PARADIGM BYTES
Newsletter for Paradigm 97
March 14, 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
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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SNIPPETS
Misread Labels as a Cause of Medication Errors
ABSTRACT
We often read about potential causes of medication errors, such as drug names that are overly similar or misplaced decimal points in iv drug administration. But sometimes we overlook more obvious dangers. My experience as a nurse suggests that our patients are increasingly at risk for medication errors because of the convergence of three factors: difficult to read medication labels, the increasing age of the nursing population, and poorly lit work environments. This combination can lead to disaster.
I initially believed the tiny print on medication labels was only a problem for older nurses with aging eyes like me. (Presbyopia, the decreased ability of the eye to focus on near objects, commonly starts to appear around the age of 40.) Working as a clinical instructor to second-year nursing students, I found older nurses are not the only ones having trouble with fine print. One of my students, while carefully reviewing each of her patient's medications with me, was ready to administer an extended-release medication, crushed, through her patient's feeding tube. “Extended release” was printed below the name of the medication in barely readable 1-mm high letters. She hadn't seen it. Had she crushed and administered the drug, 24 hours worth of medication would have been released immediately, rather than slowly over a whole day. Her patient might not have survived that dose.
I decided to informally survey bedside nurses, nurse educators, pharmacists, and respiratory therapists to find out who else was having trouble reading drug labels. The results from the online survey are frightening. Of the nearly 100 responses I received, almost all of the nurses reported having difficulty reading the small text on medication labels. Almost half of the respondents were aware of a near miss or an actual error that could be at least partly attributed to difficulty reading the small print on medication labels and packaging. Virtually all survey respondents said that improving readability would reduce potential medication errors. The results convinced me I am not alone in my concern.
If the fine print is getting you down, it's not surprising. Unit dose package sizes that I work withFood and Drug Administration (FDA) recommends the use of more readable fonts, as well as a minimum point size for labels and adequate white space between words; however, it also requires that labels include drug name, dose, lot number, manufacturer, expiration date, special requirements for handling, and important descriptors such as SR, XL, and EC. Additional items drug manufacturers may choose to include are the manufacturer's address, National Drug Code number, generic name, and bar code. That's a lot of information to squeeze into a tiny space. (FDA policy states that “a firm may not claim an exemption on the basis that the label is too small to accommodate all mandatory information if all available space is not utilized or the label size can readily be made larger.”)
According to the 2008 National Sample Survey of Registered Nurses, the median age of a nurse in the United States is over 45, and nurses over 50 will soon make up nearly a quarter of the workforce. Presbyopia is an almost universal result of eye aging, so the majority of working nurses are experiencing it. Nurses care for patients 24 hours a day. Work environments can get pretty dark at 2 am; poor lighting compounds the problem, making the fine print even more difficult to read.
Small print is not just a problem for nurses my age but for everyone. Patients’ lives depend on accurate and safe medication administration. What can we do to avoid tragedy? Small print is a modifiable risk factor and needs to be addressed to prevent medical errors. So read carefully, and for now, wear your cheaters and turn the bright lights on!
© 2014 Lippincott Williams & Wilkins. All rights reserved.
AJN, American Journal of Nursing:
doi: 10.1097/01.NAJ.0000444470.78692.78
Viewpoint on a daily basis average around 3.5 cm × 2 cm, with some print as small as 1 mm in height (about the thickness of a dime). The U.S.
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INTERESTING READING
Please remember that the REUTERS articles usually good for only 30 days
Prenatal acetaminophen exposure linked to ADHD risk
( Reuters Health) - Children born to women who take acetaminophen during pregnancy may be at increased risk of attention deficit hyperactivity disorder (ADHD) and similar behavioral problems, new findings suggest.
The study does not show that prenatal exposure to the medication causes ADHD, and the increase in risk is small, Dr. Jorn Olsen, one of the study's authors, told Reuters Health.
Nevertheless, "it's reasonable to say that there's no reason to use these drugs during pregnancy unless there is a clear medical indication," said Olsen, a professor of epidemiology at UCLA and at Aarhus University in Denmark.
Acetaminophen, or paracetamol, has been available over the counter since the 1950s, Olsen and his colleagues note in their report in JAMA Pediatrics.
While the medication is widely considered to be safe to use during pregnancy, they add, recent studies have shown it can disrupt hormone function in pregnant rats and mice.
Given that hormones play a key role in guiding fetal development, the researchers decided to investigate whether acetaminophen exposure might be related to ADHD risk. They looked at 64,322 children and mothers enrolled in the Danish National Birth Cohort between 1996 and 2002. ...
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BP May Be Lower Without Meat in the Diet
Vegetarians had lower blood pressure than their omnivorous counterparts, a meta-analysis showed.
Blood pressure was an average of 4.8/2.2 mm Hg lower among vegetarians in controlled trials and 6.9/4.7 mm Hg lower in cross-sectional studies (P<0 .001="" a="" according="" all="" differences="" for="" href="http://www.ncvc.go.jp/english/" mph="" of="" phd="" target="_blank" the="" to="" yoko="" yokoyama="">National Cerebral and Cardiovascular Center
The findings -- reported online in JAMA Internal Medicine -- suggest that "such diets could be a useful nonpharmacologic means for reducing blood pressure," they wrote, adding that "further studies are needed to explore the relationships between specific foods and nutrients and blood pressure." ...http://www.medpagetoday.com/Cardiology/Hypertension/44455
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Hundreds of foods in U.S. contain 'ADA' plastics chemical: report (Reuters) -
Nearly 500 foods found on grocery store shelves in the United States, including many foods labeled as "healthy," contain a potentially hazardous industrial plastics chemical, according to a report issued Thursday by a health research and advocacy group.
Azodicarbonamide, also known as ADA, was found as an ingredient in breads, bagels, tortillas, hamburger and hot dog buns, pizza, pastries, and other food products, according to a report by the Environmental Working Group, based in Washington
Azodicarbonamide is fully approved for use in food by the United States Food and Drug Administration and the Canadian Food Inspection Agency. But ADA is banned as an additive in Australia and some European countries.
As a food additive, azodicarbonamide is used as a flour bleaching agent and as an oxidizing agent in dough to improve its performance for bakers. It is also used in plastics to improve elasticity and can be found in yoga mats and shoes.
The World Health Organization states that epidemiological studies in humans and other reports have produced "abundant evidence that azodicarbonamide can induce asthma, other respiratory symptoms, and skin sensitization" to people working with the chemical.
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Quick Vision Test May Help Spot Concussions on Sidelines Combined with two other simple screenings, all cases of head injury were caught, researchers report
WEDNESDAY, Feb. 26, 2014 (HealthDay News) -- A simple vision test given on the sidelines can help identify athletes who've suffered a concussion, a new study finds.
Researchers found that the test -- known as the King-Devick, or K-D -- was able to detect 79 percent of concussions among college athletes who were followed over a season. When the results were combined with those of two other screening tests, all of the concussions were caught.
The findings were released Wednesday by the American Academy of Neurology (AAN), ahead of its annual meeting this spring.
Experts said the study bolsters evidence that the K-D is a reliable way to help spot athletes' head injuries -- though the test, by itself, is not enough.
"People have been looking for quick, on-the-field screening tests," said Steven Broglio, an athletic trainer and director of the NeuroSport Research Laboratory at the University of Michigan in Ann Arbor.
The new findings suggest the K-D is "one option," said Broglio, who was not involved in the study. "But it's not definitive, and you wouldn't want to rely on this alone," he added.
The K-D takes a minute or two, and it can be given by an athletic trainer, coach or even a parent right on the sidelines. It requires test-takers to read a few rows of single-digit numbers that are unevenly spaced, as quickly and accurately as possible. If they are slower to finish than they were on their "baseline" test -- taken before the season starts -- that's a potential sign of a concussion.
There are other sideline screening tests already in use, including ones that test balance and short-term memory.
But the K-D test "fills a gap" by looking for vision-related problems, explained study co-author Dr. Steven Galleta, chair of neurology at NYU Langone Medical Center in New York City. ...
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Fact:
one in 88 children have some form of autism... That is up 78% from 10 years ago
one in 54 boys in the United States have autism
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How Much Sleep Do You Really Need?
Eight hours is often quoted as the standard amount of time needed in order to feel refreshed for the day ahead. The truth is, everyone's needs are different.
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| 10 Tips For Better Sleep
Tossing and turning each night? Maybe you're guilty of one of the 10 worst things you can do to ruin a good night's sleep.
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| Top Health Benefits of Getting Your ZZZs
Not only does lack of sleep zap your energy levels, it can also impact your health. Reduce stress, your risk of cancer, and keep your heart healthy by getting more shut eye. If nothing else, sleeping more can make you smarter.
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| Do You Have a Sleep Disorder?
If regular sleeping problems are interfering with your every day life, you may have one of these common sleep disorders.
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Sound Bending Invention Could Reduce Stressful Hospital Noise
Excessive hospital noise is stressful for both patients and nurses and can lead to medical errors due to alarm fatigue. To address these issues, Eve Edelstein, an associate professor at the University of Arizona, is collaborating with University of California San Diego Music and Sonic Arts Professor Peter Otto on unique noise reduction strategies, KPBS Radio reports.
Edelstein, a neuroscientist and architect, measured sound levels in emergency departments during shift changes and found levels as high as 100-110 decibels, equivalent to the noise levels of a jet engine. To explore new ways of reducing the noise, Edelstein partnered with Otto, who developed a “sound bender,” a small machine that directs sound in a specific direction without allowing it to spill over to other locations.
In a hospital setting, the sound bender could be used to channel the sound and restrict it specifically to the people who need to hear it, Otto told KPBS. For example, announcements or alarms could specifically be directed to nurses’ stations without disturbing patients or other staff.
Otto is also exploring the effects of different building materials, room sizes, and room shapes on acoustics in hospitals, according to the article.
Edelstein, a neuroscientist and architect, measured sound levels in emergency departments during shift changes and found levels as high as 100-110 decibels, equivalent to the noise levels of a jet engine. To explore new ways of reducing the noise, Edelstein partnered with Otto, who developed a “sound bender,” a small machine that directs sound in a specific direction without allowing it to spill over to other locations.
In a hospital setting, the sound bender could be used to channel the sound and restrict it specifically to the people who need to hear it, Otto told KPBS. For example, announcements or alarms could specifically be directed to nurses’ stations without disturbing patients or other staff.
Otto is also exploring the effects of different building materials, room sizes, and room shapes on acoustics in hospitals, according to the article.
(The primary goal of the Interdisciplinary Nursing Quality Research Initiative (INQRI) is to generate, disseminate and translate research to understand how nurses contribute to and can improve the quality of patient care.)
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Here are some facts from a 2014 NCHS report about the financial burden of medical care that families bear.
1:
In 2012, more than one in four families experienced financial burdens of medical care.
In 2012, more than one in four families experienced financial burdens of medical care.
0:
Families without children were less likely to have financial burdens.
Families without children were less likely to have financial burdens.
16.5%:
Percent of families who had problems paying medical bills in the past 12 months.
Percent of families who had problems paying medical bills in the past 12 months.
250%:
Levels of financial burden of medical were greatest for families with incomes at or below 250% of the federal poverty level.
Levels of financial burden of medical were greatest for families with incomes at or below 250% of the federal poverty level.
Source: http://www.cdc.gov/nchs/data
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We only have one pair of eyes, yet we take them for granted. Consider these facts.
65:
People who are 65 or older should get an eye exam every 1 to 2 years.
People who are 65 or older should get an eye exam every 1 to 2 years.
90%:
Percent of eye accidents that are preventable
Percent of eye accidents that are preventable
1905:
Year of the first corneal transplant
Year of the first corneal transplant
90%:
The success rate for corneal transplants is more than 90%.
The success rate for corneal transplants is more than 90%.
142,648,393:
Estimated number of vision problems in people 40 years or older
Estimated number of vision problems in people 40 years or older
Source: http://www.preventblindness.org/
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RANDOM FACT: Poison is absorbed or ingested; a poisonous animal can only deliver toxic chemicals if another animal touches or eats it.
Venom, on the other hand, is always injected. Every venomous animal has a mechanism to inject toxins directly into another animal. Stab with tails. Slash with spines. Pierce with fangs or stings. Spike with spurs. Shoot with harpoons. Chew with teeth.
For example, frogs are usually poisonous while snakes are usually venomous.
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Bonus Fact:
Some animals you might now know are venomous; the duck-billed platypus, the gila monster, centipedes, Millipedes, the komodo dragon and coral !
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Venom, on the other hand, is always injected. Every venomous animal has a mechanism to inject toxins directly into another animal. Stab with tails. Slash with spines. Pierce with fangs or stings. Spike with spurs. Shoot with harpoons. Chew with teeth.
For example, frogs are usually poisonous while snakes are usually venomous.
Some animals you might now know are venomous; the duck-billed platypus, the gila monster, centipedes, Millipedes, the komodo dragon and coral !
| Quiz Time |
Which of the following statements about pregnant hemophilia carriers is correct?
a. Factor VI levels tend to decrease during pregnancy.
b. Pregnant women should receive regular infusions of a factor product.
c. Factor VIII levels tend to increase during pregnancy.
d. Forceps delivery should be used for women delivering a boy.
Answer at end of Newsletter:
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Does an Epidural Prolong Labor? CME/CE
Reducing unnecessary primary cesarean delivery is an important goal, as national rates of vaginal birth after cesarean delivery are less than 10%. Therefore, a single cesarean delivery virtually guarantees that all subsequent deliveries will be by the same route.
At present, nearly one third of pregnant women in the United States undergo cesarean delivery. Active-phase arrest and arrest of descent are 2 common indications for cesarean delivery during labor, mandating accurate definitions for prolonged labor.
Study Synopsis and Perspective Duration of second-stage labor was more than 2 hours longer when epidural anesthesia was given during labor for both nulliparous and multiparous women, according to a retrospective cohort study reported in the March issue of Obstetrics & Gynecology. The duration of second-stage labor observed in the study is twice as long as typically estimated for epidurals in clinical guidelines. ...
HINTS:
Do you ever wash your washing machine? You should and here's a quick and cheap way to clean your machine: Pour two cups of vinegar or lemon juice into the tub, and run the washing machine through a complete cycle on the hottest setting to remove odors, stains and detergent build up.
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Hint 1: Storing your wreath in a box can easily bend it's delicate needles. Here's a quick solution:
Hang it up. Slip the hoop over the neck of a coat hanger, then store upright in a closet so it keeps its shape perfectly. Shield it from dust and dirt by covering it with a plastic garbage bag. Poke a small hole in the bottom of the bag and gently slide it over the hanger.
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Hint 2:
Liberally apply cooking spray to both sides of a plastic or
metal shovel before clearing away snow, and ice will slide
right off instead of building up.
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Hint 1: Storing your wreath in a box can easily bend it's delicate needles. Here's a quick solution:
Hang it up. Slip the hoop over the neck of a coat hanger, then store upright in a closet so it keeps its shape perfectly. Shield it from dust and dirt by covering it with a plastic garbage bag. Poke a small hole in the bottom of the bag and gently slide it over the hanger.
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Hint 2:
Liberally apply cooking spray to both sides of a plastic or
metal shovel before clearing away snow, and ice will slide
right off instead of building up.
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WORD ORIGINS
Skype -- Invented in 2003 by Janus Friis, from Denmark, and Niklas Zenstrom, from Sweden. Skype is a popular voice-over-Internet telephone service. It was originally confined to Europe, which makes use of the Sky satellite service; thus the original name, "Sky peer-to-peer network," which wa soon shortned to Skype.
IKEA --In 1943, a seventeen-year-old entrepreneur named Ingvar Kamprad opene a small furniture store in his hometown in southern Sweden, selling goods such as dressers, bed frames, and lamps. A decade later, he opened a larger store with a more complete line of home furnishings. By the 1980s , Kamprad had stores throughout Europe, Asia, and North America. He called his company IKEA, an acronym formed from his initials; the fam on which he grew up, called Elmtaryd; and his hometown of Agunnaryd.
woodchuck --The rodent called the woodchuck in some parts of North America is better known as the groundhog, thanks to the annual observance of Groundhog Day. Although the groundhog lives in the forested Atlantic seaboard country, the name woodchuck has nothing to do with wood or with chucking, as commemorated in the tongue twister with the lines" if a woodchuck could chuck wood." Instead, the name comes from the Narragansett Indian word for the animal, wuchak.
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Happy Birthday, Albert Einstein!
It's a nice coincidence today is also the birthday of genius mathematician and physicist Albert Einstein. The Nobel Prize winner might be best known for his theory of relativity and the world's most famous equation, E=mc², but here's 10 things you might not know about Einstein — like that he never wore socks.
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FRIDAY, Feb. 28, 2014 (HealthDay News) -- Although corticosteroid pills are not recommended for the management of psoriasis, new research reveals these drugs are commonly prescribed by dermatologists treating this chronic skin condition.
Corticosteroids, including prednisone, dexamethasone and methylprednisolone, were the second most commonly prescribed systemic medications (not preparations applied to the skin) for psoriasis, according to a study from Wake Forest Baptist Medical Center.
"Expert guidelines discourage their use for psoriasis due to concerns about causing flares of generalized pustular psoriasis, but there are no randomized controlled trials of systemic corticosteroids in psoriasis to look at these issues," study co-author Scott Davis, assistant director of the Center for Dermatology Research at Wake Forest Baptist Medical Center, said in a Wake Forest news release. ...
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Doctors' Germ-Laden Stethoscope May Spread Nasty Bacteria (We nurses have known this all along, wish the docs would learn it)
The diaphragm of the stethoscope picked up more bacteria, including methicillin-resistant Staphylococcus aureus, than any part of the providers' hand except the fingertips during a physical exam, according to a study in the journal Mayo Clinic Proceedings. The findings highlight the need to cleanse a stethoscope after every use, according to the study's lead author.
They discovered that a diaphragm will pick up more bacteria during a patient examination than any part of the doctor's hand except the fingertips.
The tube of the stethoscope also can become laden with bacteria, and the contamination level of both the diaphragm and the tube increases with the amount of bacteria on the doctor's fingertips, the study said.
"Germs are acquired from the patient's skin in contact with the stethoscope, the same way hands usually get colonized with the patient's germs," said study senior author Dr. Didier Pittet, director of the Infection Control Program at University of Geneva Hospitals, in Switzerland.
"The important implication is that the stethoscope, whether used by a doctor, a nurse, an assistant nurse or any staff, needs to be cleansed after each use," said Pittet, who also heads the World Health Organization's Collaborating Centre on Patient Safety at the hospitals. ... http://consumer.healthday.com/infectious-disease-information-21/antibiotics-news-30/doctor-s-germ-laden-stethoscope-may-spread-nasty-bacteria-685307.html
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HUMOR SECTION
"How long have you been driving without a tail light?" asked the policeman after pulling over a motorist.
The driver jumped out, ran to the rear of his car and gave a long, painful groan and put his face in his hands.
He seemed so upset that the cop was moved to ease up on him a bit.
"Come on, now," he said, "you don't have to take it so hard. It isn't that serious."
"It isn't?" cried the motorist. "Then, do you know what happened to my boat and trailer?"
The driver jumped out, ran to the rear of his car and gave a long, painful groan and put his face in his hands.
He seemed so upset that the cop was moved to ease up on him a bit.
"Come on, now," he said, "you don't have to take it so hard. It isn't that serious."
"It isn't?" cried the motorist. "Then, do you know what happened to my boat and trailer?"
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CEU SITES---(CME and CNE)
Those that are-----Free and Otherwise..........
Go to www.sharedgovernance.org for access to a just released, 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.
Go to www.sharedgovernance.org for access to a just released, 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.
New CE Courses for Nurses
Pay Only $34.99 for a full year of CONTACT HOURS
www.nurse.com for CNE offerings.
www.nurse.com for CNE offerings.
Free CEs http://www.myfreece.com/welcome.asp
This site was sent in by FNPMSN@aol.com (Cindy) http://cmepain.com/ !
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WEBSITES/ LINKS
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
info@sharedgovernance.orgwww.sharedgovernance.org
RNs launch a national safe staffing campaign http://www.1199seiu.org/media/magazine/sept_2007/safe_staffing.cfm
H.R. 2123, The Nurse Staffing Standards for Patient Safety and Quality Care Act of 2007
Board Supports Your Right to Refuse An Unsafe Assignment: Nurse Practice Act cites three conditions for patient abandonment http://findarticles.com/p/articles/mi_qa4102/is_200408/ai_n9450263
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
Rozalfaro's website: http://www.alfaroteachsmart.com/articles.htm
Metric conversion calculators and tables for metric conversions
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MEDICAL RECALLS
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GE Healthcare Resuscitation Systems: Class I Recall - Oxygen and Air Inlet Fittings Reversed During Assembly Includes the following models:
- Giraffe Warmer with Resuscitation System
- Panda Warmer with Resuscitation System
- Giraffe Stand-Alone Infant Resuscitation System
- Resuscitation System Upgrade Kits
- Panda Freestanding with Resuscitation System
The oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. These recalled products may interfere with oxygen delivery, resulting in inaccurate oxygen regulation in neonates, and may lead to low blood oxygen (hypoxia) or high blood oxygen (hyperoxia). This may cause death in neonates, particularly those who are critically ill. Preterm and low-birth weight babies are also at increased risk in terms of morbidity and mortality. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm387731.htm
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ACME Monaco Guidewire .035x150 3MMJ TCFC, Item 88241 by Medline Industries: Class I Recall - Potential for Coating to Flake Off
Various convenience kits containing ACME Monaco Guidewire .035x150 3 MMJ TCFC, item number 88241, have a potential for the coating to flake off of the wire. Use of this recalled product may result in serious adverse health consequences.
Product codes included in this recall are 054372-1-1A, 054372-1-1B, and 054372-1-2A
BACKGROUND: An ACME Monaco Guidewire .035x150 3MMJ TCFC item number 88241 is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. This guidewire is used in various surgical convenience kits assembled and marketed by Medline Industries, Inc. The affected products were distributed from March 2013 through August 2013.
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Codman Neuro is informing physicians of this incorrect statement and updating the product's Instructions For Use (IFU). The product's IFU incorrectly noted: "A 2:1 (67% Ethiodized Oil / 33% nBCA) for feeding pedicle injections close to the nidus at high flow rates where venous opacification occurs on contrast injections within 1/2 second." The use of incorrectly mixed product can result in the liquid mixture solidifying too slowly in unintended areas, which may lead to embolization or reflux into arteries and pulmonary vessels. This could result in significant impact to the patient, including neurological deficits, pulmonary emboli and possibly death.
The correct information should have stated: "A 2:1 (67% Ethiodized Oil / 33% nBCA) for Intranidal injections without AV fistulae or high flow rates in order to more deeply penetrate the nidus." Trufill n-BCA is indicated for embolization of cerebral arteriovenous malformations (AVMs) when presurgical devascularization is desired. In October 2013, Codman Neuro identified an incorrect statement in the product's IFU that described suggested mixing ratios for use in certain treatment conditions.
Product is not being removed from the market. Trufill nBCA products associated with the correction notice were manufactured between February 25, 2010 and October, 31, 2013, distributed to hospitals and surgical centers, and include the following product codes (all lots): 631400 (Two 1 gram tubes nBCA) and 631500 (One 1 gram tube nBCA).
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VPRIV (velaglucerase alfa for injection): Recall - Visible Particulate Matter Shire Pharmaceuticals announced a voluntary recall in the United States of one batch, packaged into three lots, of VPRIV due to the presence of visible particulate matter, identified as stainless steel and barium sulfate. The particulate matter was found in a small number of vials in the three packaged lots of VPRIV. A Shire investigation identified the particulate matter root cause as the third party supplier fill finish process.
If infused, there is a possibility of rare but serious adverse events associated with particulate containing barium sulfate.
The following packaged lots were recalled: FEW13-001, FEW13-002, and FED13-006. These lots were distributed nationwide to hospitals, infusion clinics, patients, and home health agencies in the United States and all have the same NDC code (54092-701-04) and same expiration date of 10/15 (Oct 2015).
BACKGROUND: VPRIV is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for pediatric and adult patients with type 1 Gaucher disease. VPRIV is supplied as a sterile, preservative-free, lyophilized powder in single-use vials, for intravenous use.
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Calcium gluconate 10 percent Injections by Rx Formulations: Recall - Microbial Contamination FDA notified healthcare professionals to follow up with patients who received calcium gluconate 10% injections made by Rx Formulations, Mesa, Ariz., between Nov. 7 and Dec. 11, 2013. FDA testing confirmed the presence of microbial contamination in lot #778961 of Rx Formulations’ calcium gluconate injection product. The testing identified gram-positive rod bacteria in the product. A contaminated injectable drug can put patients at risk of adverse health consequences and possibly a serious infection.
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ADVERTISEMENTS
from the members
This ad is from Decubqueen (Gerry)..........Accu-Ruler 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
No new members this time
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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
A nation of sheep will b
Newsletter for Paradigm 97
PARADIGM BYTES
Newsletter for Paradigm 97
March 14, 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
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.
***~~~***~~~***~~~***
SNIPPETS
Misread Labels as a Cause of Medication Errors
ABSTRACT
We often read about potential causes of medication errors, such as drug names that are overly similar or misplaced decimal points in iv drug administration. But sometimes we overlook more obvious dangers. My experience as a nurse suggests that our patients are increasingly at risk for medication errors because of the convergence of three factors: difficult to read medication labels, the increasing age of the nursing population, and poorly lit work environments. This combination can lead to disaster.
I initially believed the tiny print on medication labels was only a problem for older nurses with aging eyes like me. (Presbyopia, the decreased ability of the eye to focus on near objects, commonly starts to appear around the age of 40.) Working as a clinical instructor to second-year nursing students, I found older nurses are not the only ones having trouble with fine print. One of my students, while carefully reviewing each of her patient's medications with me, was ready to administer an extended-release medication, crushed, through her patient's feeding tube. “Extended release” was printed below the name of the medication in barely readable 1-mm high letters. She hadn't seen it. Had she crushed and administered the drug, 24 hours worth of medication would have been released immediately, rather than slowly over a whole day. Her patient might not have survived that dose.
I decided to informally survey bedside nurses, nurse educators, pharmacists, and respiratory therapists to find out who else was having trouble reading drug labels. The results from the online survey are frightening. Of the nearly 100 responses I received, almost all of the nurses reported having difficulty reading the small text on medication labels. Almost half of the respondents were aware of a near miss or an actual error that could be at least partly attributed to difficulty reading the small print on medication labels and packaging. Virtually all survey respondents said that improving readability would reduce potential medication errors. The results convinced me I am not alone in my concern.
If the fine print is getting you down, it's not surprising. Unit dose package sizes that I work withFood and Drug Administration (FDA) recommends the use of more readable fonts, as well as a minimum point size for labels and adequate white space between words; however, it also requires that labels include drug name, dose, lot number, manufacturer, expiration date, special requirements for handling, and important descriptors such as SR, XL, and EC. Additional items drug manufacturers may choose to include are the manufacturer's address, National Drug Code number, generic name, and bar code. That's a lot of information to squeeze into a tiny space. (FDA policy states that “a firm may not claim an exemption on the basis that the label is too small to accommodate all mandatory information if all available space is not utilized or the label size can readily be made larger.”)
According to the 2008 National Sample Survey of Registered Nurses, the median age of a nurse in the United States is over 45, and nurses over 50 will soon make up nearly a quarter of the workforce. Presbyopia is an almost universal result of eye aging, so the majority of working nurses are experiencing it. Nurses care for patients 24 hours a day. Work environments can get pretty dark at 2 am; poor lighting compounds the problem, making the fine print even more difficult to read.
Small print is not just a problem for nurses my age but for everyone. Patients’ lives depend on accurate and safe medication administration. What can we do to avoid tragedy? Small print is a modifiable risk factor and needs to be addressed to prevent medical errors. So read carefully, and for now, wear your cheaters and turn the bright lights on!
© 2014 Lippincott Williams & Wilkins. All rights reserved.
AJN, American Journal of Nursing:
doi: 10.1097/01.NAJ.0000444470.78692.78
Viewpoint on a daily basis average around 3.5 cm × 2 cm, with some print as small as 1 mm in height (about the thickness of a dime). The U.S.
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INTERESTING READING
Please remember that the REUTERS articles usually good for only 30 days
Prenatal acetaminophen exposure linked to ADHD risk
( Reuters Health) - Children born to women who take acetaminophen during pregnancy may be at increased risk of attention deficit hyperactivity disorder (ADHD) and similar behavioral problems, new findings suggest.
The study does not show that prenatal exposure to the medication causes ADHD, and the increase in risk is small, Dr. Jorn Olsen, one of the study's authors, told Reuters Health.
Nevertheless, "it's reasonable to say that there's no reason to use these drugs during pregnancy unless there is a clear medical indication," said Olsen, a professor of epidemiology at UCLA and at Aarhus University in Denmark.
Acetaminophen, or paracetamol, has been available over the counter since the 1950s, Olsen and his colleagues note in their report in JAMA Pediatrics.
While the medication is widely considered to be safe to use during pregnancy, they add, recent studies have shown it can disrupt hormone function in pregnant rats and mice.
Given that hormones play a key role in guiding fetal development, the researchers decided to investigate whether acetaminophen exposure might be related to ADHD risk. They looked at 64,322 children and mothers enrolled in the Danish National Birth Cohort between 1996 and 2002. ...
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BP May Be Lower Without Meat in the Diet
Vegetarians had lower blood pressure than their omnivorous counterparts, a meta-analysis showed.
Blood pressure was an average of 4.8/2.2 mm Hg lower among vegetarians in controlled trials and 6.9/4.7 mm Hg lower in cross-sectional studies (P<0 .001="" a="" according="" all="" differences="" for="" href="http://www.ncvc.go.jp/english/" mph="" of="" phd="" target="_blank" the="" to="" yoko="" yokoyama="">National Cerebral and Cardiovascular Center
The findings -- reported online in JAMA Internal Medicine -- suggest that "such diets could be a useful nonpharmacologic means for reducing blood pressure," they wrote, adding that "further studies are needed to explore the relationships between specific foods and nutrients and blood pressure." ...http://www.medpagetoday.com/Cardiology/Hypertension/44455
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Hundreds of foods in U.S. contain 'ADA' plastics chemical: report (Reuters) -
Nearly 500 foods found on grocery store shelves in the United States, including many foods labeled as "healthy," contain a potentially hazardous industrial plastics chemical, according to a report issued Thursday by a health research and advocacy group.
Azodicarbonamide, also known as ADA, was found as an ingredient in breads, bagels, tortillas, hamburger and hot dog buns, pizza, pastries, and other food products, according to a report by the Environmental Working Group, based in Washington
Azodicarbonamide is fully approved for use in food by the United States Food and Drug Administration and the Canadian Food Inspection Agency. But ADA is banned as an additive in Australia and some European countries.
As a food additive, azodicarbonamide is used as a flour bleaching agent and as an oxidizing agent in dough to improve its performance for bakers. It is also used in plastics to improve elasticity and can be found in yoga mats and shoes.
The World Health Organization states that epidemiological studies in humans and other reports have produced "abundant evidence that azodicarbonamide can induce asthma, other respiratory symptoms, and skin sensitization" to people working with the chemical.
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Quick Vision Test May Help Spot Concussions on Sidelines Combined with two other simple screenings, all cases of head injury were caught, researchers report
WEDNESDAY, Feb. 26, 2014 (HealthDay News) -- A simple vision test given on the sidelines can help identify athletes who've suffered a concussion, a new study finds.
Researchers found that the test -- known as the King-Devick, or K-D -- was able to detect 79 percent of concussions among college athletes who were followed over a season. When the results were combined with those of two other screening tests, all of the concussions were caught.
The findings were released Wednesday by the American Academy of Neurology (AAN), ahead of its annual meeting this spring.
Experts said the study bolsters evidence that the K-D is a reliable way to help spot athletes' head injuries -- though the test, by itself, is not enough.
"People have been looking for quick, on-the-field screening tests," said Steven Broglio, an athletic trainer and director of the NeuroSport Research Laboratory at the University of Michigan in Ann Arbor.
The new findings suggest the K-D is "one option," said Broglio, who was not involved in the study. "But it's not definitive, and you wouldn't want to rely on this alone," he added.
The K-D takes a minute or two, and it can be given by an athletic trainer, coach or even a parent right on the sidelines. It requires test-takers to read a few rows of single-digit numbers that are unevenly spaced, as quickly and accurately as possible. If they are slower to finish than they were on their "baseline" test -- taken before the season starts -- that's a potential sign of a concussion.
There are other sideline screening tests already in use, including ones that test balance and short-term memory.
But the K-D test "fills a gap" by looking for vision-related problems, explained study co-author Dr. Steven Galleta, chair of neurology at NYU Langone Medical Center in New York City. ...
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Fact:
one in 88 children have some form of autism... That is up 78% from 10 years ago
one in 54 boys in the United States have autism
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How Much Sleep Do You Really Need?
Eight hours is often quoted as the standard amount of time needed in order to feel refreshed for the day ahead. The truth is, everyone's needs are different.
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| 10 Tips For Better Sleep
Tossing and turning each night? Maybe you're guilty of one of the 10 worst things you can do to ruin a good night's sleep.
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| Top Health Benefits of Getting Your ZZZs
Not only does lack of sleep zap your energy levels, it can also impact your health. Reduce stress, your risk of cancer, and keep your heart healthy by getting more shut eye. If nothing else, sleeping more can make you smarter.
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| Do You Have a Sleep Disorder?
If regular sleeping problems are interfering with your every day life, you may have one of these common sleep disorders.
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Sound Bending Invention Could Reduce Stressful Hospital Noise
Excessive hospital noise is stressful for both patients and nurses and can lead to medical errors due to alarm fatigue. To address these issues, Eve Edelstein, an associate professor at the University of Arizona, is collaborating with University of California San Diego Music and Sonic Arts Professor Peter Otto on unique noise reduction strategies, KPBS Radio reports.
Edelstein, a neuroscientist and architect, measured sound levels in emergency departments during shift changes and found levels as high as 100-110 decibels, equivalent to the noise levels of a jet engine. To explore new ways of reducing the noise, Edelstein partnered with Otto, who developed a “sound bender,” a small machine that directs sound in a specific direction without allowing it to spill over to other locations.
In a hospital setting, the sound bender could be used to channel the sound and restrict it specifically to the people who need to hear it, Otto told KPBS. For example, announcements or alarms could specifically be directed to nurses’ stations without disturbing patients or other staff.
Otto is also exploring the effects of different building materials, room sizes, and room shapes on acoustics in hospitals, according to the article.
Edelstein, a neuroscientist and architect, measured sound levels in emergency departments during shift changes and found levels as high as 100-110 decibels, equivalent to the noise levels of a jet engine. To explore new ways of reducing the noise, Edelstein partnered with Otto, who developed a “sound bender,” a small machine that directs sound in a specific direction without allowing it to spill over to other locations.
In a hospital setting, the sound bender could be used to channel the sound and restrict it specifically to the people who need to hear it, Otto told KPBS. For example, announcements or alarms could specifically be directed to nurses’ stations without disturbing patients or other staff.
Otto is also exploring the effects of different building materials, room sizes, and room shapes on acoustics in hospitals, according to the article.
(The primary goal of the Interdisciplinary Nursing Quality Research Initiative (INQRI) is to generate, disseminate and translate research to understand how nurses contribute to and can improve the quality of patient care.)
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Here are some facts from a 2014 NCHS report about the financial burden of medical care that families bear.
1:
In 2012, more than one in four families experienced financial burdens of medical care.
In 2012, more than one in four families experienced financial burdens of medical care.
0:
Families without children were less likely to have financial burdens.
Families without children were less likely to have financial burdens.
16.5%:
Percent of families who had problems paying medical bills in the past 12 months.
Percent of families who had problems paying medical bills in the past 12 months.
250%:
Levels of financial burden of medical were greatest for families with incomes at or below 250% of the federal poverty level.
Levels of financial burden of medical were greatest for families with incomes at or below 250% of the federal poverty level.
Source: http://www.cdc.gov/nchs/data
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We only have one pair of eyes, yet we take them for granted. Consider these facts.
65:
People who are 65 or older should get an eye exam every 1 to 2 years.
People who are 65 or older should get an eye exam every 1 to 2 years.
90%:
Percent of eye accidents that are preventable
Percent of eye accidents that are preventable
1905:
Year of the first corneal transplant
Year of the first corneal transplant
90%:
The success rate for corneal transplants is more than 90%.
The success rate for corneal transplants is more than 90%.
142,648,393:
Estimated number of vision problems in people 40 years or older
Estimated number of vision problems in people 40 years or older
Source: http://www.preventblindness.org/
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RANDOM FACT: Poison is absorbed or ingested; a poisonous animal can only deliver toxic chemicals if another animal touches or eats it.
Venom, on the other hand, is always injected. Every venomous animal has a mechanism to inject toxins directly into another animal. Stab with tails. Slash with spines. Pierce with fangs or stings. Spike with spurs. Shoot with harpoons. Chew with teeth.
For example, frogs are usually poisonous while snakes are usually venomous.
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Bonus Fact:
Some animals you might now know are venomous; the duck-billed platypus, the gila monster, centipedes, Millipedes, the komodo dragon and coral !
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Venom, on the other hand, is always injected. Every venomous animal has a mechanism to inject toxins directly into another animal. Stab with tails. Slash with spines. Pierce with fangs or stings. Spike with spurs. Shoot with harpoons. Chew with teeth.
For example, frogs are usually poisonous while snakes are usually venomous.
Some animals you might now know are venomous; the duck-billed platypus, the gila monster, centipedes, Millipedes, the komodo dragon and coral !
| Quiz Time |
Which of the following statements about pregnant hemophilia carriers is correct?
a. Factor VI levels tend to decrease during pregnancy.
b. Pregnant women should receive regular infusions of a factor product.
c. Factor VIII levels tend to increase during pregnancy.
d. Forceps delivery should be used for women delivering a boy.
Answer at end of Newsletter:
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Does an Epidural Prolong Labor? CME/CE
Reducing unnecessary primary cesarean delivery is an important goal, as national rates of vaginal birth after cesarean delivery are less than 10%. Therefore, a single cesarean delivery virtually guarantees that all subsequent deliveries will be by the same route.
At present, nearly one third of pregnant women in the United States undergo cesarean delivery. Active-phase arrest and arrest of descent are 2 common indications for cesarean delivery during labor, mandating accurate definitions for prolonged labor.
Study Synopsis and Perspective Duration of second-stage labor was more than 2 hours longer when epidural anesthesia was given during labor for both nulliparous and multiparous women, according to a retrospective cohort study reported in the March issue of Obstetrics & Gynecology. The duration of second-stage labor observed in the study is twice as long as typically estimated for epidurals in clinical guidelines. ...
HINTS:
Do you ever wash your washing machine? You should and here's a quick and cheap way to clean your machine: Pour two cups of vinegar or lemon juice into the tub, and run the washing machine through a complete cycle on the hottest setting to remove odors, stains and detergent build up.
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Hint 1: Storing your wreath in a box can easily bend it's delicate needles. Here's a quick solution:
Hang it up. Slip the hoop over the neck of a coat hanger, then store upright in a closet so it keeps its shape perfectly. Shield it from dust and dirt by covering it with a plastic garbage bag. Poke a small hole in the bottom of the bag and gently slide it over the hanger.
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Hint 2:
Liberally apply cooking spray to both sides of a plastic or
metal shovel before clearing away snow, and ice will slide
right off instead of building up.
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Hint 1: Storing your wreath in a box can easily bend it's delicate needles. Here's a quick solution:
Hang it up. Slip the hoop over the neck of a coat hanger, then store upright in a closet so it keeps its shape perfectly. Shield it from dust and dirt by covering it with a plastic garbage bag. Poke a small hole in the bottom of the bag and gently slide it over the hanger.
_________________________________________________
Hint 2:
Liberally apply cooking spray to both sides of a plastic or
metal shovel before clearing away snow, and ice will slide
right off instead of building up.
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WORD ORIGINS
Skype -- Invented in 2003 by Janus Friis, from Denmark, and Niklas Zenstrom, from Sweden. Skype is a popular voice-over-Internet telephone service. It was originally confined to Europe, which makes use of the Sky satellite service; thus the original name, "Sky peer-to-peer network," which wa soon shortned to Skype.
IKEA --In 1943, a seventeen-year-old entrepreneur named Ingvar Kamprad opene a small furniture store in his hometown in southern Sweden, selling goods such as dressers, bed frames, and lamps. A decade later, he opened a larger store with a more complete line of home furnishings. By the 1980s , Kamprad had stores throughout Europe, Asia, and North America. He called his company IKEA, an acronym formed from his initials; the fam on which he grew up, called Elmtaryd; and his hometown of Agunnaryd.
woodchuck --The rodent called the woodchuck in some parts of North America is better known as the groundhog, thanks to the annual observance of Groundhog Day. Although the groundhog lives in the forested Atlantic seaboard country, the name woodchuck has nothing to do with wood or with chucking, as commemorated in the tongue twister with the lines" if a woodchuck could chuck wood." Instead, the name comes from the Narragansett Indian word for the animal, wuchak.
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Happy Birthday, Albert Einstein!
It's a nice coincidence today is also the birthday of genius mathematician and physicist Albert Einstein. The Nobel Prize winner might be best known for his theory of relativity and the world's most famous equation, E=mc², but here's 10 things you might not know about Einstein — like that he never wore socks.
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FRIDAY, Feb. 28, 2014 (HealthDay News) -- Although corticosteroid pills are not recommended for the management of psoriasis, new research reveals these drugs are commonly prescribed by dermatologists treating this chronic skin condition.
Corticosteroids, including prednisone, dexamethasone and methylprednisolone, were the second most commonly prescribed systemic medications (not preparations applied to the skin) for psoriasis, according to a study from Wake Forest Baptist Medical Center.
"Expert guidelines discourage their use for psoriasis due to concerns about causing flares of generalized pustular psoriasis, but there are no randomized controlled trials of systemic corticosteroids in psoriasis to look at these issues," study co-author Scott Davis, assistant director of the Center for Dermatology Research at Wake Forest Baptist Medical Center, said in a Wake Forest news release. ...
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Doctors' Germ-Laden Stethoscope May Spread Nasty Bacteria (We nurses have known this all along, wish the docs would learn it)
The diaphragm of the stethoscope picked up more bacteria, including methicillin-resistant Staphylococcus aureus, than any part of the providers' hand except the fingertips during a physical exam, according to a study in the journal Mayo Clinic Proceedings. The findings highlight the need to cleanse a stethoscope after every use, according to the study's lead author.
They discovered that a diaphragm will pick up more bacteria during a patient examination than any part of the doctor's hand except the fingertips.
The tube of the stethoscope also can become laden with bacteria, and the contamination level of both the diaphragm and the tube increases with the amount of bacteria on the doctor's fingertips, the study said.
"Germs are acquired from the patient's skin in contact with the stethoscope, the same way hands usually get colonized with the patient's germs," said study senior author Dr. Didier Pittet, director of the Infection Control Program at University of Geneva Hospitals, in Switzerland.
"The important implication is that the stethoscope, whether used by a doctor, a nurse, an assistant nurse or any staff, needs to be cleansed after each use," said Pittet, who also heads the World Health Organization's Collaborating Centre on Patient Safety at the hospitals. ... http://consumer.healthday.com/infectious-disease-information-21/antibiotics-news-30/doctor-s-germ-laden-stethoscope-may-spread-nasty-bacteria-685307.html
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HUMOR SECTION
"How long have you been driving without a tail light?" asked the policeman after pulling over a motorist.
The driver jumped out, ran to the rear of his car and gave a long, painful groan and put his face in his hands.
He seemed so upset that the cop was moved to ease up on him a bit.
"Come on, now," he said, "you don't have to take it so hard. It isn't that serious."
"It isn't?" cried the motorist. "Then, do you know what happened to my boat and trailer?"
The driver jumped out, ran to the rear of his car and gave a long, painful groan and put his face in his hands.
He seemed so upset that the cop was moved to ease up on him a bit.
"Come on, now," he said, "you don't have to take it so hard. It isn't that serious."
"It isn't?" cried the motorist. "Then, do you know what happened to my boat and trailer?"
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CEU SITES---(CME and CNE)
Those that are-----Free and Otherwise..........
Go to www.sharedgovernance.org for access to a just released, 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.
Go to www.sharedgovernance.org for access to a just released, 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.
New CE Courses for Nurses
Pay Only $34.99 for a full year of CONTACT HOURS
www.nurse.com for CNE offerings.
www.nurse.com for CNE offerings.
Free CEs http://www.myfreece.com/welcome.asp
This site was sent in by FNPMSN@aol.com (Cindy) http://cmepain.com/ !
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WEBSITES/ LINKS
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 info@sharedgovernance.orgwww.sharedgovernance.org
RNs launch a national safe staffing campaign http://www.1199seiu.org/media/magazine/sept_2007/safe_staffing.cfm
H.R. 2123, The Nurse Staffing Standards for Patient Safety and Quality Care Act of 2007
Board Supports Your Right to Refuse An Unsafe Assignment: Nurse Practice Act cites three conditions for patient abandonment http://findarticles.com/p/articles/mi_qa4102/is_200408/ai_n9450263
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
Rozalfaro's website: http://www.alfaroteachsmart.com/articles.htm
Metric conversion calculators and tables for metric conversions
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MEDICAL RECALLS
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GE Healthcare Resuscitation Systems: Class I Recall - Oxygen and Air Inlet Fittings Reversed During Assembly Includes the following models:
- Giraffe Warmer with Resuscitation System
- Panda Warmer with Resuscitation System
- Giraffe Stand-Alone Infant Resuscitation System
- Resuscitation System Upgrade Kits
- Panda Freestanding with Resuscitation System
The oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. These recalled products may interfere with oxygen delivery, resulting in inaccurate oxygen regulation in neonates, and may lead to low blood oxygen (hypoxia) or high blood oxygen (hyperoxia). This may cause death in neonates, particularly those who are critically ill. Preterm and low-birth weight babies are also at increased risk in terms of morbidity and mortality. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm387731.htm
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ACME Monaco Guidewire .035x150 3MMJ TCFC, Item 88241 by Medline Industries: Class I Recall - Potential for Coating to Flake Off
Various convenience kits containing ACME Monaco Guidewire .035x150 3 MMJ TCFC, item number 88241, have a potential for the coating to flake off of the wire. Use of this recalled product may result in serious adverse health consequences.
Product codes included in this recall are 054372-1-1A, 054372-1-1B, and 054372-1-2A
BACKGROUND: An ACME Monaco Guidewire .035x150 3MMJ TCFC item number 88241 is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. This guidewire is used in various surgical convenience kits assembled and marketed by Medline Industries, Inc. The affected products were distributed from March 2013 through August 2013.
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Codman Neuro is informing physicians of this incorrect statement and updating the product's Instructions For Use (IFU). The product's IFU incorrectly noted: "A 2:1 (67% Ethiodized Oil / 33% nBCA) for feeding pedicle injections close to the nidus at high flow rates where venous opacification occurs on contrast injections within 1/2 second." The use of incorrectly mixed product can result in the liquid mixture solidifying too slowly in unintended areas, which may lead to embolization or reflux into arteries and pulmonary vessels. This could result in significant impact to the patient, including neurological deficits, pulmonary emboli and possibly death.
The correct information should have stated: "A 2:1 (67% Ethiodized Oil / 33% nBCA) for Intranidal injections without AV fistulae or high flow rates in order to more deeply penetrate the nidus." Trufill n-BCA is indicated for embolization of cerebral arteriovenous malformations (AVMs) when presurgical devascularization is desired. In October 2013, Codman Neuro identified an incorrect statement in the product's IFU that described suggested mixing ratios for use in certain treatment conditions.
Product is not being removed from the market. Trufill nBCA products associated with the correction notice were manufactured between February 25, 2010 and October, 31, 2013, distributed to hospitals and surgical centers, and include the following product codes (all lots): 631400 (Two 1 gram tubes nBCA) and 631500 (One 1 gram tube nBCA).
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VPRIV (velaglucerase alfa for injection): Recall - Visible Particulate Matter Shire Pharmaceuticals announced a voluntary recall in the United States of one batch, packaged into three lots, of VPRIV due to the presence of visible particulate matter, identified as stainless steel and barium sulfate. The particulate matter was found in a small number of vials in the three packaged lots of VPRIV. A Shire investigation identified the particulate matter root cause as the third party supplier fill finish process.
If infused, there is a possibility of rare but serious adverse events associated with particulate containing barium sulfate.
The following packaged lots were recalled: FEW13-001, FEW13-002, and FED13-006. These lots were distributed nationwide to hospitals, infusion clinics, patients, and home health agencies in the United States and all have the same NDC code (54092-701-04) and same expiration date of 10/15 (Oct 2015).
BACKGROUND: VPRIV is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for pediatric and adult patients with type 1 Gaucher disease. VPRIV is supplied as a sterile, preservative-free, lyophilized powder in single-use vials, for intravenous use.
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Calcium gluconate 10 percent Injections by Rx Formulations: Recall - Microbial Contamination FDA notified healthcare professionals to follow up with patients who received calcium gluconate 10% injections made by Rx Formulations, Mesa, Ariz., between Nov. 7 and Dec. 11, 2013. FDA testing confirmed the presence of microbial contamination in lot #778961 of Rx Formulations’ calcium gluconate injection product. The testing identified gram-positive rod bacteria in the product. A contaminated injectable drug can put patients at risk of adverse health consequences and possibly a serious infection.
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ADVERTISEMENTS
from the members
This ad is from Decubqueen (Gerry)..........Accu-Ruler 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
No new members this time
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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
If a nation becomes a nation of sheep,
then it will beget a government of wolves.
Edward R. Murrow
Edward R. Murrow
Hope to hear from you..... Frankie
Edward R. Murrow
Hope to hear from you..... Frankie
