Знайшов "свіжу" статтю з Італії. Виявляється я вже давно оперую майже таким же методом...
Ця новина звучить як виправдання... Близько 200 трансплантацій в Україні протягом року - сором для галузі!
Кабінет Міністрів України також передбачив механізм проведення трансплантацій до початку роботи ЄДІСТ та роботи Уповноваженого органу з питань трансплантації.
Уже у наступному році кожен повнолітній українець зможе письмово затвердити своє бажання чи небажання стати донором або призначити уповноважену особу, яка зможе прийняти це рішення за нього після його смерті. Відповідну Постанову КМУ ухвалили на засіданні Уряду 27 грудня 2018 року.
Порядок затверджує письмові форми для волевиявлення громадян щодо можливого донорства, які будуть вноситися до Єдиної державної інформаційної системи трансплантації. Зокрема це:
Кількість заяв, які може подати фізична особа, є необмеженою. Крім того, після подання нової форми заяви, дія попередньої автоматично анулюється. А отже, рішення, бути чи не бути донором, людина може змінювати протягом усього життя.
Заяви про донорство можна буде надати як особисто трансплант-координатору в медзакладах, що здійснюють діяльність пов’язану з трансплантацією, так і посадовій особі Уповноваженого органу з питань трансплантації. Також порядок перебачає, що у майбутньому буде можливість подання електронної заяви про згоду чи незгоду на донорство шляхом заповнення онлайн-форми на сайті Уповноваженого органу з питань трансплантації, яку необхідно обов’язково завірити особистим електронним цифровим підписом.
Важливо наголосити, що з 1 січня 2019 року трансплантація в Україні проводитиметься. Ті лікарні, які проводять лікування цим надзвичайно складним методом, матимуть змогу і далі рятувати людські життя. Щороку українські лікарі виконують близько 200 операцій з трансплантації. Для того, щоб цей показник суттєво збільшився і більше українців могли отримувати вчасну спеціалізовану допомогу, необхідно, щоб запрацювала уся система, що передбачена новим законом про трансплантацію.
З 1 січня 2019 року рішення про проведення лікування методом трансплантації прийматиме консиліум лікарів медзакладу, де пацієнта внесено до списку очікування. Свою згоду або незгоду на отримання лікування пацієнт надаватиме лікуючому лікарю медзакладу, який проводить трансплантацію.
Заяви про рішення стати донором або відмовитися стати донором українці подаватимуть або лікарю медзакладу, що має здійснювати трансплантацію, або трансплант-координатору, уповноваженій особі у центрах донорства крові та центрах вилучення анатомічних матеріалів для трансплантації. Також такі заяви можна буде надати своєму сімейному лікарю чи терапевту. Усі заяви зберігатимуться у закладах охорони здоров’я, де їх прийняли, з дотриманням законодавства щодо захисту персональних даних. Упродовж трьох днів від початку роботи Уповноваженого органу з питань трансплантації усі заяви будуть перенаправлені до нового ЦОВВ.
Нагадаємо, новий закон вступив в дію 24 липня 2018 року. Отже, часу для створення ЄДІСТ, окремого ЦОВВ, що має координувати систему трансплантації, закупівлю нового обладнання для 4 центрів з трансплантації, навчання нової професії трансплант-координатора та розробку близько 30 нових нормативно-правових актів у Міністерства було близько 5 місяців. Для того, щоб виконати увесь необхідний обсяг роботи, передбачений законом, необхідно щонайменше 1 рік і належне фінансування з Державного бюджету усіх складових системи, яке Парламент не передбачив при прийнятті нового закону.
Розуміючи, що виконання норм закону не були реалістичними, був розроблений законопроект, що мав відтермінувати дію нового закону. Його підтримав Комітет з питань охорони здоров’я, але парламентарі не встигли його розглянути та проголосувати в останній сесійний тиждень роботи Верховної ради у 2018 році.
Бачив і пробував попередню версію Anatomage Table. Просто Супер!
In recent years, Intuitive Surgical has been at the center of controversy with claims they hid more than 700 injury claims, numerous patient lawsuits and new robotic technology vying for FDA approval from every major medical device company in an effort to unseat them as the leader in robotic surgery.
This hasn’t deterred Intuitive though.
Surgeons are still flocking to the da Vinci and helping the company grow. In the first quarter of 2018, Intuitive blew past their projections in system growth and procedure volume.
The most interesting thing is, amid the controversy, the company has kept quiet and continued working hard…until now.
Intuitive released an amazing video with a list of their accomplishments and they are impressive.
Laurie Featherstone says she was about to have a hysterectomy in March 2015 when her doctor asked a question she was not expecting. Did she want to have the surgeon use a robot for the procedure?
“[The doctor] said if she were me, she’d elect to have the robot,” recalled Featherstone, a hairstylist from this suburb northeast of Des Moines.
The robot is the only one of its kind: the da Vinci surgical system made by Silicon Valley’s Intuitive Surgical. The reasons the doctor recommended it, Featherstone recalled, included “less downtime, less scarring, and less than a 3 percent complication rate.”
Featherstone, who needed the operation in part because of fibroids in her uterus, followed her doctor’s advice. But a few weeks after the robot-involved procedure, complications emerged.
Excess fluids accumulated in her kidneys, an ailment called hydronephrosis. There was an injury to one of her ureters, the duct that carries urine from the kidney to the bladder. One of her doctors wrote in her medical records that he assumed “the problem is a thermal injury” and was “due to robotic hysterectomy.”
Her ureter was burned and her colon damaged during the surgery, according to her medical records. Her prognosis calls for a permanent colostomy.
“Less downtime for me turned into we are three years later and still dealing with it,” said Featherstone.
Featherstone filed a lawsuit in 2017 in an Iowa county court against Intuitive and her doctor’s practice, but later voluntarily withdrew the case against Intuitive. She says she did not pursue the suit against her doctor because she ran up against the statute of limitations.
The da Vinci Surgical System — which can be found at Cottage, Sierra Vista, Marian, and French hospitals on the Central Coast — is touted as a breakthrough in minimally invasive surgery. It is known to have multiple advantages, including a monitor that lets surgeons see better inside patients, a steady robotic arm allowing for more precision, and a record of faster recoveries for patients. But the da Vinci also comes with risks, including injuries like Featherstone’s.
NBC News spoke to more than a dozen patients who say they were burned or otherwise injured during surgery with the da Vinci.
An NBC News analysis of adverse event reports filed in the U.S. Food and Drug Administration MAUDE database over the past 10 years showed there were more than 20,000 adverse events related to the da Vinci filed with the FDA. Intuitive Surgical, the maker of the da Vinci, filed the great majority of the reports, though some were also filed by hospitals, doctors and patients. To be sure, the da Vinci is used in a large number of surgeries and the adverse events appear to occur in a relatively small portion of the overall surgeries. The number of da Vinci surgeries performed in the U.S. has increased by 52 percent since 2013, to nearly 700,000 procedures in 2017.
More than 2,000 adverse events were categorized as involving injuries, 274 were categorized as deaths, and nearly 17,000 events were classified as device malfunctions — some minor, others more serious, including robotic arms uncontrollably going in the wrong direction and insulation cracking off and dropping inside patients’ bodies.
But NBC News also found in the data that there were 12 instances of Intuitive batching large numbers of adverse events into one report. In one instance, Intuitive combined 200 injuries into a single filing.
In all, the batched filings amounted to 2,000 reports of injury of patients by the da Vinci, meaning there could be as many as 4,000 reported injuries. However, it is not known if any of the bundled injury reports duplicate injuries reported elsewhere in the MAUDE database.
The FDA told NBC News it granted permission to Intuitive Surgical to bundle multiple adverse events that are the subject of lawsuits into a single filing.
The FDA uses the database as a key tripwire to spot problems with medical devices, but it has acknowledged that the reporting system has limitations and can contain “incomplete, inaccurate, untimely, unverified, or biased data.”
At the same time, the machine has had 175 recalls in the past decade, according to an NBC News review of recalls filed with the FDA. Recalls associated with the device have steadily declined over the years, peaking in 2014 with 49 but dropped to one a year in both 2010 and 2011. There were eight in 2018. Recalls in the past two years include minor adjustments such as instruction clarifications and software updates, as well as more serious recalls such as a surgical knife that may not move when needed to cut, surgical arms that could fail, and others that could unexpectedly move.
The robot is piloted by a surgeon who sits at a console and it costs on average $1.4 million. Introduced in 2000, there are nearly 3,000 da Vincis in use in the U.S., and Intuitive has launched new models and updates throughout the past two decades.
Though companies like Google are working on rival robotic devices, the da Vinci remains alone in the marketplace. Local hospitals and surgeons promote its use, often making public pronouncements once they acquire one for their operating rooms.
In 2013 the FDA sent the company a warning letter stemming from problems like electrical arcing, in which electricity arcs from the tip of the robotic arm to the patient’s flesh, causing injury, and for improperly marketing the machine for certain thyroid surgeries. The company was sued by shareholders for misleading statements about its difficulties, and in June of this year settled the class-action case for $42.5 million. The legal documents state the settlement was not an admission of fault.
In July of this year, another medical study found that payments from Intuitive appeared to “influence” doctors when they conducted research on the robot. The study found that if there was a financial relationship between the doctors in each study and Intuitive, there was a higher likelihood of studies reporting a benefit of robotic surgery.
Public records show that since 2013, Intuitive has paid over $144 million to doctors and hospitals, for education, research, and travel. The company says that the majority of the payments made to doctors were for education, such as paying doctors to train other doctors.
Dr. Robert Poston, chief of cardiothoracic surgery at SUNY Downstate Medical Center, is an avid user of the robot. He says his patients are able to recover faster, there’s less blood loss, and fewer complications.
“I notice my ability to be precise is better even than with my own hands,” he said.
But he also believes many surgeons begin using the da Vinci with too little training.
“It’s woefully inadequate, woefully inadequate the way it’s currently being done,” said Poston. “We shouldn’t be operating until we’ve done all of the training that we think is reasonable.”
Poston says while he has now done about 1,200 procedures using the da Vinci, before he did his first he had only had two hours of training on the device, and is deeply concerned that many other surgeons are inadequately trained.
“We should live in a world where we practice brutal transparency with our patients,” said Poston. “So if we lived in that world we would tell the patient, ‘I’d like to operate on you, but I didn’t have the time or money to have all the training that I really think that we ought to have had. Is that okay? Is that okay? Would you be okay with that?’ “
Intuitive offers a four-level training program, but cannot legally require surgeons to complete it and cannot train surgeons on patients.
In response to questions from NBC News, Intuitive Surgical said, “At Intuitive, our mission is to help surgeons safely and effectively improve patient outcomes and decrease surgical variability. Our training, systems and technologies reflect, and are informed by, our commitment to patient safety, so we offer a comprehensive, intensive training program on our technology that depends on the surgeon’s capabilities — and we also strongly recommend they continue training throughout their careers. As with any medical device manufacturer, we are only permitted to train on our technology — we cannot, by law, train on clinical practice or the clinical application of our technology.
“While any surgery regardless of modality carries risk, the best evidence of the safety and efficacy of robotic-assisted surgery can be found in the more than 15,000 peer-reviewed scientific publications that are fully grounded in scientific method and that, in aggregate, support the safety and efficacy of our systems.”
The FDA also said it does not have the authority to oversee training and education.
There are no national requirements regulating how much training a surgeon must have to operate using the da Vinci. The level of training is left to local hospitals and the surgeons themselves.
“The root cause here is the training,” said Poston. “The willingness to sell robots to people and promote them doing surgeries when they weren’t adequately trained, the willingness of hospital credentialing committees to sign off on them and allow them to do it.”
Featherstone, meanwhile, said she is concerned with making sure more patients do not get hurt and that the company improves outcomes.
“I have some guilt because I asked more questions about the shoes I put on my feet or products that I use, you know, for my skin or my hair,” said Featherstone. “But I put all my faith in the doctor and didn’t ask questions.”
NBC News probed medical device alerts around the world as part of a global project organized by the International Consortium of Investigative Journalists, a news organization notable for its work on the Panama Papers, to examine the medical device industry. More than 250 reporters in 36 countries worked on stories that began publishing November 25, 2018.
Cynthia McFadden and Kevin Monahan reported from Iowa. Emily Siegel, Andrew W. Lehren and Pauliina Siniauer reported from New York.
A next-generation surgical robotic system has been developed in Cambridge, UK. It will be used on NHS patients for the first time next year.
The Versius robot seen here was designed and built by CMR Surgical, formed in 2014, whose five founders brought with them global experience across the diverse disciplines of surgery, medical device development, start-ups and commercialisation. In June 2018, the company announced a record-breaking financing round that raised $100m in total, Europe’s largest private Series B medical device funding raise.
CMR’s stated aim is “to make minimal access surgery available to all”, by creating “a paradigm shift in robotic-assisted surgery”. Minimal access surgery (sometimes known as keyhole or minimally invasive surgery) is an alternative to open surgery that was first pioneered around 40 years ago. For patients and healthcare providers alike, the benefits are numerous and compelling – reduced trauma, faster recovery and improved clinical outcomes. For example, the risk of infection from a robotically assisted hysterectomy is reduced by almost a factor of three compared with open surgery (from 6.5% to 2.2%).
There are an estimated six million open surgery procedures each year that could be performed using minimal access surgery. CMR Surgical believes that robotics opens up the potential for millions more people to benefit from laparoscopic surgery.
Versius, developed by CMR’s team of 100 scientists and engineers, is designed to meet the complex requirements of laparoscopic surgery and is intended to be used across a range of surgical specialities. Versatile and highly capable, its small and modular form factor and individually cart-mounted arms allow it to be moved effortlessly around the operating room, between operating suites and even hospitals. This combination of adaptability and portability allows hospital administrators to drive up utilisation of their robotics programme, improving hospital efficiency and clinical outcomes.
Versius mimics the dexterity and range of movement in the surgeon’s own hand and wrist, and is designed to be flexible enough to handle the majority of laparoscopic procedures. With 3D HD vision, easy-to-adopt instrument control and a choice of ergonomic working positions, the open surgeon console has been designed to reduce stress and fatigue; offering the potential to prolong a surgeon’s career. In addition, the versatility of the system and compelling commercial model allows healthcare providers to offer the benefits of robotic-assisted procedures in a cost-effective way.
“It takes around 80 hours to teach suturing with manual laparoscopic tools and some surgeons find it impossible to master,” said Addenbrooke’s Hospital surgeon Mark Slack, a co-founder of CMR Surgical. “By contrast, it takes half an hour to teach using Versius – this will enable many more surgeons to deliver the benefits of keyhole surgery.”
The Versius machine is a rival to the American da Vinci system. CMR expects to introduce their new robotic system to hospitals within the next six months, beginning in the UK and Europe, then with international expansion shortly afterwards. The $4bn global market for surgical robots is predicted to increase five-fold to reach $20bn by 2024.
“Surgeons will remain in control, but as we develop the human-robot interface there may be simple parts of an operation, such as suturing or closing a wound that may be automated,” said Dr Hachach-Haram, a member of the Royal College of Surgeons’ Commission on the Future of Surgery.
In the coming decades, much greater advances may arrive. A large survey of experts in artificial intelligence, conducted last year, suggested that robotic surgery could be fully automated by 2053.
A new study suggests that antibiotics are being overused in up to 60 percent of patients undergoing common urological procedures. The study, led by Daniel Livorsi, MD, University of Iowa assistant professor of internal medicine, shows that the high rates of overuse were mostly due to extended use of antibiotics following the procedure. The findings were published Dec. 21 in JAMA Network Open.
It is common for patients undergoing a urological or any other surgical procedure to be given antibiotics as a precaution to prevent a surgery-related infection. But overuse of antibiotics can promote antibiotic resistance, which the Centers for Disease Control and Prevention has defined as a major health concern. Moreover, unnecessary use of antibiotics exposes patients to potential harm, such as an increased risk of infection by C. difficilebacteria.
Based on evidence that a longer course of antibiotics does not add any benefit to patient outcomes and may in fact increase risks to patient health, the American Urological Association (AUA) recommends that antibiotics should be given for no more than 24 hours following most urological procedures.
Livorsi and his colleagues took two approaches to investigate whether urologists are following the AUA guidelines for antibiotic prescribing. They manually reviewed the medical records of 375 patients who had one of three common urological procedures. These procedures all use endoscopic devices inserted into the urethra to examine and manipulate portions of the urinary tract. The patients were treated between January 2016 and July 2017 at five Veterans Health Administration hospitals located in different parts of the U.S.
The team also reviewed administrative data from 29,530 patient records from the entire Veterans Health Administration system.
Overall, the study found that 217 of the 375 patients (58 percent) were prescribed antibiotics in a way that did not follow the AUA guidelines. The most common deviation from the guidelines involved antibiotic-prescribing after the procedure: 211 patients (56 percent) were given antibiotics for longer than 24 hours following a procedure. In fact, patients were often given antibiotics for three to five days following a procedure instead of the 24 hours or less that the guidelines recommend.
The national administrative data also showed high rates of excess antibiotic prescribing; nearly 40 percent of records showed a median of three extra days of antibiotic therapy. Overall, there was good agreement between the results from the manual chart reviews and the administrative data among the cases evaluated by both data sources.
“This study shows that antibiotics are often continued for several days after common urologic procedures, even when there is no clear indication for antibiotics. This seemingly unnecessary use of antibiotics is exposing patients to potential harm,” says Livorsi, who also is a physician with University of Iowa Health Care and the Iowa City VA Health Care System. “Reducing unnecessary antibiotic use in this setting is just one example of how physicians can be better stewards of antibiotics.”
The team chose to look at patients within the VA system because it is the largest integrated health care system in the United States, which makes it easier to do this type of study. However, Livorsi does not think the findings are unique to the VA. He notes other studies in non-VA settings have found similar results.
The study did not investigate why urologists are prescribing antibiotics for longer than recommended after a procedure. Given that the AUA provides clear recommendations for antibiotic therapy during these procedures, Livorsi believes it would be helpful to understand if urologists are not aware of the guidelines and the evidence behind them, or if there are other reasons why urologists are not adhering to the recommendations.
Nonetheless, the researchers believe the study identifies the post-procedure period as a good opportunity to improve antibiotic prescribing in a way that could decrease antibiotic resistance and reduce health care costs without harming patient outcomes.
“If a patient undergoing surgery is given antibiotics for more than 24 hours, he or she should ask the provider to explain why more antibiotics are necessary,” Livorsi says.
Materials provided by University of Iowa Health Care. Note: Content may be edited for style and length.
University of Iowa Health Care. “Antibiotic overuse is high for common urology procedures: Almost 60 percent of patients were prescribed antibiotics in a way that did not follow AUA guidelines.” ScienceDaily. ScienceDaily, 21 December 2018. <www.sciencedaily.com/releases/2018/12/181221123652.htm>.