1. Mosocco, Doris J. RN, BSN, CHCE, COSC

Article Content

Class I Recall on Colleague and Colleague CX Volumetric Infusion Pumps

The FDA initiated a recall of all models of Baxter Healthcare Corp. Colleague Volumetric Infusion Pumps with model numbers 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R on December 13, 2005. The electronic pumps are used to give controlled amounts of medications or other fluids to patients through an IV or IA, epidural, or other direct line into the bloodstream.


The reasons for the recall include battery undercharging, false air detection alarms, gearbox wear, underinfusion, and nondetection of upstream occlusion. Any of these failures may delay or interrupt therapy, which could result in a life-threatening situation for the patient, depending on the type of therapy being administered.


The FDA has issued previous recall notices for the COLLEAGUE Volumetric Infusion pumps. Information explaining the reason for previous recalls can be found on the Agency's Web site under the following:


* September 19, 2005, Recall for Baxter COLLEAGUE Volumetric Infusion Pumps


* July 19, 2005, Recall for Baxter COLLEAGUE Volumetric Infusion Pumps



On December 13, 2005, Baxter sent a notice to all COLLEAGUE customers alerting them to the additional problems with the pump identified at this time. Questions regarding this recall can be answered at Baxter's Medication Delivery Services at 1-800-843-7867. 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 injury or death.


Comprehensive Information on Alzheimer's Disease

Looking for up-to-date information on Alzheimer's disease? Try ADEAR and check out the 2004-2005 Progress Report on Alzheimer's Disease, which is new to the site. The booklet is free and discusses recent scientific advances in the research of the disease. It begins with what is currently known about the disease, moves into highlights of recent studies related to AD, and finishes with a section on outlook for the future and discussion of AD research initiatives. The pamphlet is a great resource for staff development in educating clinicians on AD.


Focus on Elderly Fallers

In an article written by Debra J. Rose, PhD, and Leslie Allison, MS, PT, NCS, entitled "Identifying and Managing Elderly Fallers," the authors state that falls are not a normal part of aging and can be preventable to a large degree. An elderly person's fear of falling and psychological trauma can limit activity because the person may impose restrictions upon himself/herself. This can lead to loss of strength, flexibility, and mobility and actually increase the risk of future falls.


Elderly fallers are different from healthy, aged-matched counterparts according to current research. These fallers usually have small problems across multiple systems that interact to produce instability, thus increasing the risk of falling. Individually, none of the problems would cause a fall, but in combination the risk increases greatly. The more risk factors, the greater the risk for falls.


Statistics show that every year one third to one half of the population 65 years of age and older experiences falls, with half of this population falling repeatedly. Falls are considered the leading cause of injury in older adults. Five percent of falls lead to a fracture and cause approximately 300,000 hip fractures annually. Approximately 40% of those experiencing a hip fracture require nursing home admission, and 50% require a cane or walker for ambulation. Twenty percent will die each year.

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Falls are not considered a normal part of aging and can be prevented to a large degree. The article includes links to a variety of multidimensional geriatric balance assessments that can be printed for teaching and reference. If you want to learn more about setting the standard in balance and mobility, log on to the Web site for the entire article:


Additional reference material and information is also available.


Alzheimer's Disease Medications Fact Sheet

The Alzheimer's Disease Education & Referral (ADEAR) Center has available for download on their Web site a fact sheet containing the five prescription drugs currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of Alzheimer's disease (AD). The fact sheet is available in English or Spanish. Printable in PDF format, it makes for an excellent tool in educating patients and caregivers about the medications and includes dosage, side effects, and possible drug interactions.

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Source: ADEAR is a service of the National Institute on Aging, National Institutes of Health, and U.S. Department of Health and Human Services. The Web site address is


FDA Warning on Children's Teething Rings

On February 9, 2006, the FDA released a warning to stop using recalled liquid-filled children's teething rings manufactured by RC2 Brands (The First Years). The FDA states the liquid contained in these rings is contaminated with bacteria that may cause serious illness if swallowed, enters the lungs, or is absorbed through the mouth.

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RC2 Brands (The First Years), located in Stoughton, Massachusetts, stopped distributing the teethers and began a recall of these products in January 2006. The teething rings were sold nationwide between July 2005 and January 2006 at major retailers and grocery, drug, and specialty stores. The specific products subject to the recall are:


* Disney Days of Hunny Soft Cool Ring Teether-Style Y1447


* Disney Soft Cool Ring Teether-Style Y1470


* Disney Soft Cool Ring Teether-Style Y1490


* Sesame Beginnings Chill & Chew Teether-Style Y3095


* The First Years Cool Animal Teether, fish, zebra, and dinosaur designs-Style Y1473


* The First Years Floating Friend Teether-Style Y1474



According to Dr. Daniel Schultz, Director of the FDA's Center for Devices and Radiological Health, "FDA is closely monitoring the recall to ensure that all these teething rings are removed from the market and that consumers are alerted to the problem."


This is considered a Class I recall, and to date the firm has received 105 complaints of fluid leakage, 14 reports of sharp edges that resulted in 9 incidents of cuts, and 2 reports of infants biting through the rings.


The firm is asking consumers who purchased one of the recalled items to place it in a plastic bag and return it to:


Parent Service Center


RC2/The First Years


100 Technology Center Dr.


Stoughton, MA 02072



For additional information, go to the firm's Web site at




Rose, D. J, Allison, L. (2005). Identifying & managing elderly fallers. Retrieved February 6, 2006 from the NeuroCom International Web site:


Listing of Abbreviations Associated With Errors

Looking for a table of abbreviations, symbols, and dose designations that are often associated with errors? The Institute for Safe Medication Practices (ISMP) has one available for download and printing on their Web site. The table is 2 pages and contains the abbreviations, symbols, and dose designations reported to ISMP through the USP-ISMP Medication Error Reporting Program as being frequently misinterpreted and involved in harmful medication errors.


Those agencies accredited by the Joint Commission on Accreditation of Healthcare Organizations have established certain abbreviations must appear on a "do-not-use list," and ISMP has identified these on their listing with a double asterisk (**).


The ISMP indicates the abbreviations and symbols contained on this list should NEVER be used when communicating medical information. They caution including this information on internal communications, telephone/verbal prescriptions, computer-generated labels, labels for drug storage bins, medication administration records, and pharmacy and prescriber computer order entry screens.


The list also includes what to use in place of the do-not-use symbol or abbreviation: a handy tool for any clinician in the field!!


The Web site for the Institute for Safe Medication Practices is To find the table, scroll down to "medication safety tools & resources" and click on "Error-Prone Abbreviation List."


Keeping Your Brain Fit

As we age, our brain may lose some agility and can even deteriorate if we don't exercise it. The Alzheimer's Association Maintain Your Brain campaign list several ways to help keep our brain healthy as we age.

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Staying Mentally Active: We can strengthen our brain cells and the connections between them through stimulation. Activities aimed at strengthening and even generating new brain cells can include reading, working crossword puzzles, and memory games.


Social Activity: A brain-healthy diet consists of a combination of physical and mental activity, along with social interaction. Including each of these activities has proven more effective than any one of them alone. A study conducted of 800 men and women older than 75 years demonstrated a lower risk for the development of dementia if the subjects included in their daily schedules physical or mental activity or were socially active. The risk decreased even more when all three activities were included in their daily schedules.


Physical Activity: Physical activity increases blood flow to the brain and encourages the development of new brain cells. Exercise also reduces the risk of heart disease, stroke, and diabetes, which are all risk factors related to Alzheimer's disease. The Centers for Disease Control and Prevention and Tufts University developed a exercise program designed to help older adults increase muscle strength, maintain bone density, and increase balance, coordination, and mobility. The program is available at The program is Growing Stronger: Strength Training for Older Adults. The Web site includes exercise log sheets that can be downloaded, printed, and used to track and monitor progress.


Brain-Healthy Diet: A low-fat, low-cholesterol diet that includes dark vegetables and fruits has been highly recommended. A diet rich in these foods contains antioxidants that will help to protect brain cells. The brain needs the right balance of nutrients, including protein and sugar, to function well. A long-term study conducted with 1,500 adults concluded those who were obese in their middle-age years were two times as likely to experience dementia later in life. The risk of dementia was six times greater in those having high cholesterol and high blood pressure. The 2005 Dietary Guidelines for Americans are available for download at For additional information, see the Alzheimer's Association Web site at


Living With Alzheimer's at Home: Modification Tips

Research studies have found environmental modifications improve day-to-day functioning in people with AD. Physical factors, such as lighting, color, or noise, have an affect on the behavior of a person with the disease. Making these changes will make the home environment safer and can reduce symptoms such as wandering.


Initial changes include keeping often-used items in a certain place and labeling doors or drawers, which can enable the person to find items easily. Progression of the disease requires more extensive measures to ensure safety and reduce unwanted behaviors.


Clinical experience and research have proven that if physical environments are designed to support the abilities of the Alzheimer's patients, they can remain more independent and socially engaged and have fewer paranoid delusions and aggressive outbreaks. People with Alzheimer's eventually may lose access to what has been termed the "map room" of the brain: the systems that orient us in time and space. This loss can cause the patient to wander and lose their way to or from destinations. Modifying the home can jog short-term memories and assist patients in accessing long-term memories.


Several specific home modifications have proven to be beneficial in reducing certain behaviors in patients with Alzheimer's. They include the following:


* low levels of light during meals (improving eating habits)


* spaces that have minimal distractive clutter


* consistent background noise (favorite music or simulated nature sounds)


* placing objects that cue memories in clear view (photographs or mementoes)


* ensuring privacy and personalizing space (especially if the person resides in a healthcare facility)



The site also includes an extensive list to make your home safer, improve activities of daily living, and address specific behavioral problems, such as rummaging or wandering.


Driving with Alzheimer's: At what point should patients not be allowed? This site includes suggestions from the National Institute on Aging to assist in determining when it is no longer safe for the person with Alzheimer's to drive. Guidelines have also been issued by the American Academy of Neurology to physicians regarding the risks associated with patients with Alzheimer's driving.


Installing alarms or locks on doors can decrease the risk of wandering. Using identity bracelets also can facilitate the safe return of a wandering patient. "Supervised wandering" also is being tested, which enables the patient to wander and pace in safe, enclosed spaces or having someone accompany the person on walks.

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Additional information on the care of the patient with Alzheimer's can be found at The Alzheimer's Information Site at




The National Institute on Aging. Caregiver guide: Tips for caregivers of people with Alzheimer's disease. Available at:


Loss of Body Mass Linked to Alzheimer's Disease

A report published in the September 27, 2005, issue of Neurology links the decline in body mass index (BMI) with the eventual onset of AD. The study was conducted by Aron S. Buchman, MD, David A. Bennett, MD, and colleagues at Rush University Medical Center in Chicago as part of the Religious Orders Study. Funded by the National Institute on Aging (NIA), the Religious Orders Study is conducting research on aging and AD among Catholic nuns, priests, and brothers nationwide. According to Dallas W. Anderson, PhD, program director for population studies in the Dementias of Aging Branch of NIA's Neuroscience and Neuropsychology of Aging Program, "The study is significant in that it looks at body mass changes in the years preceding dementia and cognitive decline. Other studies have looked at BMI at only one point in time or studied body mass loss in people who already have AD."

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The study included 820 participants older than 65 years. Each participant received a yearly clinical evaluation to include a medical history, neurological examination, and extensive cognitive function testing. At the beginning of the study, the participants' BMI was measured and logged, with the average score of 27.4, and tracked annually thereafter. At the start of the study, none of the participants had dementia. During the follow-up period, 18% experienced AD. People who experienced a loss of one unit of BMI per year had a 35% greater risk of AD than did people with no change in BMI. Those with no change in BMI had a 20% greater risk of the disease than did people who gained 0.60 of a unit of BMI per year.


Investigators found a similar relationship between changes in BMI and rate of cognitive decline, the clinical hallmark of AD. The researchers found that a loss of 1 pound per year was associated with a 5% increase in the risk of AD. Dr. Bennett, director of the Rush Alzheimer's Disease Center, stated, "These findings suggest that subtle, unexplained body mass and weight loss in an older person may be an early sign of AD and can precede the development of obvious memory problems." Dr. Bennett goes on to say changes in a person's BMI are easy to measure in a doctor's office without expensive scanning equipment.


If you want to learn more about AD clinical trials, visit and search for Alzheimer's disease trials. Resources include the National Institute on Aging (


Pandemic Flu

What You Need to Know

The Department of Health and Human Services Centers for Disease Control and Prevention (CDC) has developed a Pandemic Influenza key fact sheet. Pandemic outbreaks are a result of new subtypes of influenza viruses that have yet to be circulated among people or that have not circulated among the human population for some time. A pandemic virus is the result of a process called "antigenic shift," causing a sudden, major change in influenza A viruses. The flu virus contains many different subtypes that differ based on certain proteins located on the surface of the virus (hemagglutinin or "HA" protein and the neuraminidase or "NA" protein). The sudden changes occur through new combinations of the HA and/or NA proteins on the surface of the virus, resulting in a new virus subtype. For the new virus to cause a pandemic, it must have the capacity to spread easily from person to person. The CDC and the World Health Organization (WHO) monitor influenza activity around the world.

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There were three pandemics during the 20th century: 1918-1919 Spanish Flu, resulting in more than 500,000 deaths in the United States and as many as 50 million deaths worldwide, making it the deadliest pandemic on record; the 1957-1958 Asian Flu caused approximately 70,000 deaths in the United States and was first identified in China, spreading to the United States within 4 months; and the 1968-1969 Hong Kong Flu was responsible for about 34,000 deaths in the United States and was first detected in Hong Kong early in 1968. Both the 1957 and 1968 pandemics were caused by viruses that contained both influenza and avian virus. The 1918 pandemic appeared to be the result of avian origin.


There are four different antiviral medications that have been approved by the FDA for the treatment or prevention of influenza: amantadine, rimantadine, oseltamivir, and zanamivir. Recent studies have found a high percentage of circulating viruses are resistant to amantadine and rimantadine, and on January 14, 2006, the CDC issued a Health Alert Notice (HAN) recommending that neither of these drugs be used for the treatment or prevention of influenza A in the United States.


Scientists are unable to predict the next pandemic or the severity of it but suggest the impact of a pandemic on the United States could be substantial. Figures estimate a medium level pandemic could cause 89,000 to 207,000 deaths, 314,000 to 734,000 hospitalizations, 18 to 42 million outpatient visits, and another 20 to 47 million people being sick. The economic impact could range between $71.3 and $166.5 billion with 15% to 35% of the U.S. population being affected.


To assist in preparing for the next pandemic, the U.S. Secretary of HHS created a multiagency National Influenza Pandemic Preparedness and Response Task Group in May 2005. The initiative involves the CDC and many other international, national, state and local agencies.


A comprehensive pandemic influenza plan can be found at the following Web site:


For additional information on pandemic flu, visit


Alzheimer's Disease Neuroimaging Study Launched Nationwide by the National Institutes of Health

The Alzheimer's Disease Neuroimaging Initiative (ADNI)-a project developed by the National Institutes of Health (NIH)-is seeking 800 older adults to participate in a study aimed at identifying biological markers of memory decline and Alzheimer's disease (AD).


Ultimately, scientists hope that brain and biological changes can be detected before memory decline and other symptoms appear, allowing the effectiveness of drugs to be evaluated at the earliest possible time. The $60 million, 5-year ADNI study is the most comprehensive effort to date to identify brain and other biological changes associated with memory decline. The project was begun by the National Institute on Aging (NIA) and is supported by more than a dozen other federal agencies and private-sector companies and organizations.


Investigators at 58 local study sites across the U.S. and Canada will be asking people aged 55 to 90 to become a part of this landmark research. Scientists are looking for new ways to measure changes in the brain that occur with normal aging and with the progression of mild cognitive impairment (MCI), a subtle but measurable transitional state between the cognitive changes of normal aging and very early AD. People with MCI have memory impairments but otherwise function well and do not meet clinical criteria for dementia.


There are investigators at all of the study sites throughout the United States and Canada. The public can find out more about participating in the research and obtain a list of study sites by contacting the NIA's Alzheimer's Disease Education and Referral (ADEAR) Center at 1-800-438-4380 or by visiting the ADNI section of the ADEAR Web site:


Those interested in participating in the project are encouraged to contact the study site closest to them. Spanish-language capabilities are available at some of the study sites. View a description of the study and list of sites at:


Source: NIA Web site: Retrieved February 10, 2006.


Recall: Ultilet Insulin Syringe 30 g 1/2 cc

Boca Medical Products and the FDA notified consumers and healthcare professionals of a recall of Ultilet Insulin Syringe 30 g 1/2 cc (Lot # 5GEXI, NDC # 08326-3002-50) because of possible bacterial presence of Bacillus cereus and Staphylococcus intermedius. This presents a risk of local infection due to soft tissue injection with a contaminated syringe as well as a risk of introduction of contaminating organisms into a previously sterile vial. The introduced contamination may degrade the insulin, which could lead to problems maintaining insulin levels. This product has been distributed to the following states: FL, NY, MA, AL, SC, NC, CO, TX, MI, AR. For any questions related to the case, consumers should call 1-800-354-8460. Read the complete FDA MedWatch 2006 Safety summary, including a link to the firm's press release, at:


HHN's Clipboard is coordinated by


Doris J. Mosocco, RN, BSN, CHCE, COSC