Paradigm Bytes Newsletter for June 2013

PARADIGM BYTES Newsletter for Paradigm 97 June 15, 2013 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. ***~~~***~~~***~~~*** SNIPPETS Do You Wash Your hands? (We nurses know how to wash the hands....especially between the fingers for the correct period of time. But we have all seen people leave the restroom doing just as the following research shows. How can we teach the correct method...to children, it would be easy. However, how about teaching adults?) In fascinating news, new research shows that most people don't wash their hands properly after using the bathroom. The study from Michigan State University found that a staggering 95 percent of people don't wash their hands long enough to kill illness-causing bacteria. Yep, that makes you just about as dirty as the person who walks out of the bathroom without stopping at the sink first. For the study, the research team trained 12 research assistants to unobtrusively watch people's behavior in public restrooms in a college town. The assistants recorded whether and how people washed their hands—if they left the bathroom without washing their hands at all, if they just wetted their hands without using soap, or if they washed their hands with soap. They also recorded how long people's hands were placed under running water during the washing process. In total, 3,749 people were observed. The findings, published in the April 2013 issue of Journal of Environmental Health, showed that only two out of three people use soap and that one out of 10 people skip the sink altogether. While women significantly wash their hands better than men, many still don't do right. "These findings were surprising to us because past research suggested that proper hand washing is occurring at a much higher rate," said Carl Borchgrevink, one of the study's authors and a Michigan State associate professor of hospitality business, in a statement. To prevent the spread of disease, the U.S. Centers for Disease Control and Prevention recommends washing hands under running water and with soap for at least 20 seconds. (Don't want to count in your head? Silently sing the "Happy Birthday" song twice.) Then, leaving the water running, dry your hands with a paper towel and use the towel to turn the faucet off and open the door, before tossing it into the trash. Tell us: Do you always remember to wash your hands properly? (We, as nurses, were taught the proper procedure of washing hands. Do you teach this procedure to your patients? If so, how? It is easy to teach children...but adults?) ****************************** (I just had to add this....didn't know just where to put it........chose this spot. Let me know if you like the Random Fact, please). With the ubiquitousness of the Internet it is easy to forget that once upon a time the recording and passing on of knowledge was a monumentally important, even sacred task and books were frequently more valuable than gold. Now, many books aren't even worth the paper they are printed on, but those rare examples of historic publications in antiquity that are still in good condition can fetch kingly prices. Some of the most expensive books ever sold at auction are... RANDOM FACTS: Traite Des Arbres Fruitiers The "Treatise on Fruit Trees" is a five volume set written in 1750. It contains illustrations and descriptions of sixteen different varieties of fruit trees. With a 2006 purchase price of $4.5 million, it has the distinction of being the most expensive book about fruit trees ever sold. The Gutenberg Bible There are 48 Gutenberg Bibles left of the original 180 believed to have been produced. They were printed in 1456 and were the first books produced with moveable type. A copy sold in 1987 for $4.9 million at Christie's New York. First Folio This book, a collection of William Shakespeare's plays, was published after his death in 1623. Seven hundred and fifty copies were published, but only 228 survived. Microsoft co-founder Paul Allen purchased a copy for around $6.1 million in 2001. The Canterbury Tales There are only 12 known first edition copies left since its publishing in 1477, and only one is in a private collection. The book was originally purchased in 1776 and not sold again until 1998 with a purchase price of $7.5 million by Christie's of London. Birds Of America This three and a half foot tall book depicts 400 life size North American bird species known to the Audubon Society in the 19th century. Only 200 complete first editions were produced, and 120 exist today. In 2010, one was sold for $11.5 million, but a 2012 copy sold for only $7.9 million. The Gospels Of Henry The Lion Commissioned by Henry the Lion for the alter of the Virgin Mary at Brunswick Cathedral, the German government purchased this 266 page book in 1983 for $11.7 million. The Codex Leicester Da Vinci wasn't only an artist, but also a scientist. This 72 page notebook is a handwritten journal chronicling his thoughts on everything from fossils to what makes the moon glow. Microsoft founder Bill Gates purchased the book for $30.8 million and had it scanned to use as a screensaver for Windows 95. ~~**~~**~~**~~**~~**~~ FROM THE MEMBERS Thank you, Laura for the following links: Nursing-related News Docs, Nurses Disagree Over Expanded Nurse Roles Postings from the KHN and Human Capital blogs. Article from HealthDay. Free, full-text article and abstract from The New England Journal of Medicine. http://dmanalytics1.com/e3ds/mail_link.php?u=http%3A%2F%2Fcapsules.kaiserhealthnews.org%2Findex.php%2F2013%2F05%2Fdoctors-nurse-practitioners-disagree-about-expanded-roles-for-nurses%2F&i=61&d=U7548693-0980-4UXV-935U-18060749V09V&e=laregis@aol.com The U.S. Nursing Workforce: Trends in Supply and Education Analysis from the HHS Health Resources and Services Administration. http://dmanalytics1.com/e3ds/mail_link.php?u=http%3A%2F%2Fbhpr.hrsa.gov%2Fhealthworkforce%2Freports%2Fnursingworkforce%2Findex.html&i=66&d=U7548693-0980-4UXV-935U-18060749V09V&e=laregis@aol.com The American Academy of Nursing Applauds Senate Confirmation of Marilyn Tavenner, MHA, BSN, RN, as New CMS Administrator News release. http://dmanalytics1.com/e3ds/mail_link.php?u=http%3A%2F%2Fwww.aannet.org%2Findex.php%3Foption%3Dcom_content%26view%3Darticle%26id%3D500%3Aacademy-applauds-senate-confirmation-of-tavenner-as-new-cms-administrator%26catid%3D23%3Apressreleases%26Itemid%3D133&i=67&d=U7548693-0980-4UXV-935U-18060749V09V&e=laregis@aol.com California Weighs Expanded Role For Nurse Practitioners Article from Kaiser Health News. http://dmanalytics1.com/e3ds/mail_link.php?u=http%3A%2F%2Fwww.kaiserhealthnews.org%2FStories%2F2013%2FMay%2F09%2FCalifornia-expanded-role-nurse-practitioners.aspx&i=68&d=U7548693-0980-4UXV-935U-18060749V09V&e=laregis@aol.com The Registered Nurse Safe Staffing Act of 2013 Is Introduced in Congress News item from the American Nurses Association web site. http://dmanalytics1.com/e3ds/mail_link.php?u=http%3A%2F%2Fwww.aannet.org%2Findex.php%3Foption%3Dcom_content%26view%3Darticle%26id%3D500%3Aacademy-applauds-senate-confirmation-of-tavenner-as-new-cms-administrator%26catid%3D23%3Apressreleases%26Itemid%3D133&i=67&d=U7548693-0980-4UXV-935U-18060749V09V&e=laregis@aol.com ~~**~~**~~**~~**~~**~~ MEDICAL NEWS The so-called Monsanto Protection Act signed into law earlier this year caused such an outrage that people around the world are planning to protest the biotech company later this month. Now a United States Senator is expected to try and repeal that law after mounting pressure. The notorious ‘Monsanto Protection Act’ rider stuffed into the non-related Senate spending bill may soon be repealed thanks to the massive amounts of activism and outrage that have now amounted into a legislative charge towards action. Action that has turned into legislation progress through Senator Jeff Merkley of Oregon, who has announced an amendment that would remove Section 735 (the Monsanto Protection Act as its known) from the Consolidated and Further Continuing Appropriations Act of 2013 Senate spending bill. The rider, which almost managed to slip incognito and pass by the alarm system of the alternative media, grants GMO juggernaut Monsanto full immunity from federal courts in the event that one of its genetically modified creations is found to be causing damage to health or the environment. Essentially, it grants Monsanto power over the United States federal government. Thankfully, I was able to get on the subject through news tips and covered the Monsanto Protection Act all the way up until the bill containing it was signed into law by Obama. Ultimately, as the Monsanto Protection Act became more a hot issue, we had an increasing amount of publicity — but the Senate vote came just too quickly for the attention to put a halt on the rider. But even after its passing, sources like Russia Today, NaturalNews, Infowars, and myself here at NaturalSociety were sounding the alarm big time. Enough so that it even led to an apology from the top Senator who actually ended up approving the bill containing the rider. Senator Barbara Mikulski of Maryland actually went and released a statement apologizing for allowing the Monsanto Protection Act through and vowing to fight against GMOs and Monsanto. Ultimately, multiple Senators had entered damage control after the jig was up. That is besides Senator Roy Blunt from Missouri, who actually worked with Monsanto (as in he let them write it while he received funding) on the Monsanto Protection Act rider. A rider he says is perfectly reasonable. After all, why not give Monsanto full immunity from the legal system the rest of us are subject to? Even Obama was getting blasted on his Facebook page following the approval of the Monsanto Protection Act, with the majority of comments coming into his page criticizing his signature on the bill that contained the rider. Thanks to this activism, it looks like the Monsanto Protection Act may soon be repealed after this new bill hits Washington. This time, we will have plenty of time to let the Senators know that they are voting against the public if they choose to side with Monsanto. And with such a specific agenda for this bill, I see it doing well in the Senate. Source: http://naturalsociety.com/monsanto-protection-act-soon-repealed-activism/ *********************** Los Angeles launches probe of alleged 'patient dumping' by Nevada (Reuters) - Nevada health officials acknowledged on Thursday that a state-run hospital improperly bused 10 newly discharged psychiatric patients out of the state with deficient plans for their care, while Los Angeles launched a criminal probe into the alleged "patient dumping." Rawson-Neal Psychiatric Hospital has been under fire since last month, after a Sacramento Bee investigative series reported that hospital staff gave as many as 1,500 patients one-way Greyhound bus tickets from Las Vegas to California and 46 other states over the past five years. "If the conduct is true as alleged, it's no less than human trafficking," Los Angeles City Attorney Carmen Trutanich told Reuters, adding he was working with San Francisco City Attorney Dennis Herrera, who last month opened an investigation into the practice. http://www.reuters.com/ ~~**~~**~~**~~**~~**~~ INTERESTING READING Please remember that the REUTERS articles usually good for only 30 days Gut bugs are implicated in heart attacks and stroke NEW YORK (Reuters) - Thousands of heart attack victims every year have none of the notorious risk factors before their crisis - not high cholesterol, not unhealthy triglycerides. Now the search for the mystery culprits has turned up some surprising suspects: the trillions of bacteria and other microbes living in the human gut. In a study released on Wednesday, scientists discovered that some of the bugs turn lecithin - a nutrient in egg yolks, liver, beef, pork and wheat germ - into an artery-clogging compound called TMAO. They also found that blood levels of TMAO predict heart attack, stroke or death, and do so "independent of other risk factors," said Dr Stanley Hazen, chairman of cellular and molecular medicine at the Cleveland Clinic's Lerner Research Institute, who led the study. That suggests a TMAO test could enter the arsenal of blood tests that signal possible cardiovascular problems ahead. "TMAO might identify people who are at risk (for heart attacks and strokes) despite having no other risk factors," Hazen said. The discovery also suggests a new approach to preventing these cardiovascular events: altering gut bacteria so they churn out less TMAO.... http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTMwNDI1LjE4MTUzMzYxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDEzMDQyNS4xODE1MzM2MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MTAxNjM1JmVtYWlsaWQ9cm5mcmFua2llQGFvbC5jb20mdXNlcmlkPXJuZnJhbmtpZUBhb2wuY29tJmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&113&&&http://www.nlm.nih.gov/medlineplus/news/fullstory_136236.html *************** Fluid and electrolyte imbalances can quickly turn into life-threatening situations and it is critical to be able to recognize subtle signs and symptoms and intervene appropriately. Test your knowledge of fluids and electrolytes by answering the following questions: What are the major organs involved in electrolyte and fluid homeostasis? What medications can cause hypernatremia? What are the recommended treatments for dilutional hyponatremia? What is the relationship between calcium level and phosphorous level? Which medication, commonly given in CCUs, is contraindicated in patients with hypokalemia? Check your answers and learn more by exploring the articles in More Resources. Also, we now have a new collection, Focus On: Fluids & Electrolytes, which includes a variety of articles, CE, and special features all about fluid and electrolytes! http://email.lww.com/t?r=1483&c=3480712&l=59027&ctl=4661F84:B54AB34282EDAD00F9F852C93A3ECCCEBB9E742C260FE2D0&; ******************** In 1970, Americans spent about $6 billion on fast food. In 2006, the spending rose to nearly $142 billion. It is not surprising that every month, approximately nine out of 10 American children visit a McDonald's restaurant. What are some other not so surprising facts about America's fast food industry. RANDOM FACTS: McDonald's is the largest purchaser of beef, pork, and potatoes and the second largest purchaser of chicken in the world. Its annual orders for french fries constitute 7.5 percent of America's entire potato crop. *** Bonus Fact: Due to anti-German sentiment during WWI, an alternative name for a hamburger (which was derived from the Hamburg steak sandwiches eaten on immigrant ships between Hamburg, Germany, and America in the 1800s) was "salisbury steak." It was named after Dr. Salisbury who prescribed ground beef for patients suffering from anemia, asthma, and other illnesses. ****************** Earlier, The Joint Commission issued a Sentinel Event Alert entitled Medical device alarm safety in hospitals to address the issues presented due to providers becoming desensitized or immune to the beeping of medical devices. We'd like to share several resources available on Lippincott's NursingCenter.com to bring attention to this important issue. http://email.lww.com/t?r=1483&c=3509676&l=49052&ctl=46D5F63:B54AB34282EDAD008407A52733B0335AABC62CF4A2E7FFFB& Creating cultures of safety: Risk management challenges and strategies Nursing Management, December 2010 http://email.lww.com/t?r=1483&c=3509676&l=49052&ctl=46D5F64:B54AB34282EDAD008407A52733B0335AABC62CF4A2E7FFFB& Increasing the Use of 'Smart' Pump Drug Libraries by Nurses: A Continuous Quality Improvement Project AJN, American Journal of Nursing, January 2012 http://email.lww.com/t?r=1483&c=3509676&l=49052&ctl=46D5F65:B54AB34282EDAD008407A52733B0335AABC62CF4A2E7FFFB& ECG Challenges: Monitor Alarms and Alarm Fatigue AACN Advanced Critical Care, December 2011 Alarms are a necessary part of monitoring and caring for patients. Awareness of the technological and human factors associated with alarm fatigue is a first step in recognizing and remedying this issue. http://email.lww.com/t?r=1483&c=3509676&l=49052&ctl=46D5F66:B54AB34282EDAD008407A52733B0335AABC62CF4A2E7FFFB& Thank you, Lisa M. Bonsall, MSN, RN, CRNP Clinical Editor, Lippincott's NursingCenter.com ****************** FDA finds fungus, bacteria in recalled pain shots The Food and Drug Administration has found bacteria and fungus in vials of pain shots made by a Tennessee pharmacy whose products have been linked to infections. FDA said it found the contaminants in two sealed vials of steroids made by Main Street Family Pharmacy, which has recalled all its products nationwide after 24 people in Arkansas, Florida, Illinois and North Carolina developed abscesses at the sites where they got the injections. “FDA, in partnership with the Centers for Disease Control and Prevention, is working to identify the exact species of fungus and bacteria observed in the vials. FDA has received reports of adverse events, including skin and soft tissue abscesses,” FDA said in a statement.... http://vitals.nbcnews.com/_news/2013/06/07/18829371-fda-finds-fungus-bacteria-in-recalled-pain-shots?lite ************************ Super Glue*** A kind of extra-sticky adhesive, or cyanoacrylate, "Super Glue" was invented during World War II by a scientist named Harry Coover, who was experimenting with sealants for aircraft turrets. In the 1950s, he went to work for Eastman Kodak, a chemical and film manufacturer, and put a product on the market with the uncatchy name Eastman 910. The company licensed the product to another manufacturer, which renamed it "Super Glue" and made a fortune. ***************** Quiz Time For elderly patients recovering from surgery, you should anticipate which of the following? a. They will require higher opioid dosages than younger patients to experience the same analgesic effect. b. They will require lower opioid dosages than younger patients to experience the same analgesic effect. c. They will require longer opioid dosing intervals and will respond more slowly to opioids. d. They are likely to have differences in genetic makeup that affect opioid response. Reprinted with permission from: Production/Electronic Channels Coordinator HealthCom Media 259 Veterans Lane Doylestown, PA 18901 *************** Preventing catheter-related bloodstream infections related to I.V. connectors A year-long national effort to minimize catheter-related bloodstream infections (CR-BSIs) has produced only modest results. The Centers for Disease Control and Prevention (CDC) compared data from January through June 2009 to data from 2006 through 2008, and found these infections had decreased only 18%. The statistics are troubling, especially given the current intense focus on preventing hospital-acquired infections. Why do CR-BSIs still kill patients every year? Some experts believe I.V. connector design is a contributing factor. The Food and Drug Administration (FDA) requires all manufacturers of positive-displacement (PD) I.V. connectors to conduct postmarketing surveillance studies to assess whether they could be linked to a higher CR-BSI rate than other types and to assess factors that may contribute to the possible increased risk. FDA has taken this step because it has received information on possible safety problems linked to PD needleless connectors, including three reports of deaths. But despite mounting evidence against these connectors, they’re still used widely. William Jarvis, MD, an internationally recognized infection control expert, notes that studies also link negative-displacement (ND) connectors with increased CR-BSIs. As primary caregivers, nurses are responsible for the care and maintenance of central venous catheters. This article describes the various I.V. connector designs available and explains why some designs are more effective than others in preventing infections. Because I.V. connectors are attached to catheter hubs, they serve as gatekeepers of the intraluminal fluid pathway (the inside of the catheter). Their design plays a critical role in supporting—or thwarting—your care and maintenance efforts. If their design makes them hard to disinfect with thorough swabbing and flushing, infections are more likely. If their design promotes thorough swabbing and flushing, they can help minimize infections.... http://www.americannursetoday.com/Article.aspx?id=9354&fid=9326&utm_source=BenchmarkEmail&utm_campaign=Weekly_eNewsletter_September_3rd_2012&utm_medium=email#comments ****************** Longer Wait for Mammogram After Benign Breast Biopsy May Be Warranted THURSDAY, May 2 (HealthDay News) -- Women who have a breast biopsy that turns out to be benign are typically told to undergo another imaging test, such as a mammogram, in six to 12 months. Now, a new study suggests that the longer interval might be better. Researchers who followed women who had benign breast biopsies say having that test less than a year later finds few cancers and is a drain on health care dollars. ''Doing a follow-up imaging study six months after a benign needle breast biopsy has a low likelihood of finding breast cancer at the biopsy site," said study author Dr. Andrea Barrio, an attending breast surgeon at Bryn Mawr Hospital, in Pennsylvania. Most of these women, she said, can wait longer than six months before repeating the mammogram, ultrasound or MRI. Dr. Demitra Manjoros, a breast fellow at Bryn Mawr, is due to present the research Thursday at the American Society of Breast Surgeons' annual meeting, in Chicago. ... http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTMwNTAzLjE4NDE1MDAxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDEzMDUwMy4xODQxNTAwMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MTEwNDM0JmVtYWlsaWQ9cm5mcmFua2llQGFvbC5jb20mdXNlcmlkPXJuZnJhbmtpZUBhb2wuY29tJmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&126&&&http://www.nlm.nih.gov/medlineplus/news/fullstory_136464.html ********************* NICU treatments linked to intellectual disabilities (Reuters Health) - Neonatal intensive care unit (NICU) interventions for babies born very small and early have drastically reduced infant deaths in the United States, but in doing so they've contributed to more intellectual disabilities, according to a new study. Past research has shown such disabilities have been reduced in recent years through vaccines and newborn screening, for example. But disability rates may also be rising due to procedures that save the lives of children who go on to have limitations in social and practical skills, according to researchers led by Dr. Jeffrey Brosco. "We actually through medical interventions, in some sense, cause a fair amount of intellectual disability as well (as preventing it)," said Brosco, from the University of Miami Miller School of Medicine. Of course, that doesn't mean doctors should stop performing life-saving procedures in the NICU and elsewhere, Brosco told Reuters Health. But the findings are part of a larger trend suggesting researchers and policymakers not focus all of their attention on new medical interventions as the best way to prevent disabilities, but start looking toward public health efforts, he added. "There's a great debate regarding the value of medical versus public health and social interventions in improving child health," said Dr. Jeffrey Baker, a medical historian who studies medical technology, ethics and child health and the Duke University School of Medicine in Durham. "What this study does is to show that medical intervention has been a two-edged sword," he said. http://links.reuters.com/r/8Q1OD/G2T0C/II35GQ/ZBG8RN/4VC4RT/YT/h?a=http://links.reuters.com/r/8Q1OD/G2T0C/II35GQ/ZBG8RN/EKXSHH/YT/h ~~**~~**~~**~~**~~**~~ HUMOR SECTION The brilliant lawyer F. E. Smith once defended a bus driver against claims that his negligence had caused injury to a young man's arm: "Will you please show us how high you can lift your arm now?" Smith asked the plaintiff. The young man obediently raised his arm to shoulder level, his face contorted with apparent pain. "Thank you," said Smith. "And now, please, will you show us how high you could lift it before the accident?" The man's arm shot above his head. ~~**~~**~~**~~**~~**~~ 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. Pay Only $34.99 for a full year of CONTACT HOURS www.nurse.com for CNE offerings. Free CEs http://www.myfreece.com/welcome.asp https://nursing.advanceweb.com/CE/TestCenter/Main.aspx This site was sent in by FNPMSN@aol.com (Cindy) http://cmepain.com/ ! ~~**~~**~~**~~**~~**~~ 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/ Robert Hess, RN, PhD, FAAN (856) 424-4270 (610) 805-8635 (cell) Founder, Forum for Shared Governance info@sharedgovernance.org www.sharedgovernance.org Decubqueen's website: www.accu-ruler.com http://www.thebreastcancersite.com/clickToGive/home.faces?siteId=2 http://www.nationalnurse3.blogspot.com/ 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 http://www.washingtonwatch.com/bills/show/110_HR_2123.html 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 The Nursing Site http://thenursingsite.com . http://www.thebreastcancersite.com/clickToGive/home.faces?siteId=2 http://www.snopes.com (to verify the veracity of a rumor) http://www.solutionsoutsidethebox.net/ Raconte's website http://www.theanimalrescuesite.com/clickToGive/home.faces?siteId=3 National Do Not Call Registry 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 This is a sampling of the offers on : Rozalfaro's website: http://www.alfaroteachsmart.com/articles.htm Metric conversion calculators and tables for metric conversions http://www.metric-conversions.org/ ******************************************************* ******************************************** * MEDICAL RECALLS * ******************************************* ****************************************************** (Considering the seriousness of both these Class I recalls, there will be only these two in this Newsletter) Symbios GOPump and GOBlock Kits Recall Class: Class I Date Recall Initiated: June 6, 2013 Product(s): Symbios GOPump in the GoPump Rapid Recovery System Kits Symbios GOBlock Kits Lot numbers: All lots of GOPumps in the GoPump Rapid Recovery System kits and GOBlock kits manufactured with flow control components before July 2012. Please see the chart below listing all the lot numbers. Manufacturing and Distribution Dates: The affected products were manufactured before July 2012 and distributed from April 27, 2011 to April 30, 2013. Use: The Symbios GOPump Rapid Recovery System is a disposable local pain management system that consists of a small balloon that is inflated with a local anesthetic medication. The medication is delivered slowly through tubes from the balloon to the surgical site. Recalling Firm: Symbios Medical Products, LLC 7301 Georgetown Road, Suite 150 Indianapolis, Indiana 46268 Distributor: B. Braun Medical Inc. 901 Marcon Blvd. Allentown, Pennsylvania 18109 Reason for Recall: The affected products may have excessively high flow rates. As a result, medications could be delivered too quickly from the balloon to the surgical site and cause patient toxicity due to the rapid influx of medication. This can lead to serious illness, including seizure, abnormal heart rhythms and death. Elderly patients and patients with low body mass are at high risk of these complications. ***************** Class I Recall and Safety Investigation of Counterfeit Polypropylene Surgical Mesh: Updated June 10, 2010 This is an update of FDA's Initial Communication on counterfeit polypropylene surgical mesh, which was issued on March 11, 2010. It contains additional information about the recall of this product and updates FDA's recommendations and activities. Audiences: Healthcare Professionals, Patients, Hospitals and Surgical Centers, Operating Rooms, Operating Room Nurses, Purchasing Departments, Risk Managers Medical Specialty: Surgery Product: Various sizes of counterfeit flat sheets of polypropylene surgical mesh have been marketed in the United States labeled with the C. R. Bard/Davol brand name. These meshes, specifically identified below, are NOT Bard-manufactured products. Surgical meshes of this kind are used to reinforce soft tissue where weakness exists, such as in the repair of hernias and chest wall defects. Summary of Problem and Scope: FDA's and Bard's investigations found the counterfeit product is labeled with the following product codes, sizes and lots of Bard Flat Mesh (commonly known as Marlex mesh). Investigations found most of the counterfeit product is labeled with genuine Bard lot numbers. To date, four product sizes have been identified: Product Codes and Sizes Lot Numbers 0112650 – Bard Flat Mesh 2" x 4" Lot 48HVS036 Lot 43APD007 0112660 – Bard Flat Mesh 10" x 14" Lot HUSD0629 Lot HURL0336 0112680 – Bard Flat Mesh 3" x 6" Lot 43HPD027 Lot 43HPD032 Lot 43HPD034 Lot HUSG0540 Lot 43HDP027 Lot HUSE0532 Lot 43LPD507 Lot HUSF0763 Lot 43IOD011 Lot 43IPD038 0112720 – Bard Flat Mesh 6" x 6" Lot 43FQD327 These counterfeit products were distributed from October 21, 2008 to October 27, 2009. Although counterfeiting of surgical mesh has occurred in the past, we are not aware of any other counterfeit mesh products being distributed at this time. Voluntary Recall: RAM Medical, Inc., a medical product distributor located in Wayne, New Jersey, initiated a voluntary recall of one lot of the counterfeit surgical mesh on March 5, 2010. RAM Medical expanded the recall on March 15, 2010 to include all of the above lots. RAM Medical sold the counterfeit products to the distributors below, who then distributed them to hospitals or possibly other distributors: Amerimed Corporation Henry Schein Inc. Marathon Medical Corporation Medline Industries MMS - A Medical Supply Company Q-Med Corporation Recommendations/Actions: Healthcare professionals and facilities Do NOT use any surgical mesh from the lots listed above. Contact RAM Medical at 973-633-0400 for further instructions about returning it. Contact Bard at 1-800-556-6275 if you received one of the recalled lots from a distributor not listed above, as Bard might be able to confirm if the product is authentic. Carefully examine all manufacturers' polypropylene surgical mesh products, packaging and labeling for anything unusual that might indicate they are counterfeit. If you notice anything unusual or suspicious with any brand of surgical mesh product, including its packaging or labeling, contact the manufacturer. If you suspect that a counterfeit product was implanted in a patient, continue to monitor the patient for adverse events as you would any patient with an authentic polypropylene surgical mesh implant. Report any adverse events to FDA as instructed in the “Reporting Problems to FDA” section below. If you believe you have received counterfeit or suspect product, contact FDA's Office of Criminal Investigations by calling 800-551-3989 or by visiting the Office of Criminal Investigations website. FDA Activities: On June 2, 2010, FDA classified the distributor's voluntary recall as a Class I recall. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death. An FDA recall notice was posted on the Medical Devices website. Here is what FDA has found in its laboratory analysis of the counterfeit mesh samples to date: The counterfeit samples are not sterile although labeled as sterile,which may mean increased risk for infection if implanted in a patient. They have a weave pattern and structure that is different from the authentic mesh. For example, the counterfeit mesh weave openings are larger than the authentic mesh. The counterfeit mesh does not have properly finished selvage edges as compared to the authentic mesh, which may allow the counterfeit mesh to unravel. The counterfeit mesh edges appear to be cut using heat, as the edge is fused or melted together. The packaging of the counterfeit samples is different from that of the authentic mesh. The expiration dates shown on the labeling of some of the counterfeit product samples do not match. The counterfeit mesh may not meet the authentic product's specifications, including strength and clinical performance. FDA is continuing to test samples of the counterfeit mesh and will update this communication if additional information becomes available. FDA is also investigating to determine who is responsible for the counterfeiting and how the counterfeiting and distribution occurred. ~~**~~**~~**~~**~~**~~ ADVERTISEMENTS from the members This ad is from Decubqueen (Gerry)..........Accu-RulerAccurate wound measurement designed by nurses, for nurses. Now carrying wound care and first-aid supplies at prices you can afford.Visit us at http://www.accu-ruler.com/. ~~**~~**~~**~~**~~**~~ NEW MEMBERS Please send the prospective members' screen names and first names to me: RNFrankie@AOL.com WELCOME TO: ccpierce62@live.com (Cecilia) May 22, 2013 Johnsie.Newman@gmail.com (Johnsie) June 8, 2013 fsdbuckley@hotmail.com (Farrar) June 12, 2013 Peggylee1.ps@gmail.com (Peggy) June 13, 2013 ~~**~~**~~**~~**~~**~~ 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. If, for personal reasons, you want to opt out...let me know, also. RNFrankie@AOL.com ~~**~~**~~**~~**~~**~~ 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) ~~**~~**~~**~~**~~**~~ PARADIGM 97 CO-FOUNDERS: MarGerlach @AOL.com (Marlene) and RNFrankie @AOL.com (Frankie) ~~**~~**~~**~~**~~**~~ 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. ~~**~~**~~**~~**~~**~~ THOUGHT FOR THE DAY The strongest reason for the people to retain the right to keep and bear arms is, as a last resort, to protect themselves against tyranny in government. --Thomas Jefferson Answer to Quiz Time: Correct answer: b. Increased age has a linear correlation to increased opioid sensitivity. Thus, elderly patients require lower opioid dosages than younger patients to experience the same analgesic effect. Take time out to write me...with suggestions/criticisms AN "atta girl" is always appreciated Frankie RNFrankie@AOL.com