Real Deal: No More Needles for Blood Draws

v12Velano Vascular is on a mission to bring compassion to healthcare and make painful blood draws more pleasant for patients.  So far, they’re succeeding. They’ve received their 3rd FDA-clearance to help children and adults who cringe at the sight of needles.

Needlephobia affects 24% of adults and 63% of children.

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The Boy Who Cried Wolf may come to mind when we talk about no more needles for blood draws because of ill-fated Theranos.  They’re the overly-hyped biotech start-up currently under federal investigation by the S.E.C. and U.S. Attorney’s office. Patients initially thrilled about no more needles got hoodwinked by fake news.

Meet the Real Deal.

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Velano Vascular creates a single-use, disposable device called PIVO.

 

It attaches to a peripheral IV line, in hospital inpatients, allowing for lab quality blood samples to be drawn back through the IV –without requiring venipuncture (needle sticks or drawing blood from central lines) .

 

Many of the questions Therano’s CEO never answered, avoided or even got asked by reporters is welcomed by Velano Vascular’s CEO, Eric Stone, who I interviewed.

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WHAT IS PIVO AN ACRONYM FOR?

ERIC STONE, CEO, VELANO VASCULAR:  PIVO derives from “peripheral intravenous catheter,” or PIV, which is a medical term for the standard IV most hospital patients are hooked up to in order to receive intravenous fluids..

WHAT IS PIVO?

STONE: PIVO is a single-use, disposable device that attaches temporarily to an IV line, allowing for needle-free blood draws from this existing line.

HOW DOES IT WORK?

STONE: It enables blood draws to be taken by clinicians from the same intravenous (IV) catheter most hospital patients already have inserted in their arms, instead of poking them again each time they need their blood drawn and instead of accessing larger catheters (Central Venous Catheters) which raise different challenges associated with each time they are accessed.

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WHO DOES THIS DEVICE HELP PEOPLE?

STONE:  The device works for any patient with an IV catheter. Of course, children tend to more commonly have an acute fear of needles, so it can make pediatric care less invasive and painful.

There are also an estimated 30% of our hospital inpatients that are classified as DVA (Difficult Venous Access) because of aging, obesity, disease and more.

PIVO helps practitioners capture critical labs from these growing populations of patients who otherwise may take significant time and expense.

STONE: Also, those in hospitals or other inpatient settings, where the average length of stay is almost 5 days in the U.S. require daily or more frequent blood draws. Many of these patients have problematic veins or skin, which requires a lot of poking and prodding to draw blood. PIVO tackles these issues head on.

According to the CDC, an estimated 35M inpatient stays occur in the U.S. alone each year.  So, PIVO is set to  help many millions of Americans, not to mention those inpatients around the world.

HOW IS PIVO MORE COMFORTABLE & LESS DANGEROUS FOR PATIENT?

STONE:  For patients who have their blood drawn for a check-up once a year in an outpatient setting, blood draws are not that disruptive.  For a “frequent flyer” in the hospital, or a DVA (difficult venous access) patient –noted as such upon admission or who has become DVA after 10 or 20 days in the hospital feeling like a pin cushion –removing the needle from the procedure can have a lifelong impact.

Enabling practitioners to avoid accessing central lines (large, surgically-placed catheters) for blood draws aims to reduce the risks of Central Line Associated Blood Stream Infection.

Further, removing the needle from blood draws helps avoid risk of injury and infection for our phlebotomists, nurses and physicians. Hospital leadership is recognizing that an important alternative to a prevalent practice is now available.

IF I GET BLOOD WORK FROM AN ANNUAL PHYSICAL WILL THEY USE PIVO?

STONE:  PIVO requires a Peripheral IV catheter in order to access the vein. The IV line serves as a temporary conduit to the vein, so without the IV line PIVO cannot access the vein.

The IV line serves as a temporary conduit to the vein, so without the IV line, PIVO cannot access a patient’s blood.  As such, this procedure is most appropriate for the hospital inpatient setting.

I do envision PIVO will adopted in other care settings, where patients possess an IV line and require frequent blood draws, but the annual physical unfortunately is not one of these.

WHY AREN’T IV’S GOOD FOR DRAWING BLOOD WITHOUT PIVO?

STONE:  IV’s are essentially plastic  tubes which overtime become soft, like a noodle. While a noodle is fine for injecting fluids and medications into a patient, its soft walls collapse under the negative pressure of suction when you try to take fluids out.

There are other reasons why IV’s are less-than-optimal for drawing blood back, but these are quite complex in nature and we’re only just now uncovering some of the novel reasons through our research with leading clinical collaborators.

PIVO simply inserts a small, stiffer tube inside the existing IV tube for the purpose of drawing blood.

It works by propping open and unkinking the IV tube temporarily while enabling lab quality blood be collected.

HOW WAS THE IDEA FOR PIVO ORIGINALLY DEVELOPED?

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STONE:   Velano’s co-founder and physician, Pitamber Devgon had an elderly patient with bruises up and down her arms from repeated needle sticks.  That patient asked him why he was continually sticking her with needles when she already had an IV catheter in her vein. He didn’t know, but began exploring if it was possible to draw lab quality samples out of the IV line using a separate device.

Stone, a Wharton MBA shares, “Most of my career has been in healthcare, plus I am a needle phobic following my childhood diagnosis with Crohn’s disease as a teenager. So, when I was looking for a company start and a product to bring to market and my former graduate school classmates introduced us, I was instantly engaged following years as a serial healthcare entrepreneur and patient advocate.  From that connection,  Velano was born. “

Velano first won FDA approval for PIVO in 2015, and has also obtained multiple U.S. and international patents for it, with additional applications outstanding in the U.S. & abroad.

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STONE: “Five years from now,” asserts Stone, “I believe, without a doubt that PIVO will be the standard of care for inpatient blood draws and vascular access.”

Thanks for a great interview and innovation for healthcare consumers! -Maria Dorfner

http://velanovascular.com

 

MEDIA:   Contact: Michael Azzano at 415-596-1978 to set up telephone or on-camera interviews with patients or Eric Stone, CEO, Velano Vascular.

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RELATED NEWS:

 

A year ago, Forbes contributor Robert Reiss called Eric Stone “The Steve Jobs of Drawing Blood” and tested PIVO himself.  Reprint of article below courtesy of Reiss.

The Steve Jobs Of Drawing Blood

by Robert Reiss , FORBES CONTRIBUTOR (specializing in writing about CEOs)

Opinions expressed by Forbes Contributors are their own.

I was recently at a board meeting at Griffin Hospital and our CEO was telling us about a new product that could transform perhaps the most ubiquitous healthcare practice – drawing blood.

The concept from a company called Velano Vascular repurposes the IV most hospital patients already have in their arms so blood can be drawn without having their veins repeatedly stuck by needles.

It aims to eliminate the associated negatives of traditional blood drawing: the pain and anxiety, injuries, excessive time and cost.

It seemed like such a revolutionary solution to a broad issue – sort of like in 1892 when Keds invented sneakers – and I was curious to understand if this was truly an historic moment where the age old process of drawing blood could once and for all be revolutionized.

It reminded me of one of my first CEO interviews back in 2007 with Jay Walker, the founder of Priceline when he described the driving force behind one of his over 700 patents, “The key to successful innovation is having a better solution for something that’s used everywhere and every day.”

So I decided to experience this innovation firsthand and a few weeks later I intentionally became a patient and experienced this new needleless way to draw numerous samples of blood.

I was amazed, the nurses were able to draw blood easily, and to do so as many times as they wanted without ever having to stick a needle in me again.

I was next introduced to the founder of Velano Vascular, Eric Stone, who I now admiringly call the Steve Jobs of drawing blood, and below are a few insights from our conversation:

Robert Reiss: How much blood is currently being drawn and what are the problems with the current system?

Eric Stone: Blood draws are not fun – and they are overlooked and underappreciated…except by patients. They are likely the most common invasive medical procedure, with an estimated half a billion in U.S. hospitals alone conducted every year, and two to three times this number across all hospitals worldwide annually.

Recognizing that the U.S. represents nearly 40 million inpatient admissions annually, with an average length of stay of five days, and a conservative estimate of two blood draws per patient per day, we are easily conducting hundreds of millions of inpatient draws each year quite readily.

This does not even take into account other non-hospital settings where patients require regular blood draws, such as long-term care facilities, skilled nursing homes and more – all locations where patients may have a peripheral IV (PIV) catheter indwelling (a requirement for our innovation to be relevant).

For a procedure that informs nearly 70% of all clinical decisions, it is remarkable that the last major innovation was the abandonment of bloodletting centuries ago.

Whether you’re the parent of a sick child or the son or daughter of an elderly parent, repeat hospitalizations and frequent blood draws hit home for just about everyone. It’s scary, it hurts, and it’s critical that we begin to pay attention and stop taking the steely reserve of our patients for granted.

Herein lies the rub. People scared of needles (trypanophobia) avoid necessary tests and treatment, needles injure healthcare workers more than 2 million times a year in accidents that can lead to serious infection, and the list of dysfunction goes on.

The way we draw blood today has real emotional, clinical and financial consequences. We can, and we must, do better. We can start by paying attention.

Reiss: What specifically is different about the Velano Vascular product?

Stone: Velano’s FDA-approved PIVO™ is a disposable, needle free device that connects to a patient’s existing IV catheter, enabling blood draws during their entire hospital stay without requiring subsequent needle sticks.

It turns out that IVs are great at putting fluids into the body but unreliable at pulling them out – that’s why patients receive so many needle sticks while in the hospital.

PIVO turns the routine IV into a reliable conduit for drawing high quality blood samples. This is an elegant solution to a centuries-old problem.

Now, patients no longer need to feel like a “pin cushions” or experience abrupt awakenings between 2:00 am and 6:00 am for the nighttime needle stick – when 40% of blood draws occur.

The company was founded based on a simple idea back in 2012, and subsequently PIVO has been used in clinical pilots and trials at a number of leading U.S. hospitals since receiving regulatory clearance in early 2015.

It has won a number of awards, including the Frost & Sullivan New Product Innovation Award for Vascular Access in 2016 and the Sheikh Zayed Institute for Pediatric Surgical Innovation competition at Children’s National Health in Washington, DC.

Reiss: What are the strengths and weaknesses of your methodology on quality outcomes?

Stone: Velano is most often measured by the clinical quality of blood samples drawn and its impact on both practitioner and patient experience.

In thousands of patients, the quality of our blood samples has been definitive and easy to measure, both through clinical studies and “real world,” commercial use.

Blood drawn from PIVO has similarly low hemolysis rates (blood cell shearing or tearing that can relegate a patient to a re-draw and delays in essential care) to needle draws.

Clinical study efforts and pilots with some of the country’s leading healthcare institutions such as University Hospitals Cleveland, Intermountain Healthcare, The University of Pennsylvania Hospital and Harvard’s Brigham and Women’s Hospital reflect clinically appropriate laboratory results – confirming that blood drawn with our compassionate technology can become a standard of care for clinical decision-making.

Practitioner and patient experience is harder to quantify, but our surveys and testimonials to-date are resoundingly positive. In fact, patients who receive PIVO draws are requesting PIVO when transferred to floors in the hospital that are not participating in our pilots or upon readmission to the hospital. They are actually asking for the product – it is remarkable.

The onus is on Velano to continue improving our quality measurements to undeniably prove this innovation is truly a win-win-win, as we seek to elevate the quality of care and outcomes for patients, practitioners and hospitals alike.

Reiss: What is the financial model for a user and what is the economic impact nationally?

Stone: The cost of a blood draw is not just the $1 or less spent for a needle. Instead, it is the many billions of dollars a year spent on wasted materials, rejected blood samples, patient and practitioner risks, delayed results, labor costs, central line escalations, and more resulting from this less-than-desirable and madly inefficient procedure.

Some of the financial downsides of traditional blood draw standards are somewhat obscure, however we’ve helped our hospital partners understand the current impact by simply asking sincere questions, seeking to learn, and paying a modicum of attention to the topic.

Think about the blood draw on an elderly or obese or diabetic patient that can take as long as an hour of a nurse’s time and 2-3 needles to find a vein and collect an adequate sample.

Consider that even one single case of an employee blood borne pathogen transmission from a needle stick can cost millions of dollars in exposure for a hospital.

For PIVO, we understand that in an environment of increasing health industry price transparency and pressures, when our entire healthcare system is experiencing economic upheaval, and cost neutrality is required for rolling out true innovation in hospitals.

 

Reiss: Why did you start Velano Vascular and what’s your vision?

Stone: The reason why is very simple – because I am first and foremost a patient, and I am a parent.   25 years ago I was diagnosed with Crohn’s disease, launching me on a lifelong journey as a healthcare entrepreneur, patient advocate, and National Trustee of the Crohn’s and Colitis Foundation of America. Since a young age, I’ve been motivated by IMPACT.

I started Velano in partnership with an intellectually curious physician inventor intrigued by a seemingly simple question posed by his patient – “why are you repeatedly sticking me with needles [when I already have an IV line in my arm]?”

This simple, yet elegant idea resonated strongly with me, for I am needle-phobic myself, and I have been that “tough stick” patient during my hospital stays. Today, this brilliant idea has become reality.

My vision for Velano is to touch every human being on the planet; for we will all spend time in a hospital at some point in life, and we will certainly need our blood drawn when we do.

 

http://velanovascular.com

 

MEDIA:   Contact: Michael Azzano at 415-596-1978 to set up telephone or on-camera interviews with patients or Eric Stone, CEO of Velano Vascular

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Maria Dorfner founder of NewsMD: What’s Hot in Health

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NewsMD Communications was founded in 1998 to educate healthcare consumers by connecting medical + media to inspire and empower millions to want to live healthy.

In 1993, Maria created Healthcare Consumers, Healthy Living, Lifestyles & Longevity and Healthcare Practitioners. The shows aired on CNBC, which she helped launch in 1989.  She is the founder of Cleveland Clinic News Service, helped launch MedPage Today (sold to CNN) and wrote & produced 21st Century Medicine for Discovery Health.  Her awards include Freddie for Excellence in Medical Reporting, Outstanding Leadership Abilities, Media Recognition, Who’s Who, Medical Reporting Scholarship. She produced for Journal of the American Medical Association (JAMA) Report, talk shows & reality programming.

She began as an intern at NBC todaylogo SHOW in NYC in 1983.

This is her blog.

Have an innovative solution healthcare consumers|media should know about?

Contact: maria.dorfner@yahoo.com  

Response only if it’s a story of interest. Thank you.

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Reading To Your Baby Early Has Benefits

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Many parents spend countless hours reading bed-time stories to their babies. Does it help?

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Sure does, according to new research. Reading books to infants can boost vocabulary and reading skills for years to come.

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Kimberly Giuliano, M.D., of Cleveland Clinic Children’’s did not take part in the study, but encourages parents to start reading to their babies “as soon as possible.”

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“Dr. Giuliano says, “It’s never too early to start. If you want to read to your newborn – that’’s great. “They get in your arms, they’’re comforted, they hear your voice and it’’s a wonderful bonding experience for parents and babies alike.””

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Researchers monitored 250 pairs of mothers and babies for four years and found book-reading quality during infancy was a good predictor of early-reading skills.

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They also found a combination of book-reading quality and quantity during toddler years was a good predictor of literacy skills, such as name-writing, by age four.

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WHEN IS A GOOD TIME TO START?

Dr. Giuliano says once babies begin opening their eyes more and become more reactive to the world around them, they’’re more than ready for books.

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She says even if they’’re only a few months old, they can still learn.

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“”Young babies, especially those under the age of one, love books that have a little bit more of a sensory feedback to them,” says Dr. Giuliano. “

She adds, “They learn by developing all different types of senses, so if they can hear, see, and touch, it really helps them to understand the concepts that are being presented to them in the book.” It’s important for kids of all ages to spend time relaxing and reading every day.”

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“”The more we engage our brains actively in reading, the better children do academically, the longer their attention spans are, and the more success they’’re likely to have in school,”” says Dr. Giuliano.

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‘Early Reading Matters: Long-term Impacts of Shared Bookreading with Infants and Toddlers on Language and Literacy Outcomes’ was originally presented at the 2017 Pediatric Academies Society Meeting on May 8, 2017.

 

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MEDIA:  See Cleveland Clinic Pathfire for b-roll and soundbites

 

Mending Little Hearts

jude4Congenital heart defects are the most common form of birth defect among American infants. 

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More than 40,000 babies born each year with a serious, underlying heart condition.

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Congestive heart failure (CHF) is a term used by cardiologists to describe a patient whose heart does not pump enough blood out to the rest of the body to meet the body’s demand for energy.

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This can be due to either a heart that pumps well but is very insufficient (due to a structural problem), or it can be a result of a weak heart muscle that does not pump a normal amount of blood to the body.

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Either situation will lead to backup of blood and fluid into the lungs if the left side of the heart is the problem or backup of blood and fluid into the liver and veins leading into the heart if the right side of the heart is problem.

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It is not uncommon for both sides of the heart to fail at the same time and cause backup into both systems simultaneously.  Backup or excessive blood flow into the lungs, which is the most common use of the term in pediatrics.

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Many cardiovascular problems that afflict older adults actually started when they were much younger.

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A new initiative by the non-profit Mended Little Hearts and St. Jude Medical, Inc. the global medical device manufacturer, will offer an important new resource for parents who need answers—and it’s being headlined by none other than the mother of “Little Darth Vader,” Jennifer Page.

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You may know her son Max from his appearances on the soap opera “The Young and the Restless” and from his well-known role as little Darth Vader in a Volkswagen Super Bowl commercial that has become a classic.

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Max was born with a congenital heart defect and received a St. Jude Medical pacemaker when he was 3 months old.

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At age 7, the child-actor had to have open-heart surgery because of his condition. The surgery replaced his pulmonary valve and repaired a hole in his heart.

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The valve should last another 10-15 years before it has to be replaced with noninvasive surgery.

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Now Jennifer is reaching out to other parents with the information they need.

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In many cases, these kinds of problems in children aren’t properly diagnosed until it’s too late, as in the tragic cases you may have heard about high school athletes dying suddenly on the basketball court or football or soccer field.

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The new initiative will spread awareness with online resources from Mended Little Hearts and St. Jude Medical.

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Jennifer Page provides a parent’s perspective and is joined by a leading cardiologist and pediatric cardiac surgeon, Dr. David A. Ferry, on staff at Childrens Hospital Los Angeles.

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In addition to doing heart surgery procedures at Children’s, Dr. Ferry is Associate Professor of Pediatrics at UCLA David Geffen School of Medicine.

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Jennifer and Dr. Ferry will provide background on the new online resource, as well as information on how your viewers can learn more.

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The mission of Mended Little Hearts is to empower families with support and education about congenital heart disease. St Jude Medical, Inc. is a worldwide leader in research and development with products to treat congenital heart disease.

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For More Information please visit the new website at: http://www.sjm.com/weheartkids

LINK TO INTERVIEW:

INTERVIEW FEATURES:

§  Jennifer Page, Max’s mom, providing the parent’s perspective, also an ambassador for new web resource

§  David A. Ferry, MD, FACC, Pediatric Cardiologist, Childrens Hospital of Los Angeles, Assoc. Prof. Peds., UCLA School of Medicine

No Flu For You! How To Tell If Your Kid Has the Flu or Worse

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It’s that time of year.   Fun.  Fun.  Fun.

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In the Cold, Cold, Cold.   Right?  Or NOT.   Freezing temps can lead to not so fun aches from a cold, the flu or worse.

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When it’s your child feeling lousy, you’ll want to pay extra attention to their symptoms.

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Sniffles.  Sneezes.  Coughs.  Temperatures.
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Pay attention for wheezing. Dr. Carolyn Clear tells me that’s the warning sign.
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 Keeping kids healthy is a priority.
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When kids get sick it can spread to make the whole family miserable.
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First, let’s distinguish between a cold or the flu.
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Since a lot of folks confuse the two, here is a comparison of symptoms:
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Next, let’s look at what to do if you get either:
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 How can you tell if your kid has something WORSE than the flu?
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TODAY, I talk to Dr. Carolyn Clear fromWest Depford Pediatrics in West Depford, NJ and parent advocate Lindsay Mathis to discuss the flu, RSV, and the differences between the viruses. 
LINK TO INTERVIEW with DR. CAROLYN CLEAR and LINDSAY MATHIS:
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They provide essential information about seasonal viruses and how all parents can protect their children this winter.
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Learn how to tell if your child is suffering from flu symptoms or different seasonal contagious virus.   
At the height of winter and cold and flu season, children are at an increased risk for contagious seasonal viruses.
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By following a simple checklist, parents can be proactive about their family’s health and renew their commitment to healthy living.
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According to the recent announcement by the Centers for Disease Control and Prevention, the flu is now at epidemic levels, with more than 21 pediatric deaths as a result of the virus across the country.
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The CDC says the epidemic is spreading and the number of states with a high amount of influenza-like activity increasing. Children are especially vulnerable.
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While the flu and Enterovirus have been at the forefront of the infectious disease conversation, what may not be top-of-mind is RSV, a common virus contracted by nearly 100 percent of babies by their second birthday.
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Often mistaken as a common cold, RSV can bring serious complications, is the leading cause of infant hospitalization, and is responsible for approximately 8 times more infant deaths each year than the flu.
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Doctors say it’s typical to see a spike in RSV cases in the winter, as we’re in the height of “RSV season,” which typically runs from November through March.
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While every baby is at risk of contracting RSV, premature babies are at an increased risk for developing severe RSV disease due to their underdeveloped lungs and immature immune systems.
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RSV is very contagious and can live on skin and surfaces for hours.
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So parents should remember to:
·       Wash your hands and ask others to do the same
·       Keep toys, clothes, blankets, and sheets clean
·       Avoid crowds and other young children during RSV season
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Parents can fulfill their commitment to better health this winter by educating themselves about common circulating viruses and following a simple checklist to help protect their families:
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 See your children’s primary care physician for an annual checkup Work with your children’s doctor to determine what seasonal vaccinations, such as the flu vaccine, your children are eligible for.
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Know the signs and symptoms of several of the most common winter illnesses, including:
o   Cold
o   Flu
o   Enterovirus
o   Sore throat
o   Respiratory Syncytial Virus (RSV)
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Remember a strong immune system is built by eating right, avoiding sugars, junk food and processed food, toxic beverages, getting enough sleep each night, daily exercise and good hygiene.
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 You CAN make it through with NO flu or virus for you!!!
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For more information please visit http://www.rsvprotection.com
 
headshot1  Maria Dorfner is the founder MedCrunch, a division of Healthy Within Network (HWN).