FDA reports nationwide recall of mislabeled ReliOn insulin syringes

The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

The recall applies to the following lot number and product information:

• Lot Number 813900, ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin. Only ReliOn syringes from this lot number and labeled as 100 units for use with U-100 insulin are the subject of the recall.

These syringes are distributed by Can-Am Care Corp and sold only by Wal-Mart at Wal-Mart stores and Sam’s Clubs under the ReliOn name. The FDA urges patients and health care professionals to check their syringe packaging carefully for syringes labeled as 100 units for use with U-100 insulin from Lot Number 813900.

Visit www.relion.com recall for more information.

Tyco Healthcare Group LP (Covidien) voluntarily recalled this lot of syringes on Oct. 9, 2008, asking that any units of the affected product be removed from inventory and placed in quarantine.

Buffalo Filter awarded contract with MAGNET

Buffalo Filter has announced that it has been awarded the MAGNET contract agreement for surgical smoke evacuation systems and accessories.  The dates of the agreement are October 1, 2008 to September 30, 2011. MAGNET has awarded Buffalo Filter a 3 year agreement for smoke evacuation systems and accessories. To learn more about Buffalo Filter, visit www.buffalofilter.com

Joint Commission Monograph to offer promising strategies for immunizing healthcare personnel

In an effort to help improve the rate of healthcare worker influenza immunization, The Joint Commission will produce a new monograph that includes examples of successful strategies and tools that have been used to improve immunization rates. The monograph, with funding from sanofi pasteur, will be produced in partnership with leaders in the fields of infection prevention and infectious disease from the Association for Professionals in Infection Control and Epidemiology (APIC), the Centers for Disease Control and Prevention (CDC), the Society for Healthcare Epidemiology of America (SHEA), and the National Foundation for Infectious Diseases (NFID).

According to the CDC, vaccination coverage of health care personnel remains low despite the documented benefits on patient outcomes, staff absenteeism, and reducing infections among staff. In addition, increased vaccination rates can reduce costs within healthcare organizations. Healthcare personnel can acquire influenza from patients and can also spread the disease to vulnerable patients or other staff. In 2007, The Joint Commission implemented a new standard in hospitals and long term care facilities requiring that influenza vaccinations be offered to staff and practitioners.

The Joint Commission will use funding derived, in part, from an educational grant from sanofi pasteur, to gather and review real-world examples of successful initiatives for implementing influenza immunization programs for health care personnel. The free, educational monograph, planned for publication in mid-2009, will include: Information about the impact and prevalence of the acquisition and transmission of influenza in the health care workplace; An overview of barriers to successful influenza immunization programs and strategies for overcoming them; and a compilation of promising practices and effective strategies for implementing health care personnel influenza immunization programs.

Health care organizations are encouraged to submit examples of immunization programs that have successfully increased immunization rates among health care personnel. Submissions can be made online at http://www.jointcommission.org/PatientSafety/InfectionControl

B. Braun expands contract agreements to include specialty pumps

B. Braun Medical Inc. announced it has signed a three-year agreement with Novation, the healthcare industry’s leading contracting services company, to provide specialty infusion pumps to Novation’s customers nationwide. The agreement, which took effect Monday, is a multi-source award for ambulatory and syringe pumps.

Ambulatory pumps covered under the agreement include the entire Curlin PainSmart IOD Pain Management System. The Curlin System is an advanced ambulatory electronic infusion system that offers a revolutionary safe, reliable and smart pain management technology for advanced pain therapy. Equipped with Information On Demand (IOD) technology for PCA, PCEA and epidural therapies, it is easy-to-use and flexible. A single pump can accommodate syringes, bags or bottles.

Healthy bones program reduces hip fractures by 37 percent

Proactive measures can reduce hip fracture rates by an average of 37.2 percent—and as much as 50 percent—among those at risk, according to a study conducted by Kaiser Permanente Southern California. The study was published online on November 3 by The Journal of Bone & Joint Surgery, a peer-reviewed journal.

The largest study of its kind, the five-year study tracked more than 625,000 male and female patients over the age of 50 in Southern California who had specific risk factors for osteoporosis and/or hip fractures. The implementation of a number of initiatives in the Kaiser Permanente Southern California Healthy Bones Program reduced the hip fracture rates beyond the goal rate of 25 percent.

The National Osteoporosis Foundation reports that although osteoporosis can affect people of all ages, the problem of osteoporosis has reached epidemic proportions with the rapidly aging population. Of the 10 million Americans who have osteoporosis, 80 percent are women. More than 300,000 hip fractures are reported annually in the United States. Twenty-four percent end up in a nursing home, 50 percent never reach their functional capacity, and 25 percent of patients with a hip fracture die in the first year after the incident.

Participating physicians in the study implemented a number of initiatives including increasing the use of bone density test (DXA scans) and anti-osteoporosis medications; adding osteoporosis education and home health programs; and standardizing the practice guidelines for osteoporosis management. www.ejbjs.org/cgi/content/abstract/90/Supplement_4/188.

J&J’s Prevention Cure

Johnson & Johnson hopes to create a new market by selling services to healthy folks to help keep them from ever needing such products. The health care giant acquired HealthMedia, a small Michigan company that develops sophisticated Web-coaching tools to help employees lose weight, quit smoking or manage stress. J&J has been a client of the firm and has been impressed with the results it has seen in its own workers. It hopes to expand the offering much more broadly and sell it to big companies and governments across the world. Ultimately J&J could sell wellness services directly to consumers as well.

The move is a path-breaking step as J&J seeks to pinpoint the next big healthcare growth opportunity. It comes as sales growth has ground to a halt in its drug business, thanks to safety problems and patent expirations that are bedeviling the entire pharmaceutical sector.

Wellness could be that next big thing, says J&J vice president Nicholas Valeriani, who was tapped a year ago to map out new business opportunities that go beyond J&J’s current focus on drugs, devices and consumer products. Today “the health care system is a disease-care system and consumers aren’t concerned about [their health] until they are sick,” says Valeriani. “A lot is pointing to the fact that the time is right for wellness and prevention.”

One problem is that counseling and behavior change is difficult and time consuming. It is easier for doctors just to prescribe a pill and send someone home, rather than teach them lifestyle changes that could produce the same benefit.

J&J hopes sophisticated web-based systems could be one answer. Using the latest evidence-based Medicine and proprietary algorithms, web coaching systems can scan in detailed patient data and design a customized program for that particular employee. Currently, various web-based wellness offerings are scattered about at various small companies, says Valeriani. “We are hoping to provide an integrated one-stop [shopping] from employers” hoping to deal with a multitude of conditions. (Forbes) http://www.forbes.com/healthcare/2008/10/28/healthcare-prevention-healthmedia-biz-healthcare_cz_rl_1028jnj.html

New model developed to estimate radiation skin doses during CT-guided interventional procedures

A new model that would allow interventional radiologists (radiologists who specialize in fine needle aspiration, fine needle biopsy and radiofrequency ablation) to better estimate patient radiation skin doses during CT guided interventional procedures has been developed according to a study performed at the Agios Savvas and Konstantopoulio Hospitals in Athens, Greece.

The theoretical model that was developed “considers the skin dose resulting from each CT slice, utilizing data that is already stored along with CT images. The skin doses calculated with this model were compared with those measured using films positioned under patients that underwent CT guided interventional procedures. The results indicate that peak skin doses can be estimated accurately using the new theoretical model that provides a base for skin dose estimation in real time,” said Dr. Tsalafoutas and colleagues.

“It is important for CT interventional radiologists to be able to monitor the radiation skin dose to their patient and optimize their techniques, so as to avoid skin injuries and minimize the probability of radiation induced carcinogenesis. The first step toward this goal is to understand the risk, to quantify it and to identify factors that affect it in order to be able to reduce it,” said Dr. Tsalafoutas.

The theoretical method developed could possibly lead to the development of specialized software for skin estimation in real time which “would be a significant technological advancement from the aspect of radiation protection,” said Dr. Tsalafoutas and colleagues. http://www.innovations-report.com/html/reports/studies/model_developed_estimate_radiation_skin_doses_ct_121732.htm

Minor shift in vaccine schedule has potential to reduce infant illness, death

A new study by researchers at Wake Forest University School of Medicine and Vanderbilt University suggests that protecting infants from a common, highly contagious and even deadly disease may be as easy as administering a routine vaccine two weeks earlier than it is typically given.

The shift has the potential to prevent at least 1,236 cases of pertussis, 898 hospitalizations and seven deaths attributable to pertussis each year in the United States, said Timothy R. Peters, M.D., co-lead author and an assistant professor of pediatrics at Brenner Children's Hospital, which is part of Wake Forest Baptist. The study appears in the November issue of Pediatrics.

"Rates of pertussis, which can be life-threatening in young infants, are increasing," Peters said. "Pertussis vaccine has been highly effective in defending children against this disease, and we find that modest adjustments in the timing of vaccine administration may offer enhanced protection to very young infants who are especially susceptible to severe disease."

While there is no lifelong protection against whooping cough, immunization is the best preventative measure. Current recommendations suggest five doses of the diphtheria-tetanus-acellular pertussis (DTaP) vaccine at 2, 4 and 6 months of age, with booster doses at 15 to 18 months and 4 to 6 years. Current recommendations also allow for administration of the first dose as early as 6 weeks of age, with the second and third doses at 3.5 months and 5.5 months.

The 2004 National Immunization Survey estimated that only 88 percent of infants had received one dose of DTaP vaccine by 3 months of age, 76 percent of infants had received two doses of DTaP vaccine by 5 months of age, and a mere 66 percent of infants had received the first three vital doses of DTaP vaccine by 7 months of age.

In this study, researchers sought to estimate the potential benefit of accelerating first dose administration from 2 months to 6 weeks of age. The data led researchers to expect that acceleration of the second and third doses by two weeks would prevent an additional 923 cases, 520 hospitalizations, and two deaths, according to the study.

Although administration of the first dose of the pertussis vaccine at 6 weeks of age is a change from the current routine practice of administration at 2 months, the minor dose acceleration falls within the current recommendations of the Advisory Committee on Immunization Practices and the American Academy of Pediatrics for the childhood vaccination schedule, and should have little impact on medical providers or on the number of outpatient physician visits for vaccines. All of the vaccines that are routinely given at a 2-month "well child" visit could be given at a replacement 6-week visit and still be in compliance with accepted vaccine schedule recommendations, the researchers report. http://www.sciencedaily.com/releases/2008/11/081103084053.htm