Support the fight against heart disease by participating in National Start! Walking Day this Wednesday, April 7. Adults nationwide are encouraged to make the pledge to Start! Walking and to become active and heart healthy, especially in the workplace.

Why walking? For starters, taking just ten minutes three times a day to walk will help you live longer. Walking also has the lowest dropout rate of any physical activity. Essentially it’s the simplest positive change you can make to effectively improve your health.

Getting at least 30 minutes of walking or moderate physical activity under your belt every day can help you:

• Reduce the risk of coronary heart disease
• Improve blood pressure and blood sugar levels
• Improve blood lipid profile
• Maintain body weight and lower the risk of obesity
• Reduce the risk of osteoporosis
• Reduce the risk of breast and colon cancer
• Reduce the risk of non insulin dependent (type 2) diabetes

Aside from the physical health benefits of exercise it also does wonders for your mental health. And who doesn’t need a mental holiday?

More information on National Start! Walking Day

Source: AmericanHeart.org

Share This

A number of people have no doubt been pulled over for speeding at some point in their lifetime. Maybe the law enforcement officer who pulled you over even lightly joked that “their sense humor stops at seven over.”

If this is you, whether pulled over and didn’t learn a lesson or have been making it by knocking on wood, pay attention. Cities and states need to fill budget gaps. One potential way to do so is issue less warnings and more tickets.

“Not only are the (speeding) tolerances much lower, but the frequency of a warning instead of a ticket is way down,” says James Baxter, president of the National Motorists Association, a Wisconsin-based drivers’ rights group that helps its members fight speeding tickets. “Most people, if they’re stopped now, are getting a ticket even if it’s only a minor violation of a few miles per hour.”

Sgt. Michael Edes, chairman of the National Troopers Coalition, which represents 45,000 troopers, claims there is no lower tolerance for speeding among state troopers. “I think you’ll find (enforcement is) actually the opposite,” he says. “A lot of states have cut (trooper) positions or frozen positions. Several states have grounded their aviation unit, so they’re not doing as many speed details.”

It’s no secret how the recession has affected community budgets across the nation. However, we have two sides to the story. What do you think? Scare tactic or are you going to listen to Ellen Griswold and slow down?

Source: USAToday.com, YouTube.com

Share This

Media Inquiries: Karen Riley, Karen.Riley@fda.hhs.gov, 301-796-4674

FDA Committed to Addressing Growing National Overdose Problem

The U.S. Food and Drug Administration (FDA) recognizes the five-fold increase in unintentional drug overdose deaths noted by the Centers for Disease
Control and Prevention between 1990 and 2006 as a serious public health concern. Much of this increase follows from increases in the deaths from the use of opioid drugs, which in 2006 accounted for more overdose deaths than heroin and cocaine combined. The agency is also concerned about misuse of benzodiazepines (e.g., Valium and Xanax), which accounted for 272,000 emergency department visits in 2008 (compared to 306,000 for opioids).

FDA is pursuing a variety of programs and initiatives in an effort to strike the right balance between ensuring patients access to important pain medications and mitigating the risks. These efforts include:

· The Safe Use Initiative: The mission of the Safe Use Initiative is to create and facilitate public and private collaborations within the healthcare community. Its goal is to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with partners who are committed to safe medication use (see http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm). Collaborations of this kind are essential for drugs like opioids, given the diverse factors that influence their use (e.g., legal, social, medical) and the many stakeholders working to assure they are used safely and effectively.

· Risk Evaluation and Mitigation Strategies (REMS) for Opioid Drugs: In 2007, Congress provided FDA with the authority to require REMS if that was necessary to ensure that the benefits of a drug outweigh its risks. These can include, for example, requirements for prescriber, pharmacist, and patient education about the risks and appropriate use of a drug, or other tools to better manage a drug’s risks On February 6, 2009, FDA sent letters to manufacturers of certain opioid drug products, indicating that these drugs will be required to have a REMS. The affected opioid drugs include long-acting and extended-release brand name and generic products that contain the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone (see http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm). FDA held a series of public stakeholder meetings in 2009 and opened a docket to receive public comments. FDA continues to accept public comments on the Agency’s approach to opioid REMS and plans to hold a public advisory committee meeting in the summer of 2010 to discuss proposals for this important safety program.

· Efforts on Acetaminophen: Every year in the United States, about 30,000 people are hospitalized with overdoses associated with acetaminophen – approximately half of which are unintentional. In June 2009, FDA convened an advisory committee meeting to provide expert input on options to reduce harm while maintaining access to this effective medication for pain. Potential strategies are currently under review.

· Strategies for the safe disposal of drugs: Certain medicines may be especially harmful and, in some cases, fatal in a single dose if they are accidentally taken. For this reason, FDA lists 26 drugs, including a number of potent opioids, that have special disposal directions indicating they should be flushed down the sink or toilet after the medicine is no longer needed. If disposed of down the sink or toilet, they cannot be accidently used by children, pets, or anybody else (Learn More: Disposal by Flushing of Certain Unused Medicines: What You Should Know).

· Evaluating the abuse potential of drugs: FDA has entered into a research collaboration with the National Institute on Drug Abuse (NIDA) to assess particular drugs for their abuse potential. The results of this research are provided to the Drug Enforcement Administration (DEA).

· Supporting efforts to identify safer pain medications. Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research recently reviewed this area in the New England Journal of Medicine. See http://content.nejm.org/cgi/content/full/361/22/2105.
Through these efforts and others, FDA will join with sister agencies, medical professionals, health care institutions, patient organizations and others to reduce the number of overdose deaths.

For more information from the Centers for Disease Control and Prevention: http://www.cdc.gov/Features/PoisonPrevention/

Presidential Proclamation — National Poison Prevention Week: http://www.whitehouse.gov/the-press-office/presidential-proclamation-national-poison-prevention-week

Source: fda.gov

Share This

FOR IMMEDIATE RELEASE - March 12, 2010 - Limerick, PA - Teleflex Incorporated provided an update today on the previously announced Arrow International, Inc. voluntary recall of ALL lots of its Arrow custom intravenous administration products (IV tubing sets and accessories) and certain Arrow arterial embolectomy catheters distributed prior to February 19, 2010.

Testing revealed pin holes in some of the pouches in which the products are packaged, and it has been determined that product sterility cannot be guaranteed. If product sterility has been compromised, there is a potential for infection, which could lead to serious injury or death. Arrow International has notified the United States Food and Drug Administration (FDA) and other health authorities of this recall.

Consumers who have:

· any Arrow product with a part number beginning with W followed by five numeric digits (e.g., W12345);
· any Arrow product with a part number beginning with MPI followed by five numeric digits (e.g., MPI-12345) which is an IV tubing set or tubing set accessory;
· either of the following two part numbers IV-850001-AAMC and IV-85020-UW;

should STOP using and return the items to Arrow International. Customers can find the entire affected product list at www.teleflexmedical.com.

The affected product was distributed globally to healthcare institutions and distributors.

No injuries have been reported to date however significant under-reporting of adverse events may have occurred.

Arrow International initiated this field corrective action in February 2010 and included notification to customers by letter. Customers were directed to immediately quarantine affected product and call the Arrow Custom IV Tubing hotline at 866-396-2111 to arrange for product return.

Customers with questions can contact the Arrow IV Tubing customer service hotline at 866-396-2111 between the hours of 8am and 8pm, ET, Monday through Friday.

Arrow International, Inc. is committed to providing high quality, safe and effective products. Any adverse events experienced with the use of this product, and/or quality problems can also be reported to the FDA’s MedWatch Adverse Event Reporting program by telephone at 1-800-FDA-1088 or online by visiting the FDA website at http://www.fda.gov/Safety/MedWatch/ default and following the instructions for submitting the appropriate forms electronically or by mail.

Neither the estimated costs nor the impact of this recall are expected to be material to Teleflex’s 2010 financial results. The voluntary recall and estimated costs were previously reported in the company’s Form 10-K filed February 25, 2010.

About Teleflex
Arrow International is a subsidiary of Teleflex Incorporated, a diversified global company with a significant presence in medical technology and niche businesses serving aerospace and commercial markets. Teleflex Medical, the company’s largest business segment, designs, manufactures and distributes medical devices for critical care and surgical applications serving customers in more than 140 countries. The company is focused on medical device technology that enables healthcare providers to improve outcomes, reduce infections and improve patient and provider safety. Additional information about Teleflex Incorporated can be obtained from the company’s website at www.teleflex.com.

Source: fda.gov

Share This

LifeScan, Inc. is conducting a voluntary recall in the United States of eight lots of OneTouch® SureStep® Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.

The eight lots of consumer OneTouch SureStep Test Strips being recalled are:

Lot #’s are located on the outer carton and test strip vial.

Patients with test strips from the recalled lots are asked to call LifeScan at 800 574-6139 between 5:00 am and 7:00 pm Pacific Time, seven days a week or visit www.SureStep.com to request replacement product. Replacement product will be shipped immediately and provided free of charge.

While waiting for replacement product to arrive, it is important that patients with recalled test strips continue to test their blood glucose. Patients with access to a meter that does not use OneTouch SureStep Test Strips should use this other meter to test their blood glucose until replacement product from LifeScan arrives. If an alternate meter is not available, patients may continue to test using the recalled OneTouch SureStep Test Strips. However, if patients obtain results above 400 mg/dL, they should contact their healthcare professional for further instructions because their glucose may be significantly higher.

LifeScan estimates approximately fourteen thousand packages (50- and 100-count) of consumer OneTouch SureStep Test Strips were distributed nationwide between August 1, 2009 and January 28, 2010.

No injuries associated with these recalled test strips have been reported. However, if patients use the falsely low test results to determine their insulin dose, they may give themselves too little insulin, which could result in poor blood glucose control. Patients with high blood glucose may or may not have certain symptoms including increased thirst, frequent urination, headaches, difficulty with concentration, blurred vision and fatigue (weak, tired feeling). High blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death.

Hospitals, clinics and other multi-patient facilities using SureStep®Pro®, SureStep®Flexx® or OneTouch® SureStep® Hospital Systems have also been notified of this issue. All three of these systems use SureStep®Pro® Test Strips which also may provide inaccurately low test results when the blood glucose reading is greater than 400 mg/dL. LifeScan has advised these facilities of the appropriate actions to take in order to continue to use these SureStepPro Test Strips. However, healthcare facilities with access to alternative means of testing should consider temporarily discontinuing their use of their SureStep Systems until replacement test strips are available.

This field action is limited to eight lots of OneTouch SureStep Test Strips sold for consumer use in the U.S., and select SureStepPro Test Strips used in healthcare facilities. Similar recall actions are being taken in other countries where the affected product was distributed.

In 2006 LifeScan stopped selling OneTouch SureStep Meters in the U.S. but continued to provide test strips. Today, OneTouch SureStep Meter users represent a very small portion of LifeScan’s total customer base. The vast majority of LifeScan’s customers now use OneTouch® Ultra® Brand Meters, which use an entirely different technology.

LifeScan, Inc. is a leading maker of blood glucose monitoring systems for people with diabetes. For information about diabetes care and LifeScan products and services, visit www.OneTouchDiabetes.com.

CONTACT: David Detmers, LifeScan, Inc., +1-408-942-5955

Source: fda.gov

Share This

Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall

Audience: Emergency medical professionals, hospital risk managers

[Posted 02/09/2010]: Cardiac Science Corporation and FDA notified healthcare professionals and consumers of a recall because the automated external defibrillator (AED) may not be able to deliver therapy during a cardiac resuscitation attempt, which may lead to serious adverse events or death. These AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions. Each of the approximately 12,200 devices affected in this recall can be confirmed at the Cardiac Science Web site, www.cardiacscience.com/AED195. The affected AEDs were manufactured or serviced between October 19, 2009 and January 15, 2010 and include the following models - Powerheart 9300A, 9300E, 9300P, 9390A, 9390E, CardioVive 92532 and CardioLife 9200G and 9231. Each affected AED should immediately be removed from service since it may not deliver the expected therapy.

Full Press Release

Source: fda.gov

Share This

Cardiovascular diseases are our nation’s number one killer. Since 1963 Congress has required the president to proclaim February “American Heart Month”. During this month the goal is to raise funds for research and pass along information about heart disease and stroke.

Not only does the American Heart Association work with administration to draft and sign this annual proclamation they also designed “My Life Check – Live Better With The Simple 7” with the goal of educating the public on how to improve their health one step at a time.

You probably guess most of these, if not all of them, but it’s never a bad idea to remind yourself of 7 Steps to a Healthier Life.

• Get Active
• Eat Better
• Lose Weight
• Stop Smoking
• Control Cholesterol
• Manage Blood Pressure
• Reduce Blood Sugar

Checkout My Life Check for more information on The Simple 7 and to get your own personal assessment test.

Sources: americanheart.org, mylifecheck.heart.org

Share This

TORRANCE, CA – January 21, 2010 – Pelican Products, Inc., the global leader in the design and manufacture of advanced lighting systems and virtually indestructible cases, today announced its contribution of $100,000 worth of head lamps and flashlights to the Haiti relief effort. The in-kind donation will help aid and assist rescuers, volunteers and emergency response teams in their relief efforts in Haiti.  Emergency triage shelters are without lighting, so head lamps allow doctors to treat patients in completely dark locations.

“Our prayers go out to the people of Haiti,” said Lyndon Faulkner, Pelican’s President and CEO. “It is impossible to see the devastation and not want to help. We hope that our donation, along with the donations of others across the county, will help bring some relief to the people of Haiti.”

Pelican™ cases are also being utilized by emergency response teams to transport and carry supplies to Haiti. Pelican cases are some of the most durable, longest lasting protector cases and are engineered to be completely watertight, crushproof and dustproof.

Source: pelican.com

Share This

The NYC ½ Marathon lottery closed last Wednesday night (1/6/10) and the winners were announced on Thursday. If you didn’t make it and you still want to take part in it you still have a chance. The FAF Team still has spots available. If you’re interested you can register with the Fresh Air Fund.

Share This

Since 1970 the first month of the year has been recognized as National Blood Donor Month. Why not kick off the New Year with a blood donation to your local Red Cross or other blood bank in honor of National Blood Donor Month? The whole process takes only about an hour of your time.

If you’re at least 17 years old, weigh at least 110 pounds, not on antibiotics, without infection or fever, feeling healthy the day of and it’s been at least eight weeks since your last donation why not go for it? There are some other guidelines but those are the biggies.

Blood has a shelf life of only 42 days. That means it constantly needs to be replenished. In the midst of not only cold and flu season but the rise in car accidents during the winter season clean, backup blood is needed.

For information on where you can donate blood here’s a link to the American Association of Blood Banks (AABB) which has a handy Blood Bank Locator Map.

Sources: aabb.org, healthnews.com, redcross.org

Share This