Saturday, November 15, 2014

PARADIGM BYTES

Newsletter for Paradigm 97
November 15 , 2014
PARADIGM DEFINED:1) an outstandingly clear or typical example or archetype.2) a philosophical and theoretical framework of a scientific school or discipline within which theories, laws, and generalizations, and the experiments performed in support of them, are formulated.

Our website......
http://paradigm97.blogspot.com/Please copy, paste, and bookmark it.

MISSION STATEMENT
We believe that nurses need each other for support during the "lean and mean" days to help survive them. We offer research results and other ideas to enrich the nursing experience.
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SNIPPET
(This month's Editorial is by one of our members)
Nursing Homes’: A Misnomer
Kennedy, Maureen Shawn MA, RN
In M. Night Shyamalan's movie The Sixth Sense, a little boy says, “I see dead people.” Well, I see old people. At first I noticed them in malls, wearing white sneakers and colorful sweat suits and power walking in packs. Lately I see old people everywhere, getting off tour buses in Manhattan's theater district and on Martha's Vineyard, sitting on park benches with their companions and walkers. Maybe it's because I'm getting older myself: I look at my reflection in the mirror and at my husband and I realize we're now joining this senior group. I'm all too aware that getting “carded” has taken on new meaning—instead of proving you're old enough to drink, you're asked to produce proof of Medicare coverage before obtaining health care services.
By 2050, according to the U.S. Administration on Aging, over 20% of the nation's population (about 88 million people) will be ages 65 years or older; 4% will be ages 85 years or older. By comparison, in 2010 people in the former group made up 13% of the population (about 40 million people); those in the latter group, 2%. Granted, many older adults are living active, independent lives thanks to advances in medications and surgical procedures, social initiatives like Social Security and Medicare, and community services. Still, it's been estimated that two-thirds of today's 65-year-olds will need some form of long-term care services during their remaining years, with institutional care necessary for approximately 20%. Given the present state of long-term care facilities, this group can expect little in the way of high-quality care. ...
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FROM A MEMBER
Thank you , Sandy Summers on Truth about Nursing!
To get an up to date viewpoint on the TV shows
October 2014 -- The fall U.S. prime time schedule has several new shows with nurses among the regular characters, although there is a notable trend toward the distant past. Outlander, the Starz series which has now aired half its first season and will resume in April, is based on popular books about a British World War II combat nurse who is transported back in time to 18th-century Scotland. There, she falls in with local rebels, has romantic adventures, and occasionally displays impressive emergency health skills--which are mistaken for witchcraft! There's not much health care, but nurse Claire is smart, tough, and ready for action. Cinemax's The Knick, which ended its first season on October 17, focuses on the exploits of early 20th-century surgeons at a New York hospital. The show's tone is unusually harsh and corruption is everywhere, but it still embraces the traditional view of surgeons as the brash 'n' brilliant heroes of health care. The nurses are peripheral handmaidens ...
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Print(sorry about this..AOL intrudes again)
In response to my request for suggestions, MarGerlach sent me the following:
"Mainly just news on what is happening in their areas, their hospitals, their nursing education, how they deal with problems at work, etc... " she wrote.
I will have that in the December Newsletter. Hopefully, you all will have sent "stuff" in for it. Thanks.
EDITORIAL COLUMN
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INTERESTING READING
Please remember that the REUTERS articles usually good for only 30 days
Assessments and Best Practices in Care of Older Adults
“Why is assessment of older adults so important?
Illnesses in older people often look different than in younger ones. For instance, younger adults with a urinary tract infection will have many or all of these symptoms: frequent urination, pain from bladder spasms, blood in the urine, and fever. Changes that occur with aging often mask these symptoms that provide early clues to a urinary tract infection. The first sign of a urinary tract infection in an older adult might be confusion or a fall. If the nurse does not have the knowledge and skills to further evaluate the older adult who might fall or become confused, the infection can go untreated and result in overwhelming infection, and possibly death.”---
http://www.nursingcenter.com/lnc/static?pageid=730390&utm_source=WhatCountsEmail&utm_medium=NursingCenter%20eNews&utm_campaign=1_NC%20eNews:%20November%202014:%20Issue%201
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DID YOU KNOW?
Nursing luminary Lillian Wald first coined the term “public health nurse” with her work in providing social services and health education to immigrant populations in New York City in 1883. Since then, public health nurses (PHNs) have worked to improve communities in a myriad of ways, including educating populations about healthcare issues, providing a wide range of preventive and clinical services in public health clinics, serving on the front lines during healthcare disasters, leading disease research and shaping healthcare policy
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Public Health Nurses Care for Populations as their Patients
“One of the challenges we face as a nation is that many people do not know what public health is or what it does,” said Patricia Drehobl, MPH, RN, associate director of Program Development and Communication at the Division of Scientific Education and Professional Development at the Center for Surveillance, Epidemiology and Laboratory Services for the Centers for Disease Control and Prevention (CDC). “I’ve encountered many misconceptions about public health, even among healthcare professionals, such as that public health is simply the provision of patient care outside of the acute care setting or care to underserved populations.”
Nursing luminary Lillian Wald first coined the term “public health nurse” with her work in providing social services and health education to immigrant populations in New York City in 1883. Since then, public health nurses (PHNs) have worked to improve communities in a myriad of ways, including educating populations about healthcare issues. ...
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RANDOM FACT:
Bears are found on almost every continent on the globe, with the notable exceptions of Australia and Antarctica. Although bears do not currently live in Africa, bear fossils have been found there.

Bears have been feared, worshipped and venerated throughout history. Some Native Americans called them "the beast that walks like a man" and in Russia bears have traditionally not only been a symbol of pride and power, but have also been common images in fairy tales and myth.


The bear that a person living in North America is most likely to run into is the black bear. They live in wooded areas in every Canadian province, many U.S. states, and parts of Mexico.

In 2004, a black bear was found unconscious in a campground in Seattle, Washington. It had broken into a cooler and used its claws and teeth to open dozens of beer cans. Although it sampled other types of beer, it chose to drink all the cans of only one type of beer. After its drinking binge, the bear passed out.
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Bonus Fact:

Bears can see almost as well as humans, and they can hear a little better. But they can smell much better. In fact, a bear's sense of smell is around 100 times greater than a human's. Polar bears can track down an odor from 20 miles away. They can smell a dead seal under 3 feet of solid ice.

Bears can run up to 40 miles per hour, fast enough to catch a running horse. The fastest known human today can run 27mph.
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Thank you, Roz for this article:
4 Steps Could Quell Ebola in West Africa, Researchers Say
Thursday, Oct. 30, 2014 (HealthDay News) -- A full-court press involving all public health tactics known to prevent Ebola transmission will be required to quell the current West African epidemic, a new study reports.
Four practices in particular -- burying the Ebola-infected dead in a hygienic way, immediately isolating new patients, tracing people potentially exposed to the virus, and providing better protection for health care workers -- can stop the epidemic within six months, researchers believe.
If public health officials can achieve these goals 60 percent of the time, the number of new Ebola cases in Liberia could fall to seven a day by Dec. 1 and to nearly none by March 15, the researchers report in the Oct. 30 issue of the journal Science. ... http://consumer.healthday.com/senior-citizen-information-31/misc-death-and-dying-news-172/4-steps-could-quell-ebola-in-w-africa-study-says-693217.html
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Nigeria declared Ebola-free, holds lessons for others ABUJA/LAGOS (Reuters) - Nigeria was declared free of the deadly Ebola virus on Monday after a determined doctor and thousands of officials and volunteers helped end an outbreak still ravaging other parts of West Africa and threatening the United States and Spain.
Caught unawares when a diplomat arrived with the disease from Liberia, authorities were alerted by Doctor Ameyo Adadevoh, who diagnosed it, kept him in hospital despite protests from him and his government and later died from Ebola herself.
They then set about trying to contain it in an overcrowded city of 21 million where it could easily have turned a doomsday scenario if about 300 people who had been in direct or indirect contact with him not been traced and isolated.
"This is a spectacular success story," Rui Gama Vaz from the World Health Organization (WHO) told a news conference in the capital Abuja, where officials broke into applause when he announced that Nigeria had shaken off the disease. ...
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Ebola crisis turns a corner as U.S. issues new treatment protocols DALLAS (Reuters) - The United States issued stringent new protocols on Monday for health workers treating Ebola victims, directing medical teams to wear protective gear that leaves no skin or hair exposed to prevent medical workers from becoming infected.
(Reuters) - The United States issued stringent new protocols on Monday for health workers treating Ebola victims, directing medical teams to wear protective gear that leaves no skin or hair exposed to prevent medical workers from becoming infected.
The new guidelines from the U.S. Centers for Disease Control and Prevention in Atlanta come as 43 people who were exposed to the first patient diagnosed in the United States were declared risk free, easing a national sense of crisis that took hold after two Texas nurses who treated him contracted the disease.
Under new protocols, Ebola healthcare workers also must undergo special training and demonstrate competency in using protective equipment. Use of the gear, now including coveralls, and single-use, disposable hoods, must be overseen by a supervisor to ensure proper procedures are followed when caring for patients with Ebola, which is transmitted through direct contact with bodily fluids but is not airborne. (CDC protocols: 1.usa.gov/1vYIwWA)
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Thanks, Roz (Rozalfaro) for this article:
UCLA study: Non-drug treatment may reverse Alzheimer's --
Alzheimer's disease was officially recognized a hundred years ago, but there's still no effective treatment for it. Now researchers at UCLA say they've developed a program that shows for the first time memory loss being reversed.

It's not a drug; it's not a procedure; it is a novel, comprehensive and personal approach to treating memory loss associated with Alzheimer's. UCLA researchers spell out exactly what can be done to reverse what the disease does to the brain.

In the report provided by UCLA, Dr. Dale E. Bredesen explains how Alzheimer's is a complex disease affected by sleep, diet, even exercise.

"These all -- and other things -- all contribute to this critical balance in plasticity," said Bredesen.

Ten memory-loss patients, some with brain-scan-confirmed patterns of Alzheimer's, participated in a small UCLA trial called MEND (Metabolic Enhancement for NeuroDegeneration). ...
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Thank you, Laura (Laregis)for the following:
Answers to Your Ebola Questions
NIH expert Anthony Fauci, MD, answers WebMD readers' questions to ease concerns about Ebola and explain how the virus spreads -- and can be stopped.Watch Video
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Up Next on Congress' Menu: CHIP and SGR
Once Congress comes back in November from its pre-election recess, members will be considering what to do about two important healthcare policy issues: reauthorizing the Children's Health Insurance Program (CHIP) and repealing and replacing the long-reviled sustainable growth rate (SGR) formula for physician reimbursement under Medicare.

The question is: can they afford to look at both issues? The price tag for repealing and replacing the SGR is
estimated at $131 billion, while a 5-year reauthorization of CHIP -- proposed a few months back by outgoing Sen. Jay Rockefeller (D-W. Va.) -- has an estimated cost of $88.7 billion. The money for CHIP runs out in September 2015. ...
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WHO expects around 200,000 Ebola vaccine doses by mid-2015
GENEVA/LONDON (Reuters) - The World Health Organization (WHO) set out plans on Friday for speeding up development and deployment of experimental Ebola vaccines, saying hundreds of thousands of doses should be ready for use in West Africa by the middle of 2015. ...
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LONDON (Reuters) - A Bulgarian man who was paralyzed from the chest down in a knife attack can now walk with the aid of a frame after receiving pioneering transplant treatment using cells from his nose.
The technique, described as a breakthrough by a study in the journal Cell Transplantation, involved transplanting what are known as olfactory ensheathing cells into the patient's spinal cord and constructing a "nerve bridge" between two stumps of the damaged spinal column.
"We believe... this procedure is the breakthrough which, as it is further developed, will result in a historic change in the currently hopeless outlook for people disabled by spinal cord injury," said Geoffrey Raisman, a professor at University College London's (UCL) institute of neurology, who led the research. ...
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First Sickle Cell Patient Undergoes Gene Therapy
Bluebird bio announced that the first subject with severe sickle cell disease has undergone infusion with LentiGlobin BB305 drug product in an autologous hematopoietic stem cell transplantation.

The patient is enrolled in the HGB-205 Study being conducted in Paris, France. A separate US-based trial (HGB-206) in the United States is also enrolling up to 8 severe sickle cell disease patients to also test LentiGlobin BB305. The company plans to present preliminary data from these studies in 2015.

Marina Cavazzana, MD, PhD, Professor of Medicine at Paris Descartes University and Research Director at the Centre for Clinical Research in Biotherapy, Necker Hospital, and at the Institute of Genetic Diseases, Imagine, Paris France said: “We are treating a sickle cell patient for the first time with gene therapy” ...
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FDA Approves Obizur for Acquired Hemophilia A
The U.S. Food and Drug Administration (FDA) has approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVII] deficiency).

Acquired hemophilia A is a rare, but potentially life threatening, bleeding disorder caused by the development of antibodies (immune system proteins) directed against the body’s own FVIII. Acquired hemophilia A has been linked to pregnancy, cancer, or the use of certain medications, but in approximately half of the cases, the underlying cause is not known. Diagnosis of this condition can be difficult and the severity of the bleeding can make treatment challenging.

Karen Midthun, MD, director of FDA’s Center for Biologics Evaluation and Research said: “The approval of this product provides an important therapeutic option for use in the care of patients with this rare disease.”...
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Researchers say there is a relationship between depression and dementia. A new study finds the clearest evidence yet of a possible link.
Researchers have long theorized that depression as people age may be linked to dementia later in life. Now a new study reveals that it may indeed be a risk factor.
“In this study we wanted to find out if the reason depression predicts dementia is because it is really an early sign of the disease,” says Robert S. Wilson, PhD, lead researcher on the study and a professor of neuropsychology at Rush University in Chicago. “This has been a persistent question throughout the research. We know that it takes years for dementia to develop, and sometimes these subtle changes in behavior that predict later disease are really early signs.” ...
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HINTS:
Hint 1: How many of you dye your hair at home? it's hard to dish out almost $100 for a color treatment and haircut. Well, if you do dye your own hair at home try this next time. Apply petroleum jelly around your hairline and on the tops of your ears before adding the dye to your hair. It forms a barrier that doesn't let the dye adhere to your skin.

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Hint 2:

Plastic food containers have a funny way of hanging onto odors no matter how many times you wash them. All you need is some newspaper to shake the nasty scent. Bunch the newspaper and stuff it inside the container overnight. By morning, the paper will have absorbed the odor, and your container will smell as good as new.

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Hint 3:

Before lighting candles, coat the inside of the candle holders with petroleum jelly. The leftover wax will slide right out after the candle burns down. How awesome is that?
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7 Signs You Don't Make Enough Money
If you are constantly struggling to make ends meet, you may be facing a combination of problems. It can be frustrating to be in a financial rut and not be able to find a way out. You may think that you make decent money, but you are still struggling each month. You may be overspending or you may not make enough money. You may be overspending while not making enough to cover your basic needs. This can lead to real trouble. If you do not make enough to cover your bills, you will need to take steps now to increase your income. Even if you feel like you are too poor to budget, a budget can help you get back on track, and you can use these strategies to help you cope with being poor. Learn these seven signs. ...
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Researchers discover new way of curing MRSA

Targeting cells known as persisters is a new and highly effective way of eradicating methicillin-resis­tant staphylococcus aureus, according to newly published research.
http://www.mcknights.com/researchers-discover-new-way-of-curing-mrsa/article/320861/?DCMP=EMC-MCK_Daily

Because they are resistant to antibiotic treatment, MRSA infections have plagued long-term care facilities and other healthcare settings. Northeastern University's Kim Lewis, Ph.D., believed that persister cells played a significant role in the antibiotic-resistant nature of these infections. Persisters are able to become dormant and so survive in the presence of antibiotics, which target active cells.
http://www.nature.com/nature/journal/vaop/ncurrent/full/nature12790.html

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Urine Tests Don't Always Confirm Urinary Infections, Study Finds; D
octors can rely on symptoms to start treatment, experts say
WEDNESDAY, Nov. 13, 2013 (HealthDay News) -- When doctors suspect a patient has a urinary tract infection, they often request a urine sample so they can test for the presence of bacteria. Now, new research suggests this step may be unnecessary.

Nearly one-quarter of women who had signs of a urinary tract infection -- a burning feeling when urinating or feeling an urgent need to pee -- had no evidence of bacteria in their urine or in their bladders, the study found. And although a number of urine culture tests found a
variety of different bacteria, only one bug -- Escherichia coli -- was found in both the urine test and the bladder. ... http://tinyurl.com/Treat-UTI

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CDC develops new faster test for enterovirus D68
On Oct. 14, the Centers for Disease Control and Prevention (CDC) announced that it has started using a new, faster lab test for detecting enterovirus D68 (EV-D68). This test will allow CDC to more rapidly test remaining specimens received from states since mid-September. The agency expects that EV-D68 infections will likely begin to decline by late fall. ...
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FDA approves two drugs for idiopathic pulmonary fibrosis
On Oct. 15, the U.S. Food and Drug Administration (FDA) approved Ofev (nintedanib) and Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis. Read more about nintedanib and prifenidone ... http://www.fda.gov/NewsEvents/Newsroom/
PressAnnouncementsucm418991.htm
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Quiz Time
Which statement about rewarming the patient receiving therapeutic hypothermia is correct?
a. Paralytic agents should be restarted when the patient’s temperature is normothermic.
b. During rewarming, patients do not pass through the shivering phase.
c. After rewarming is complete, the cooling device should be left in place for 2 to 36 hours.
d. During the rewarming phase, patients are at risk for hypokalemia.
See correct answer at end of Newsletter:
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FDA approves new implantable hearing device
On March 20, the U.S. Food and Drug Administration (FDA) approved the first implantable device for people 18 and older with severe or profound sensorineural hearing loss of high-frequency sounds in both ears, but who can still hear low-frequency sounds with or without a hearing aid. The Nucleus Hybrid L24 Cochlear Implant System may help those with this specific kind of hearing loss who do not benefit from conventional hearing aids. ...
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Thank you , Barbara (BAcello)
MO hospitals ditch "code" calls Plain language directives heighten patient safety, increase response time
Missouri hospitals will no longer use phrases like "code black" and
"code orange" in high-alert situations.

The Missouri Hospital Association wants organizations to use more transparent phrases like
"bomb threat" or "active shooter" rather than code phrases, according to the St. Louis Post-Dispatch. Pain language alerts and warnings will heighten patient safety and response time,
Leslie Porth, vice president of health planning at the Missouri Hospital Association, told the
newspaper.

"With outdated codes that didn't have clarity, there was sometimes a delay in the response
from patients and visitors who didn't understand the directive," Porth said. "A lot of research
supports the fact that plain language leads to increased patient safety and reduces confusion."
Drugs for diabetic neuropathy similarly effective despite cost differences
Newswise — ANN ARBOR, Mich. — Millions of people with diabetes take medicine to ease the shooting, burning nerve pain that their disease can cause. And new research suggests that no matter which medicine their doctor prescribes, they’ll get relief.
But some of those medicines cost nearly 10 times as much as others, apparently with no major differences in how well they ease pain, say a pair of University of Michigan Medical School experts in a new commentary in the Annals of Internal Medicine.
That makes cost -- not effect -- a crucial factor in deciding which medicine to choose for diabetic neuropathy, or diabetes nerve pain, the U-M researchers say. ...
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Improved patient handoffs reduces medical errors
Improved patient handoffs using the I-PASS bundle reduces medical errors by 30%, according to a study in the New England Journal of Medicine (NEJM). ...
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Statistics:
Facts about child safety (ages 0 to 19) from the CDC
300:
Every day, over 300 children are treated in EDs for burn-related injuries.
1:
Falls are the leading cause of non-fatal injuries for children.
2.6 million:
More than 2.6 million children are treated in the emergency department each year for sports and recreation-related injuries.
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Address Look Up Website:
Type any address "s l o w l y " & watch the picture of the current address unfold.*
ANY ADDRESS ALL OVER THE WORLD!
Much faster than Google Earth. Is there nowhere to hide?
After opening the link below, type in the address you want SLOWLY, letter by letter, space by space, and watch each time where it takes you.
Typing in one letter at a time (go slow) took me to - New York - Thailand - Las Vegas - Australia - Phillipines,- France and eventually where I live, it is
Educational, fascinating and fun (a little un-nerving as well to know how closely BIG BROTHER is watching you.)
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Genetic testing recommended for colorectal cancer patients
A new guideline from the U.S. Multi-Society Task Force on Colorectal Cancer recommends genetic testing of tumors for all newly diagnosed colorectal cancer patients. Read more and read an abstract of the consensus statement.
FDA approves new drug for skin infections
On August 6, the U.S. Food and Drug Administration (FDA) approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections. Read more.
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FDA approves new drug for type 2 diabetes
On August 1, the U.S. Food and Drug Administration (FDA) approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes. Read more.
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HUMOR SECTION
I had been teaching my seventh-graders about World War II, and a test question was, "What was the largest amphibious assault of all time?"

Expecting to see "the D-Day invasion" as the answer, I found instead on one paper, "Moses and the plague of frogs."

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My teenaged niece Elizabeth was nervous as she took the wheel for her first driving lesson. As she was pulling out of the parking lot, the instructor said, "Turn left here, and don't forget to let the people behind you know what you're doing."

Elizabeth turned to the students sitting in the backseat and announced, "I'm going left."
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CEU SITES---(CME and CNE)
Those that are-----Free and Otherwise..........
For CE credit, don't miss this special offer of 6.8 contact hours for $19.99!
Journal of Christian Nursing, January/March 2014
This article explores elder abuse and its prevalence, potential causes, and risk factors, offering case studies, assessment tools, resources, and interventions.
Expires: 3/31/2016 CE: 2.5
Injury Patterns and Causal Mechanisms of Bruising in Physical Elder Abuse
Journal of Forensic Nursing, April/June 2013
The recognition of injury patterns can aid forensic nurses to identify victims of elder abuse.
Expires: 6/30/2015 CE: 2.3
Elder abuse: Screening, intervention, and prevention
Nursing2012, October 2012
This article will offer valuable information on how to screen patients for elder abuse, help them get the help they need, and provide them with resources to prevent elder abuse from happening.
Expires: 10/31/2015 CE: 2.0
Lisa M. Bonsall, MSN, RN, CRNP
Clinical Editor, Lippincott's NursingCenter.com
Go to www.sharedgovernance.org for access to a free continuing education module about shared governance, written by Robert Hess, Forum’s founder, and Diana Swihart, Forum advisory board member.
Please follow me on Twitter as Dr Robert Hess.
Pay Only $34.99 for a full year of CONTACT HOURS
www.nurse.com for CNE offerings.
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WEBSITES/ LINKS
Always on the lookout for interesting websites / links. Please send them to:
This is an excellent nursing site, check it out: http://nursingpub.com/

Robert Hess, RN, PhD, FAAN
(856) 424-4270 (610) 805-8635 (cell) Founder, Forum for Shared Governance
Decubqueen's website: www.accuruler.com.
If you're buying a used car, it is recommended having a mechanic inspect it first. And screen the car's VIN through the free database at carfax.com/flood

Metric conversion calculators and tables for metric conversions
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MEDICAL RECALLS
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Hospira Announces Voluntary Nationwide Recall Of One Lot Of 1% Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose. Preservative-Free
Hospira, Inc. (NYSE: HSP), announced today it will initiate a voluntary recall of one lot of 1% Lidocaine HCI for Injection, USP, 10 mg per mL, 30 mL Single-dose, Preservative-Free (NDC 0409-4279-02; Lot 40-316-DK, Expiry 1APRIL2016) to the user level due to a confirmed customer report of particulate in a single unit. Hospira has identified the particulate as a human hair, embedded in and attached to a pinched area of the stopper.
Docetaxel: Drug Safety Communication - May Cause Symptoms of Alcohol Intoxication
FDA is warning that the intravenous chemotherapy drug docetaxel contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment. FDA is revising the labels of all docetaxel drug products to warn about this risk.
Docetaxel is a prescription chemotherapy drug used to treat different kinds of cancer, including cancers of the breast, prostate, stomach, head and neck cancers, and non-small-cell lung cancer.
Health care professionals should consider the alcohol content of docetaxel when prescribing or administering the drug to patients, particularly in those whom alcohol intake should be avoided or minimized and when using it in conjunction with other medications.
Read the MedWatch safety alert :
Pradaxa (dabigatran): Drug Safety Communication - Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin
The FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. The new study included information from more than 134,000 Medicare patients, 65 years or older, and found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, than warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin. The MI risk was similar for the two drugs.
Importantly, the new study is based on a much larger and older patient population than those used in FDA’s earlier review of post-market data, and employed a more sophisticated analytical method to capture and analyze the events of concern. This study’s findings, except with regard to MI, are consistent with the clinical trial results that provided the basis for Pradaxa’s approval. As a result of these latest findings, the FDA still considers Pradaxa to have a favorable benefit to risk profile and have made no changes to the current label or recommendations for use.

BACKGROUND: Pradaxa and warfarin are used to reduce the risk of stroke and blood clots in patients with a common type of abnormal heart rhythm called non-valvular atrial fibrillation (AF).at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm397179.htm

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Medical Device Safety and Recalls: Baxter Healthcare Corporation, Sigma Spectrum Infusion Pumps with Master Drug Library Model No. 35700BAX and 35700ABB
A recall has been issued for the Baxter Healthcare Corporation Sigma Spectrum Infusion Pumps with Master Drug Library Model No. 35700BAX and 35700ABB. Baxter has received over 3500 reports of System Error 322 “Link Switch Error (low)” incidents in which the device has malfunctioned, including nine severe adverse events and no deaths. The System Error 322 occurs when the pump improperly detects that the door is open when it is physically closed. A System Error 322 may lead to an interruption or delay in therapy. For more information, please see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm395617.htm
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Dräger Medical Inc., Evita V500 and Babylog VN500 Ventilators with Optional PS500 Power Supply Units - Battery Depletion
A recall has been issued for the Dräger Medical Inc. Evita V500 and Babylog VN500 Ventilators with Optional PS500 Power Supply Units due to battery depletion. The firm identified instances when the battery installed in the optional PS500 power supply unit depleted faster than expected and the device shut down even though the visual indicator showed a sufficient charge. Additionally, malfunctions of the battery depletion alarms occurred and they were not consistently triggered when the remaining battery capacity fell below a specific threshold. The company has not received any patient injury reports due to this issue. However, the use of products affected by this recall may cause serious adverse health consequences, including death. For more information, please see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm391562.htm
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Spacelabs Healthcare Ltd., ARKON Anesthesia Delivery System with Version 2.0 Software - Software Defect May Cause System to Stop Working Spacelabs Healthcare is recalling the ARKON Anesthesia System with Version 2.0 Software due to a software defect. This software issue may cause the System to stop working and require manual ventilation of patients. In addition, if a cell phone or other USB device is plugged into one of the four USB ports for charging, this may also cause the System to stop working. For more information, please see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm393536.htm
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Marcaine (Bupivacaine HCI Injection, USP) 0.25 percent, 10 ml, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates
Hospira, Inc. announced a voluntary nationwide recall to the user level for one lot of 0.25% Marcaine (Bupivacaine HCl Injection, USP), 10 mL, Single-dose Vial – Preservative Free (NDC 0409-1559-10), Lot 34-440-DD. The recall is due to a confirmed customer report of discolored solution with visible particles embedded in the glass as well as discolored solution. Hospira has attributed the embedded particulate to a supplier’s glass defect.
Read the MedWatch safety alert:
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ConvaTec, Inc., Flexi-Seal CONTROL Fecal Management System Kit - Not Cleared for Marketing
A recall has been issued for the ConvaTec, Inc., Flexi-Seal CONTROL Fecal Management System Kit as it is not cleared for marketing. The firm received reports from U.S. healthcare facilities of 13 adverse events including twelve serious injuries and one death for the period February 2013 through March 2014. A 510(k) application should have been submitted. The Auto-Valve feature that is unique to the Flexi-Seal CONTROL Fecal Management System Kit has not consistently performed relative to the inflation and deflation of the device’s retention balloon. For more information, please see htp://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm402137.htm
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ADVERTISEMENTS
from the members
This ad is from Decubqueen (Gerry).......... Accurate wound measurement designed by nurses, for nurses. Now carrying wound care and first-aid supplies at prices you can afford.
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NEW MEMBERS
Please send the prospective members' screen names and first names to me: RNFrankie@AOL.com
MistyHawk19@yahoo.com (Misty) October 27, 2014
Kimbaird@tds.net (Kim) November 12, 2014
Samanthadixon123@yahoo.com (Samantha) November 12, 2014

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NOTICE:
I attempt to send newsletters to your email addresses on file and if the newsletters are rejected THREE consecutive times, I must then delete the email address until you contact me with an updated email address. So, be certain to let me know when you change your address. RNFrankie@AOL.com
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EDITORIAL STAFF:
GingerMyst @AOL.com (Anne), GALLO RN @AOL.com (Sue), HSears9868 @AOL.com (Bonnie), Laregis @AOL.com (Laura), Mrwrn @AOL.com (Miriam), and Schulthe @AOL.com (Susan)

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PARADIGM 97 CO-FOUNDERS:
MarGerlach @AOL.com (Marlene) and RNFrankie @AOL.com (Frankie)

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DISCLAIMER: The intent of this PARADIGM BYTES Newsletter is to provide communication and information for our members. Please research the hyperlinks and information provided by our members. The articles and web sites are not personally endorsed by the editors, nor do the articles necessarily reflect the staff's views.
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THOUGHT FOR THE DAY
When will our consciences grow so tender that we will
act to prevent human misery rather than avenge it?

Eleanor Roosevelt
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Optimism is the faith that leads to achievement.
Nothing can be done alone without hope and
confidence.
Helen Keller
Hope to hear from you..... Frankie
Answer to Quiz Time:
Correct Answer: C. To avoid posthypothermia fever, it's recommended to leave the cooling device in place for 24 to 36 hours after the patient has been rewarmed and maintain normothermia for the duration of the rewarming period.