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95% of surgeons have either been personally affected by a needlestick injury or have seen a colleague experience one, a new global survey has found, increasing their risk of infection. The survey – the first of its kind undertaken – was conducted by SERMO for Mölnlycke, a wound care and surgical products company.
The survey looked at key opinions from 510 surgeons across six countries relating to infection prevention and the role of high-quality gloves in improving patient and clinician safety. In particular, it demonstrated the importance that surgeons place on high quality gloves in the fight against needlestick injuries and exposure to blood-borne viruses, like HIV.
An estimated two million needlestick injuries occur among health workers each year, resulting in increased exposure to HIV, Hepatitis C
and other blood-borne viruses. Needlestick injuries occur when a needle or other sharp instrument accidentally penetrates the skin, yet the underreporting to occupational health departments is well established.
The survey revealed that 93% of surgeons think that high quality gloves reduce the chance of exposure to blood-borne viruses and 83% said that the quality of gloves affects their sense of being protected from needlestick injuries.
On the topic of patient safety, 81% of surgeons believe that high quality gloves impact overall patient outcomes and 89% agreed that high quality gloves improve patient safety in the operating theatre. When asked about glove failure during an operation, 78% of surgeons responded that it increases the risk of surgical site infections.
Commenting on the survey findings, John Timmons, Clinical Staff Nurse and Internatio-
nal Medical Director, said: “Each year, millions of surgeons and their teams risk exposure to life threatening blood-borne viruses and this ground-breaking survey highlights the value that surgeons across the globe place on high quality gloves. Surgeons clearly recognise their role in both ensuring the safety of surgeons and improving outcomes for patients.
“Surgical gloves are one of the key factors that prevent infections in the operating room and should not be viewed as a commodity. High quality means fewer glove failures, yet we are increasingly seeing healthcare systems around the world prioritise price over quality.”
Healthcare-associated infections (HAIs) are the most frequent adverse event in healthcare delivery worldwide. Hundreds of millions of patients are affected by HAIs worldwide each year, leading to significant mortality rates. Of every 100 hospitalized patients at any given time, an estimated seven patients in developed countries will acquire at least one HAI. www.molnlycke.com/biogel/
Although electrical stimulation has therapeutic potential for various disorders and conditions, ungainly power sources have hampered practical applications. Now bioengineers have developed implantable and wearable nanogenerators from special materials that create electrical pulses when compressed by body motions. The pulses controlled weight gain and enhanced healing of skin wounds in rat models.
The work was performed by a research team led by Xudong Wang, Ph.D., Professor of Material Sciences and Engineering, College of Engineering, University of Wisconsin-Madison, and supported by the National Institute of Biomedical Imaging and Bioengineering (NIBIB).
The researchers used what are known as piezoelectric and dielectric materials, including ceramics and crystals, which have a special property of creating an electrical charge in response to mechanical stress.
“Wang and colleagues have engineered solutions to a number of technical hurdles to create piezoelectric and dielectric materials that are compatible with body tissues and can generate a reliable, self-sufficient power supply. Their meticulous work has enabled a simple and elegant technology that offers the possibility of developing electrical stimulation therapies for a number of major diseases that currently lack adequate treatments,” explained David Rampulla, Ph.D., director of the Program in Biomaterials and Biomolecular Constructs at NIBIB.
Worldwide, more than 700 million people — over 100 million of them children — are obese, causing health problems such as cardiovascular disease, diabetes, kidney disease, and certain cancers. In 2015 approximately four million people died of obesity-related causes.
To address this crisis, Wang and his colleagues developed a vagal nerve stimulator (VNS) that dramatically improves appetite suppression through electrical stimulation of the vagus nerve. The approach is a promising one that has previously not proven practical because patients must carry bulky battery packs that require proper programming, and frequent recharging.
The VNS consists of a small patch, about the size of a fingernail, which carries tiny devices called nanogenerators. Minimally invasive surgery was used to attach the VNS to the stomachs of rats. The rat’s stomach movements resulted in the delivery of gentle electrical pulses to the vagus nerve, which links the brain to the stomach. With the VNS, when the stomach moved in response to eating, the electric signal told the brain that the stomach was full, even if only a small amount of food was consumed.
The device curbed the rat’s appetite and reduced body weight by a remarkable 40 percent. “The stimulation is a natural response to regulate food intake, so there are no unwanted side effects,” explained Wang. When the device was removed the rats resumed their normal eating patterns and their weight returned to pre-treatment levels.
“Given the simplicity and effectiveness of the system, coupled with the fact that the effect is reversible and carries no side-effects, we are now planning testing in larger animals with the hope of eventually moving into human trials,” said Wang.
In another NIBIB-funded study in a rat experimental model, the researchers used their nanogenerator technology to determine whether electrical stimulation would accelerate healing of wounds on the skin surface.
For this experiment, a band of nanogenerators was placed around the rat’s chest, where the expansion from breathing created a mild electric field. Small electrodes in a bandage-like device were placed over skin wounds on the rat’s back, where they directed the electric field to cover the wound area.
The technique reduced healing times to just three days compared with nearly two weeks for the normal healing process.
Similar to the case with appetite suppression, it was known that electricity could enhance wound healing, but the devices that had been developed were large and impractical. The nanogenerator-powered bandage is completely non-invasive and produced a mild electric field that is similar to electrical activity detected in the normal wound-healing process.
The researchers observed electrical activation of normal cellular healing processes that included the movement of healthy skin fibroblasts into the wound, accompanied by the release of biochemical factors that promote the growth of the fibroblasts and other cell types that expand to repair the wound space.
“The dramatic decrease in healing time was surprising,” said Wang, “We now plan to test the device on pigs because their skin is very similar to humans.”
The team believes the simplicity of the electric bandage will help move the technology to human trials quickly. In addition, Wang explained that the fabrication of the device is very inexpensive and a product for human use would cost about the same as a normal bandage.
NIBIB
https://tinyurl.com/y3cxut6p
Researchers from the Department of Experimental Psychology at the University of Oxford have developed a new mental health treatment programme to provide frontline healthcare workers with one-to-one support, including fast-track access to post-traumatic stress disorder (PTSD) or depression treatment. This evidence-based programme, called SHAPE Recovery < www.shaperecovery.com >, builds on an outreach programme shown to reduce rates of PTSD and depression.
SHAPE Recovery is working with 3,300 frontline healthcare workers across England and has now been invited to work with 8,000 London Ambulance employees and staff from associated partner organisations.
Around the world, frontline healthcare workers, such as intensive care doctors, nurses, support staff and paramedics, are risking their lives daily to stem the tide of the COVID-19 pandemic. They are at an increased risk of developing mental health problems, such as PTSD as well as depression, sleep problems and anxiety. Although many hospitals offer well-being initiatives, there is little evidence to support their effectiveness and they require staff to come forward for help.
Associate Professor Jennifer Wild, Programme Lead, said: “SHAPE is based on 15 years of research to examine what predicts PTSD and depression in frontline workers. We used the findings from these studies to create a highly effective support programme to prevent the development of PTSD and depression. SHAPE is the outcome of this work. It is evidence-based, affordable, and with ongoing evaluation could, if needed, be incorporated within NHS services within 12 to 24 months. The aim is to support staff to stay well, to recover if unwell, and to continue to be able to work, providing much-valued patient care.”
Zidan Mozumder, a paramedic who has benefitted from the progamme, commented: “Work-related stress has been at an all-time high for my peers due to the current COVID-19 pandemic. Fortunately, though, my weekly calls with my well-being coach have mitigated that stress significantly. For this I am eternally grateful. I feel very lucky to have had all of this support.”
SHAPE is unique because it moves the burden of outreach for help from frontline staff to well-being coaches. This means staff don’t have to come forward for help. Instead, they can access one-to-one confidential help, independent from their employers, on their phones. In addition, SHAPE facilitates fast access to gold-standard treatment for PTSD and depression should it be indicated.
Data collected from the programme will help Oxford researchers determine:
Waltham, MA–Nova Biomedical to host “COVID-19 Bedside Glucose Management: Risk of Ascorbic Acid and Hematocrit Interference,” a webinar led by Charbel Abou-Diwan, PhD, Director of Medical and Scientific Affairs, to help inform and support healthcare workers treating COVID-19 patients.
Interest in the antioxidant properties of ascorbic acid use in critically ill patients is growing especially during the in the COVID-19 pandemic. As clinicians search for effective treatments for COVID-19, sepsis, and other critical illness, high dose ascorbic acid is widely considered. These patients are admitted to the ICU where routine POC glucose monitoring becomes part of their care path. Unfortunately, two widely used hospital glucose meters have a substantial interference from ascorbic acid that radically elevates glucose meter results, leading to potential adverse events. This webinar examines the risk of inaccurate glucose meter results due to ascorbic acid interference and how hospitals can protect their patients and protect themselves against this threat.
The webinar will be delivered on three dates: Thursday, April 30th at 2:00 PM EST, Thursday, May 28th at 1:00 PM EST, and Thursday, June 18th at 4:00 PM EST. Attendees can earn educational credits for attending and can register online at novabiomedical.com/poc/glu/covid
About Nova Biomedical
Incorporated in 1976 and based in Waltham, MA, Nova Biomedical is a world leader in the development and manufacturing of state-of-the-art, whole blood, point-of-care and critical care analyzers, as well as providing the biotechnology industry with the most advanced instruments for cell culture monitoring. Nova is one of the fastest growing in vitro diagnostic companies in the world. Nova’s biosensor technology is incorporated in products ranging from handheld meters for glucose self- and point-of-care testing to critical care whole blood analyzers designed for rapid measurement of over 20 analytes. Nova’s biotechnology-specific BioProfile line has pioneered comprehensive cell culture testing, providing over 20 critical cell culture tests with over 12 unique instrument offerings for broad range of cell culture applications. Nova employs over 1,300 people worldwide and has wholly owned subsidiaries located in Brazil, Canada, Great Britain, France, Spain, Italy, Germany, Switzerland, and Japan.
www.novabiomedical.com
The cloud-based platform “teamplay” by Siemens Healthineers, together with its applications teamplay Dose, teamplay Usage, teamplay Protocols, teamplay Images, and teamplay Images Research, has been awarded the European Privacy Seal (EuroPriSe). The European Privacy Seal was first granted to teamplay in 2016, and must be regularly renewed. The privacy seal in its current version relates to the expansions made in recent years to the range of functions the teamplay applications offer, and now specifically checks whether the requirements of the EU General Data Protection Regulation (GDPR) have been satisfied.
From the start, teamplay was developed in accordance with the principle of “Data Protection by Design and Default” and the level of transparency this principle implies. The Privacy Seal confirms that users who utilize teamplay as instructed by Siemens Healthineers can work with the cloud platform and the above applications in full compliance with the GDPR.
With more than 4,000 healthcare institutions connected to teamplay, it is one of the world’s largest cloud-based networks for physicians, medical professionals, and decision-makers in the healthcare industry. Over 18,000 modalities from different vendors deliver data directly to the cloud platform. The teamplay applications for performance management help healthcare providers, for example, support in making rapid, sound decisions based on transparent performance data.
That means it is possible to evaluate the number of imaging examinations just as easily as the radiation dose used in scans, or the capacity utilization of devices, rooms, and resources in a given department, down to individual devices and patient examinations. Teamplay simplifies the reporting process and highlights where workflows need to be adjusted. In addition, users can connect via teamplay, sharing data to obtain comparisons and benchmarks and easily exchanging images and reports.
www.siemens-healthineers.com
A new study from the University of Iowa finds rural hospitals that use telemedicine to back up their emergency room health care providers not only save money but find it easier to recruit new physicians.
Marcia Ward, study author and professor of health management and policy in the UI College of Public Health, says the results suggest that expanded use of tele-emergency services could play a key role in helping small, rural critical access hospitals maintain their emergency rooms.
“The study finds that expanding options for provider coverage to include telemedicine in some rural emergency departments has noticeable benefits,” says Ward. “This supports the viability of critical access hospitals at risk of closing and leaving their communities without local emergency care.”
Many of the nearly 1,400 rural hospitals in the United States are struggling to provide health care services generally because of declining population and rising costs. One of those services is emergency medicine, as emergency rooms are expensive to operate and, until 2013, were required to be staffed with a physician on site or on call 24 hours a day. As a result, Ward says many rural hospitals are unable to staff their ERs with doctors trained in emergency medicine. Instead, they’re covered by family physicians from the community who share ER coverage along with their regular clinic and hospital practice.
However, in 2013, a Medicare rule clarification allowed rural hospitals to fulfill their on-site staffing requirements using an advanced practice provider, such as a physician assistant or nurse practitioner, as long as they have remote access to a physician using a telemedicine link. To measure the impact of that rule change, UI researchers analysed 19 rural hospitals in the Sioux Falls, South Dakota-based Avera Health network. Seven of the hospitals took advantage of the Medicare rule clarification to back up their ER providers with telemedicine doctors who work at the hub hospital in Sioux Falls.
The spoke hospitals were located in Iowa, Minnesota, North Dakota, South Dakota, and Nebraska.
Key findings from the study include:
The amount of time with on-site coverage by advanced practice providers backed up by a tele-ER increased from zero hours to an average of 17.1 hours a day within three years. Two hospitals adopted this model 24 hours a day.
Rural hospitals that switched to tele-ER back-up saved an average of $117,000 annually in health care provider costs because advanced practice providers receive less compensation than physicians. Rural hospitals in the same network that continued to staff their ER with on-site or on-call physicians saw an average increase of $138,000 in annual provider compensation costs.
Hospitals that switched to tele-ER services found it easier to recruit new physicians because they could offer a better work-life balance, as the doctor would not have to cover an ER shift. The model also gives physicians more downtime, Ward says, reducing burnout and increasing retention.
Ward also is director of the College of Public Health’s Center for Health Policy and Research and conducted the study under the auspices of the university’s Rural Telehealth Research Center.
University of Iowa
https://tinyurl.com/yxwyfs5x
Despite recent controversy suggesting that popular medications prescribed to lower blood pressure may increase the risk of infection by the novel coronavirus and lead to more severe outcomes in COVID-19, a retrospective study by Cleveland Clinic, Ohio, US, has supported the view that there is no foundation to these claims, although the researchers called for larger studies as the pandemic develops.
The medications in question are Angiotensin-converting enzyme (ACE) inhibitors and Angiotensin II receptor blockers (ARBs), both of which dilate blood vessels to increase the amount of blood pumped by the heart. The result is lowered blood pressure and increased blood flow, which helps to lower the heart’s workload and reduce the risk of heart failure. The medications are commonly prescribed in cases of coronary artery disease, heart failure, diabetes and hypertension (high blood pressure).
“Our analysis found no association between ACEI or ARB use and COVID-19 test positivity,” says Cleveland Clinic cardiologist Ankur Kalra, MD, the study’s corresponding author.
“These medications are important tools in the management of coronary artery disease, heart failure, diabetes and hypertension. As there may be a risk to withdrawing these agents, our findings support current professional society guidelines to not discontinue ACEI or ARB therapy in the context of the COVID-19 pandemic,” he added.
The Cleveland Clinic study looked at 18,472 individuals tested for COVID-19 at its locations in Florida and Ohio, with a mean age of 49 (± 21 years), and who were predominantly female (60%) and white (69%). Testing for COVID-19 was positive in 1,735 patients, or 9.4% of the total sample.
First study author Neil Mehta, MD of the Department of Medicine at the Cleveland Clinic Lerner College of Medicine, says: “Our findings with regard to clinical outcomes and measures of COVID-19 severity while on ACEI or ARB therapy give some reassurance. However, they must be interpreted with caution, due to the small sample size and the limitations of observational studies. They require replication and reanalysis in larger patient samples later in the course of the ongoing COVID-19 pandemic.”
A secondary analysis among COVID-19-positive patients showed no association between use of these medications and risk for mechanical ventilation.
According to a new study, an ultrasonic vessel-sealing device can improve patient outcomes by reducing the incidence of thoracotomy conversion for VATS/robotic anatomical lung resection. The trial, which included patients in the United States, United Kingdom, and Canada, is the first to evaluate the use of ultrasonic sealing for lobectomy, the most common thoracic surgical procedure.
Technology device trials in thoracic surgery are uncommon, with this study being the first intraoperative device study in more than 20 years. 150 patients planned for VATS/robotic anatomical lung resection in seven centres were enrolled. PA Branches of 7mm or less were sealed and divided with an ultrasonic energy vessel-sealing device. The remainder of the lobectomy was performed according to surgeon preference. A total of 424 PA branches were divided; 239 with the ultrasonic vessel-sealing device, 181 with endostaplers, and 4 with endoscopic clips.
Intraoperative, in-hospital, and 30-day post-operative bleeding and complications were observed. 1.3 percent of the PA branches divided with the ultrasonic vessel-sealing device and 2.2 percent of PA branches divided with endostaplers bled intraoperatively. Among the patients with seal failures, one patient required conversion to thoracotomy for vascular repair in the ultrasonic energy group. There was no postoperative bleeding from divided PA branches with either sealing method. One patient was re-operated for hemothorax from a bleeding bronchial artery. Mean and median length of stay was 4.1 and 3.8 days, respectively. There was no mortality at 30-days.
Preliminary results appear to show that use of an ultrasonic sealing device can decrease the rate of conversion to thoracotomy, resulting in safer and less-invasive procedures.
Lead author, Moishe Liberman, MD, PhD, of the Division of Thoracic Surgery, University of Montréal, explains, "This is an exciting new application of technology to enable minimally invasive lung surgery for the benefit of patients today and in the future. By promoting less invasive procedures, we promote quicker healing and reduce risks, resulting in improved outcomes for patients."
EurekAlert
www.eurekalert.org/pub_releases/2019-05/aaft-ntf050419.php
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.
Reuters
https://tinyurl.com/yyqe7pp3
April 2024
The medical devices information portal connecting healthcare professionals to global vendors
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PanGlobal Media IS not responsible for any error or omission that might occur in the electronic display of product or company data.
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