Sun Safety Tips

Summer is just around the corner and many of us are excited about the warm weather and sunshine. Because of the long winters and great local beaches, most New Englanders look forward to spending time outdoors in the sunshine. However, without adequate protection, the sun can be very dangerous. Skin cancers, such as melanoma, are a huge concern. According to the Centers for Disease Control and Prevention (CDC) there are 47,000 new cases of melanoma each year. But, melanoma causes 79% of skin cancer deaths. These sobering statistics emphasize the importance of protecting yourself while still enjoying the sun. Some sun safety tips are:

1. Always wear sunscreen. You should always wear sunscreen, even on cloudy days. It is important that it have an SPF of 15 or higher. Put on sunscreen at least 30 minutes before you plan to be in the sun; this allows time for the sunscreen to be absorbed into your skin. Sunscreen needs to be reapplied every two hours.


2. Re-apply sunscreen. Sunscreen must be reapplied throughout the day. It is very important to reapply after sweating, swimming or drying off with a towel. All of these activities actually wipe off the sunscreen you have applied.


3. Check the expiration dates. Sunscreen can expire and usually products have a listed expiration date. If there is not a date listed, you can use the sunscreen for 3 years. The U.S. Food & Drug Administration requires a 3-year effectiveness for sunscreen.
   
   
4. Avoid the sun during the middle of the day. The atmosphere does not absorb as many harmful UV rays during the middle of the day. That is way it is important to avoid the sun between 10a.m. and 4 p.m.


5. Wear sunglasses and protective clothing. Sunglasses help to shield your eyes from the direct sunlight. A wide-brimmed hat is a great way to protect your face from exposure to sunlight.


6. Avoid tanning. Having a tan, may look good now, but in the future can lead to wrinkles and age spots. There is not any safe way to tan. A tan is actually your body’s way of telling you the sun has injured your skin.


7. Be careful of tanning products. If you must tan, be aware of the products you are using. Not all tanning products contain sunscreen. Make sure to check the label. The U.S. Food & Drug Administration (FDA) requires a warning on tanning products that do not contain sunscreen or protect against sunburn.
   
   
8. Spend time in the shade. You can still enjoy the warm weather and sunshine without being directly exposed to the sun.


9. Carefully monitor your skin. If you notice any growths, bleeding or changes to your skin, it may be early signs of skin cancer. Skin cancer is highly treatable if caught early.

New Recalls Issued

On April 22, 2009, the U.S. Consumer Product Safety Commission (CPSC) issued two recalls involving outdoor activities, playground equipment and bicycles. The playground equipment was recalled because lead paint, while the bicycles were recalled because of defective parts.

The playground equipment was manufactured in Turkey, but it was distributed in the U.S. by SportsPlay Equipment Inc. The recalled equipment was sold nationwide, from January 2003 to December 2007. The equipment was recalled because it contained high levels of lead paint. Specifically the handrails and posts on the playgrounds had very high levels of lead. The lead paint on the equipment violates the lead paint ban. The new lead paint ban was passed last year in Congress. The ban was passed in response to the problems with Chinese toys and lead. There are new lead standards in place. Children’s products, such as playground equipment, are not supposed to contain any lead.

According to the CPSC, consumers should immediately stop using the recalled equipment. Owners of the playground equipment should call the CPSC to receive free replacement parts. There were many types of models are equipment recalled. The complete list can be found on the CPSC’s website.

It is very important that consumers stop using the playground equipment immediately, especially children. Children are at an increased risk of developing lead poisoning if they ingest chipping lead paint. Lead poisoning is very dangerous to children and can lead to learning problems, behavioral problems, slowed growth, mental retardation and brain damage.

The other recall focused upon bicycles. The recalled bicycles were manufactured in Taiwan and sold in the U.S. by Specialized Bicycle Components Inc. They were sold throughout the U.S. from September 2003 to August 2004. It is the parts of the bicycle that are defected and the reason for the recall.

The cable stop on the bicycle frame can loosen. When the cable loosens, the bicycle rider can lose control of the bike and fall off. There have been reports of two falls by riders. Both falls were serious, as the riders suffered fractures, which required surgery and other medical attention. Only bicycles with a single rivet attaching the cable stop to the bike frame are recalled. Other bicycles with two rivets are not included in the recall.

The CPSC advises consumers to stop using the bicycles immediately. Bike owners should return the bicycles to Specialized Bicycle Competent Inc. The bicycle will then receive free repairs. More information about both recalls can be found on the CPSC’s website.

Bicycle Safety

As the weather is starting to get warmer, people want to spend more time outdoors. Bike riding is a fun outdoor activity for people of all ages. However, bike riding can be dangerous if riders are not safe. According to the U.S. National Highway Traffic Safety Administration, there were nearly 700 died while riding a bike in 2007 and 43,000 bicyclists suffered injuries. There are a few basic safety tips to follow to keep you and your family safe when riding a bike:

1. Fit the bike to the child. Make sure the child can sit on the seat and balance the bicycle with the balls of both feet touching the ground without leaning to either side.
   
   
2. Measure your child before allowing your child to ride a bike. Measure your child’s inseam to the ground. Then measure the bike, from the top horizontal bar to the ground. The measurement should be 1-2 inches shorter than your child’s inseam. When looking at girl’s bikes, measure where the top bar would be if it were designed as a boy’s bike.
   
   
3. Look at the type of brakes on the bike. Bikes are designed with hand brakes or coaster brakes (stop when pedal backwards). Children under 10 should not use bikes with hand brakes. Only when children are 10 and older are their hands and wrists strong enough to use hand brakes.
   


4. Always wear a helmet. Children under the age of 15 are required to wear bicycle helmets in Rhode Island. Massachusetts does not require helmets to be worn, but they are strongly encouraged. However, helmets protect against head injuries. Wearing a helmet can reduce the risk of hear injury by 85%. Helmets should be wore level and low on the forehead, with two-finger widths space between the eyebrows and the helmet.
   


5. Measure your child’s head for the helmet. A correct fitting helmet is very important. Measure your child’s head at the forehead to determine what size helmet to purchase. Make sure the Snell Foundation or ANSI approves the helmet.
   


6. Always ride on the right side of the road. You should always be riding with the flow of traffic, which is normally on the right side of the road.
   


7. Obey all traffic laws, signs, lights and signals. When on the road, bicyclists are subject to the same traffic rules and laws as automobiles. Learning and using the appropriate hand signals is very helpful on the road.

For more Information about Bicycle Safety and Area Bike Paths, check out:

Rhode Island: http://www.dot.state.ri.us/bikeri/

Massachusetts:http://www.mhd.state.ma.us/default.asppgid=content/bikepaths01&sid=about

Volumetric Infusion Pumps Get Class One Recall

On March 11, 2009, the U.S. Food & Drug Administration (FDA) issued a Class One Recall for Single and Triple Channel COLLEAGUE Volumetric Infusion Pumps. Baxter Healthcare Corporation manufactures these infusion pumps. This is not the first recall for Baxter’s infusion pumps; it is the 7th recall in the past FOUR years. The FDA has failed at its job to protect the public’s safety. The FDA is allowing this product to remain on the market after seven recalls!

Volumetric infusion pumps are a type of medical device. The pump delivers intravenous medicine and fluids to patients. The drugs and fluids are delivered to the patient in controlled doses through intravenous (the vein), intra-arterial (the heart) or an epidural (through the spine). However, Baxter’s infusion pumps are defective.

On January 23, 2009, Baxter sent an Urgent Device Correction Letter to its users of the infusion pumps. According to the letter from Baxter, there were failure codes in the pumps. This caused the pumps to stop infusing when delivering medication and fluids to patients. In addition, the letter warned of a possibility the pump would overheat. If the pump overheated, this could lead to smoke and fire. These delays or failures to infuse medicine can be deadly. Patients may experience serious injury or even death. That is what a Class One Recall means; it is the most serious recall the FDA can order. In ordering a Class One Recall, there is a “reasonable probability that use of the product will cause serious injury or death.” This most recent recall pertains to several model types: Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161 and 2M9163.

What’s worse, the FDA has known about the problems with Baxter’s pumps for years. In July 2005, the FDA issued its first of seven recalls for Baxter Volumetric Infusion Pumps. The July 2005 recall involved a WORLD-WIDE recall of ALL models. The infusion pumps shut down while they were delivering medication to patients. As a result, the pump failure caused six serious injuries and three deaths. There were two more Class One recalls in September and December 2005. Not to mention, the THREE recalls in 2007. With the most recall, that makes seven recalls in less than four years.

Even knowing all of this information, the FDA waited nearly two months before issuing the current recall. Baxter sent the letter to customers on January 23rd, but it took the FDA until March 11th to issue a formal Class One Recall. Why did the FDA wait so long? People’s lives are at stake. Since 2005, Baxter has not sold the infusion pumps in the U.S. However, that does not mean pumps are not still being used. It is estimated that 200,000 pumps are currently in use in the United States, at hospitals and clinics. Patients are obviously still been affected these pumps. There have been at least 16 more deaths reported because of Baxter’s pumps, since the initial 2005 recall.

Why has the FDA not done more? The FDA needs to order hospitals to discontinue use of Baxter infusion pumps. Obviously Baxter will not do it. Even in their letter to users, Baxter did not mention recalling their pumps. Instead, Baxter advised users on how to replace their defective pumps. The FDA has failed the public by allowing seven recalls to occur. What more reasons does the FDA need to act? Seven recalls and nearly 20 deaths should be enough to make the FDA do its job.

U.S. Supreme Court Decision Favors Consumers

The U.S. Food & Drug Administration (FDA) recently gave a Black Box Warning the drug Reglan. This warning is needed because of the serious risks caused by Reglan.

Chronic use of Reglan causes a neurological disorder called tardive dyskinesia. This disorder is characterized by Parkinson-like symptoms. Patients suffer from repetitive and involuntary movements throughout their body. These symptoms are often irreversible. In addition, there is no treatment for tardive dyskinesia; people will suffer with these symptoms for the rest of the lives. In addition, Reglan can actually mask symptoms of tardive dyskinesia. The active drug in Reglan, metoclopramide, suppresses symptoms of tardive dyskinesia.

The FDA knows people are taking Reglan too long. Anything beyond three months is considered chronic use. The FDA knows these people are at risk for developing tardive dyskinesia. According to a study data from the FDA, over 20% of patients take Reglan for more than three months. In addition, two studies have shown that nearly 30% of patients who take Reglan for over a year develop tardive dyskinesia. These patients will constantly suffer from involuntary movements of their face, mouth, jaw, tongue, eyes, neck, shoulders, torso, larynx, diaphragm, arms, legs, feet, and hands. Clearly patients are not being made aware of the dangers of long term use. The FDA is not doing enough to warn patients about the risks of developing tardive dyskensia. In addition, the FDA has reports of people developing tardive dyskensia even though they took Reglan for less than three months.

Reglan is prescribed to treat gastroesophageal refleux, gastroesophageal relflux disease and diabetic gastroparesis. Older, female patients are at a high risk of developing tardive dyskinesia. However, children and infants have a greater risk of developing tardive dyskinesia than adults. Children and infants will also have to suffer from the symptoms of tardive dyskinesia for their entire lives.

The FDA is failing the public by not putting the Black Box Warning on Reglan sooner. The FDA also needs to make it clear that Reglan should only be used as a drug of last resort, meaning if all other treatments have failed. Because of the risk of developing an irreversible disorder, the FDA has to be better about warning the public of the dangers associated with Reglan. Patients should know the risk that taking a drug to treat acid reflux can lead to neurological disorders.