FUJIFILM SonoSite is helping ultrasound users to assess the total cost of ownership for imaging equipment. Medical device warranties: Fine print, major total cost implications – a recently published report by the company’s Chief Operating Officer Rich Fabian – tackles the intricate details of warranties head-on, helping to clarify key considerations and unpack some of the hidden costs, for both patient care and financial planning. Warranties are intended to mitigate the risks related to ownership by allowing hospitals to control expenditure on training, servicing, repairs, replacement parts and software updates over the course of an instrument’s useful lifecycle. The two-page article is essential reading for procurement departments, helpfully examining how the appeal of generous multi-year warranties may be undermined by taking into account the exceptions mentioned in the fine print. For example, limitations on replacement parts can sometimes result in hospitals spending more on transducers than the cost of the original system. A key aim for buyers is to choose equipment in which the quality and durability are commensurate with the warranty offered. The mean time between instrument failures and the frequency of repairs is a critical factor to consider as downtime is costly, both in terms of patient care and delayed procedures. Raising awareness of these considerations will help ultrasound users to get the best value for money when purchasing a new clinical imaging system.
www.beckershospitalreview.com/finance/medical-device-warranties-fine-print-major-total-cost-implications.html
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Researchers at Okayama University report in The Journal of Vascular Access a supporting device for accurately placing hemodialysis catheters on kidney patients. The device was successfully used on a group of 10 patients and is expected to become an essential tool in situations where other, catheter-free hemodialysis approaches are not possible.
Patients with improperly functioning kidneys often need to undergo hemodialysis — the procedure of purifying blood in an artificial kidney outside the body — on a regular basis. Hemodialysis requires access to blood vessels, for the collection of blood and its re-introduction after purification. In this context, vascular access is commonly achieved with a so-called tunneled cuffed catheter (TCC). Accurate TCC placement is important; incorrect positioning can lead to blood clots and induce central vein thrombosis. Assistant Professor Toshiaki Ohara from Okayama University and colleagues have now developed a device enabling accurate TCC placement. The researchers’ insertion support device accommodates for individual body shape differences and is expected to decrease the rate of TCC replacements — typically ranging between 8.9% and 56%.
The device was made from a material called expanded polytetrafluoroethylene (ePTFE), having the property of maintained plasticity. It can be described as a bendable ribbon with holes (eyelets) spaced 1 cm apart; the holes allow making markings on the patient’s body with a felt-tip pen.
The insertion support device was tested on 10 Japanese adult hemodialysis patients (6 men and 4 women with a mean age of 71.3 years) treated at Shigei Medical Research Hospital. Placement of the device on the body took place with the help of X-ray imaging: the tip of the device, for marking the TCC entry site, was laid so that it overlaps with the right heart border. With the help of the markings made on the patient’s body, the physician could insert the TCC within an error of about 1 cm. The patients were observed for 2 months, during which there was no catheter replacement needed.
The device of Dr.Ohara and colleagues helps to reduce catheter waste and the overall cost of hemodialysis. In addition, as the attachment of a catheter requires exposure to X-rays, it reduces accumulated radiation doses for both patients and physicians. Although the study was only carried out for 10 patients in a short observation period, the scientists “anticipate that this new device … can be used for catheter intervention in many fields”.
http://www.okayama-u.ac.jp/index_e.html
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Patients in the UK who have survived critical illnesses requiring care in an intensive care unit (ICU) frequently report symptoms of anxiety, PTSD and/or depression, according to a study. Those reporting symptoms of depression after critical illness appear to be at a greater risk of death. Researchers in our department led by Peter Watkinson investigated psychological disorders in a cohort of 4,943 of former ICU patients. They found that 46% of patients reported symptoms of anxiety, 40% reported symptoms of depression and 22% reported symptoms of PTSD, while 18% of patients in the study reported symptoms of all three psychological conditions. To investigate possible links between treatment in an ICU and symptoms of psychological disorders, the authors asked a total of 4,943 patients who received treatment in one of 26 ICUs in the UK between 2006 and 2013, to complete a questionnaire on their symptoms of anxiety, depression and PTSD three months after discharge from ICU and again 12 months after discharge. The authors found that patients who reported symptoms of depression were 47% more likely to die from any cause (all-cause mortality) during the first two years after discharge from the ICU than those who did not report these symptoms. Dr Peter Watkinson said: ‘Our findings suggest that depression following care of a critical illness in the ICU may be a marker of declining health and clinicians should consider this when following up with former ICU patients.’ The authors caution that the generalisability of the results outside of the UK may be limited as the data was only collected from UK based patients. Furthermore, the observational nature of the study and its reliance of self-reported data mean that it does not allow for conclusions about cause and effect between ICU care and symptoms of psychological disorders.
Nuffield Department of Clinical Neuroscience www.ndcn.ox.ac.uk/news/over-half-of-former-intensive-care-patients-in-the-uk-report-symptoms-of-psychological-disorders
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Computer Tomography (CT) is a standard procedure in hospitals, but so far, the technology has not been suitable for imaging extremely small objects. A team from the Technical University of Munich (TUM) describes a Nano-CT device that creates three-dimensional X-ray images at resolutions up to 100 nanometers. The first test application: Together with colleagues from the University of Kassel and Helmholtz-Zentrum Geesthacht the researchers analysed the locomotory system of a velvet worm. During a CT analysis, the object under investigation is X-rayed and a detector measures the respective amount of radiation absorbed from various angles. Three-dimensional images of the inside of the object can be constructed based on several such measurements. Up until now, however, the technology reached its limits when it came to objects as small as the tiny, 0.4 millimeter long legs of the velvet worm (Onychophora). High-resolution images of this magnitude required radiation from particle accelerators, yet there are only a few dozen such facilities in Europe. Approaches suitable for the typical laboratory still had to struggle with low resolutions, or the samples investigated had to be made of certain materials and could not exceed a certain size. The reason was often the use of X-ray optics. Put simply, X-ray optics focus X-ray radiation similar to the way optical lenses focus light – but they also have several limitations. The TUM Nano-CT system is based on a newly developed X-ray source, which generates a particularly focused beam, without relying on X-ray optics. In combination with an extremely low-noise detector, the device produces images that approach the resolution possible with a scanning electron microscope, while also capturing structures under the surface of the object under investigation. “Our system has decisive advantages compared to CTs using X-ray optics,” says TUM scientist Mark Müller, lead author of the PNAS article. “We can make tomographies of significantly larger samples and we are more flexible in terms of the materials that can be investigated.” Like so many other imaging instruments, the Nano-CT system was developed and installed at the Munich School of BioEngineering (MSB). This TUM interdisciplinary research centre is Europe’s thematically most comprehensive university facility for the intersection of medicine, engineering sciences and natural sciences. “Our goal in the development of the Nano-CT system is not only to be able to investigate biological samples, such as the leg of the velvet worm,” says Franz Pfeiffer, TUM Professor for Biomedical Physics, Director of the MSB, and a Fellow at the TUM Institute for Advanced Study (TUM-IAS). “In the future, this technology will also make biomedical investigations possible. Thus, for example, we will be able to examine tissue samples to clarify whether or not a tumour is malignant. A non-destructive and three-dimensional image of the tissue with a resolution like that of the Nano-CT can also provide new insights into the microscopic development of widespread illnesses such as cancer.”
A novel positron emission tomography (PET) imaging method shows promise for noninvasively pinpointing sites of inflammation in people with inflammatory bowel disease (IBD), which includes ulcerative colitis and Crohn’s disease. Amanda C. Freise, PhD, first author of the study and a lecturer at UCLA, explains the research and its significance. The U.S. Centers for Disease Control states that approximately three million Americans reported being diagnosed with IBD in 2015 (latest data). Managing patients with chronic bowel inflammation can be challenging, relying on symptoms and invasive procedures such as colonoscopy and biopsy. In a mouse model of colitis, this study uses PET imaging with antibody fragment probes (immunoPET) to target a specific subset of immune cells, the CD4+ T cells, which are characteristic of IBD. “CD4 immunoPET could provide a non-invasive means to detect and localize sites of inflammation in the bowel and also provide image guidance for biopsies if needed,” explains Anna M. Wu, PhD, professor of Molecular and Medical Pharmacology at UCLA and director of the UCLA Jonsson Comprehensive Cancer Center’s Cancer Molecular Imaging Program, who headed the project and collaborated with Jonathan Braun, MD, and Arion Chatziioannou, PhD, also of UCLA. She adds, “Assessment of CD4 infiltration could also potentially provide a means for detection of subclinical disease, before symptoms occur, and provide a readout as to the efficacy of therapeutic interventions.” A zirconium-89 (89Zr)-labe7lled anti-CD4 engineered antibody fragment [GK1.5 cDb] was used for non-invasive imaging of the distribution of CD4+ T cells in the mice with induced colitis, and it successfully detected CD4+ T cells in the colon, ceca and mesenteric lymph nodes. The study demonstrates that CD4 immunoPET of IBD warrants further investigation and has the potential to guide development of antibody-based imaging in humans with IBD. Wu points out that the ability to directly image immune responses could have wide applications, saying, “It could unlock our ability to assess inflammation in a broad spectrum of disease areas, including oncology and immune-oncology, auto-immunity, cardiovascular disease, neuroinflammation, and more. ImmunoPET is a robust and general platform for visualization of highly specific molecular targets.”
Society of Nuclear Medicine and Molecular Imaging www.snmmi.org/NewsPublications/NewsDetail.aspx?ItemNumber=29170
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Pilot study by Brigham investigators finds that an innovative care-delivery program helped 81 percent of participants achieve blood pressure control in seven weeks. Hypertension, or high blood pressure, is a widespread clinical problem affecting nearly half of all adults. Despite the serious consequences that can result from hypertension, which puts patients at increased risk for heart attacks, strokes and other cardiovascular events, elevated blood pressures often remain untreated or undertreated for years, and the control rate for hypertension hovers at just 50 percent. Seeing opportunities for improvement, innovators and clinicians at Brigham and Women’s Hospital have developed a new home-based, care-delivery program aimed to improve hypertension control rates quickly and at significantly lower cost than traditional, office-based blood pressure programs. The new approach, piloted among 130 participants, helped 81 percent of patients bring their blood pressures under control in, on average, just seven weeks. “This is a striking result, especially given the very short time frame in which control was reached: an average of seven weeks,” said corresponding author Naomi Fisher, MD, director of the Hypertension Service and Hypertension Specialty Clinic at the Brigham. “There are a few notable healthcare systems that have matched or exceeded this control rate, but most clinical practices do not approach this rate of success.” To overcome some of the challenges that clinical practices face, Fisher and colleagues combined several innovative strategies to create their program. Enrolled participants each received a Bluetooth-enabled blood pressure device that could automatically transmit the blood pressure measurements patients took at home into their electronic medical records. Patients had easy and frequent access to “patient navigators”—non-physicians who had been trained to use a clinical algorithm developed by hypertension specialists. The program enabled rapid assessment and medication dosage adjustments for the patients. The pilot was conducted as a prospective cohort study. The team enrolled 130 patients whose blood pressure was uncontrolled (greater than 140/90 mmHg). Patients were recruited from two clinics to test efficacy in two settings: a Brigham primary care clinic (800 Huntington Ave.), and the Brigham’s Watkins Cardiovascular Clinic. All adults were eligible except pregnant women and those with advanced kidney disease. Enrolled patients were given a Bluetooth-enabled blood pressure device and taught how to use it. Patients were instructed to measure their blood pressure at home twice daily in duplicate. Medication adjustments were made every two weeks until home blood pressure was controlled at <135/85 mmHg. The team’s next step will be to scale up the program to test its generalizability and sustainability. With this approach, the team anticipates significant cost effectiveness and cost savings, in addition to the prevention of cardiovascular events and death from treating hypertension more intensively in men and women. “The time-honoured model of treating hypertension via traditional visits to the doctor is neither effective nor sustainable,” said Fisher. “Development of innovative solutions to manage hypertension effectively and efficiently, and thus reduce the cardiovascular risk burden in larger populations, is critical. Organizations can and should develop and adopt innovative technologies to create sustainable solutions for the control of hypertension.”
Brigham and Women’s Hospitalhttps://tinyurl.com/yatadjyf
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The U.S. Food and Drug Administration last year called for tougher warnings and “additional research” into a dye commonly used with standard MRIs. The dye – a contrast agent – contains a metal called gadolinium. It made news recently after claims from actor Chuck Norris that its use during MRI scans seriously affected his wife’s brain. Contrast agents are injected into the body during an MRI scan to enhance image quality. Last year, Norris and his wife, Gena, filed a lawsuit against several medical companies alleging she fell ill after exposure to gadolinium during MRI scans. The suit said Gena Norris was left weak, tired and suffering bouts of pain and burning sensations. After reviewing available data, the FDA on Tuesday recommended that radiologists consider how much gadolinium might be left behind in a patient’s body when selecting a gadolinium-based contrast agent [GBCA] for an MRI. The recommendation is especially important “for patients who may be at higher risk, such as those who may require repeat GBCA MRI scans to monitor a chronic condition,” explained Dr. Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research. Patients who are sent for an MRI should also now receive a medication guide outlining issues surrounding gadolinium, Woodcock added. But for most patients, “gadolinium retention has not been directly linked to adverse health effects,” the FDA stressed. It also said “the benefit of all approved GBCAs continues to outweigh any potential risks.” For now, the FDA says gadolinium agents have only one known health risk: A “small subgroup” of kidney failure patients has developed a rare skin condition that causes a painful thickening of the skin. But gadolinium can linger in the body “for months or years after receiving the drug,” the agency said, noting more research is warranted. It is asking manufacturers of GBCAs to “also conduct human and animal studies to further assess the safety of these contrast agents.” This was not the agency’s first warning on gadolinium. Preiously, an FDA panel had called for a warning to be added to the agents’ labels. The warning specifies that trace amounts of gadolinium may be retained in various organs, including the skin, bone and brain. The big question remains, though: What, if any, are the harms? Radiologists have used gadolinium-based agents for 30 years — totalling more than 300 million doses, said Dr. Vikas Gulani. He’s an associate professor of radiology at Case Western Reserve University in Cleveland. But, Gulani explained, researchers have only recently discovered that trace amounts of the metal can be left behind in the brain. One study on the issue was presented at the 2017 meeting of the Radiological Society of North America. It involved nearly 4,300 older adults and found no evidence that gadolinium exposure was related to faster mental decline over several years, according to a team led by Dr. Robert McDonald, of the Mayo Clinic in Rochester, Minn. “This study provides useful data that at the reasonable doses 95 percent of the population is likely to receive in their lifetime, there is no evidence at this point that gadolinium retention in the brain is associated with adverse clinical outcomes,” McDonald said. So, “at this point,” Gulani said, “we are not aware of any harms from these agents being retained in the brain.” Still, he added, the latest study does not rule out that possibility. There are open questions — including whether gadolinium exposure could be related to other neurological issues, such as movement problems. Also, any theoretical risks from the agents have to be balanced against their proven benefit in improving MRI image quality. However, there are cases where an MRI can be done without a contrast agent, Gulani said. “It’s reasonable for patients to ask their doctor whether it’s needed or not,” he added.
UPIhttps://tinyurl.com/y7xm6h6y
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A review of research studies that assessed alarm accuracy and/or clinical relevance in hospitalized patients published over a 30-year period found low proportions of clinically relevant patient alarms. The findings underscore the need for more rigorous alarm intervention research as hospitals work to meet Joint Commission requirements to reduce unnecessary alarms and implement new practice standards related to electrocardiographic (ECG) monitoring from the American Heart Association. “Measurement of Physiological Monitor Alarm Accuracy and Clinical Relevance in Intensive Care Units” examined the approaches used to measure alarm accuracy and/or clinical relevance of physiological monitor alarms in intensive care units (ICUs). The integrative review also compared proportions of inaccurate and clinically irrelevant alarms reported in the studies, which were published from 1986 through 2015. When clinically irrelevant alarms were compared as a percentage of total annotated alarms, most studies revealed that only 5 to 13 percent were clinically relevant; however, the definitions of clinical relevance were inconsistent across studies, which made clinical relevance of alarms difficult to determine. Co-author Halley Ruppel, RN, MS, is a PhD candidate at Yale University School of Nursing, West Haven, Connecticut, and a Robert Wood Johnson Foundation Future of Nursing scholar. She worked with Yale nursing professors Marjorie Funk, PhD, RN, and Robin Whittemore, PhD, APRN, on the article. Advances in monitoring technology may have improved the accuracy of alarm systems and simplified much of the data collection but haven’t affected the clinical relevance of alarms. “Clinical relevance can be a subjective term, and interventions should focus on reducing clinically irrelevant alarms, with careful consideration for how clinical relevance is defined and measured,” Ruppel said. “Especially in ICUs, nurses may use alarms to help them track changes in a patient’s condition. Clinical relevance should reflect alarms that may be informative, even if not immediately actionable or corresponding to a life-threatening incident.” For the review, the authors conducted an in-depth search of five databases for relevant articles, analysing more than 1,700 records before identifying 12 studies that met the inclusion criteria. The review follows the recent publication of “Update to Practice Standards for Electrocardiographic Monitoring in Hospital Settings: A Scientific Statement From the American Heart Association.” The comprehensive document provides an interprofessional, comprehensive review of evidence and recommendations for indications, duration and implementation of continuous ECG monitoring of hospitalized patients. The updated practice standards address several emerging issues related to ECG monitoring, including the overuse of arrhythmia monitoring among a variety of patient populations and alarm management. “Alarms have become ubiquitous in ICUs, but inaccurate or clinically irrelevant alarms remain a threat to patient safety,” said Funk, who also served as a co-author of the AHA statement. “Further research is needed to ensure that we are providing the best-quality monitoring for those who truly benefit from this diagnostic intervention.”
American Association of Critical-Care Nurseshttps://tinyurl.com/y7pf9m2r
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An automated text messaging system increases patient engagement with home-based exercise and promotes faster recovery after total knee or hip replacement surgery, reports a study. Patients receiving timely texts showed improvement in several key outcomes, including fewer days on opioid pain medications, more time spent on home exercises, faster return of knee motion, and higher satisfaction scores, according to the research by Kevin J. Campbell, MD, of Rush University Medical Center, Chicago, and colleagues. “A chatbot that texts timely, informative and encouraging messages to patients can improve clinical outcomes and increase patient engagement in the early postoperative period after total joint replacement,” Dr. Campbell comments. The randomized trial included 159 patients undergoing primary total knee or hip replacement. All received standard education, including instructions on home exercises after surgery. In addition, one group of patients received a series of automated, physician-specific text messages. The pre-programmed texts provided recovery instructions along with encouraging and empathetic messages, personalized video messages from the surgeon, and brief instructional therapy videos. The texts were sent via a service called STREAMD; Dr. Campbell is the CEO and Co-Founder of STREAMD. “The content of the text and video messages reinforced the perioperative instructions and were delivered to patients at the appropriate time based on their recovery progress,” the researchers write. Over the six-week period after surgery, patients in the text-message group received about 90 texts. The system did not accept inbound text responses from patients, although patients could access further information on topics they selected. Patients who received automated texts performed their home exercises an average of 46 minutes per day, compared to 38 minutes in the standard-care group, a significant difference of nine minutes per day. The texted group had greater knee motion at three weeks’ follow-up, suggesting faster short-term recovery, but by six weeks, knee motion was similar between groups. Patients in the text-message group stopped using opioid pain medications about 10 days sooner than those in the control group (22 versus 32 days). They also had higher mood scores and were more likely to say that their postoperative instructions were clear. Patients assigned to automated texts also made fewer phone calls to the surgeon’s office. There was a trend toward fewer emergency department visits as well, although this difference was not statistically significant. There is growing interest in using text messages to increase patient engagement in recovery after surgery. But previous digital patient engagement platforms have not been widely adopted by either patients or healthcare providers. This study provides evidence of improved outcomes when an automated text-message system makes daily contact with patients and provides them with relevant information and encouragement. Advantages include more time doing recommended home exercises, faster recovery of knee motion, and improved patient satisfaction. The 10-day reduction in opioid use is a potentially important advantage, reducing the risk of persistent opioid use and other complications. “This finding could be related to improved patient education and to the encouraging and empathetic tone of the text and video messages,” Dr. Campbell comments. “It could also reflect improved mood scores and patients’ confidence in their ability to manage their recovery, which have been shown to be very effective pain relievers.” The benefits of such an automated system could be especially important at a time when more patients are undergoing joint replacement surgery with less overall contact with the treatment team. “As we search for practical methods to engage patients, automated messages providing education, support, and encouragement create a natural and convenient way for patients to receive information, potentially improving key outcomes without placing extra time demands on the surgeon and staff,” Dr. Campbell concludes.
EurekAlerthttps://tinyurl.com/ycbrthu3
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Routine oral care to treat gum disease (periodontitis) may play a role in reducing inflammation and toxins in the blood (endotoxemia) and improving cognitive function in people with liver cirrhosis. Cirrhosis, which is a growing epidemic in the U.S., is the presence of scar tissue on the liver. When severe, it can lead to liver failure. Complications of cirrhosis can include infections throughout the body and hepatic encephalopathy, a build-up of toxins in the brain caused by advanced liver disease. Symptoms of hepatic encephalopathy include confusion, mood changes and impaired cognitive function. Previous research shows that people with cirrhosis have changes in gut and salivary microbiota— bacteria that populate the gastrointestinal tract and mouth—which can lead to gum disease and a higher risk of cirrhosis-related complications. In addition, studies have found that people with cirrhosis have increased levels of inflammation throughout the body, which is associated with hepatic encephalopathy. Researchers studied two groups of volunteers that had cirrhosis and mild-to-moderate periodontitis. One group received periodontal care (“treated”), including teeth cleaning and removal of bacteria toxins from the teeth and gums. The other group was not treated for gum disease (“untreated”). The research team collected blood, saliva and stool samples before and 30 days after treatment. Each volunteer took standardized tests to measure cognitive function before and after treatment. The treated group, especially those with hepatic encephalopathy, had increased levels of beneficial gut bacteria that could reduce inflammation, as well as lower levels of endotoxin-producing bacteria in the saliva when compared to the untreated group. The untreated group, on the other hand, demonstrated an increase in endotoxin levels in the blood over the same time period. The improvement in the treated group “could be related to a reduction in oral inflammation leading to lower systemic inflammation, or due to [less harmful bacteria] being swallowed and affecting the gut microbiota,” the research team wrote. Cognitive function also improved in the treated group, suggesting that the reduced inflammation levels in the body may minimize some of the symptoms of hepatic encephalopathy in people who are already receiving standard-of-care therapies for the condition. This finding is relevant because there are no further therapies approved by the U.S. Food and Drug Administration to alleviate cognition problems in this population, the researchers said. “The oral cavity could represent a treatment target to reduce inflammation and endotoxemia in patients with cirrhosis to improve clinical outcomes.”
The American Physiological Societyhttps://tinyurl.com/y9xyw3rj
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