete picture of each patient’s health so that doctors across the care continuum can make more-informed decisions.
  • Understanding how an artificial intelligence platform can help impact patient care, improve workflows, and drive new research.
  • Building and implement an enterprise imaging strategy to reduce the cost of care and impact patient outcomes.

The AI revolution is underway, in an increasingly complex healthcare environment with larger datasets and rising demand for high quality care, Fujifilm, under the REiLI brand, is developing an open platform to realize a new diagnostic imaging workflow.
REiLI fits perfectly with our latest release Synapse 5: the server-side-rendering technology and the centralized processing of Synapse 5 allow the easy application of the Artificial Intelligence technology within the normal workflow management tool to support of health professionals. The new open platform will not only host Fujifilm’s AI technologies, but will also host various other AI technologies from external partners. We will strive to support our customers’ by combining diverse AI technologies offering them the best support for their daily work which is currently increasing due to the sheer volume of Imaging scans as well as the complexity of the diseases their patients are facing
The Fujifilm Healthcare IT platform Synapse displayed at HIMSS will include our comprehensive medical informatics and enterprise-imaging portfolio:
SYNAPSE 5 (PACS) sets a new standard for enterprise imaging. With a focus on speed and interactivity, Synapse 5 PACS provides remarkable on-demand access to massive datasets and the ability to immediately interact with the data.
SYNAPSE VNA (vendor-neutral archive) was designed for true imaging interoperability to enable practitioners to provide enhanced patient care across the enterprise. The VNA provides secure, easy-to-manage storage and access to the complete patient imaging record and links all HIT systems.
SYNAPSE Enterprise Viewer uses the latest server-side rendering technology to stream imaging securely and quickly to any authorized user. It can be used within applications, directly from your EHR, or on our mobile device apps. Both within and outside of the Enterprise, giving access to imaging immediately and helping clinicians making the most informed and accurate decisions. Synapse Enterprise Viewer allows multiple users to view images simultaneously, and to take control of them as they are presented in real time, thereby improving speed, efficiency and patient care.
SYNAPSE 3D is Fujifilm’s portfolio of clinical modules (currently 55) for advanced processing and analysis of the medical imaging: it is a state of the art system which provides powerful and complete tools not only for Oncology, Radiology and Cardiology Departments, but also supports the Clinical and Surgical workflow. Fast, reliable and accurate, based on our heritage of Excellence in Imaging (across, our Photography, Graphics, Film and other mature business domains) Image Intelligence Fujifilm technology, Synapse 3D is the software platform that fully meets the new requirements for advanced processing and displaying of clinical and diagnostic imaging and for oncology and surgical planning.
SYNAPSE CWM, Clinical Workflow Manager, is the most advanced Information System on the market today, covering Radiology, Endoscopy and multiple Screening services – Breast, Bowel, AAA and many others. It continues to evolve to support the unique imaging and information needs in today’s busy imaging departments. One platform can support acute care facilities, imaging centers, and radiology practices providing distributed diagnosis.
SYNCRO-DOSE is Fujifilms Radiation Dose Index Monitoring system, compliant with European Union Directive 2013/59 / EURATOM. Syncro-Dose is a comprehensive system for monitoring and managing patient radiation exposure at enterprise level across different imaging modalities and hospital facilities. It is a support for the optimization of radiological procedures and acquisition protocols, a tool for supporting clinical audit and it provides a comprehensive Patient Dosimetric History.
NEVER STOP… Innovating Healthcare
Fujifilm launched Fuji Computed Radiography (FCR), becoming the first company in the world to offer a digital X-ray diagnostic imaging system. Fujifilm saw the opportunity to leverage the technologies it had developed for FCR and contribute to the evolution of connectivity within and among medical facilities. What made Fujifilm’s SYNAPSE concept different was that it used the emerging Internet and web technologies instead of private networks. It was, in essence, a Web-based PACS: the first in the world in 1999
SYNAPSE’s rapid rate of adoption was due in large part to its capability, to contribute significantly to the quality of medical care by delivering images to clinicians fast and securely. We have over 800 Synapse sites in Europe, and over 5000 Synapse systems are installed in healthcare facilities around the world, earning the largest market share worldwide.
(*): Fujifilm’s artificial intelligence software is a work in progress and is not commercially available in Europe.
(**) Fujifilm estimation based on a set of data from multiple market research studies
(***) Synapse 3D is also known as Synapse Vincent is some global markets (Red Dot Award was given to Synapse Vincent)
Experts and product specialists are available at Fujifilm booth for product demonstration and to create tailor-made solutions for any healthcare provider.

FUJIFILM Healthcare IT booth: #6D1

https://synapse.fujifilm.eu/index.html

Cleveland Clinic advises different approach to preventing CVD in women

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Women have unique risk factors for heart disease that need to be taken into account in prevention and treatment strategies, according to a Cleveland Clinic cardiologist who led a team tasked with updating recommendations on women and cardiovascular disease for the American College of Cardiology.
Traditionally, doctors have treated men and women as the same when it comes to heart disease, but the director of the Women’s Cardiovascular Center at Cleveland Clinic, Leslie Cho, M.D., says that it is time to start thinking differently.
She explains: “For years, we’ve thought about men and women as having the exact same risk factors, namely, high blood pressure, hyperlipidemia, smoking, diabetes and family history. However, while heart disease is the number-one killer and most prevalent disease in women, women actually have very low risk in terms of the traditional risk factors.
“However, some conditions specific to women, such as endometriosis, have been found to raise the risk of developing coronary artery disease – the leading cause of heart attacks – by 400% in women under age 40.”
In compiling the updated recommendations, Dr. Cho and her team reviewed diseases that are more prevalent in women; sex-related differences in traditional risk factors; and risk factors that only women experience, such as those related to pregnancy.
Risks unique to women
In terms of pregnancy-related conditions, they noted that high blood pressure during pregnancy, gestational diabetes, preterm birth and miscarriages all increase a woman’s risk of developing heart disease. Identification of pregnancy-related conditions is important, says Dr Cho, as it can help identify younger women, with low traditional-risk scores, to allow for earlier monitoring of cardiometabolic factors and management.
Hormonal conditions specific to women have also been associated with increased heart risk. One of these is premature menopause, defined as menopause before the age of 40.
Dr Cho explains: “Estrogen offers women some protection from heart disease until after menopause, when estrogen levels drop. This is why the average age of for a heart attack in women is later, at 70, as opposed to 66 in men.”
Another sex-specific risk factor is a hormonal condition called polycystic ovarian syndrome (POCS), found in one in 10 women. This is associated with cardiometabolic factors, which, in turn, are associated with increased heart disease risk. The cardiometabolic factors associated with POCS include abdominal obesity, abnormal glucose control and diabetes, elevated blood pressure, and abnormal amounts of fats – such as cholesterol – in the blood, known as dyslipidemia.
Differences in traditional risks
Regarding sex-related differences in the traditional risk-factor category, it has been found that hypertension and diabetes are strong risk factors in women. Another risk factor, high blood pressure, is more common in women over the age of 50 than in men.
Woman are also more likely than men to experience depression or mental health issues, such as anxiety and chronic emotional stress, that can have an impact on their heart health.
“We really should be treating not just the blood pressure number, or the cholesterol number, but rather treating the whole patient, including their mental health, to have a good cardiovascular outcome,” says Dr. Cho.
She adds that studies have also shown sex differences in response to treatments, and doctors need to take these into account.
Common prevention strategies
Despite the different sex-related risks, Dr. Cho points out that there are common areas where either sex can lower their risk for heart disease by making changes to their lifestyles. Among these she includes avoiding smoking, getting regular exercise – at least a 30-minute walk daily – and maintaining normal weight, blood pressure, blood lipid and blood sugar levels. She recommends a diet high in fruits, vegetables, whole grains and fish, and low in animal products, simple carbohydrates and processed foods.

Mental health expert urges people to accept grief and other feelings amid COVID-19 pandemic

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As the COVID-19 pandemic upends life as people know it, changing daily routines, limiting social interactions and shaking their sense of safety, a mental health experts from U.S. hospital Cleveland Clinic’s Mellen Center is stressing that it is perfectly acceptable to feel sad about all of it.
She points out that grief is a natural response to loss – whether it is the loss of a loved one, or the loss of a sense of normalcy.
“We are experiencing a lot of disappointment right now – in both small and big ways – and grief is going to be a factor,” says clinical health psychologist Amy Sullivan, PsyD, ABPP.
“It’s really important that we process this and stay connected to other people in safe ways,” she adds.
Regarding how people should go about dealing with all of these difficult and unexpected feelings bubbling up, she says there is no right or wrong way. However, she offers four suggestions that can help people to cope with current events.
1. Look through the lens of grief and process emotions
She says that the stages of grief can provide a helpful framework for navigating these complex emotions. Experts recognize these stages as denial, anger, bargaining, despair, and acceptance. However, these experts also know that people do not step neatly from one stage to the next in this exact order, she says.
“Grief can come in waves and change on a very regular basis. Our feelings can change on a daily, or even an hourly, basis,” she explains.
Dr. Sullivan adds it is normal to go from feeling despair one day to anger the next.
“The first thing we need to do is to recognize that it is normal to have these waves of emotions that are happening on a regular basis,” Dr. Sullivan says.
Next, she says, acknowledge the loss whether it is knowing or losing someone with COVID-19, losing jobs, missing friends or family.
“Those are all very sad, difficult things for people to manage,” Dr. Sullivan says.
“Feel what you are feeling – whether it is being overwhelmed, anxious, powerless or anything else, it can help to identify and name these emotions,” she advises.
“It can be quite powerful to sit with those feelings for a few moments – to really recognize those emotions and normalize them,” she says.
However, she advises people to set a time limit on this, suggesting they give themselves five minutes to feel that emotion, and then move on to something that they know is a positive coping skill for them.
“It is important for us to accept where our feelings are at the moment and process through them, and then move into a more positive position of acceptance,” she says.
She says this can be done by identifying their own best coping mechanisms
“This is a time when people need to become innovative and develop their own individual sense of coping that works for them during this time,” she says. Examples might include deep breathing, mindfulness exercises, journaling, talking with another person, or going for a walk.
“If it comes to a point where someone cannot handle these feelings on their own, they need to seek mental health help,” Dr. Sullivan says.
2. Fight the urge to disengage
Dr. Sullivan stresses that staying connected is a powerful tool for coping during hard times. Whether that comes in the form of video chatting or sending a good old-fashioned letter, staying in touch with family, friends, neighbours and coworkers can help people to keep a positive attitude, she says.
She adds that many trained mental and behavioural health professionals are currently seeing patients through virtual visits, so that if people are having trouble coping, this could be a solution.
3. Focus on what can be controlled
Dr. Sullivan says that when there is so much uncertainty about the future, it is easy for people to get carried away, playing out the worst-case scenarios in their heads, for example worrying about themselves or someone else getting COVID-19, or wondering if things will ever get back to normal.
“Anticipating negative events can bring a sense of anxiety or fear,” Dr. Sullivan says.
She advises that, instead of agonizing over the things that cannot be known or controlled, people should be aware of what they do have control over. For example, they can choose how much news or social media they consume in a day, and they can decide what they eat. She recommends being mindful about these choices, and focusing on staying in the present.
4. Be open to joy
Lastly, Dr. Sullivan advises people to find joy and gratitude in the small things, like a video chat with family members, or the rush of fresh air when they open a window or step outside. She adds that if they are under a lockdown order, they can find ways to appreciate the opportunity to step back from the hustle and bustle of everyday life and being home.

Will Europe’s clampdown on faulty medical devices hurt patients?

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When a Californian company founded by a U.S. veteran wounded in Afghanistan sought to register a new medical device this year, it turned to Europe before the United States. The European approvals system had long been quicker, the company said, but the introduction of new rules is changing all that.
 “Now it has flipped,” said Bill Colone, CEO of San Clemente-based Spinal Singularity, which hopes to launch a ‘smart’ catheter for men with spinal injuries or disease early next year after squeezing in its application under the old European rules.
Colone is part of a chorus of industry voices warning that a switch to stricter European rules governing medical devices, due to come into force a year from now, will slow or even halt the release of products in Europe that could transform patients’ lives.
Defenders of the regulations say they will not significantly complicate the process and are vital to prevent problems like rupturing silicone breast implants and debris from all-metal hip implants damaging tissue and bones.
Many patient advocates say the new rules do not go far enough to reform a European system in which a top U.S. official suggested in 2011 patients may be “guinea pigs” here. The comment drew a sharp response from the European Union, which still firmly rejects that characterization.
That transatlantic spat, and the subsequent evolution of medical device certification around the world, are part of a wider global struggle by governments to attract businesses seeking light-touch regulation without scaring off their voters.
The new medical devices rules agreed by the European Union in 2017 will tighten control of devices before they come to market, improve transparency and strengthen surveillance by national authorities, a European Commission spokesperson said.
The new system changes less than some proposals – which envisaged regulation by a public body, along U.S. lines, replacing the existing practice of certification by profit-making private firms.
But players in medical technology – which ranges from surgical implants to scans – say it is too burdensome and is being built too slowly, risking not only hampering innovation but also harming patients by interrupting supplies.
“Immediate action is needed now to avoid severe disruption of product supply to patients and hospitals,” seven European Associations said in a joint statement last week.
All 55,000 devices certified under the old directives have to be re-certified along with other products such as reusable scalpels, nasal saline sprays and dental imaging software.
The industry says there are not enough Notified Bodies – the private firms charged with certifying the safety of devices ranging from bandages to pacemakers, and that manufacturers may have to take products off the market or delay new launches.
Reutershttps://tinyurl.com/yyqe7pp3

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