We reported recently about Medco's pacemaker recall. Earlier this week, the FDA announced another Medco recall of specific lots of Quick-set® infusion sets that are used with MiniMed Paradigm insulin pumps.
An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days.
The affected Medco infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number "8." Medtronic recently discovered that approximately two percent of "Lot 8" Quick-set infusion sets (which represents approximately 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers) may not work properly. The affected infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death.
Patients should discontinue using "Lot 8" Quick-set infusion sets. The lot number (for example 8XXXXXX) is clearly marked on both the product box label, and on each individual infusion set package. Visit the Medtronic Diabetes website to view the labels of "Lot 8" Quick-set infusion sets.
Last year we reported that the FDA has issued an advisory recommending that over-the-counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years of age because serious and potentially life-threatening side effects can occur from such use.
Recent research published in the June 2009 issue of Pediatrics found that graphics (such as pictures of teddy bears and droppers) and text (such as "pediatrician recommended") on OTC cough and cold medicines can mislead parents and other caregivers into giving them to children under 2 without first consulting a physician. Specifically, the study found that:
Lesson: don't give an OTC cough and cold medicine to a child under 2 without consulting with your pediatrician first.
As Independence Day celebrations draw near, it's important to remember that fireworks are inherently dangerous, and if not used wisely, can cause blinding, amputations, severe burns or death. For example, each year in the United States, approximately 2,400 people are treated in hospital emergency rooms for eye injuries caused by fireworks. Twenty-five percent of those injuries result in permanent vision loss or blindness. According to the Oregon Health & Science University Casey Eye Institute, eye injuries happen in less than a second but often cause lifelong visual impairment.
Doctors at OHSU offer the following tips to avoid firework injuries:
One recent study estimated that more than 500,000 U.S. college students suffered alcohol-related injuries in 2001. Additional research reported on MedPage Today shows that male college students increase their risk of an injury by 19% for every day of drinking eight or more drinks. For females, the risk increased by 10% for every day of drinking five or more drinks. In other words, it's not just the quantity of alcohol alone or frequency of consumption alone. Rather, a drinking pattern of frequent extreme intoxication causes injury rate to escalate rapidly. At the highest levels, the research found, males who drank nine or more drinks per day on 11 or more occasions in the previous 28 days had a 43% chance of an alcohol-related injury over the previous six months.
Results of the research are available online in Alcoholism: Clinical & Experimental Research.
The message for parents? If you suspect your college-aged son or daughter has a drinking problem - get them help fast. It could save their life.
Recently we came across a website called "Aftertheinjury.org", which we have found to be an informative website geared toward helping loved ones of children who have suffered catastrophic injuries.If your child has been injured due to negligence on the part of another, they may be suffering both physically and emotionally. "After the Injury" can be a resource to help you, as the child's loved one get through the difficult times ahead. It gives parents knowledge of what to expect after their child has been injured, how to help the child recover and how to rate the child's reaction to traumatic stress, along with other important information. The site offers quick links to tip sheets, tips from other parents, pain management and information on when to get outside help in managing traumatic stress. Along with a personal injury attorney, "After the Injury" may be a helpful resource in your child's time of need after a catastrophic injury.
According to the Oregonian, last weekend a semi-truck and a Toyota Camry carrying two people, traveling northbound on I-5 near the Charbonneau Interchange, collided when the truck made an unsafe lane change.
The truck pushed the car across three lanes of northbound traffic where it then careened into the concrete median and flipped over. The driver of the car, David William Brown, 32, of Junction City, Oregon was treated at OHSU for minor injuries while the passenger, David Campbell, 65 also of Junction City was taken to OHSU by LifeFlight in critical condition.
The driver of the semi-truck, Martin Landeros, 41, of Salinas, California, was not injured and was cited for making an unsafe lane change.
Medtronic and the FDA recently announced a Class 1 recall of approximately 21,300 Kappa and Sigma pacemakers manufactured primarily between November 2000 and November 2002. Patients can enter the serial number of their device at this Web site to find out whether it is included in the recall.
The reason for the recall is that the "devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery." In rare cases, patients who are pacemaker-dependent may experience serious injury or death resulting from the defect.
See further details on MedPage Today.
Research recently reported in the May/June 2009 issue of Archives of Facial Plastic Surgery indicates that wearing a seatbelt has the most protective effect against facial injury in auto accidents, while airbags have little effect on injuries if seatbelts aren't worn. In other words, airbags alone were not associated with a reduced chance of facial fracture injury while seatbelts, together with front airbag use, were associated with a significantly decreased likelihood of facial fracture.
Researchers also concluded that automakers still have some work to do to protect occupants from side impacts, which were significantly associated with an increased risk of facial fractures. As explained, side impacts remain "an area where current vehicle and restraint technology may be inadequate."
Finally, researchers found that "[t]he most significant risk for all fracture types was impact with . . . with stationary objects such as trees, phone poles, or other static structures."
Read the full story on MedPage Today.
Summer is a time for fun, outdoor activities. But you might be surprised to learn it's also the busiest season for the emergency room. Six of the most common summer hazards are: heat stroke, drowning, bicycle accidents, car accidents, sun damage, and insect bites and stings.
A recent article in the online version of the Dallas Morning News provided advice to readers on how to avoid injury from these hazards. Among other tips:
Click here to read the full article.
Under the Supreme Court's 2008 decision in Reigel v. Medtronic making the FDA the final arbiter of medical device safety, if a medical device receives premarket approval from the FDA, the manufacturer cannot be sued for damages by any individuals injured by the device. Following that decision, lower courts threw out 1,400 lawsuits against device manufacturers.
Ironically, drug manufacturers do not enjoy the same immunity. Under the Supreme Court's March 2009 decision in Wyeth v. Levine, FDA approval of a drug does not shield its manufacturers from lawsuits commenced by injured patients.
Now Congress is considering rectifying that inconsistency with the Medical Devices Safety Act of 2009, which would provide injured parties with legal recourse if they are injured by an implanted medical device.
For arguments for and against the passage of the legislation, see this article recently appearing on MedPage Today.