ivWatch Monitors IV Placement Sites for Leakage, Now Cleared by FDA

ivWatch, a company based in Newport News, Virginia, won FDA clearance for its SmartTouch sensor that detects peripheral IV infiltration and extravasation events. Though somewhat rare, these can be difficult to notice and a late response can lead to grave consequences. The SmartTouch sensor can warn physicians that something is wrong, sometimes hours before a clinician would notice any visual or tactile changes on the patient’s body.

The sensor, which is already cleared in Europe, is a single-use disposable device that can be used on patients of any age, including those in the neonatal intensive care unit. Thanks to the SmartTouch, clinicians can take advantage of additional options in terms of where to place the IV, which is especially important for neonates, to choose longer dwell times, and to keep an eye on active patients that may be ambulatory at times.

The device, which uses visible and near-infrared light to penetrate the skin, can be used alongside the ivWatch Patient Monitor that algorithmically analyzes the optical signatures of tissue around the IV site while compensating for patient movements. The system can detect changes as small as .2 mL of IV fluid, with an average detection volume of 2.02 mL, according to ivWatch. Any adverse events are immediately relayed to the clinical team for a quick response.

The adhesive on the back side of the sensor is breathable, leading to minimal irritation and compatibility with existing IV dressings.

More from ivWatch regarding the tested efficacy of the SmartTouch:

A series of seven IRB-approved studies were conducted to test the efficacy and safety of the SmartTouch Sensor. Five verification studies were conducted to understand the performance and optimize ivWatch’s proprietary algorithm to maximize sensitivity to infiltrated tissues, while limiting the number of false notifications issued. Two validation studies were conducted to investigate device sensitivity and false notification rates.

Clinical data shows that the SmartTouch Sensor issued notifications for 99.0%* of early stage infiltrations in less than 10 mL of infused IV fluid. Results also showed less than one false notification was issued every six days, therefore having minimal contribution to clinician alarm fatigue.[3],[4],[5] The majority of the non-infiltration notifications were attributed to a force applied to the IV site, which may beneficially notify clinicians of conditions that could place the peripheral IV site at a greater risk for complications. ivWatch also has a proven record of detecting IV infiltrations an average of 15 hours before the clinician.[2]

Flashbacks: ivWatch Detects IV Infiltrations and Extravasations: Interview with Gary Warren, President and CEO; ivWatch Monitors IV Placement Sites for Leakage Outside Veins; ivWatch IV Infiltration Detection Device Cleared in Europe; ivWatch Detects Leaks Near IV Placement Sites;

Product page: SmartTouch Sensor

Via: ivWatch
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States Allow In-Person Nursing Home Visits As Families Charge Residents Die ‘Of Broken Hearts’

For the most part, visitors are required to stay outside and meet relatives in gardens or on patios where they stay at least 6 feet apart, supervised by a staff member. Appointments are scheduled in advance and masks are mandated. Only one or two visitors are permitted at a time.

Before these get-togethers, visitors get temperature checks and answer screening questions to assess their health. Hugs or other physical contact are not allowed. If residents or staff at a facility develop new cases of COVID-19, visitation is not permitted.

As of July 7, 26 states and the District of Columbia had given the go-ahead to nursing home visits under these circumstances, according to LeadingAge, an association of long-term care providers. Two weeks earlier, the Centers for Medicare & Medicaid Services clarified federal guidance on reopening nursing homes to visitors.

Eighteen states and the District of Columbia were similarly planning to allow visits at assisted living centers.

Visitation policies may change, however, if state officials become concerned about a rise in COVID-19 cases. And individual facilities are not obligated to open up to families, even when a state says they can do so.

Relaxing restrictions is not without risks. Frail older adults in long-term care are exceptionally vulnerable to COVID-19. According to various estimates, 40% to 45% of COVID-related deaths have occurred in these facilities.

But anguished families say loved ones are suffering too much, mentally and physically, after nearly four months in isolation. Since nursing homes and assisted living centers closed to visitors in mid-March, under guidance from federal health authorities, older adults have been mostly confined to their rooms, with minimal human interaction.

The goal was to protect residents from the coronavirus as the pandemic began to escalate. But the virus entered facilities nonetheless as staffers came and went. And now, families argue, the harms of isolation exceed potential benefits.

“My mother stopped eating around the middle of April — now she just picks at her food,” said Marlisa Mills of Asheville, North Carolina. “Every week, she becomes more delusional.” Mill’s mother, 95, has dementia and lives in a nearby nursing home that remains closed to visitors.

Residents “are dying of broken hearts and neglect,” said Lelia Sizemore, whose 84-year-old father’s health deteriorated precipitously after her mother stopped her daily visits to his Dayton, Ohio, nursing home in early March.

Diagnosed with severe dementia, blind and unable to feed himself, Sizemore’s father lost more than 10 pounds in two months and succumbed to respiratory failure on May 24. Even at the end, the nursing home refused her mother’s requests to see him in person.

“I didn’t even get to say goodbye,” sobbed Sizemore, who lives in Oregon and last saw her father in July 2019.

Ohio began allowing visitors at assisted living centers on June 8 and will permit outdoor get-togethers at nursing homes as of July 20.

New Jersey has the second-highest number of COVID deaths in the country. On June 19, the state’s health commissioner announced that all long-term care facilities could accept visitors outdoors — just in time for Father’s Day.

Broadway House for Continuing Care, a Newark facility, quickly notified families and arranged to pitch a tent with chairs and tables underneath in a garden area.

“It’s time to open things up some more: We’ve all been operating under a sense of being under house arrest,” said James Gonzalez, chief executive officer of Broadway House and chair of the board of the Health Care Association of New Jersey.

With weekly tests, 10 residents and 26 staffers at Broadway House have learned they had COVID-19. One resident has died since the outbreak began.

“Are we worried about visitors bringing the virus? Yes, but I think we can manage that,” Gonzalez said. “We’re going to have to take this day by day.”

On Father’s Day, Raul Lugo arrived at Broadway House to visit his grandmother, Rosa Perez, 89, who raised him after his mother died when he was an infant. He had not seen Perez, who had contracted COVID-19 and spent two months in the hospital, since the end of March. Because Perez is frail and it was extremely hot, they met in the facility’s vestibule.

“She told me she missed me and that she loves me. I told her I love her back,” said Lugo, a truck driver. “It was 1,000 times better seeing her in person than talking to her on the phone. You can’t compare it. It was awesome.”

Raul Lugo wanted to hug his grandmother, Rosa Perez, 89, during their in-person visit at her nursing home on June 21. The two had not seen each other for three months.(Courtesy of Damary Lugo)

Complete Care Management, which operates 16 nursing homes in New Jersey, opened all its facilities to visitors within a week of the announcement of the state’s new policy.

Complete Care asks visitors to sign consent forms indicating they understand the risks and will let staffers know if they become ill. No one is allowed to bring food or enter the buildings, even to use the restrooms. For the time being, get-togethers are short – no more than 15 minutes and no more than two visitors at a time.

“Really, the only burdensome part of it is having staff available to bring residents outside, wait with them and bring them back in,” said Efraim Siegfried, Complete Care’s chief executive officer. “If we do everything right, I don’t see a negative outcome. And to see how excited people are, how happy they are, it’s a beautiful thing.”

Before the pandemic, Patricia Tietjen, 72, visited her husband of 52 years, Robert, who has dementia, every day at Complete Care at Green Acres in Toms River, New Jersey. Though staffers tried to arrange FaceTime visits when the home closed to visitors, “it was hard because he was never awake – he started sleeping all the time – and he can’t speak anymore,” Tietjen said.

Robert became ill with COVID-19 in April. Although he survived that, he recently entered hospice care and Tietjen has twice been let into the facility because he is near the end of his life. “It was extremely emotional,” she said, breaking into tears.

Although federal guidance says visitors should be permitted inside long-term care facilities at the end of life, this is not happening as often as it should, said Lori Smetanka, executive director of the National Consumer Voice for Quality Long-Term Care, an advocacy group.

She wants family visitation policies to be mandatory, not optional. As it stands, facility administrators retain considerable discretion over when and whether to offer visits because states are issuing recommendations only.

Smetanka’s organization has also begun a campaign, Visitation Saves Lives, calling for one “essential support person” to be named for every nursing home or assisted living resident, not just those who are dying. This person should have the right to go into the facility as long as he or she wears personal protective equipment, follows infection control protocols and interacts only with his or her loved one.

Not doing so is “inhumane and cruel” punishment for more than 2 million people — most of them older adults — living in “solitary confinement conditions,” said Tony Chicotel, a staff attorney at California Advocates for Nursing Home Reform, a campaign partner.
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Nanoparticles for Large Gene Therapy to Cure Common Eye Diseases

Wet age-related macular degeneration and a number of other eye diseases, including congenital conditions, are related to mutated genes that result in blood vessel abnormalities. These can be treated with gene therapy, but delivering genetic material has proven to be difficult when dealing with large gene sequences that are common in retinal conditions.

Viruses have been the go-to vectors for delivering genes into the eye, but the immune system wants to fight them. Too often this results in poor efficacy on follow-up treatments. Moreover, they are not good at carrying large genetic payloads and there’s also a risk of cancer.

Now, researchers at Johns Hopkins University have devised a way to tightly pack long chains of DNA into nanoparticles and deliver those into the eye. Once inside the cells of the retina, the DNA bundles are released to promote the production of a therapeutic protein without worrying about any viral side-effects.

To make this possible, the team created a novel large polymer molecule to compress the DNA bundles very tightly. This molecule is biodegradable and leaves the eye and the body once its job is done. The compact vessel of the DNA and the polymer is small enough to enter living cells without causing damage.

Initially, the scientists delivered genetic material for a fluorescent protein into the eyes of mice to see whether it gets into the cells and produces the protein. Even months later, the eyes of the mice continued to glow. Once it was confirmed that the approach works and does so for a long time, the researchers delivered a gene that produces a protein (vascular endothelial growth factor (VEGF)) that leads to abnormal blood vessel growth into a group of rats. These animals developed blood-vessel growth similar to that seen in people with wet macular degeneration.

The last experiment was essentially the opposite, delivering gene therapy that generates a protein that deactivates VEGF. This is the same therapy as that already available but in the form of a nanoparticle that produces long-term effects and doesn’t require frequent eye injections. The results showed that after the nanoparticle injections, the animals had a 60% reduction in abnormal blood vessels compared with the controls, and the effect lasted for over a month.

“These results are extremely promising,” said Jordan Green, Ph.D., professor of biomedical engineering at the Johns Hopkins University School of Medicine, in a press release. “We have the ability to reach the cells most significantly affected by degenerative eye disease with non-viral treatments that can allow the eye to create its own sustained therapies.”

Full study in Science Advances: Suprachoroidal gene transfer with nonviral nanoparticles

Via: Johns Hopkins
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Colorado, Like Other States, Trims Health Programs Amid Health Crisis

As a teenager, Paulina Castle struggled for years with suicidal thoughts. When her mental health was at its most fragile, she would isolate herself, spending days in her room alone.

“That’s the exact thing that makes you feel significantly worse,” the 26-year-old Denver woman said. “It creates a cycle where you’re constantly getting dug into a deeper hole.”

Part of her recovery involved forcing herself to leave her room to socialize or to exercise outside. But the COVID-19 pandemic has made all of that much harder. Instead of interacting with people on the street in her job as a political canvasser, she is working at home on the phone. And with social distancing rules in place, she has fewer opportunities to meet with friends.

“Since the virus started,” she said, “it’s been a lot easier to fall back into that cycle.”

Between the challenges of the pandemic, the social unrest and the economic crisis, mental health providers are warning that the need for behavioural health services is growing. Yet faced with budgetary shortfalls, Colorado is cutting spending on a number of mental health and substance use treatment programs.

Across the country, the recession has cut state revenues at the same time the pandemic has increased costs, forcing lawmakers into painful decisions about how to balance their budgets. State legislatures have been forced to consider health care cuts and delay new health programs even in the midst of a health care crisis. But many lawmakers and health experts are concerned the cuts needed to balance state budgets now could exacerbate the pandemic and the recession down the line.

“Health care cuts tend to be on the table, and of course, it’s counterproductive,” said Edwin Park, a health policy professor at Georgetown University. When there’s a recession, people lose their jobs and health insurance, he noted, the very moment when people need those health programs the most.

‘Everything Has To Be On The Table’

In Colorado, for example, lawmakers had to fill a $3.3 billion hole in the budget for the fiscal year 2020, which started July 1. That included cuts to a handful of mental health programs, with small overall savings but potentially significant impact on those who relied on them.

They cut $1 million from a program designed to keep people with mental illness out of the hospital and another million from mental health services for juvenile and adult offenders. Lawmakers reduced funding for substance abuse treatment in county jails by $735,000 and eliminated $5 million earmarked for addiction treatment programs in underserved communities. And that’s all on top of a 1% cut to Medicaid community providers who offer health care to the state’s poorest residents.

Some of those cuts were offset by $15.2 million in federal CARES Act funding allocated to behavioural health care programs. But some programs were completely defunded. Cuts were targeted primarily at programs that hadn’t started yet or hadn’t been fully implemented. The rationale: Those cuts wouldn’t have as deep an impact.

Doyle Forrestal, CEO of the Colorado Behavioral Healthcare Council, which represents 23 behavioural health care providers, worries that resources won’t be there for an emerging wave of people who have developed mental health or addiction issues during the pandemic.

“People who are isolated at home are drinking a lot more, maybe having other problems — isolation, economic despair,” she said. “There’s going to be a whole new influx once all of this takes hold.”

State legislators said they tried to avoid cutting programs that would hamper the response to the pandemic or the economic recovery.

“There was a desire on both sides to do everything we could to protect health care spending in Colorado,” said Democratic Rep. Dylan Roberts. “But when you’re looking at across-the-board cuts, everything has to be on the table.”

Every state is facing a similar conundrum. With tax filing deadlines pushed back to July 15, states are unsure how much income tax revenue they will collect.

So in addition to cutting back where possible, states are raiding discretionary funds — Colorado repurposed money from the tobacco settlement and marijuana taxes — to shore up their budgets. States are also tapping rainy day funds, which, according to the National Association of State Budget Officers, grew to record levels after the 2008 recession.

New Policies Delayed

Overall, at least 43 states have made some changes to facilitate access to Medicaid or the Children’s Health Insurance Program as many people have lost their job-based health insurance in the COVID crisis. And in late June, voters in Oklahoma approved expanding Medicaid to more residents. But since the start of the pandemic, states including Kansas and California have put off plans to expand eligibility for Medicaid, which provides health care to low-income people.

“These are symptoms of states that can’t deficit-spend, despite this great need for more coverage,” said Sara Collins, vice president for health care coverage and access at the Commonwealth Fund, an independent health policy research foundation based in New York. “If they spend more in one area, that means cuts in another.”

Paulina Castle uses weekly routines to manage her mental health — made worse from isolation during the coronavirus pandemic. “We need to start treating mental health the same as we do physical health,” she says. “This is an issue we need to stop keeping in the dark.”(Courtesy of Paulina Castle)

Colorado has had an aggressive health agenda in recent years but had to defer plans for a public health insurance option that could have provided a more affordable plan for people buying insurance on their own.

The legislature killed a proposal to create an annual mental health checkup. The measure would have cost the state only $13,000, but Democratic Gov. Jared Polis signaled he wouldn’t sign any bills that included new mandates for insurance companies.

Democratic Rep. Dafna Michaelson Jenet, who sponsored the checkup measure, was disappointed.

“Not every one of us is going to catch COVID, but every single one of us will have a mental health impact,” she said.

Long-Term Implications

Once the economic crisis eases, Roberts said, lawmakers will look to restore funding to some of the programs they cut.

But cuts are often easier to make than to restore — as illustrated by cutbacks made during the 2008 recession, according to Georgetown’s Park.

“Many cuts were never fully restored, even though we were in one of the longest economic expansion periods in our country’s history,” Park said.

He also worries many of the smaller primary care and behavioural health providers, who saw fewer patients come through their doors because of stay-at-home orders during the pandemic, might not survive.

“That means less access to care, including routine care like vaccinations,” he said. “If kids aren’t vaccinated, they may be more vulnerable to flu and measles, making them more vulnerable to COVID-19. That makes it more difficult for a stressed health care system to try to deal with a potential second wave of infections.”

The longer-term mental health toll may be harder to catalogue.

Castle, for one, has focused on establishing routines to help her manage her mental health during the pandemic. Every Wednesday night, she plays games online with her friends. And every Friday night, she and her boyfriend build a fire in the backyard.

“If I know people are expecting me to be somewhere at 6 o’clock, that obligation encourages me to go out,” she explained. “There are days it’s a struggle. I have to focus on baby steps.”

Still, Castle worries about others who may be struggling during the pandemic. She has signed on to work with the Colorado chapter of Young Invincibles, which lobbies for health care, higher education and workforce policies to help young adults. Even as states and the federal government have found the money to help hospitals and doctors treat the physical effects of the COVID pandemic, she doesn’t see the same commitment to treating its mental health toll.

“We need to start treating mental health the same as we do physical health,” she said. This is an issue we need to stop keeping in the dark.”

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Micro-LEDs and Solar Panels Wirelessly Power Medical Implants

Researchers at the Gwangju Institute of Science and Technology in South Korea have developed a method to wirelessly power implanted devices using light. The technique involves a micro-LED patch to transmit light through the skin and a photovoltaic system on implanted devices that can turn this light into electricity. This technology could help researchers to develop devices that do not need batteries, avoiding the need to remove and replace them when the batteries are depleted.

Implantable electronic medical devices have had a significant impact on healthcare, particularly on the long-term management of chronic conditions. Such devices include old favorites, including the pacemaker, and those in development, such as the artificial pancreas. However, a common stumbling block for these devices, particularly those intended for long-term implantation, is their supply of power.

“One of the greatest demands in biomedical electronic implants is to provide a sustainable electrical power for extended healthy life without battery replacement surgeries,” says Jongho Lee, a researcher involved in the study. “Currently, a lack of a reliable source of power limits the functionality and performance of implant devices. If we can secure enough electrical power in our body, new types of medical implants with diverse functions and high performance can be developed.”

At present, electronic implants must either be powered through external wires, which penetrate the skin and pose an infection risk, or through an internal battery. There are some wireless techniques already in use, such as inductive coupling, but they are generally only safe at lower power levels. Internal batteries can have a significant life-span, on the other hand, but will eventually become depleted, requiring a surgical procedure to replace them. This is inconvenient for patients, and also comes with risks such as infection and other complications.

To address these limitations, the Korean researchers have developed a method to wirelessly power implanted devices, using the implantable equivalent of solar panels. The technique, described in the Proceedings of the National Academy of Sciences, relies on an externally applied light source in the form of a micro-LED patch that is stuck to the skin above where an implanted device resides.

The patch exploits the translucent nature of tissue, which allows light penetration to some extent – think of the glow that happens when light from a flashlight, that is pressed against your fingers, passes through your skin.

The second component is a photovoltaic system that is attached to an implanted device, which uses the light transmitted through the skin to generate electricity. So far, the researchers have tested the system in mice and demonstrated that it can successfully power an implanted device.

“These results enable the long-term use of currently available implants, in addition to accelerating emerging types of electrical implants that require higher power to provide diverse, convenient diagnostic and therapeutic functions in human bodies,” said Lee.

Study in Proceedings of the National Academy of Sciences: Active photonic wireless power transfer into live tissues

Via: Gwangju Institute of Science and Technology
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Amid Surge, Hospitals Hesitate To Cancel Nonemergency Surgeries

Three months ago, the nation watched as COVID-19 patients overwhelmed New York City’s intensive care units, forcing some of its hospitals to convert cafeterias into wards and pitch tents in parking lots.

Hospitals elsewhere prepped for a similar surge: They cleared beds, stockpiled scarce protective equipment, and — voluntarily or under government orders — temporarily canceled non-emergency surgeries to save space and supplies for coronavirus patients.

In most places, that surge in patients never materialized.

Now, coronavirus cases are skyrocketing nationally and hospitalizations are climbing at an alarming rate. But the response from hospitals is markedly different.

Most hospitals around the country are not canceling elective surgeries — nor are government officials asking them to.

Instead, hospitals say they are more prepared to handle the crush of patients because they have enough protective gear for their workers and know-how to better treat coronavirus patients. They say they will shut down nonessential procedures at hospitals based on local assessments of risk, but not across whole systems or states.

Some hospitals have already done so, including facilities in South Florida, Phoenix and California’s Central Valley. And in a few cases, such as in Texas and Mississippi, government officials have ordered hospitals to suspend elective surgeries.

Hospitals’ decisions to keep operating rooms open are being guided partly by money. Elective surgeries account for a significant portion of hospital revenue, and the American Hospital Association estimates that the country’s hospitals and health care systems lost $202.6 billion between March 1 and June 30.

“What we now realize is that shutting down the entire health care system in anticipation of a surge is not the best option,” said Carmela Coyle, president of the California Hospital Association. “It will bankrupt the health care delivery system.”

The association projects that California hospitals will lose $14.6 billion this year, of which $4.6 billion has so far been reimbursed by the federal government.

But some health care workers fear that continuing elective surgeries amid a surge puts them and their patients at risk. For instance, some nurses are still being asked to reuse protective equipment like N95 masks and gowns, even though hospitals say they have enough gear to perform elective surgeries, said Zenei Cortez, president of the National Nurses United union.

“They continue to put us at risk,” Cortez said. “They continue to look at us as if we are disposable material.”

Elective surgeries, generally speaking, are procedures that can be delayed without harming patients, such as knee replacements and cataract surgery.

At least 33 states and the District of Columbia temporarily banned elective surgeries this spring, and most hospitals in states that didn’t ban them, such as Georgia and California, voluntarily suspended them to make sure they had the beds to accommodate a surge of coronavirus patients. The U.S. surgeon general, the Centers for Disease Control and Prevention and the American College of Surgeons also recommended health care facilities suspend nonemergency surgeries.

The suspension was always intended to be temporary, said Dr. David Hoyt, executive director of the American College of Surgeons. “When this all started, it was simply a matter of overwhelming the system,” he said.

Today, case counts are soaring after many states loosened stay-at-home orders and Americans flocked to restaurants, bars and backyards and met up with friends and family for graduation parties and Memorial Day celebrations.

Nationally, confirmed cases of COVID-19 have topped 3 million. In California, cases are spiking, with a 52% jump in the average number of daily cases over the past 14 days, compared with the two previous weeks. Hospitalizations have gone up 44%.

Governors, county supervisors and city councils have responded by requiring people to wear masks, shutting down bars and restaurants — again — and closing beaches on the July Fourth holiday weekend.

But by and large, government leaders are not calling on hospitals to proactively scale back elective surgeries in preparation for a surge.

“Our hospitals are telling us they feel very strongly and competent they can manage their resources,” said Holly Ward, director of marketing and communications at the Arizona Hospital and Healthcare Association. If they feel the situation warrants it, “they on their own will delay surgeries.”

In some states, like Colorado, public health orders that allowed hospitals to resume nonemergency surgeries in the spring required hospitals to have a stockpile of protective equipment and extra beds that could be used to treat an influx of COVID-19 patients.

States also set up overflow sites should hospitals run out of room. In Maryland, for example, the state is using the Baltimore Convention Center as a field hospital. The state of California last week reactivated four “alternative care sites” — including a hospital that was on the verge of closure in the San Francisco Bay Area — to take COVID-19 patients should hospitals fill up.

But the decision to reduce elective surgeries in California will not come from the state. It will be made by counties in consultation with hospitals, said Rodger Butler, a spokesperson for the California Health and Human Services Agency.

The question is whether hospitals have systems in place to meet a surge in COVID-19 patients when it occurs, said Glenn Melnick, a professor of health economics at the University of Southern California.

“To some extent, elective care is good care,” Melnick said “They’re providing needed services. They are keeping the system going. They are providing employment and income.”

In Los Angeles County, more than 2,000 COVID patients are currently hospitalized, according to county data. While that number is projected to go up by a couple of hundred people over the next few weeks, hospitals believe they can accommodate them, said county Health Services Director Christina Ghaly. In the meantime, hospitals are preparing to bring on additional staff members if needed and informing patients who have scheduled surgeries that they could be delayed.

“There’s more patients with COVID in the hospitals than there has been at any point previously in Los Angeles County during the pandemic,” Ghaly said. “Hospitals are more prepared now for handling that volume of patients than they were previously.”

While hospitals have not stopped elective surgeries, many have not ramped up to the full schedule they had before COVID-19. And they say they are picking and choosing surgeries based on what’s happening in their area.

“We were all things COVID when it was just starting,” said Joshua Adler, executive vice president for physician services at UCSF Health. “We didn’t know what we were facing.”

But after a couple of months of treating patients, hospitals have learned how to resupply units, how to transfer patients, how to simultaneously care for other patients and how to improve testing, Adler said.

At Scripps Health in San Diego, which has taken more than 230 patients from hard-hit Imperial County to the east, its hospitals have scaled back how many transfers they will accept as confirmed COVID-19 cases rise in their own community, said Chris Van Gorder, president and CEO of Scripps Health.

A command center set up by the hospital system reviews patient counts and medical supplies and coordinates with county health officials to study how the virus is spreading. Only patients who need urgent surgeries are being scheduled, Van Gorder said.

“We’re only allowing our doctors to schedule cases two weeks out,” Van Gorder said. “If we see a sudden spike, we have to delay.”

In California’s Central Valley and in Phoenix, where cases and hospitalizations are surging, Mercy hospitals have suspended elective surgeries to focus resources on COVID-19 patients.

But the other hospitals in the CommonSpirit Health system, which has 137 hospitals in 21 states, are not ending elective surgeries — as they did in the spring — and are treating patients with needs other than COVID, said Marvin O’Quinn, the system’s president and chief operating officer.

“In many cases their health deteriorated because they didn’t get care that they needed,” said O’Quinn, whose hospitals lost close to a $1 billion in two months. “It’s not only a disservice to the hospital to not do those cases; it’s a disservice to the community.”

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Revolutionizing IV Access With TournIQ: Interview With Jonathan Ilicki, Co-Founder of Ortrud Medical

IV access is one of the most common clinical procedures in healthcare, with over 300 million hospitalized patients in the United States receiving a peripheral venous catheter every year. However, as many have painfully experienced, catheter insertion isn’t always successful on the first attempt. Often times, we place the blame on dehydration, our deep veins, or the healthcare worker’s lack of skill.

Surprisingly, the humble tourniquet plays a very significant role in whether or not IV access is successful on the first poke. To maximize the chances of success, and to spare our arms the additional pain, Stockholm-based Ortrud Medical has designed TournIQ, a tourniquet that helps the user apply optimal pressure on the arm to increase vein visibility, palpability, and size when gaining IV access.

TournIQ is unique in that it features “Kiri-Tech” which are mechanical features built into the tourniquet that allow it to stretch to indicate when optimal pressure has been reached. Moreover, TournIQ is single-use, but made from recyclable paper-like Tyvek, which uses 6 times less material than other single-use tourniquets, and helps allay concerns about hygiene compliance and environmental impact.

We wanted to learn more about why re-innovating the tourniquet is so important right now, so we sat down with Ortrud Medical’s co-founder and board member, Dr. Jonathan Ilicki, to share more about TournIQ.

Scott Jung, Medgadget: Tourniquets have reliably been around for many years with little innovation. What are some of their problems, and how does TournIQ address them?

Dr. Jonathan Ilicki, Ortrud Medical: Several studies have shown that reusable tourniquets can spread drug resistant bacteria. Single-use tourniquets address this, but these disposable tourniquets often apply the wrong pressure on the arm, which causes poor venous dilation. This is one of the reasons why up to every third IV attempt fails.

TournIQ combines the hygienical aspects of single use tourniquets with a unique pressure indicator that guides the user to apply pressure that gives the quickest and largest venous dilation. Bigger veins mean more successful IV attempts. As IV access is performed so often, and is so critical, this can really help patients and reduce complications and costs for healthcare providers.

Medgadget: Why is TournIQ particularly important during COVID-19?

Dr. Ilicki: Disposable tourniquets have been used in the US for some time but adoption has been slow in Europe and the rest of the world. COVID-19 has made many European health care providers rapidly shift to disposable tourniquets. However, this shift has often met resistance as disposable tourniquets often are less user friendly and apply a lower pressure, and nurses get frustrated over the sudden difficulty of having to place IVs in small veins. We designed TournIQ to specifically address this: being hygienical as well as simplifying IV access through correct pressure, and is why several larger providers have shifted to using it following our market launch in Sweden only 6 months ago.

Medgadget: What’s the story behind TournIQ’s creation and development?

Dr. Ilicki: A few years ago the co-founders and I participated in a Clinical Innovation Fellowship, . The program matched me, an MD with a business degree, with Patrik Nilsson, MSc in Industrial Design, and Caroline Dahl, phD in Biomechanics, with the aim to solve a big problem in healthcare. We spent weeks observing clinical needs and quickly zoomed in IV access. At the end of the fellowship, we realized that we had come up with a simple and groundbreaking innovation – and that we could create a new global standard for safe IV access. TournIQ was created and Ortrud Medical was founded.

Medgadget: What was your process in evaluating different materials and ultimately choosing Tyvek for TournIQ?

Dr. Ilicki: We were looking for a material that was resilient, comfortable for patients, and most importantly recyclable and as environmentally friendly as possible. TournIQ’s low weight and recyclable material mean a smaller carbon footprint and a more sustainable product life cycle than other tourniquets.

Medgadget: Can you share some of the successes you’ve had with your customers who are using TournIQ?

Dr. Ilicki: There are many interesting stories! One example is a leading private surgical clinic that gave TournIQ a trial run, but they liked it so much that the whole clinic shifted from reusable tourniquets to TournIQ. We’ve done several follow up studies and see that users love TournIQ. In one study 90% of nurses stated that TournIQ gives better venous dilation. Another study showed that users got an average increase in venous dilation of 70% – which makes IV access a lot easier!

Another example is an emergency department that previously had shifted from reusable tourniquets to a market-leading disposable tourniquet in order to improve hygiene. However, due to poor usability and poor venous dilation, the staff refused to use the disposable and went back to reusable tourniquets. The department then tried TournIQ, loved it, and have now shifted to only using TournIQ at their emergency department.

During the past months, covid-19 has catalyzed the interest in TournIQ – and it’s now being used in half of Sweden’s 21 regions! Distributors have also contacted us and the tourniquet will within short be used in other parts of the world.

Medgadget: Lastly, where does the name “Ortrud” come from?

Dr. Ilicki: During the fellowship, we did a deep dive into IV access and the role of tourniquets. We were tutored by a senior nurse named Ortrud Kasche who had been placing IVs ever since when they were made of metal instead of flexible plastic! She emphasized the role of optimizing the core factors in order to succeed with IV access, such as applying correct pressure to get proper venous dilation. We decided to name the company after Ortrud as a tribute to really understanding IV access and getting the basics right – which we feel she personifies.

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In Texas, Individual Freedoms Clash With Efforts To Slow The Surge Of COVID Cases

HOUSTON — The Fourth of July was a little different this year here in Texas’ biggest city. Parades were canceled and some of the region’s beaches were closed. At the city’s biggest fireworks show, “Freedom Over Texas,” fireworks were shot higher in the air to make it easier to watch from a distance. Other fireworks displays encouraged people to stay in their cars.

After weeks of surging COVID-19 cases and dire warnings that Houston’s massive medical infrastructure would not be able to keep pace, Republican Gov. Greg Abbott issued an executive order on July 2 requiring Texans to wear masks in public, after previously reversing course on the state’s reopening by again closing bars and reducing restaurant capacity.

While most Houstonians appear to be taking heed, not everyone is on board. Small protests against the orders occurred over the holiday weekend. Lawsuits have been filed. At least one Houston-area law enforcement agency said it would not enforce the mask requirement. The State Republican Executive Committee plans to hold its mid-July convention downtown, drawing an expected 6,000 people from around the state.

Democratic Mayor Sylvester Turner said he and other local leaders sent a letter to GOP leaders asking them to convert the convention into a virtual event. But the party remains steadfast.

“There simply is no substitute for the in-person debate we value so strongly,” Texas GOP Chairman James Dickey said, adding that the party committee explicitly affirmed it would not voluntarily cancel the convention. He said there would be thermal scanners, social distancing, deep cleaning between meetings, hand sanitizer and thousands of donated masks available for those in attendance.

“My sincerest sympathies go out to anyone who is affected by any severe disease, including this one,” he said. “But on a per capita basis, Harris County, and Texas in general, are both dramatically better than most of the states in the United States.”

However, confirmed cases in Houston’s surrounding county, Harris, more than doubled in a month to reach more than 37,000 positive cases as of July 6. Hospitals in the Texas Medical Center had 2,261 COVID-positive patients that day in intensive care or medical-surgical units, up from 1,747 the week before, according to the center’s tracking website. All told, the nine-county Houston region has had more than 52,000 confirmed cases and 572 deaths.

The Texas Medical Center has predicted that unless the spread of the virus is mitigated, Houston hospitals could exceed existing capacity by mid-July. A federal assessment team came to Houston to determine how the federal government can help the city respond to the current surge.

Local officials had tried to protect Houston. Early in the pandemic, Harris County Judge Lina Hidalgo, a Democrat who serves as the county’s top elected leader, implemented business closures and stay-at-home and masking orders. But Lt. Gov. Dan Patrick and U.S. Rep. Dan Crenshaw, both Republicans, called them an “overreach” that “could lead to unjust tyranny.” On April 27, Abbott overruled the county guidance, and announced plans to reopen businesses and relax social distancing guidelines.

For those who live in Houston, it’s all meant lots of confusion.

“This whole thing has been a messaging nightmare from the beginning,” said Joe Garcia, 50, who works in data management. “When a flood happens, when a hurricane happens, nobody cares what side you’re on — blue, red, whatever else — all you know is it’s a disaster and everybody comes in and helps. That’s just the way things are. This wasn’t treated as a disaster.”

Public discourse about the pandemic has been disheartening, said Norma Ybarbo, 55, who avoids leaving home beyond socially distant visits with her father and attending a lightly populated early morning mass. She said the political arguments and conflicting communication from the Texas Medical Center in June about hospital capacity have made an already stressful situation worse.

“It’s worrisome, for sure,” Ybarbo said. “It’s really hard to determine what is right and what is true.”

Marine veteran S.D. Panter, 44, said it all has deepened his concern about bias in doctors and politicians who are advocating for businesses to be shut down. Panter, who doesn’t deny the virus is troublesome, said he prefers to do his own research because, for him, the dire picture being painted by those in the spotlight doesn’t make sense. He does wear a mask in public, even though he is not sure it is necessary.

“There’s just so much information. Just let me make my own decision, my own informed decision,” said Panter, who helps his parents and his wife’s parents stay socially isolated. “The older population should probably stay indoors, and let’s protect them the best we can.”

The state’s reopening this spring coincided with Mother’s Day, graduations, Memorial Day and Black Lives Matter protests. Once Texans were released from pandemic-induced restrictions, many happily took advantage of the chance to socialize.

Alyssa Guerra, 27, who lost her job when the store she managed closed, said she now knows people who have contracted the virus, and a few who have become sick or lost loved ones. She has friends who went to bars and social events, without masks, when the state reopened. She went out to eat once, but felt so uncomfortable she hasn’t done it since.

“It’s affecting us in greater numbers now because of the selfish decisions we are making,” said Guerra. “At some point, yes, we are going to have to start living our lives again, but we did it so quickly this time that people just had no care in the world.”

While the number of confirmed COVID-19 infections is rising in all age groups here, those seeing the most rapid growth in positive tests and hospitalizations are 20 to 40 years old. Dr. David Persse, public health authority with the Houston Health Department, said recently that 15% of COVID patients being admitted to the hospital are younger than 50, and 30% are younger than 60.

That could explain lower rates of death now than earlier in the pandemic, said Dr. Angela Shippy, chief medical and quality officer at Memorial Hermann Health System. Another reason for the lower death rates could be that providers have learned more effective treatments for the virus, using different respiratory and drug therapies to avoid intensive care units and intubation.

Still, Houston’s hospitals are being challenged by the rapid spike in COVID patients as a whole. Without taking steps to slow the spread of the virus, hospitals could become unable to manage the load. That has been the message from hospitals — including in multiple full-page ads in the Houston Chronicle advising people to stay home or wear a mask in public.

“We still have the ability to grow capacity, but there will come a limit to how much capacity you can grow,” said Roberta Schwartz, executive vice president, chief innovation officer and CEO of Houston Methodist Hospital.

The area’s public hospitals, which had been steadily handling COVID cases since March, have been transferring adult patients the past several weeks to private hospitals, including Texas Children’s Hospital, which had 29 COVID patients as of July 6. Houston Fire Chief Sam Peña said it has been taking an hour, in some cases, to transfer patients from ambulances to some emergency rooms — which Schwartz said have been “inundated.”

The fire and police departments have large numbers of staff in quarantine. Hospitals report staffers are testing positive, which they attribute to contracting the virus outside the hospital. Some area hospitals are bringing in traveling nurses to help.

“We encourage everyone to do their part and always wear a mask when leaving home, wash your hands often and maintain social distance,” Mark A. Wallace, president and CEO of Texas Children’s Hospital, said in an emailed statement. “This is the best way to protect yourself, your loved ones and our health care workers.”
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What Seniors Should Know Before Going Ahead With Elective Procedures

For months, Patricia Merryweather-Arges, a health care expert, has fielded questions about the coronavirus pandemic from fellow Rotary Club members in the Midwest.

Recently people have wondered “Is it safe for me to go see my doctor? Should I keep that appointment with my dentist? What about that knee replacement I put on hold: Should I go ahead with that?”

These are pressing concerns as hospitals, outpatient clinics and physicians’ practices have started providing elective medical procedures — services that had been suspended for several months.

Late last month, KFF reported that 48% of adults had skipped or postponed medical care because of the pandemic. Physicians are deeply concerned about the consequences, especially for people with serious illnesses or chronic medical conditions.

To feel comfortable, patients need to take stock of the precautions providers are taking. This is especially true for older adults, who are particularly vulnerable to COVID-19. Here are suggestions that can help people think through concerns and decide whether to seek elective care:

Before you go in. Give yourself at least a week to learn about your medical provider’s preparations. “You want to know in advance what’s expected of you and what you can expect from your providers,” said Lisa McGiffert, co-founder of the Patient Safety Action Network.

Merryweather-Arges’ organization, Project Patient Care, has developed a guide with recommended questions. Among them: Will I be screened for COVID-19 upon arrival? Do I need to wear a mask and gloves? Are there any restrictions on what I can bring (a laptop, books, a change of clothing)? Are the areas I’ll visit cleaned and disinfected between patients?

Also ask whether patients known to have COVID are treated in the same areas you’ll use. Will the medical staffers who interact with you also see these patients?

If you’re getting care in a hospital, will you be tested for COVID-19 before your procedure? Is the staff being tested and, if so, under what circumstances?

Hospitals, medical clinics and physicians are offering this kind of information to varying degrees. In the New York City metropolitan area, Mount Sinai Health System has launched a comprehensive “Safety Hub” on its website featuring extensive information and videos.

Mount Sinai also encourages physicians to reach out to patients with messages tailored to their conditions. People “want to hear directly from their providers,” said Karen Wish, the system’s chief marketing officer.

Don’t hesitate to press for more details, said Dr. Allen Kachalia, senior vice president of patient safety and quality at Johns Hopkins Medicine: “Where people get in trouble is when they’re afraid to bring their concerns forward.”

Seeking care. Wendy Hayum-Gross, 57, a counselor who lives in Naperville, Illinois, had been waiting since mid-March to get blood tests that would help doctors diagnose the underlying cause of a new condition, a goiter. A few weeks ago, she decided it was time.

The hospital lab she went to, operated by Edward-Elmhurst Health, told Hayum-Gross to wear a mask and gave her a number to call when she arrived in the parking lot. Outside the front door, she was met by a staffer who took her temperature, asked several screening questions and gave her hand sanitizer.

“Once I passed that, a phlebotomist met me on the other side of the door and took me to a chair that was still wet with disinfectant. She wore a mask and gloves, and there was no one else around,” Hayum-Gross said. “When I saw the precautions they had put in place and the almost military precision with which they were carrying them out, I felt much better.”

Marjorie Helsel DeWert, 67, of Athens, Ohio, was similarly impressed when she visited her dentist recently and noticed circular yellow signs on the floor of the office, spaced 6 feet apart, indicating where people should stand. Staffers had even put pens used to fill out paperwork in individual containers and arranged to disinfect them after use.

DeWert, a learning scientist, came up with a patient safety checklist and distributed it to family and friends. Among her questions: Can necessary forms be completed online before a medical visit? Can I wait in the car outside until called? What kind of personal protective equipment is the staff using? And is the staff being checked for symptoms daily?

Bringing a caregiver. Some medical centers are allowing caregivers to accompany patients; others are not. Be sure to ask what policies are in place.

If you feel your presence is necessary — for instance, if you want to be there for a relative who is frail or cognitively compromised — be firm but also respectful, said Ilene Corina, president of the Pulse Center for Patient Safety Education & Advocacy.

Be prepared to wear a gown, gloves and mask. “You’re not there for yourself: You’re there to support the health care team and the patient,” said Corina, whose organization offers training to caregivers.

In Orland Park, Illinois, debi Ross, an interior designer, and her sister live with her 101-year-old mother. Eight years ago, when her mother had a tumor removed from her colon, Ross and her sister wiped down every electric socket, cord, surface and door handle in her mother’s hospital room.

“Unless Mom absolutely needs [medical] care, we’re not going to take her anywhere,” Ross said. “But I assure you, if she does have to go see somebody, we’re going to clean that place down from top to bottom, I don’t care what anybody says.”

If you are not allowed into a medical facility, get a phone number for the physician caring for a loved one and make sure they have your number as well, Merryweather-Arges said. Ask that you be contacted immediately if there are any complications.

Afterward. Patients leaving hospitals are fearful these days that they may have become infected with COVID-19, unwittingly. Ask your physician or a nurse what equipment you’ll need to monitor yourself. Will a pulse oximeter and a thermometer be necessary? Will you need masks and gloves at home if someone is coming in to help you out with the transition? Can someone provide that equipment?

“Family caregivers need instructions that are clear,” said Martin Hatlie, chief executive of Project Patient Care. “They need to know who to call 24/7 if they have a question. And they need clear guidance about infection control in the home.”

If home care is being ordered, ask the agency whether they have trained staff to recognize COVID symptoms. And have home care workers been tested for COVID-19 or had symptoms?

If follow-up care is being provided via telehealth, make sure the setup works before your loved one comes home. Ask your physician’s office what kind of equipment you will need, which service they use (Zoom? Skype?) and whether you can arrange a test in advance.

Finally, as you resume activities, help protect others against COVID-19 as well as yourself. When you go out into the world again, “mask up, socially distance and wash your hands,” said Kachalia of Johns Hopkins. “And if you’re sick or have symptoms, by all means, let your doctor’s office know before you come in for a checkup.”
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Robotic Transcranial Doppler for Stroke Detection and Risk Assessment in COVID: Interview with Diane Bryant, Neural Analytics

Emerging evidence suggests that COVID-19 patients are at a higher risk of stroke and promptly diagnosing and treating such patients is a priority in hospitals across the world. Moreover, identifying which COVID-19 patients are at increased risk of developing a stroke is also important, and may help with preemptive treatment and monitoring.

The Lucid Robotic System, developed by LA-based Neural Analytics, is a transcranial doppler system that allows clinicians to identify clots and changes in blood flow in the brain in real time, without needing a specialized technician. The device is robotically assisted and automatically optimizes placement of the ultrasound probe, which can help to minimize clinician exposure when assessing COVID-19 patients.

Positioning the probe and patient takes less than five minutes, and the procedure can be performed at the bedside. Crucially, the device allows clinicians to rapidly identify blood clots in COVID-19 patients, and then implement timely treatment.

The system has already been used in COVID-19 patients, and may help clinicians to identify which patients are at higher risk of vascular complications. Neural Analytics has begun shipping units specifically to support the COVID-19 response. For instance, a unit sent to a hospital in New York was used to scan COVID-19 patients in the ICU the same day that it was delivered and installed.

See a video about the technology below:

Medgadget had the opportunity to talk to Diane Bryant, Chairman and CEO of Neural Analytics, about the technology.

Conn Hastings, Medgadget: Please give us an overview of the Lucid Robotic System.

Diane Bryant, Neural Analytics: Our founder, Dr. Robert Hamilton, developed the Lucid Robotic System as a means to monitor and assess the blood flow to the brain. It is the only fully automated, real-time method to non-invasively display the intensity and direction of intracranial blood flow. These data enable rapid identification of blood clots and other neurological abnormalities. Robert succeeded in his mission by combining long-established ultrasound technology with state-of-the art robotics and artificial intelligence. Brain illnesses, such as stroke, require immediate intervention to avoid life-long disability or death. The Lucid Robotics System uniquely provides precise insight into blood flow velocity, the existence of clots or other deposits, and the narrowing or widening of the blood vessels.

Brain derived illnesses have touched all our lives, whether personally or through someone close to us. Stroke, dementia, Alzheimer’s, traumatic brain injury, Parkinson’s disease – all manifest themselves in the brain. I personally find it distressing that in our annual physical check-ups our general practitioner informs us of the health of our heart and lungs but provides no insight into the health of our brain, an organ clearly as critical. At Neural Analytics, we strive to become the fifth vital sign.

Medgadget: How is the Lucid Robotic System being used in COVID-19 patients?

Diane Bryant: In mid-April we were contacted by three renowned medical institutions. Their message was consistent: emerging evidence showed COVID-19 patients are entering a hypercoagulable state leading to blood clotting in multiple organs including the lungs and brain. The medical community is faced with an alarming 700% increase in stroke for COVID patients under the age of 50 compared to historical norms. Patients of COVID-19 are emerging from ventilation with impaired speech, immobility, loss of memory and in some cases they do not survive.

The medical community requested the use of our Lucid Robotics System to continuously monitor the blood flow of COVID-19 patients. Once a patient is sedated and ventilated there is no other means to assess brain function. The clinical teams also face the issue of infection, necessitating limited exposure to the COVID-19 patient. The Lucid Robotics System allows them to maintain strict infectious disease protocols by robotically monitoring the patient from outside the room.

Medgadget: How long does it take to scan someone? How does the system avoid the need for specialized technicians?

Diane Bryant: The time to set up the robotic system and lock on the arteries in the brain is less than five minutes. The physician may view the blood flow for minutes in the identification of existing abnormalities, or may use the system for hours to continuously monitor the brain through surgeries or monitor in the neuro-intensive care unit to alert for possible strokes.

When the ultrasound-based transcranial doppler system was invented in 1982 it pledged to be the stethoscope of the brain. The technology failed to meet its vision due to the difficulty in locating the thinnest part of skull, providing the necessary window into the brain. We have solved that problem using robotics and artificial intelligence.

Medgadget: Please give us an overview of how data from the system may help to increase our understanding about which COVID-19 patients are at greater risk of stroke, and how this could influence pre-emptive treatment.

Diane Bryant: The medical community’s understanding of the COVID-19 virus continues to evolve. It affects different people in different ways. Infected people have had a wide range of symptoms and the death rate is alarming. Initially believed to be a typical acute respiratory distress syndrome like the flu, it increasingly appears this is not the case. The Lucid Robotics System provides a unique view into the disease. Just this past week our system was confirmed by the FDA to cover COVID-19 patients. Although our system was initially developed for illness of the brain, we have realized through our work with medical institutions that insights into pulmonary diseases like COVID-19 can be obtainable through analysis of cerebral blood flow. The body is clearly interconnected.

Our clinical training team has been working side by side with critical care physicians, scanning all COVID-19 patients. A paper was published on May 5th in the New England Journal of Medicine connecting COVID-19 and stroke. Scans of five patients under the age of 50 were completed and the results were staggering. All five showed physical signs of large-vessel stroke. We are working with Mount Sinai and other medical institutions to improve the outcome of COVID-19 patients through assessment and monitoring of blood flow through the brain. Our mission is to contribute to a better understanding of the virus, have a positive impact on COVID-19 patients, and reduce the impact of the disease nationwide.

Product page: Lucid Robotic System…

Link: Neural Analytics homepage…

Flashbacks: Now Available: Neural Analytics’ Lucid Robotic Ultrasound System for Brain Blood Flow Assessment; Lucid M1 Ultrasound Brain Damage Assessment System Cleared by FDA; Lucid M1 Brain Damage Assessment Transcranial Doppler Ultrasound System Now Available; Lucid M1 Transcranial Ultrasound Cleared in Europe to Help Assess Brain Damage
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