Sunday, July 8, 2007

PARADIGM BYTES

PARADIGM BYTES
Newsletter for Paradigm 97
July 8, 2007

Our website...... http://paradigm97.blogspot.com/

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.
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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. Please drop in ...the AOL chatroom is "manned" by GingerMyst for 45
min on Tuesday evenings: 9 pm EST, 8 pm CST, 7 pm MST, 6 pm PST

Now, the
Paradigm97 chatroom is always there....door open, lights on,
waiting for visitors to come in. Check your Buddy List.....and invite
your friends in for a little chat Let me know if you want others
involved.
SNIPPETS

JCAHO Issue 10

Blood Transfusion Errors: Preventing Future Occurrences
Since the Joint Commission began tracking sentinel events more than "There should be blue ribbon panels set up to find optimal ways to develop a system for patient identification."

James B. Battles, Ph.D., co-principal investigator, a medical event reporting system for transfusion medicine three years ago, the Accreditation Committee of the Joint Commission's Board of Commissioners has reviewed 12 cases related to transfusion errors. For each of the events reviewed, a root cause analysis was completed.

Ten of the cases resulted in patient deaths while in two of the cases the patients recovered. Also, 11 of the cases were hemolytic reactions, while one was an infectious reaction. Eleven of the transfusion reactions took place in a general hospital with eight occurring in high-risk areas: the operating room, emergency room or intensive care unit, or during resuscitation. One of the 12 cases was in a long term care organization.

Incomplete patient/blood verifications were identified as at least one of the causes of eight of the 12 cases. Three of the 12 cases involved the handling or processing of blood samples or blood units for more than one patient at the same time in the same location. In all but one case (contaminated platelets), there were multiple failures to follow established procedures, usually involving the verification of patient identity and correct blood unit for that patient.

The Joint Commission learned of eight of the 12 cases through self-reporting. Three events were reported by state or federal regulatory agencies, and the Joint Commission learned about one case through media coverage.

Risk Factors
The processes involved in blood transfusion exhibit virtually all of the factors recognized to increase the risk of an adverse outcome:

a.. Variable input (The patients have different blood types.)
b.. Complexity (This includes the technical aspects of crossmatching as well as administering and monitoring the effects of blood.)
c.. Inconsistency (Despite efforts to clearly define procedures within a hospital, there is no standardization across all hospitals.)
d.. Tight coupling (When steps in a process happen so closely together, if there is a failure in one step there is little opportunity for intervention. It is difficult to interrupt the sequence of the process, especially in an emergency room, operating room or intensive care unit.)
e.. Human intervention (This is in processes that require a higher level of consistency than is reasonably achievable by health care
workers without computer support.)
f.. Tight time constraints (This occurs especially in an emergency room, operating room or intensive care unit.)
Root Causes Identified
Root causes fell into six general areas:

a.. Patient assessment such as incomplete patient/blood verification. "When an order for a transfusion occurs, a dedicated team should manage the entire process."

Kathleen Sazama, M.D., J.D., chair of accreditation program committee, American Association of Blood Banks

Patient assessment such as the signs and symptoms of a transfusion reaction not being recognized.
b.. Care planning such as no informed consent for a transfusion.
Laboratory procedures such as multiple samples crossmatched at the same time or a crossmatch being started before the order was received.
c.. Staff-related factors such as insufficient orientation and training or insufficient staffing levels.
d.. Equipment-related factors such as blood for multiple operating room patients being stored together in the same refrigerator.
Information-related factors such as incomplete communication among caregivers or patient identification band, specimen label or blood label errors.
Suggested Strategies for Reducing Risk
The organizations that experienced the sentinel events offered the following risk reduction strategies:

a.. People-focused actions that included in-service training on transfusion-related procedures and revising the staffing model.
b.. Process redesign issues such as revising the patient identification band procedures; revising patient/blood verification procedures; revising and implementing new informed consent procedures; discontinuing processing of multiple samples; or discontinuing the use of the room number as the patient identifier.
c.. Technical system redesign efforts such as enhanced computer support or new patient identification band system.
d.. Environmental redesign issue such as discontinuing use of an operating room refrigerator for multiple blood units or adding
laboratory workstations.
In addition, the Joint Commission suggests the following actions:

a.. Prohibiting simultaneous crossmatching of multiple patients by the same technologist.
b.. Not using the patient's room number to identify blood samples or transfusion units.
c.. Considering the use of "unique" identification bands for patients receiving blood transfusions.
d.. Introducing a computerized verification step into the process.
Experts' Recommendations
Experts as well as Joint Commission standards emphasize that health care organizations should have unique patient identifier processes in place. This would be a way to take human fallibility out of the equation, says Kathleen Sazama, M.D., J.D., a professor of pathology and laboratory medicine at MCP Hahnemann University in Philadelphia.

Sazama says organizations should use a hand-held bar code reader to read both bar coded wristbands on every patient and a barcode identifier on the tag of the components. If the bar code reader fails to confirm the identity between the wristband and the tag, then the health care worker cannot proceed with the transfusion.

James B. Battles, Ph.D., a professor of medical education for the University of Texas Southwestern Medical Center, Dallas, says bar coding can help but he believes there still is not a good patient identification system in place. He says a major effort needs to be made to study the problem and find the best method.
http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_10.htm
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MEDICAL NEWS
The Little Known H-1C Visa For Nurses By Bob Kraft
The United States currently has a severe shortage of licensed nurses, and this is expected to intensify as baby boomers age and the need for health care grows. To address this concern, the US implemented a visa category allowing nurses ...
http://dfwimmigrationlaw.clarislaw.com/immigration-laws/the-little-known-h1c-visa-for-nurses.php
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INTERESTING READING

Please remember that the REUTERS articles are good for 30 days only
PAIN
Acute Pain versus Chronic Pain

Acute pain is relatively brief and diminishes as healing occurs.

Chronic pain is usually subdivided into either malignant or non-malignant pain (McCaffery & Pasero, 1999). Chronic non-malignant and chronic malignant pain may be either nocioceptive or neuropathic depending upon its origin and dissemination. For example, a patient may experience visceral, nocioceptive pain from liver metastasis, but may also be experiencing neuropathic pain from chemotherapy induced neuropathy. Additionally, a person with chronic pain may have exacerbations of acute pain, known as breakthrough pain.

Nocioceptive versus Neuropatic Pain
Nocioceptive Pain

Nocioceptive pain occurs from real or impending tissue damage, either to the viscera or the soma. Nocioceptive, somatic pain usually occurs due to real or impending damage to bone, muscle, skin, or connective tissue. Somatic pain is most commonly described as localized,aching, or throbbing. Nocioceptive visceral pain usually occurs due to real or impending damage to the thoracic, abdominal, or pelvic organs (i.e. heart, liver, bowel). Visceral pain is often described as deep, cramping, referred, aching, or gnawing (Griffie, McKinnon, Berry, & Heidrich, 2002).
Neuropathic Pain

Alternatively, neuropathic pain occurs from damage to peripheral or central nervous tissues or from distorted processing of pain. Examples of neuropathic pain include peripheral neuropathies, neuralgias, phantom limb pain, and spinal cord injuries. It is often described as burning, piercing, lacerating, and pricking (Griffie, McKinnon, Berry, & Heidrich, 2002).
Quality of Pain

Pain descriptors such as aching, throbbing, burning, piercing, shooting, boring, tearing or crushing can also give clues to the origins of pain. Remember, somatic pain is most commonly described as localized, aching and throbbing. Visceral pain is often described as deep, cramping, referred, aching or gnawing. Neuropathic pain is often described as burning, piercing, lacerating and pricking. Qualifying the patient's pain allows you and your team to determine the appropriate analgesic or adjuvant to request to be prescribed.

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See those beads of sweat dripping onto the control panel of your exercise machine? That's a good sign for your colon.
Exercise helps keep your colon healthy, but moderate-to-vigorous exercise -- the kind that gets you winded and makes you perspire -- may be particularly important. It can help slow down the growth of colon cells, which is a good thing; slower growth means a lower risk of cancer. So be kind to your colon by sweating to the oldies -- or to whatever it is you like to sweat to -- for at least 30 minutes a day. Bump it up to over 40 minutes or more and you'll do even better. You know that exercise can stave off deadly diseases, from diabetes to cancer. So what are you waiting for? Get moving! Walking is hard to beat if you're just getting started. Aim for a brisk 30 minutes at least 5 days a week and when that gets easy, increase the time and intensity to keep your body challenged. Even better, add some weight work and stretching three times a week.

The protective effects of exercise on colon health seem to be greater in men than in women, but the overall health benefits for both genders are overwhelming. Other things you can do to keep your colon healthy: Make sure your daily diet contains adequate calcium (1,200 milligrams) and vitamin D (400 international units), get plenty of fiber, and limit red meat intake to no more than once per week. References: Effect of a 12-month exercise intervention on patterns of cellular proliferation in colonic crypts: a randomized controlled trial. McTiernan, A., Yasui, Y., Sorensen, B., Irwin, M. L., Morgan, A., Rudolph, R. E., Surawicz, C., Lampe, J. W., Ayub, K., Potter, J. D., Lampe, P. D., Cancer Epidemiology, Biomarkers & Prevention 2006 Sep;15(9):1588-1597.
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Think you're a multitasking wiz? That may be why your memory's slipping." The more things you do at once, the less likely you are to remember any of them. Sometimes that's no biggie -- if you're flipping through a catalog and watching a sitcom, who cares?
But if you're hunting for flights on the Internet while talking on the phone and listening to the radio, well, good luck -- both the flight info and the conversation will probably be a blur. The solution's obvious: When something is important, be single-minded. To sharpen your recall of new information -- whether it's health instructions, vital dates, or learning how to work your new cell phone -- make it easy for your mind to absorb it. Limit distractions and focus on the matter at hand, not three other things as well. If other tasks keep popping into your head, stop and jot them down on a notepad. Then go back to what's really important. It's a good bet that this time it will stick with you. References: Modulation of competing memory systems by distraction. Foerde, K., Knowlton, B. J., Poldrack, R. A., Proceedings of the National Academy of Sciences of the United States of America 2006 Aug
1;103(31):11778-11783.
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Ultrasound may identify emerging pressure ulcers
Research performed in Montana nursing homes found that an ultrasound can identify pressure ulcers developing beneath the skin before they are visible to the naked eye, reported the Billings Gazette. Over the course of six months, residents admitted to the Montana facilities studied were given the option of being scanned with the ultrasound machine. Most agreed to participate in the study. More than 90% had subcutaneous tissue injuries in their heels that put them at risk for developing pressure ulcers. Traditional assessment techniques would have identified only about one-third of them as being at risk, according to the Gazette.
http://www.billingsgazette.net/articles/2007/03/24/news/local/35-sore.txt
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Database to help reduce medication errors
A new database used by Rice Memorial Hospital in Willmar, MN, may help to reduce medication errors, according
to a West Central Tribune article. The database will be used to record medication errors and classify individual incidents for further study. By using a computerized system, the hospital will be able to track trends in errors, find common errors, and devise ways to reduce mistakes, according to the article. Common errors found include transcription, dosing, and wrong drug errors. http://tinyurl.com/ysko5m
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Health Literacy RDH - Tulsa,OK,USA
It is a serious problem that costs the health-care system more than $58 billion a year and could result in a malpractice claim against any medical...
http://rdh.pennnet.com/display_article/288158/56/ARTCL/none/none/Health-Literacy/
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This is recent info; an excellent article that is well worth the required (free) registration.......BA (BAcello@aol.com)
Opioid and Nonopioid Therapies for the Management of Pain Medscape (subscription) - USA
Pharmacogenomics and TDM for pain management: toward personalized medicine.
Program and abstracts of the 23rd Annual Meeting of the American Academy of Pain ...
http://www.medscape.com/viewarticle/554001
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Nurses are divided about setting staffing standards (In my opinion, charge nurses do this all the time,....the only major problems are: 1). lack of staffing according to acuity and 2). the way nurses are treated on the east coast........having 7 to 8 patients very acute care (cardiology/step down, etc.)

Some nurses asked lawmakers Tuesday to specify how many patients can be assigned to a registered nurse in a hospital.

Linda Boly, who works at Legacy Good Samaritan Hospital in Portland, said a patient who had just left surgery went unattended for nearly an hour because all the nurses had their hands full with other patients.

"We believe hospitals will not regulate themselves," she told the House health-policy subcommittee. "We need staffing standards in place, and we also need a union to enforce safe patient standards."

Legacy Health System is not unionized. House Bill 3416 was introduced at the request of the Oregon Federation of Nurses and Health Professionals, AFT Local 5017, and would specify minimums based on the
nature of the hospital unit.

"For the sake of patients, there needs to be enough nurses to ensure quality care," said Kathy Geroux, a registered nurse at Kaiser Permanente and the local's president.

California enacted staffing standards in 1999. But other nurses, and the hospitals, oppose the bill.
http://www.statesmanjournal.com/apps/pbcs.dll/article?AID=/20070328/LEGISLATURE/703280330/1042
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Vision For E-Prescribing Outstrips Reality While physicians who have embraced e-prescribing wouldn't go back to paper prescriptions, they report major barriers to using advanced e-prescribing features that many advocates believe offer the greatest potential to improve the safety and quality of health care, according to a study by Center for Studying Health System Change researchers (HSC) published today as a Web Exclusive in the journal Health Affairs. While physicians werepositive about the basic features of e-prescribing, products often lacked advanced features, or if they had them, physicians often did not use them because of implementation hurdles or their perceptions that the features did not add value. You can find read the article by HSC senior health researcher Joy Grossman and coauthors at http://content.healthaffairs.org/cgi/content/full/hlthaff.26.3.w393
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Fish Oil Added to Statin Therapy Reduces Risk for Major Coronary Events

Results of the Japan EPA Lipid Intervention Study (JELIS), first presented at the American Heart Association's 2005 Scientific Sessions, have now been published in the March 31 issue of The Lancet. As previously reported by heartwire, the addition of eicosapentaenoic acid (EPA) to low-dose statin therapy significantly
reduced the incidence of major coronary events, largely driven by a reduction in unstable angina, when compared with statins alone.

A subgroup analysis of the study, which involved a large number of primary-prevention patients, revealed that statin-treated secondary-prevention patients gained the most benefit from fish-oil supplementation.

The investigators, led by Mitsuhiro Yokoyama, MD, from Kobe University Graduate School of Medicine in Kobe, Japan, believe the benefit provided by the addition of EPA, a long-chain, n-3 polyunsaturated fatty acid, to statin therapy does not appear to be mediated by the effects of cholesterol lowering. In both treatment groups, there was a
26% reduction in levels of low-density lipoprotein (LDL) cholesterol.

"The beneficial effects of EPA could have stemmed from many biological effects that lead to the attenuation of thrombosis, inflammation, and arrhythmia, in addition to a reduction of triglycerides," write the authors. "Overall,
this study shows that EPA, at a dose of 1800 mg per day, is a very promising regimen for prevention of major coronary events, especially since EPA seems to act through several biological mechanisms."... http://www.medscape.com/viewarticle/554559?src=mp (cme for MDs, only)
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Medical Products Online, Inc. Provides Free Pain Management This was done to help persons with limited income to get medical products and services at cost-effective pricing. Dr. Louis D. Sclafani, co-founder, states, ...

DANBURY, Conn., April 6, 2007 -- Medical Products Online, Inc. launched its new webpage providing FDA-approved medical products for people in chronic pain. This was done to help persons with limited income to get medical products and services at cost-effective pricing.

Dr. Louis D. Sclafani, co-founder, states, "We offer an Indigent Program for persons in need. In rare cases doctors and patients contact us for FREE products and/or services. This allows the healthcare professionals to better treat patients." Also offered is Free Medical Consulting by Dr. Sclafani.

Co-founder Michael Grillo states, "Medical Products Online, Inc.'s founding mission is to improve quality of life for persons with chronic pain. We provide education, products, and the latest information in healthcare."

According to Mitchell J. Reiff, founder and CEO of Medical Products Online, Inc. and the parent company MML Inc., "This is our way of giving back to the local communities for persons in need."
Visit
http://www.medicalproductsonline.org for further details.
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Members of the National Nursing Network Organization Board of Directors frequently receives emails from supporters like the one below:

"Nurses have so much to offer and we need to show consumers our holistic and health promotion roots, and how they're different from a medical approach. The Office of the National Nurse is an excellent way to provide this information and
put forth a role model who can be an articulate spokesperson for the profession."...
http://nationalnurse.blogspot.com/2007/04/board-certified-holistic-nurse-speaks.html
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In the United States, a person's chance of surviving cardiac arrest is probably much lower than most people realize: 17-19 percent in hospitals. New device increases circulation and blood flow to vital organs during CPR
This is why the results reported by Ken Thigpen and his colleagues at St. Dominic - Jackson Memorial Hospital in Jackson, Miss. are so exciting. They are using the ResQPOD, a fist sized device that increases circulation and blood flow to vital organs during CPR. Since Thigpen's team began using the device on patients who experience cardiac arrest at St. Dominic, the patient survival rate after a cardiac arrest has increased to 57 percent. That is nearly triple the national average.
"In the instances where ResQPODs have been used, our rates are re-writing survival numbers," said Thigpen, Administrative Director of Pulmonary Services. "This device is probably having as significant an impact on influencing the outcomes of 'code situations' as anything I've seen in my 25 years in the field." The hospital has been tracking results since implementing the device in its hospital in October, 2006....
http://www.news-medical.net/?id=23556
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Physician Self-Referral: Banned, But Surprisingly Common

A study published today on the Health Affairs Web site provides the first empirical evidence concerning how often physicians are stretching federal and state laws -- and perhaps breaking them -- by referring patients to imaging providers with whom they have a financial relationship.

"Laws enacted during the early 1990s to curb physician self-referral were a major step toward addressing the concerns about these arrangements; however, they contain exceptions that could enable self-referral to reappear," writes study author Jean Mitchell, a Georgetown University professor of public policy. "The findings presented here, which are based on a comprehensive list of providers who billed a large private insurer in California for advanced imaging procedures in 2004, indicate that prohibition exceptions have enabled self-referral to persist, but in new forms" tailored to fit the exceptions. ...
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(sent in by Rozalfaro.......thank you.)

Predictors of Patient Satisfaction With Telephone Nursing Services -- Clinical Nursing Research
Susan Randles Moscato, et al. - Patient satisfaction has been shown to be a factor in clinical outcomes, health care quality, and patient follow-through. Thus, a high level of satisfaction is a desired outcome of patient care. This article examines predictors of patient satisfaction with telephone nursing services among a sample of 1,939 respondents, using a conceptual model derived from the literature and preliminary work. The study was conducted in medical offices and call centers of a large national health maintenance organization...
http://www.mdlinx.com/NurseLinx/newsl-article.cfm/1837227
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Study says obese workers costing employers CHICAGO, Illinois (AP) -- Overweight workers cost their bosses more in injury claims than their lean colleagues, suggests a study that found the heaviest employees had twice the rate of workers' compensation claims as their fit co-workers.

Obesity experts said they hope the study will convince employers to invest in programs to help fight obesity. One employment attorney warned companies that treating fat workers differently could lead to discrimination complaints.

Duke University researchers also found that the fattest workers had 13 times more lost workdays due to work-related injuries, and their medical claims for those injuries were seven times higher than their fit co-workers.

Overweight workers were more likely to have claims involving injuries to the back, wrist, arm, neck, shoulder, hip, knee and foot than other employees.

The findings were based on eight years of data from 11,728 people employed by Duke and its health system. Researchers found that workers with higher body mass indexes, or BMIs, had higher rates of workers'
compensation claims... http://www.cnn.com/2007/HEALTH/04/23/diet.obesitycosts.ap/index.html
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Overcrowding and Patient Safety According to the American College of Emergency Physicians®, overcrowding occurs when the need for emergency services outstrips available resources in the unit. This happens when there are more patients than staffed emergency department (ED) treatment beds and wait times exceed reasonable periods. Overcrowding usually results in patients being monitored in non-treatment areas, such as hallways, while waiting for ED treatment or inpatient beds.

Managing patient flow can eliminate factors that lead to ED overcrowding. The following are some strategies to improve your hospital's patient flow and thereby improve patient safety: http://www.medinfonow.com/min/ct/5/60336/fuwluz/KAAK/80/default.aspx
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This was sent in by Laregis: When hand antiseptics won’t cut it

They're less drying than soap and water, but hand sanitizers cannot kill three main categories of viruses and bacteria. In these instances, healthcare workers should follow any virus- or bacteria-specific hand washing recommendations. For example, when working with C. difficile patients, the Centers for Disease Control and Prevention recommends that healthcare workers wash their hands with nonantimicrobial or antimicrobial soap and water, which can physically remove spores from the surface.

Below are the major categories of viruses and bacteria that are not susceptible to alcohol-based hand gels:

Nonenveloped or nonlipohilic viruses:
Norovirus
Calicivirus
Picornavirus
Parvovirus

Bacterial spores:
B. anthracis (anthrax)
B. cereus (food poisoning)
C. botulinum (botulism)
C. tetani (tetanus)
C. perfringens (gas gangrene)
C. difficile

Protozoan oocysts:
Amebic dysentery
Giardia lamblia

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San Jose Mercury News - San Jose,CA,USA The recent discovery of half-empty bags of human blood, syringes and unshredded medical records at a San Jose landfill has regulators, hospitals and ...
http://www.mercurynews.com/healthandscience/ci_5836344?nclick_check=1

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HUMOR SECTION

THESE ARE ACTUAL EXCERPTS FROM STUDENT SCIENCE EXAM PAPERS:

Charles Darwin was a naturalist who wrote the organ of the
species.

Benjamin Franklin produced electricity by rubbing cats
backwards.

The theory of evolution was greatly objected to because it
made man think.

Three kinds of blood vessels are arteries, vanes and
caterpillers.

The process of turning steam back into water again is
called conversation.

The Earth makes one resolution every 24 hours.

To collect fumes of sulfur, hold a deacon over a flame
in a test tube.

Algebraical symbols are used when you do not know what
you are talking about.

The pistol of a flower is its only protection against
insects.

Dew is formed on leaves when the sun shines down on
them and makes them perspire.

A super-saturated solution is one that holds more than
it can hold.

A triangle which has an angle of 135 degrees is called
an obscene triangle.

When you haven't got enough iodine in your blood you
get a glacier.

For fractures: to see if the limb is broken, wiggle it
gently back and forth.

To remove dust from the eye, pull the eye down over
the nose.

For asphyxiation: apply artificial respiration until
the patient is dead.

When you smell an odorless gas, it is probably carbon
monoxide.

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CEU SITES---(CME and CE)
Those that are-----Free and Otherwise..........

Risks and Benefits of COX-2 Selective Inhibitors CME/CE 1.5 hrs
A comprehensive review of the current knowledge surrounding NSAIDs and
COX-2 inhibitors to enable rheumatologists to make informed decisions
about the management of pain in patients with arthritic diseases.
http://www.medscape.com/viewprogram/6872?sssdmh=dm1.258588&src=nlcmealert
this site is loaded with CE/CME offerings.......check it out.

Pay Only $34.99 for a full year of CONTACT HOURS
http://www.nursingspectrum.com/

Lifestyle and Complementary Therapies for ADHD: How Health Professionals Can Approach Patients...
CME/CE 0.75 CE........ Do these treatments work? Are they safe? Kathi J. Kemper, MD, MPH, examines the available data.
http://www.medscape.com/viewprogram/6929?sssdmh=dm1.262246&src=nlcmealert
CE 0.75 hrs.......... Urinary Tract Infections-- A primer for Clinicians
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WEBSITES/ LINKS

Always on the lookout for interesting websites / links. Please send
them to:
RNFrankie@bellsouth.net.


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MEDICAL RECALLS
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FDA notified healthcare professionals of a nationwide Class I recall of RF Denervation probes used with the Smith & Nephew Electrothermal 20S Spine System in RF heat lesion procedures for the relief of pain. The product was mislabeled. The device is a non-sterile (not germ free) device but it was labeled incorrectly as sterile (germ-free). It is a reusable item that is intended to be sterilized (made germ-free) by the medical facility prior to each use, including initial use. This error may result in infections with associated risks including, organ failure and/or death. http://www.fda.gov/medwatch/safety/2007/safety07.htm#RFprobes
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Woodridge Labs and FDA informed consumers and healthcare professionals of a recall of all lots of its DermaFreeze365 Instant Line Relaxing Formula and DermaFreeze365 Neck and Chest products. The products were recalled because certain lots tested positive for Pseudomonas aeruginosa bacteria. The bacteria may cause serious eye infections, urinary tract infections, respiratory system infections, dermatitis, soft tissue infections, bacteremia, bone and joint infections, gastrointestinal infections and a variety
of systemic infections, particularly in patients with severe burns and in cancer and AIDS patients who are immunosuppressed. Because DermaFreeze365 Instant Line Relaxing Formula may be applied in the area of the eye, there is a possibility that if the recalled product is inadvertently introduced in the eye, it could result in serious eye infections and, in rare circumstances, possible blindness.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#DermaFreeze365
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FDA notified consumers and healthcare professionals of a special webpage launched to warn about the dangers of buying isotretinoin online. Isotretinoin is a drug approved for the treatment of severe acne that does not respond to other forms of
treatment. If the drug is improperly used, it can cause severe side effects, including birth defects. Serious mental health problems have also been reported with isotretinoin use.

The new webpage,
http://www.fda.gov/buyonline/accutane, will appear in online search results for Accutane (isotretinoin) or one of the generic versions, Amnesteem, Claravis, and Sotret. The webpage warns that the drug should only be taken under the close
supervision of a physician or a pharmacist, and provides links to helpful information. The new webpage is in addition to special safeguards put in place by FDA and manufacturers of isotretinoin to reduce the risks of the drug, including a risk management program called iPLEDGE. The aim of iPLEDGE is to ensure that women using isotretinoin do not become pregnant, and that women who are pregnant do not use isotretinoin.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Accutane
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The manufacturers of pergolide in its brand-name (Permax; Valeant Pharmaceuticals) and generic forms have agreed to take it off the market after a pair of studies implicated the dopamine agonist in causing serious heart valve damage, the US Food and Drug
Administration (FDA) has announced [1].

Pergolide Withdrawn From US Market (Heartwire/ WebMD) March 29, 2007 Two case control studies published in the January 4, 2007 issue of the New England Journal of Medicine (NEJM) found significantly increased rates of valvular dysfunction in patients with Parkinson's disease taking pergolide and another dopamine antagonist, cabergoline [2,3]. As reported at the time by heartwire, the findings were consistent with abundant clinical and mechanistic evidence that inhibitors of the serotonin receptor 5-hydroxytryptamine 2B (5-HT2B), such as pergolide and cabergoline, cause a histologically distinct form of fibrotic
valvulopathy. Cabergoline is approved in the US for the treatment of hyperprolactinemic disorders at doses much lower and safer than those used in Parkinson's disease, according to the FDA statement.
http://www.medscape.com/viewarticle/554347?sssdmh=dm1.258910&src=nldne
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Ortho-McNeil and FDA informed healthcare professionals and consumers of a nationwide recall of griseofulvin oral suspension, a prescription medication used to treat ringworm and other fungal infections. The recall was issued based on two reports of glass
fragments found in bottles of the liquid formulation. The recall is limited to the liquid formulation of the medication and does not include
any other dosage form. Consumers in possession of the medication should contact the pharmacy where they purchased the drug to determine if they have the product that has been recalled and direct medical questions to their healthcare professional.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Grifulvin
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FDA Seizes All Medical Products From N.J. Device Manufacturer for Significant Manufacturing Violations
U.S. Food and Drug Administration (FDA) investigators and U.S. Marshals today seized all implantable medical devices from Shelhigh, Inc., Union, N.J., after finding significant deficiencies in the company's manufacturing processes. The deficiencies may compromise the safety and effectiveness of the products, particularly their sterility.

The products include pediatric heart valves and conduits (tube-like devices for blood flow), surgical patches, dural patches (to aid in tissue recovery after neurosurgery), annuloplasty rings (to help repair heart valves) and arterial grafts. The tissue-based devices are used in many surgical settings, including open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery. Critically ill patients, pediatric patients and immuno-compromised patients may be at greatest risk from the use of these devices.

All medical device companies must follow current good manufacturing practice, a set of requirements that help to ensure the safety and effectiveness of all medical products. Shelhigh's violations include: manufacturing products in a facility with a poorly constructed and poorly maintained clean room where sterilized devices are further processed; failing to adequately monitor critical manufacturing environments for possible microbial contamination; failing to properly test products for sterility and fever-causing contaminants; and failing to scientifically support product expiration dates.

The seizure follows an FDA inspection of the Shelhigh manufacturing facility last fall, as well as meetings with the company at which FDA warned Shelhigh that failure to correct its violations could result in an enforcement action. FDA also alerted the company to its manufacturing deficiencies and other violations in two warning letters. For a list of Medical devices manufactured by Shelhigh: FDA's Recalls, Market Withdrawals and Safety Alerts Page:
http://www.fda.gov/opacom/7alerts.html
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NURSING HINTS CORNER

Help Parients Get some Sleep-on the Night Shift Research shows that 80% of patients reported noises from other patients, equipment and the night staff makes sleeping in the hospital difficult. Here are some tips to help your patients get some sleep: (If the nurse does hourly rounds, patients are less upset, also).

> Turn down the lights and keep the noise to the bare minimum.
> Reduce the frequency of nighttime vital sign checks whenever possible.
> Be responsive to your patient's pain, and give analgesics as ordered.
> Minimize daytime sleeping.
> Be positive. Patients with positive feelings sleep better than those with negative feelings about their care.
> Keep in mind that pain and sleep medications can worsen sleep apnea in those who suffer from it.
Beverly Natole,BS,RRT
Neil S. Frriedman, RN, BA, RPSGT
Morristown, NJ.
www.rn.web Vol 70, No.4 April 2007 RN p55
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ADVERTISEMENTS
from the members


This ad is from Decubqueen (Gerry)..........

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This ad is from: GShort @AOL.com (Gwen) These are great little cakes !

http://www.delightfulgreetingcakes.com/worldsgreatest.php

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NEW MEMBERS

Welcome to :

mmacdonald@woodlakenursing.com (Marie)

Please send the prospective members' screen names and first names to
me:
RNFrankie@bellsouth.net

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ADDRESS CHANGES

NOTICE: I attempt to send newsletters to your current 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; I have no way to reach you without a correct email
address....You could always send me your Home number.......lol

So please send me your new name/address, ok?
RNFrankie@bellsouth.net


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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)

Membership BIO Committee...(if you haven't sent in your BIO....Please
send it to the appropriate section below) : Check by your screen
name's first letter.........

BCK131 @AOL.com (Chris) A thru B section,

Dick515 @AOL.com (Eileen) C thru D section,

GALLO RN@AOL.com (Sue) E thru I section,

rnfrankie @bellsouth.net (Frankie) J thru K section,

Jntcln@AOL.com (Janet) L thru M section,

GALLO RN @AOL.com (Sue) N thru Q section


Schulthe@AOL.com (Susan) R thru T section

Sandy1956@AOL.com (Sandy) U thru Z section.

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


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DISCLAIMER:

The intent of this PARADIGM BYTES Newsletter is to provide
communication and information for our members. Please research the
hyperlinks and information provided by our members. The articles and
web sites are not personally endorsed by the editors, nor do the
articles necessarily reflect the staff's views.

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THOUGHT FOR THE DAY

When will our consciences grow so tender that we will act
to prevent human misery rather than avenge it?
--ELEANOR ROOSEVELT

It is the spirit and not the form of law that keeps
justice alive.
--EARL WARREN

Hope to see you online..... Frankie
(
rnfrankie@bellsouth.net)

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