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Health Subcommittee Considers Bill To Eliminate Pre-Emption For Medical Devices
The House Energy and Commerce Health Subcommittee on Tuesday heard testimony on the Medical Device Safety Act of 2009 (HR 1346), which would allow consumers to sue medical device manufacturers in state courts, CQ HealthBeat reports. The bill responds to last year"s Supreme Court ruling that says medical devices with FDA pre-marketing approval can be pre-empted from lawsuits under state law, in accordance with the Medical Device Amendments of 1976. Rep. Frank Pallone (D-N.Y.), who introduced the bill, said that the 2008 Supreme Court ruling "ignor[ed] congressional intent" by providing blanket immunity for medical device makers. According to Rep. John Dingell (D-Mich.), a co-sponsor of the bill, the original 1976 law sought to grant regulatory authority to FDA for medical devices, but it did not aim to eliminate state liability. Committee Chair Rep. Henry Waxman (D-Calif.), another co-sponsor, said last year"s ruling already has caused 1,400 injury cases to be thrown out of court, adding that the threat of litigation provides manufacturers with additional safety incentives. David Vladeck -- a law professor at Georgetown University Law Center who testified at the hearing -- added that immunity from lawsuits "removes incentive to manufacturers to fix devices quickly and get defective devices off the market."Rep. Nathan Deal (R-Ga.) said the class of device that must obtain pre-marketing approval -- which includes pacemakers and replacement heart valves -- represents only 2% of all approved medical devices each year. Rep. Michael Burgess (R-Texas) added that the measure could create an inconsistent system that allows both FDA experts and jurors in various states to make decisions on medical device safety standards. In addition, Rep. Joe Pitts (R-Pa.) cautioned that the bill might encourage manufacturers to limit distribution of their devices to certain states (Kim, CQ HealthBeat, 5/13). Related Editorial
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British Dental Association Reaction To Publication Of Earnings And Expenses Statistics
Statistics released yesterday by the NHS Information Centre reflect a year when dentists were working hard to make the new dental contract of 2006 work, according to the British Dental Association (BDA). The Dental Earnings and Expenses, England and Wales, 2007/08 report, which considers the earnings of dentists who undertook NHS work in England or Wales in the second year of the new contract, paints a picture of earnings settling after a transitional year in 2006/07.
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Take Precautions To Prevent Heat Illnesses, Alabama Dept. Of Health
Alabama"s summer climate with its extreme temperatures and high humidity can lead to heatrelated
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National Athletic Trainers' Association (NATA) Offers Guidelines For Management Of Serious Spine Injuries On The Athletic Playing Field

According to a new position statement from the National Athletic Trainers" Association (NATA), proper management of acute spinal injuries on the athletic playing field is crucial, given that sports participation constitutes the second most common cause of spinal cord injuries for Americans age 30 and younger. Sports medicine providers and others on the sidelines need to be familiar with the appropriate acute-management guidelines for athletes with cervical-spine injuries. Published in this month"s Journal of Athletic Training, NATA"s scientific publication, the position statement provides detailed guidelines for the immediate treatment and transport of athletes who are injured on the playing field. "Serious spinal injuries can be devastating, due to the high incidence of long-term neurological impairment and premature death," said Erik E. Swartz, PhD, ATC, lead author of the statement. "That"s why we urge players and parents, as well as coaches and medical personnel, to become better versed about how to prevent these types of injuries and how to care for injured athletes and safely prepare them for transport to a hospital." According to "National Athletic Trainers" Association Position Statement: Acute Management of the Cervical Spine-Injured Athlete," athletic trainers and other health care professionals, coaches, athletes, and people on the sidelines should be aware of, and follow, these guidelines in order to avoid injury or exacerbate spinal injuries that have already occurred: 1. Understand how cervical spine injuries occur and be fully aware of the importance of avoiding contact with the head in any sport, and emphasizing proper techniques of tackling or checking in football, ice hockey and lacrosse. 2. Keep current on all pertinent safety rules enacted for the prevention of cervical spine injuries. 3. Properly maintain all sporting equipment, and wear and use equipment as intended by the manufacturer. 4. The importance of a proper fit when it comes to equipment cannot be understated, because correctly fitted helmets and other equipment often helps with spine stabilization in the event of an injury. 5. Immediate care by knowledgeable health care providers, such as athletic trainers, is critical to the successful treatment of an athlete with a spine injury, so make sure these types of professionals are on the sidelines. 6. Ensure that an emergency action plan is in place and has been reviewed by all medical personnel, administrators, coaches and players. 7. Non-medical professionals should refrain from touching or moving an athlete who might have a spinal injury and should never remove any helmets, pads or other equipment from an injured athlete; the team"s athletic trainer and/or other on-site medical staff will assess the injured athlete and determine whether he or she requires an ambulance. While football is associated with the greatest number of catastrophic spinal injuries for all U.S. sports, skiing, rugby, gymnastics, swimming and diving, track and field (e.g., pole vaulting), cheerleading and baseball also involve activities that place participants at risk for spine injuries. "Sports participation is a leading cause of these types of injuries, especially in younger people," Swartz said. "An average of eight catastrophic cervical spine injuries occurred annually in football alone between 1997 and 2006." "The athletic trainer is very often the first responder when an athlete goes down on the field," said Swartz. "NATA"s review of precautions and practices for immediate care helps ensure athletic trainers and other health care professionals understand the most effective methods to care for athletes with cervical spine injuries." To read NATA"s position statement in its entirety, visit here. National Athletic Trainers" Association (NATA)


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