Hoverboard Injury Attorneys

One of the hottest 2015 holiday gifts, “hoverboards” may look fun,  but they also pose serious risks—and not just from falling. Also known as a smart board or balance board, these electric skateboards can catch fire or explode, prompting online retailers to pull some brands of self-balancing scooters.

hoverboard fire hazard
Photo: U.S. Consumer Product Safety Commission (CPSC)

How does a hoverboard work?

Although the term “hoverboard” evokes images of a floating skateboard or surf board-like device, current devices on the market actually roll on two wheels. In reality, a more accurate description of a hoverboard would be “a self-balancing scooter.”

Self-balancing scooters have several unique components that allow them to maintain their pitch and balance, including a gyroscope, microprocessors and independent motors that balance the board. Powering these components is a lithium ion battery, which is prone to catching fire or exploding, even when used as intended.

Hoverboard injuries

Hoverboard fall hazards

Like any ride-on toy with wheels, hoverboards present an inherent risk of falling. Nevertheless, since riders expect the board to balance itself, it is possible that more severe injuries will occur because the microprocessors, gyroscopes and motors can malfunction. If the board fails to stabilize itself, jerks unexpectedly or malfunctions, serious injuries may occur. According to the CPSC, ERs across the country have reported life-altering injuries including traumatic brain injuries, organ damage, concussions and bone fractures.

Hoverboard fire risks

Regrettably, falls may not be the cause of the most serious injuries associated with self-balancing scooters. According to the CPSC, there have been at least 16 reports of hoverboard fires in 12 states since the devices hit the market.

Fortunately, the harm caused by hoverboard malfunctions and fires have been limited largely to property thus far. However, the multiple house fires that have occurred while these devices were charging resulted in significant and serious losses. If there is a design flaw or manufacturing defect in these devices, the number of serious injuries and even fatalities will likely increase.

Hoverboard recall

Despite the reports of personal injuries and fires, no manufacturer has issued a hoverboard recall. However, the Consumer Product Safety Commission (CPSC) recognizes that hoverboards have caught fire during charging and use and is actively investigating the cause. On December 16, U.S. CPSC Chairman Elliot F. Kaye issued a statement regarding the risks. Chairman Kaye stated that he has directed the CPSC to “work non-stop” until the cause of the hoverboard fires is determined. Kaye also stated, “While the fire hazard has generated significant attention, I do not want to downplay the fall hazard.” He also expressed concern that “there is no safety standard in place for hoverboards.”

Hoverboard Safety Tips

For the thousands of families with hoverboards, the CPSC offers the following safety tips to help reduce the risk of an incident:

  • Avoid buying the product at a location (like a mall kiosk) or on a website that does not have information about who is selling the product and how they can be contacted if there is a problem
  • Do not charge a hoverboard overnight or when you are not able to observe the board
  • Charge and store in an open dry area away from items that can catch fire
  • Do not charge directly after riding (let the device cool for an hour before charging)
  • If giving a hoverboard to someone as a gift, leave it in its partially charged state. Do not take it out of the package to bring it to a full charge and then wrap it back up.
  • Look for the mark of a certified national testing laboratory. While this does not rule out counterfeits, the absence of such a mark means your safety is likely not a priority for that manufacturer.
  • Do not ride near vehicular traffic
  • Wear safety gear when using a hoverboard, including a skateboard helmet, knee and elbow pads and wrist guards

Please report incidents to CPSC via www.SaferProducts.gov.

Hoverboard lawsuit

If you or a loved one has suffered a life-changing injury due to a hoverboard malfunction that caused a serious fall or you are the victim of an explosion or fire due to a hoverboard’s lithium ion battery, contact an experienced personal injury attorney to discuss your claim.

You Are What You Eat

FDA proposes new guidelines for nutrition labels

Making healthy choices at the grocery store may soon get a bit easier. The FDA announced that it will focus on updating nutrition labels this year. The details have not been made public yet, but nutrition experts are hopeful that the new labels will be more straightforward.

“It’s time to update [labels] to make [them] easier for consumers to use,” said Margo Wootan, director of nutrition policy for the Center for Science in the Public Interest (CSPI).

The Center’s “wish list” for label changes includes:

  • Calories per serving should be more prominent
  • Eliminated extraneous information
  • Updated serving sizes
  • Eliminating deceptive single-size servings and providing nutrition information for large single serving containers
  • Differentiate between natural and added sugars and establish a Daily Value for added sugars
  • Fiber content should only reflect intact fibers from whole grains, beans, vegetables, fruit and other foods 

Pesticides

We like the CSPI nutrition label proposals, but wouldn’t it be nice if we knew what pesticides are used on the foods we eat? The American Academy of Pediatrics, the President’s Cancer Panel, and physicians nationwide have publicly advised consumers, especially children and pregnant women, to reduce our dietary exposure to synthetic pesticides. For example, the synthetic pesticide DDT – banned in the United States since 1972 but still used as a pesticide in other countries – may increase the risk of Alzheimer ’s disease.

In a study recently published JAMA Neurology, Rutgers scientists discuss their findings in which levels of DDE, the chemical compound left when DDT breaks down, were higher in the blood of late-onset Alzheimer’s disease patients compared to those without the disease.

Although the levels of DDT and DDE have decreased significantly in the United States over the last three decades, the toxic pesticide is still found in 75 to 80 percent of the blood samples collected from the Centers for Disease Control and Prevention for a national health and nutrition survey. This occurs, scientists say, because the chemical can take decades to breakdown in the environment. In addition, people may be exposed to the pesticide by consuming imported fruits, vegetables and grains where DDT is still being used and eating fish from contaminated waterways.

GMOs

As more and more crops containing genetically modified organisms, known as GMOs, make their way into the marketplace, there has been a rise in public sentiment to require GMO labeling.

Reuters reports, “The issue is hotly contested, with more than 20 states considering laws to mandate labeling of foods made with gene-altered corn, soybeans, sugar beets and other biotech crops. Currently, labeling of such foods is voluntary.”

If you want to avoid GMOs in your diet, look for foods labeled as “organic.” Federal law prohibits the use of genetic engineering prohibited in foods defined as organic. Nevertheless, these products may contain slight traces of genetically modified organisms in certain cases.

Knowledge is power 

Please take the time to read the labels on foods you buy. Be wary of front labels claiming a product is “natural,” that it can reduce cholesterol, or provides other medical benefits.

“In a perfect world, agencies such as the Food and Drug Administration and the Federal Trade Commission would be aggressively policing the marketplace and taking enforcement action against companies like these,” said CSPI executive director Michael F. Jacobson. “Until then, lawsuits by consumer groups and private citizens can play an important role by using the courts to get companies to change their labeling and advertising for the better.”

What information would YOU like to see on nutrition labels?
Post your suggestions in the comments section below.

 

Sources:

Fat, calories, sugar: Nutrition labels getting a makeover” by Jen Christensen, CNN, January 24, 2014.

Food Labeling Chaos: The case for reform” by Bruce Silverglade and Ilene Ringel Heller, © 2010 by Center for Science in the Public Interest.

DDT exposure more common in people with Alzheimer’s: study” by Genevra Pettman, Reuters Health, January 27, 2014.

Organic food and farm groups ask Obama to require GMO food labels” by Carey Gillam, Reuters, January 16, 2014.

Mass Torts and Class Action Suits

Most of the things we purchase are safe. Unfortunately, however, sometimes a defective product, drug, or medical device causes consumers to suffer an injury. In the U.S., when many people are harmed by the same defendant (or group of defendants), depending on the circumstances, individual lawsuits may be grouped together.

Learn the Lingo

 

A tort is a civil wrong that results in injury to someone’s health or property. The person (or corporation) who commits the tort is liable for the harm suffered by the victim.

If a lawsuit is filed, the victim becomes a plaintiff and party sued is the defendant. The plaintiff typically sues the defendant to recover damages (monetary compensation for the plaintiff’s injury).

To begin preparing for trial, both sides engage in discovery – the formal exchange of information between parties about the witnesses and evidence they will present at trial.

Class Action

A Class Action is a type of legal action where a single lawsuit is filed on behalf of an entire group of plaintiffs who share a set of similar circumstances, damages and injuries. These proceedings are designed to cut down on the number of court cases, and occur when each person’s injury is not worth the time and money of hiring an attorney on an individual basis.

A class action lawsuit must meet certain criteria. Members of the class must be notified of the suit and given the change to “opt out” or find their own private counsel. Before filing a class action lawsuit, a motion is filed in court for the lead plaintiff to act on behalf of the group or class.

Mass Tort

In a Mass Tort action, sometimes referred to as Multi District Litigation (MDL), each plaintiff has an individual claim resulting from distinct damages. Although Mass Tort claims also seek to streamline the court schedule, they are handled differently than a Class Action.

In most cases, Mass Tort claims are brought when dangerous drugs or defective products injure a large number of consumers who reside in different states. Since drugs and product defects can cause a wide range of problems for different individuals, their cases rarely fit into a single class.

Mass Tort litigation allows one attorney (or groups of attorneys) to represent several injured parties in individual cases. To speed things along, pretrial investigations conducted by one attorney can be shared among all cases. This permits a nationwide network of lawyers to pool their resources, information and ideas to help secure fair settlements for all plaintiffs. Once the pretrial discovery phase is complete, each case returns to the local court where it was originally filed for trial.

If you have been injured by a defective product, drug, or medical device, you may be entitled to recover money damages. Call 1-800-ELK-OHIO or contact us online to schedule your free consultation.


Judge Fines Pradaxa Drugmaker $1M over Missing Files

German pharmaceutical company Boehringer Ingelheim has been fined $931,000 in federal court for withholding or failing to preserve documents sought by plaintiffs in hundreds of Pradaxa lawsuits.

According to court documents, Boehringer failed to preserve or produce files belonging to a high-level scientist, sales representatives, consultants and others. The drugmaker also failed to provide access to documents on their computer network and allowed text messages to be deleted.

U.S. District Judge David Herndon, overseeing the multidistrict litigation, called the wrongs “egregious in the eyes of the Court.” In his scathing 51-page decision, Herndon ruled that Boehringer executives acted “in bad faith,” calling their defenses unbelievable and “nonsense.”

This was not the first time Boehringer has been sanctioned for failure to comply with a court order during the trial. In his September 18, 2013 decision, Judge Herndon imposed a $29,540.00 fine  – one he thought would remedy the discovery abuses and prevent them from occurring in the future.

The judge’s patience had obviously worn thin as he imposed the nearly $1 million in additional fines on Monday, “Once again, the defendants do not get to choose which evidence they want to produce and from which sources.”

About Pradaxa

The FDA approved the anticoagulant Pradaxa (dabigatran) in 2010 for the prevention of stroke in patients with atrial fibrillation. Just one year later, there were 3,781 reports of serious adverse events, including 542 patient deaths. According to the Institute for Safe Medication Practices, Pradaxa surpassed all other regularly monitored drugs in reports of hemorrhage (2,367 cases), acute renal failure (291), and stroke (644). It was also suspect in 15 cases of liver failure.

Court records indicate more than 1,700 lawsuits have been filed in the Southern District of Illinois on behalf of alleged victims of Pradaxa bleeding. Boehringer Ingelheim is accused of concealing knowledge about the drug’s risks. Plaintiffs also allege that the company failed to provide adequate warnings regarding the lack of an effective antidote for Pradaxa bleeding.

The case is titled In re Pradaxa Products Liability Litigation, 12-MD-02385-DRH-SCW, U.S. District Court, Southern District of Illinois (East St. Louis). The first bellwether trial in the Pradaxa Multi District Litigation is currently scheduled for August 2014.

 

Source:

“Boehringer to Pay $931,000 Fine Over Lost Pradaxa Files” by Jef Feeley and Phil Milford, Bloomberg News, December 10, 2013.

Dangerous Toys

dec_article2This holiday season, we all need to be aware of the toys we buy and make sure they are safe for children. Be sure to read labels and only buy age-appropriate toys. Remember that siblings share toys, and a gift intended for an older child with small parts could pose a safety hazard in the hands of a younger sibling. You can avoid recalled products by checking the Consumer Product Safety Commission (CPSC) website, www.cpsc.gov.

While some risks are obvious, other hidden dangers may be lurking in your child’s toys. (Scroll down for the full “Trouble in Toyland” list of dangerous toys.)

Lead and other Toxic Chemicals

Exposure to lead can affect almost every organ and system in the human body, especially the central nervous system. Lead can cause permanent mental and developmental impairments in young children. While the government has placed limits on lead in toys, not every toy is individually tested.

Choking Hazards

Choking – on small toy parts, on small balls, on marbles, batteries and on balloons – continues to be the major cause of toy-related deaths and injuries. Between 2001 and 2012, more than 90 children died from choking incidents.

Wheeled Riding Toys

Scooters and other riding toys, such as skateboards, and in-line skates go fast, and falls could be deadly. Helmets and safety gear should be worn properly at all times, and they should be sized to fit. Parents should be aware that even small children may be harmed at slow speeds. According to the CPSC, in 2012 four children were found dead in swimming pools with their tricycles, and one child received a fatal head injury after his tricycle toppled over

Magnets

Magnet toys such as the Buckyball magnets that are the subject of a CPSC court action, are still available and continue to cause accidents. The CPSC staff has estimated that between 2009 and 2011 there were 1,700 emergency room cases nationwide involving the ingestion of high powered magnets. More than 70% of these cases involved children between the ages of 4 and 12.

Noisy Toys

Research has shown that 33 percent of Americans with hearing loss can attribute it in part to noise. The third National Health and Nutrition Examination Survey showed that one in five U.S. children will have some degree of hearing loss by the time they reach age 12. This may be in part due to many children using toys and other children’s products such as music players that emit loud sounds.The National Institute on Deafness and Other Communication Disorders advises that prolonged exposure to noise above 85 decibels will cause gradual hearing loss in any age range.

Trouble in Toyland

The 2013 Trouble in Toyland report is the 28th annual U.S. Public Interest Research Group (PIRG) survey of toy safety. In the report, U.S. PIRG provides safety guidelines for consumers when purchasing toys for small children and provides examples of toys currently on store shelves that may pose potential safety hazards. The private consumer safety group visited numerous national toy stores, malls and dollar stores this fall to identify potentially dangerous toys. Their investigation focused on toys that pose a potential toxic, choking, strangulation or noise hazard.

PIRG’s List of Dangerous Toys*

Toys containing small parts

  • Princess Wand, made by Greenbrier International, sold at Dollar Store for $1

Toys containing small parts with label violations

  • Bead Kit, made by Greenbrier International, sold at Dollar Store for $1
  • Littlest Pet Shop – #2744 Horse, made by Hasbro, sold at Kmart for $3.99
  • Littlest Pet Shop – Candyswirl Dreams Collection #3313, made by Hasbro, sold at Wal-Mart for $4.49
  • Littlest Pet Shop – Sunil Nevla, made by Hasbro, sold at Wal-Mart for $3.99
  • Littlest Pet Shop – Candyswirl Dreams Collection #3317, made by Hasbro, sold at Wal-Mart for $4.49
  • Littlest Pet Shop – Seal and Dolphins, made by Hasbro, sold at Kmart for $4.49

Small ball-Like toys, toy parts, and rounded food toys posing choking hazards

  • Gobble Gobble Guppies, made by Swimways, sold at Kmart for $14.99
  • Super Play Food Set, made by Geoffrey, sold at Toys-R-Us for $19.99

Near-small parts that may pose choking hazards

  • Fisher-Price Loving Family Outdoor Barbecue, made by Mattel, sold at Kmart for $22.99

Balloons marketed to children under eight years old

  • Punch Balloons made by Toy Investments, sold at Toys-R-Us for $.98

Toys and children’s products containing lead and other toxic chemicals

  • Captain America Soft Shield, made by Disguise, sold at Toys-R-Us for $8.99
  • Set of 10 Rings/Bagues, made by Greenbrier International, sold at Dollar Tree for $1
  • Teenage Mutant Ninja Turtles Pencil Case, made by Innovative Design, sold at Toys-R-Us for $4.99
  • Lamaze Take and Tidy Activity Mat, made by TOMY, sold at Babies-R-Us for $39.99
  • Monster High Skelita Halloween Costume, made by Rubie’s Costume Co, sold at Toys-R-Us for $29.99

Examples of Potentially hazardous magnet toys

  • Sonic Sound Sizzlers Noise Magnets, made by JA-RU, sold at Dollar General for $1

Examples of Potential Noise Hazards

  • Chat & Count Smart Phone, made by Leap Frog Enterprises, sold at Babies-R-Us for $17.99
  • Lil’ Pal Phone, made by Leap Frog Enterprises, sold at Babies-R-Us for $9.99
  • Fisher Price Laugh & Learn Remote, made by Mattel, sold Babies-R-Us for $12.99

*Remember, not all toys are tested and there is no comprehensive list of potentially hazardous toys. Examine toys carefully for potential dangers before you make a purchase.

Sources:

Toy-Related Deaths and Injuries Calendar Year 2012” by Yongling Tu, Division of Hazard Analysis, Directorate for Epidemiology, U.S. Consumer Product Safety Commission, November 2013.

‘Trouble in Toyland’ report finds dangerous toys still for sale” by Michelle Castillo, CBS News, November 26, 2013.

Your Halloween contact lenses may be scarier than you think

Halloween contact lenses can cause serious eye injuries

(Updated 10/15/2015) – Those eerie contact lenses you saw online might seem like the perfect addition to your Halloween costume, but decorative contact lenses may limit your vision and can cause permanent damage to your eyes.

Also known as cosmetic or theatrical lenses, decorative contact lenses are used to change the look of your eyes, not to correct vision. Available in a wide range of styles, they can simply change the color of your eyes or create fantastic effects, such as cat eyes.

Study: Decorative contact lenses contain dangerous chemicals

The American Academy of Ophthalmology issued a warning about over-the-counter decorative contact lenses after a recent study revealed that several varieties tested positive for chlorine and other harmful chemicals.

“One pair seeped chlorine after a routine rinse, prompting concern from researchers about toxicity to the eye,” the ophthalmology academy wrote in a release. “The study also noted that colorants printed or pressed onto some decorative lenses create an uneven texture. Those rough surfaces could scratch the eyes, potentially allowing in bacteria that can cause infection and even blindness.”

Novelty lenses can limit vision

Another study, published in the British Journal of Ophthalmology, showed that some colored lenses make it difficult to see, especially in low light. Vision exams indicated people wearing contacts with a limited clear, open space around the pupil had difficulty focusing. Objects at a distance became blurrier and contrast was diminished, making it difficult to spot dark objects at night or pale items against a light background.

Halloween contact lens safety tips

You should never buy any contact lenses from a street vendor, a beauty supply store, flea market, novelty store, Halloween store or online if the site doesn’t require a prescription.

Wearing any contact lenses can cause serious damage to your eyes if the lenses are not used correctly. Decorative contacts can lead to eye pain, bacterial infections and corneal ulcers. One study found that the lenses increased by 16 times the risk of developing keratitis, a potentially blinding infection that causes ulcers in the eye.

Prevent Blindness Ohio offers the following safety tips regarding cosmetic contact lenses:
Always visit a licensed eye care professional to be fitted for cosmetic contact lenses.

  • Never buy contact lenses without a prescription.
  • Always clean and disinfect contact lenses according to instructions.
  • Always use water-soluble cosmetics or those labeled safe for use with contact lenses. Do not apply skin creams or moisturizers too close to the eyes.
  • Never wear opaque lenses if you have any problems with night vision.
  • Never share or trade your contact lenses with anyone.
  • Be watchful about your child’s or teen’s appearance. If they are wearing cosmetic contacts, question them about where they obtained them.

Feds seize illegal contact lenses

In 2013, the federal government warned consumers about the dangers associated with decorative contact lenses and began cracking down on illegal sales.

Contact lenses are actually medical devices and as such, are overseen by the U.S. Food and Drug Administration (FDA).[1] In an ongoing effort – dubbed “Operation Double Vision” – the FDA and Immigration and Customs Enforcement (ICE) officials are working to seize counterfeit contact lenses and illegally imported decorative lenses.

That same year, Ohio Attorney General Mike DeWine teamed with Prevent Blindness Ohio and the Ohio Optical Dispensers board to warn consumers about the dangers of decorative contact lenses.

“As we prepare for Halloween, we want to remind Ohio families that over-the-counter sales of decorative contact lenses are illegal,” DeWine said. “Contact lenses are medical devices, and if they are not administered properly, they can cause serious eye infections that can lead to permanent damage, including blindness.”

Buying Decorative Contact Lenses

You can buy contact lenses, including decorative contact lenses, from an eye care doctor, on the Internet or from a mail-order company. It’s very important that you only buy contact lenses from a company that sells FDA-cleared or approved contact lenses and requires you to provide a prescription.

Anyone selling you contact lenses must get your prescription and verify it with your doctor. They should request not only the prescription, but also the name of your doctor and their phone number. If they don’t ask for this information, they are breaking federal law and could be selling you illegal contact lenses.

Protect your eyes by having an eye exam, getting a prescription and buying contact lenses from a legal source.

For more information or to report the illegal sales of cosmetic contact lenses, contact the Ohio Optical Dispensers Board at (614) 466-9709 or www.optical.ohio.gov.

Editor’s Note: This post was originally published in October 2013 and has been updated with new content.

 

Sources

Ji, Yong Woo, et al. “Comparison of Surface Roughness and Bacterial Adhesion Between Cosmetic Contact Lenses and Conventional Contact Lenses.” Eye & contact lens 41.1 (2015): 25-33.

Jung, Ji Won, et al. “Effect of the pigment-free optical zone diameter of decorative tinted soft contact lenses on visual function.” British Journal of Ophthalmology (2015): bjophthalmol-2015.

 


 

[1] On November 9, 2005, section 520(n) was added to the Federal Food, Drug, and Cosmetic Act (the Act) by Public Law 109-96 to establish that all contact lenses are devices under section 201(h) of the Act. Because all contact lenses are now regulated as devices, including decorative, non-corrective contact lenses intended only to change the normal appearance of the eye, all contact lenses must be the subject of a cleared premarket notification (510(k)) or an approved premarket approval application (PMA) before they may be legally marketed. Additional device authorities, such as the requirement that lenses be dispensed only upon a prescription order, also apply.

 

Toyota Recall Due to Spiders?

Toyota is recalling over 800,000 vehicles worldwide because of electrical issues that may cause problems with airbag deployment.

Spider WebIn a press release, Toyota announced a recall of the 2012 and 2013 model years of the Camry, Camry Hybrid, Avalon, Avalon Hybrid, and Venza due to a problem with the air conditioning condenser unit housing. Toyota spokesperson Cindy Knight told CNN that spider webs in the vents could create a blockage, causing excess condensation.

The company says that water from the air conditioning condenser unit housing could leak onto the airbag control module and cause a short circuit. This may cause the air bag light to come on, render air bags inoperable, or even cause the driver’s side air bag to deploy inadvertently. Since air bags deploy so rapidly and caustic chemicals are used to inflate them, injuries such as burns, abrasions, as well as damage to hearing and vision may occur. Deployment may also cause broken nose, fingers, hands, or arms. Head, neck, and internal injuries are also a frequent casualty of airbag deployment.

Toyota reported there could also be a loss of power steering in some cases. This dangerous condition makes the steering wheel difficult to turn and limits a driver’s ability to steer the vehicle. To fix the problem, Toyota says its dealers will apply sealant and install a cover to the air conditioning condenser unit-housing seam located above the airbag control module.

Owners of the involved vehicles will be notified by first class mail to return their vehicles to a Toyota dealer for the repair. For more information, visit www.toyota.com/recall or phone Toyota customer service at 1-800-331-4331.

 

Source:Toyota recall: Spiders are causing airbag problems” by Schuyler Velasco, Christian Science Monitor, October 18, 2013.

Medical Apps – Who’s Responsible?

FDA looking at mobile medical applications

photo_13870_20090831From programming your DVR to dealing with a car accident, these days there seems to be an “app” for everything. Now, according to the U.S. Food and Drug Administration, when a mobile device runs certain medical applications, it will be subject to FDA oversight.

The FDA has issued guidance to mobile app developers in an effort to protect patients from medical apps that could be harmful if they do not work properly. The guidance document states that the FDA will focus its oversight on medical mobile apps that meet the definition of a medical device in the Federal Food, Drug, and Cosmetic Act and are intended to:

  • transform a mobile device into a medical device regulated by FDA; or
  • be used as an accessory to a medical device regulated by the FDA

A mobile device is “transformed” into a medical device when it performs the same task as a medical device that is already regulated by the FDA, such as controlling the inflation and deflation of a blood pressure cuff. Accessories to medical devices would include apps that enable physicians to make diagnoses based on medical test results sent to their mobile device, such as x-rays or blood work.

Not all medical apps will be regulated

While many medical apps may fall into these two categories, the FDA stated they are focusing their oversight “on mobile apps that are devices for which safety and effectiveness are critical.” This means apps that recommend calorie or carbohydrate intake or track trends in a patient’s blood pressure or glucose levels would not be regulated.

As more medical apps are developed for the healthcare industry, the government must adapt its standards to protect patients and to set standards for liability in the event of an adverse effect. The FDA has made it clear that their policy only applies to the application software and not to the use of smartphones or tablets themselves. Providers of mobile medical apps, such as the iTunes store, would not be treated as a medical device manufacturer.

The FDA has already cleared around 100 mobile medical apps so far, and experts expect the market to grow exponentially in the future. If you are considering using a medical app on your mobile device, it is important to speak to your doctor. While many of these apps are helpful, they are not meant to be a substitute for care from a qualified professional.

 

Sources:

FDA to regulate some medical-related apps” by Michelle Castillo, CBS News, September 24, 2013.

“Keeping Up with Progress in Mobile Medical Apps” FDA Consumer Health Information, September 2013.

IKEA Beds Recalled

Scandinavian furniture chain IKEA has recalled 40,000 children’s beds. The U.S. Consumer Product Commission and Canadian officials both received reports of breakage and an increased risk of injury.

IKEA announced Thursday it is recalling KRITTER and SNIGLAR junior beds because a metal rod may detach, causing partial detachment of the guard rail and exposed sharp metal edges that present a laceration hazard.

If you own either of these beds, you should immediately check the product label, located either on the headboard or on the underside of the bed. According to IKEA, the company is “recalling for repair” batches of KRITTER beds stamped with manufacturing dates 1114-1322 and SNIGLAR beds labeled 1114-1318.

The beds were sold at IKEA stores and on its website from July 2005 through May 2013. Customers should stop using the beds immediately and contact customer service at (888) 966-4532 for a free repair kit.

While we’re on the topic of children’s beds, here’s some information I’d like to share:

Bunk Bed Safety Tips

Playing on any bed can be risky, but bunk beds are especially dangerous. In the United States, kids sustain around 36,000 bunk bed-related injuries every year. Accidents don’t just happen when children are playing around on the beds, they can also be at risk while sleeping. It’s important to talk to your kids about bunk bed safety. Nationwide Children’s Hospital in Columbus, Ohio suggests the following guidelines:

  • Use guardrails on both sides of the top bunk. The gaps in the guardrails should be 3.5 inches or smaller to prevent strangulation.
  • Guardrails need to extend at least 5 inches above the mattress top to prevent kids from rolling off.
  • Check that the mattress foundation is strong and that the right mattress size is used.
  • Children younger than 6 are too young to sleep in the top bunk.
  • Never let kids play on the bunk or ladder.
  • Remove dangerous objects from around the bed.
  • Keep the top bunk away from ceiling fans.
  • Install a night light near the ladder.
  • Do not use the bunk bed or ladder if any parts are damaged or broken.
  • Teach kids how to carefully climb the ladder.
  • Do not allow children to attach belts, scarves or ropes to the bunk bed. This can lead to strangulation.

Be especially careful if you have an older bunk bed, as materials may deteriorate and safety regulations have changed over the years.  For current federal bunk bed requirements, click here.

 

Sources:

IKEA Recalls 40,000 Children’s Beds in U.S., Canada” by Kristin Jones, Wall Street Journal, August 15, 2013.

Bunk Bed SafetyNationwide Children’s Hospital, accessed August 15, 2013.

Laser toys put children at risk

Lasers are everywhere. They allow us to listen to a CD, scan our purchases at the checkout counter and then, there is the omnipresent laser pointer. As adults we know not to shine these devices into anyone’s eyes, but what about lasers in the hands of children?

In the U.S., toys are generally overseen by the Consumer Product Safety Commission (CPSC). However, all lasers, whether wielded by a surgeon, used to cut metal, or sitting atop a child’s toy, are regulated by the Food and Drug Administration. This week the FDA issued a statement on laser toy safety, warning parents of potential health risks including:  serious eye injuries and even blindness. Anyone in the room when a laser is used may be harmed, including pets. These  injuries often manifest over time and are not readily apparent.

What You Should Know

  • Never aim or shine a laser directly at anyone, including animals. The light energy from a laser aimed into the eye can cause injuries, perhaps even more than staring directly into the sun.
  • Do not aim a laser at any reflective surface.
  • Remember that the startling effect of a bright beam of light can cause serious accidents when aimed at a driver in a car or otherwise negatively affect someone who is engaged in an activity (such as playing sports).

Current FDA regulations do not specifically address children’s toy laser products.

According to Dan Hewett, health promotion officer at the FDA’s Center for Devices and Radiological Health (CDRH), “For toys to be considered minimal risk, we recommend that the levels of radiation and light not exceed the limits of Class 1, which is the lowest level in regulated products.” He explained that lasers used for industrial and other purposes often require higher radiation levels. But in toys, those levels are not only unnecessary, they are also potentially dangerous.

Right now, there is no mandatory labeling to consumers how intense a toy laser beam may be; although, some manufacturers do voluntarily reveal this information. To prevent injuries, the FDA urges parents to look for a statement on the label that a laser toy “complies with 21 CFR (the Code of Federal Regulations) Subchapter J.” Such devices do not exceed the Class 1 limits.

The agency warned parents not to assume a laser is safe just because it is promoted as a plaything. Common types of laser toys include:

  • Lasers mounted on toy guns that can be used for “aiming
  • Spinning tops that project laser beams while they spin
  • Hand-held lasers used during play as “lightsabers”
  • Lasers intended for entertainment that create optical effects in an open room

Future Regulation

The FDA recently issued a proposed rule that would define children’s toy laser products and require them to be within International Electrotechnical Commission (IEC) Class 1 emission limits. While this rulemaking process is ongoing, the Center for Devices and Radiological Health encourages manufacturers to keep children’s toy laser products within IEC Class 1 emission limits in order to minimize the risk they pose to this vulnerable population.

 

Source:

Laser Toys Are Dangerous for Kids, FDA Says”, by Mandy Velez, The Huffington Post, August 6, 2013.