Sunday, September 27, 2015

Paradigm Bytes Newsletter for September 2015

PARADIGM  BYTES Newsletter

September 26, 2015

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


FDA issues alert for facial soft tissue fillers
  • Health care providers who inject patients with facial soft tissue fillers
  • Health care providers who treat patients following unintentional injection of soft tissue fillers into blood vessels
  • People considering, or who have had, procedures that use soft tissue fillers
Specialties: Dermatologists, plastic surgeons, cosmetic surgeons, dentists, and other medical providers who treat patients using soft tissue fillers; other health care providers who may treat patients following unintentional injection of soft tissue filler into blood vessels, such as ophthalmologists, neurologists, and neurosurgeons.
Product:Soft tissue fillers, also called dermal fillers, injectable facial implants, or wrinkle fillers, can create a smoother or fuller appearance of the face. They are FDA-approved to reduce the appearance of wrinkles or to augment lips or cheeks.
Soft tissue fillers are injected directly into a treatment area. Successful results will depend on the patient’s overall health and skin condition, the skill of the health care provider, the location of injection and the type of filler used. Patients may need more than one injection to get the desirable smoothing/filling effect.
Soft tissue fillers should be injected only by health care providers who have appropriate training and experience and who are knowledgeable about the anatomy at and around the injection site.
Purpose: The FDA is alerting health care providers and consumers about the possibility of rare, but serious, injuries that may occur due to unintentional injection of soft tissue filler into blood vessels in the face.
Summary of Problem and Scope: The FDA has reviewed information that suggests unintentional injection of soft tissue fillers into blood vessels in the face can result in rare, but serious side effects. Unintentional injection can block blood vessels and restrict blood supply to tissues. Sometimes this can result in embolization. This means the filler material has traveled to other parts of the body. This can cause vision impairment, blindness, stroke and damage and/or death of the skin (necrosis) and underlying facial structures.
While unintentional injections into blood vessels may occur with injection sites anywhere on the face, the FDA’s review of literature disclaimer icon and adverse event reports submitted to the FDA identifies certain injection locations where blood vessel blockage have been reported more often. These sites include the skin between the eyebrows and nose (glabella), in and around the nose, forehead, and around the eyes (periorbital region).
Recommendations:
For Health Care Providers:
  • Do not inject soft tissue fillers if you do not have the appropriate training or experience.
  • Make sure that you are familiar with the anatomy at and around the site of injection, keeping in mind that blood vessel anatomy disclaimer icon can vary among patients.
  • Before injection, thoroughly inform the patient of all risks of the procedure and the specific product you intend to use.
  • Note that the approved indications for use of soft tissue fillers vary depending on the product. The FDA may not have reviewed use of soft tissue fillers in some locations in the body.
  • Take extra care when injecting soft tissue fillers, for example inject the product slowly and apply the least amount of pressure necessary.
  • Know the signs and symptoms disclaimer icon associated with injection into blood vessels, and have an updated plan detailing how you plan to treat the patient if this should this occur. This may include on-site treatment and/or immediate referral to another health care provider for treatment.
  • Immediately stop the injection if a patient exhibits any signs or symptoms associated with injection into a blood vessel, such as changes in vision, signs of a stroke, white appearance (or blanching) of the skin, or unusual pain during or shortly after the procedure.
  • Tell patients that they should seek immediate medical attention after the procedure if they experience signs and symptoms associated with injection into a blood vessel.
  • Educate health care facility employees on how to quickly assist patients that report signs and symptoms of filler complications. They must understand how to instruct the patient to receive appropriate medical care.
  • Report to the FDA and the manufacturer if you become aware of a patient experiencing an adverse event associated with unintentional injection of soft tissue filler into a blood vessel.
For Consumers:
  • Before deciding to have soft tissue filler injections, talk with your health care provider about appropriate treatment injection sites and the risks associated with the procedure.
  • Be aware that FDA reviewed and approved different products for use in certain areas of the face. The FDA may not have reviewed the use of certain soft tissue fillers for all locations in the body.
  • Ask your health care provider about their training and experience injecting soft tissue fillers in the face.
  • Read and discuss the patient labeling for the specific filler you are receiving. Your doctor can provide this information, or you can find it on the FDA’s website.
  • Seek immediate medical attention if you develop symptoms such as unusual pain, vision changes, a white appearance of skin near the injection site, or any signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion) during or shortly after the procedure.
FDA Actions:
After reviewing additional information on this subject, the FDA is working with manufacturers to update their labeling. The requests asks that the labeling include additional warnings, precautions, and other statements about the risk of unintentional injection into blood vessels, consistent with the recommendations in this communication, so that both health care providers and patients would have a better understanding of the risks.
The FDA continuously monitors reports of injuries caused by soft tissue fillers. With the increased popularity of soft tissue fillers, more information is available about unintentional injection into blood vessels. While current labeling includes some information about this risk, the FDA believes that additional information can be included in the labeling to better inform health care providers and patients.
Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with these products.
If you suspect or experience a problem with soft tissue fillers, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject toFDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Additional Resources
Contact Information:
If you have questions about this communication, please contact CDRH’s Division of Industry Communication and Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041, or 301-796-7100.

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm448255.htm?utm_source=BenchmarkEmail&utm_campaign=InfoBytes_Newsletter_061215&utm_medium=email
 
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HINTS:
  How to keep your apples slices from turning brown?

Slices apples and place in a medium sized bowl. Pour enough lemon lime soda (like Sprite) so it barely covers the slices. The carbonated soda contains citric acid which is an effective anti-oxidant. Allow the apples slices to soak for about 15 minutes.

Take the slices out of the soda and place in snack-sized 
storage bags. These will stay crisp and colorful for a few 
days in your fridge.

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Windex can be used as a toy cleaner: Children's toys can get downright gross over time. Give them a quick mist with Windex, wipe clean, and rinse with plain water. Viola!
  
 

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HUMOR SECTION

My wife, a registered nurse, once fussed over every pain or mishap that came my way. Recently, however, I got an indication that the honeymoon is over.

I was about to fix the attic fan, and as I lifted myself from the ladder in the attic, I scratched my forehead on a crossbeam. 

Crawling along, I picked up splinters in both hands, and I cut one hand replacing the fan belt. 

On the way down the ladder, I missed the last two rungs and twisted my ankle.

When I limped into the kitchen, covered in dust and blood, my wife took one look and said, "Those better not be your good pants!" 

Eight Rules of Nursing

  1. If it's wet, make it dry.
  2. If it's dry, make it wet.
  3. Always ask for on-call pay before agreeing to overtime. 
  4. Never tell management what you are really thinking.
  5. Never finish a report with, "You have an easy assignment."
  6. Never say, "This looks like an easy assignment."
  7. Don't expect doctors to believe anything you tell them.
     8.   If it moves, rattles, shakes, falls down, or won't stay in place--- tape it. (my favorite)

Thank you Terri....great contribution.  Appreciated.

Blooper:    He was advised to force fluids through his interpreter. 
  
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CEU SITES---(CME and CNE)
Those that are-----Free and Otherwise..........
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. info@sharedgovernance.orgwww.sharedgovernance.org 
Pay Only $34.99 for a full year of CONTACT HOURS 
www.nurse.com for CNE offerings.

CNE Center
  
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MEDICAL RECALLS
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Magnesium Sulfate: Drug Safety Communication - Recommendation Against Prolonged Use in Pre-term Labor     
ISSUE: FDA is advising health care professionals against using magnesium sulfate injection for more than 5-7 days to stop pre-term labor in pregnant women. Administration of magnesium sulfate injection to pregnant women longer than 5-7 days may lead to low calcium levels and bone problems in the developing baby or fetus, including thin bones (osteopenia), and fractures. The shortest duration of treatment that can result in harm to the baby is not known. See the Data Summary in the Drug Safety Communication for additional information.

BACKGROUND: This use of the drug is off-label, and is not an FDA-approved use of the drug. Magnesium sulfate is approved to prevent seizures in preeclampsia, a condition in which the pregnant woman develops high blood pressure and protein in the urine, and for control of seizures in eclampsia. Both preeclampsia and eclampsia are life-threatening complications that can occur during pregnancy. Preeclampsia can lead to eclampsia, seizures, stroke, multiple organ failure, and death of the woman and/or baby.

RECOMMENDATIONS: In light of this new safety information about low calcium levels and bone problems in the developing baby, the following information is being added to the drug label for Magnesium Sulfate Injection, USP 50%:
  • A new Warning stating that continuous administration of magnesium sulfate injection beyond 5-7 days in pregnancy for the treatment of pre-term labor can cause low calcium levels and bone changes in the baby.
  • A new Teratogenic Effects section conveying the potential harm to developing babies by changing the Pregnancy Category to D from A. Pregnancy Category D means there is positive evidence of human fetal risk, but the potential benefits from using the drug in pregnant women may be acceptable in certain situations despite its risks.
  • A new Labor and Delivery section emphasizing that continuous administration of magnesium sulfate injection to treat pre-term labor is not approved and that the safety and efficacy of use for this indication are not established. When used in pregnant women for conditions other than its approved indication, magnesium sulfate injection should be administered only by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities. 
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm354603.htm 

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WEBSITES/ LINKS
Always on the lookout for interesting websites / links. Please send them to: RNFrankie@AOL.com.

This is an excellent nursing site, check it out:http://nursingpub.com/

                                             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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ADVERTISEMENTS
from the members
This ad is from Decubqueen (Gerry)..........AccuRuler 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

Welcome to:  
brianlabudde@hotmail.com, (Brian) 

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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

Old Address:   lfoster@s2interactive.com  


New Address:    ljfoster@outlook.com  (thank you, Larry)


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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 evil men take office, the whole gang will be in 
collusion...and they will keep the people in utter 
ignorance and steal their liberty by ambuscade [means 
ambush]. 

 Patrick Henry  



Hope to hear from you..... Frankie

 
   c. Guidelines for Nutrition Support Therapy in Critically Ill Patients from the American Society of Parenteral and Enteral Nutrition and the Society of Critical Care Medicine suggest initiating parenteral nutrition therapy after 7 days with no oral intake.
 
Learn more by reading the continuing nursing education article “Supplemental nutrition for hospital patients with diabetes.” 
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