About 280,000 external defibrillators used worldwide in health care facilities, public places, or in the home may malfunction during attempts to rescue people in sudden cardiac arrest, the U.S. Food and Drug Administration warned today.
Sudden cardiac arrest is a condition in which the heart suddenly and unexpectedly stops beating. When this happens, blood stops flowing to the brain and other vital organs, leading to death if not treated within minutes.
External defibrillators can send an electric shock to the heart to try to restore normal heart rhythm when sudden cardiac arrest occurs.
Faulty components in defibrillators manufactured by Cardiac Science Corp. of Bothell, Wash., may cause the devices to fail to properly deliver a shock. In addition to failure to deliver needed shocks, other problems with the affected models may include interruption of electrocardiography (ECG) analysis, failure to recognize electrode pads, and interference or background noise that makes the device unable to accurately analyze heart rhythm.
The 14 models, which include automated and semi-automated devices, are:
• Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A and 9390E
• CardioVive models 92531, 92532 and 92533
• Nihon Kohden models 9200G and 9231 and
• GE Responder models 2019198 and 2023440.
The FDA recommends that hospitals, nursing homes and other high-risk settings obtain alternative external defibrillators and arrange for the repair or replacement of the affected defibrillators.
For all other users, including those who use the device at home or as part of public access programs, the FDA recommends using alternative external defibrillators if they are available, and arranging for the repair or replacement of the affected models.
If alternative external defibrillators are not immediately available, then FDA recommends continuing to use the affected devices if needed, because they may still deliver necessary therapy. The potential benefits of using the available external defibrillators outweigh the risk of not using any of the affected external defibrillators or the risk of device failure.
“The FDA is issuing this notice so that users can take the proper steps necessary to assure they have access to safe and effective defibrillators,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
Cardiac Science recalled its Powerheart and CardioVive models, manufactured between August 2003 and August 2009, on Nov. 13, 2009. But the FDA has since learned that additional Cardiac Science models, two marketed under the Nihon Kohden name, and two marketed by GE Healthcare as GE Responder have similar problems.
Cardiac Science issued a software update for two of its Powerheart defibrillators in February 2010 and plans to issue similar software updates for other affected devices. However, FDA’s review of the updated software indicates that the software detects some, but not all, identified defects.
Nihon Kohden is based in Tokyo, Japan. GE Healthcare is located in Britain.
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Wednesday, April 28, 2010
Wednesday, April 21, 2010
Tuna Surprise: Over One Third of Mercury Exposure From This Fish, New Study Finds
/PRNewswire/ -- A new study ranking exposure risks from methylmercury finds that tuna accounts for over one third of total mercury exposure from seafood consumption in the United States. These key findings were published in a peer-reviewed paper by Dr. Edward Groth III, "Ranking the contributions of commercial fish and shellfish varieties to mercury exposure in the United States: Implications for risk communication," and appearing in the April 2010 issue of Environmental Research.
"Canned tuna is the number one fish product consumed in the U.S. today at just under 3 pounds per capita per year," said Michael Bender, director of the Mercury Policy Project. "Based on these new findings, tuna is also the number one mercury exposure risk."
Tuna contributes 37% of the total mercury in the seafood supply -- almost six times as much as the combined total of the four highest mercury-laden fish: swordfish, shark, king mackerel and Gulf tilefish, according to the study.
"Eating tuna can be a toxic gamble, especially for pregnant women, mothers, babies and children," said Buffy Martin Tarbox, Campaign Coordinator for GotMercury.org, based in Forest Knolls, CA.
Groth's paper explains seafood varieties differ by over 120-fold in average mercury content, so which fish you choose drives your mercury exposure. For anyone who eats fish twice a week or more -- not just mothers-to-be -- choosing low-mercury fish is an important health strategy.
"Unfortunately," Groth notes, "most consumers have no idea which fish are high in mercury and should be avoided, or which are low in mercury and are safe to consume."
Canned "light" tuna, the most popular fish in the American diet, has an above-average mercury level, and some "light" tuna has even higher levels. Canned albacore (white) tuna and tuna steaks have still higher average mercury levels. "Women who are trying to minimize their mercury exposure should avoid all forms of tuna," says Groth.
Dr. Groth's study also found that two-thirds of the seafood supply and nine of the 11 most consumed fish and shellfish are low or very low in mercury. So if consumers know what to pick, they can easily find low-mercury alternatives.
To view an abstract of Dr. Groth's paper and also his chart grouping 51 fish varieties into six categories by mercury content, visit: www.mercurypolicy.org
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"Canned tuna is the number one fish product consumed in the U.S. today at just under 3 pounds per capita per year," said Michael Bender, director of the Mercury Policy Project. "Based on these new findings, tuna is also the number one mercury exposure risk."
Tuna contributes 37% of the total mercury in the seafood supply -- almost six times as much as the combined total of the four highest mercury-laden fish: swordfish, shark, king mackerel and Gulf tilefish, according to the study.
"Eating tuna can be a toxic gamble, especially for pregnant women, mothers, babies and children," said Buffy Martin Tarbox, Campaign Coordinator for GotMercury.org, based in Forest Knolls, CA.
Groth's paper explains seafood varieties differ by over 120-fold in average mercury content, so which fish you choose drives your mercury exposure. For anyone who eats fish twice a week or more -- not just mothers-to-be -- choosing low-mercury fish is an important health strategy.
"Unfortunately," Groth notes, "most consumers have no idea which fish are high in mercury and should be avoided, or which are low in mercury and are safe to consume."
Canned "light" tuna, the most popular fish in the American diet, has an above-average mercury level, and some "light" tuna has even higher levels. Canned albacore (white) tuna and tuna steaks have still higher average mercury levels. "Women who are trying to minimize their mercury exposure should avoid all forms of tuna," says Groth.
Dr. Groth's study also found that two-thirds of the seafood supply and nine of the 11 most consumed fish and shellfish are low or very low in mercury. So if consumers know what to pick, they can easily find low-mercury alternatives.
To view an abstract of Dr. Groth's paper and also his chart grouping 51 fish varieties into six categories by mercury content, visit: www.mercurypolicy.org
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Wednesday, April 14, 2010
The Health Risks of Smokeless Tobacco Use Deserve Congressional Attention, Advocates Say
/PRNewswire/ -- Oral Health America (OHA) participated in a congressional hearing today on the use of smokeless tobacco by young people, the effects it has on oral health, and the impact of its use by professional baseball players. The hearing, "Smokeless Tobacco: Impact on the Health of our Nation's Youth and Use in Major League Baseball," was held by Chairman of the House Energy and Commerce Committee Henry Waxman (D-CA) and Health Subcommittee Chairman Frank Pallone, Jr. (D-NJ). Speakers included OHA's former NSTEP® (National Spit Tobacco Education Program) Chairman, Joe Garagiola, and Gruen Von Behrens, an oral cancer survivor and member of the NSTEP speaker's bureau.
"I wish to thank the Committee for bringing this important, but overlooked health issue to the table. Smokeless tobacco is not harmless," Mr. Von Behrens said at the hearing. "It has ruined my life."
Mr. Von Behrens first started using smokeless tobacco at the age of 13 to fit in with his peers. As a high school baseball star at the age of 17, he was diagnosed with cancer and has since undergone 34 surgeries in the past 15 years. He now travels throughout the country and has shared his story with over 2 million young people and collegiate and professional athletes.
OHA established the NSTEP program in 1994 to reduce the use of spit tobacco and help break baseball's association with it. NSTEP reaches up to 325,000 Little League players every year with its relationship with Little League Baseball and Softball and its presence at the Little League World Series each August.
"We applaud the committee's attention to this serious health issue today, and maintain our ongoing commitment to providing educational outreach to young baseball and softball players throughout the country," said Beth Truett, President and CEO, Oral Health America.
Oral Health America's mission is to change lives by connecting communities with resources to increase access to oral health care, education and advocacy for all Americans, especially those most vulnerable. For more information, visit www.oralhealthamerica.org.
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"I wish to thank the Committee for bringing this important, but overlooked health issue to the table. Smokeless tobacco is not harmless," Mr. Von Behrens said at the hearing. "It has ruined my life."
Mr. Von Behrens first started using smokeless tobacco at the age of 13 to fit in with his peers. As a high school baseball star at the age of 17, he was diagnosed with cancer and has since undergone 34 surgeries in the past 15 years. He now travels throughout the country and has shared his story with over 2 million young people and collegiate and professional athletes.
OHA established the NSTEP program in 1994 to reduce the use of spit tobacco and help break baseball's association with it. NSTEP reaches up to 325,000 Little League players every year with its relationship with Little League Baseball and Softball and its presence at the Little League World Series each August.
"We applaud the committee's attention to this serious health issue today, and maintain our ongoing commitment to providing educational outreach to young baseball and softball players throughout the country," said Beth Truett, President and CEO, Oral Health America.
Oral Health America's mission is to change lives by connecting communities with resources to increase access to oral health care, education and advocacy for all Americans, especially those most vulnerable. For more information, visit www.oralhealthamerica.org.
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NLC: Women's Clothing Lines for Nygard/Dillard's, J.C. Penney and Wal-Mart Linked to Human Trafficking in Jordan Sweatshop
/PRNewswire/ -- Self-described as the "number one sportswear manufacturer in Canada," Peter Nygard's women's clothing is sewn at the International British Garments (IBG) factory, where 1,200 guest workers from Sri Lanka, Bangladesh and India -- 75 per cent of them young women -- have been trafficked to Jordan, stripped of their passports and held under conditions of indentured servitude, according to a new report from the National Labor Committee.
Charles Kernaghan, director of the U.S.-based National Labor Committee, whose report on IBG "Dirty Clothes," is being released today, said that, while sewing Nygard International Ltd.'s Alia, Tan Jay, and Investments labels, the women are forced to work 16-hour shifts, from 7 a.m. to 11 p.m., seven days a week.
"There are also mandatory, all-night 23-hour shifts, from 7 a.m. to 6 a.m. at least once a week," Kernaghan said. "The exhausted workers are at the factory over 110 hours a week, while being cheated of over half the legal wages due them. Instead of earning the 74.5-cents-an-hour minimum wage in Jordan, they are paid just 35 cents an hour." Nygard International's clothing is also sold at Dillard's in the U.S. J.C. Penney and Wal-Mart are beginning production at the IBG plants.
"When workers ask for the return of their passports and to be paid correctly, they are slapped and threatened with forcible deportation," said Kernaghan "There are also serious allegations of sexual harassment, even rape, and of workers being overworked to death."
Workers are housed in filthy primitive dormitories without heat and with only sporadic access to water for two hours, three or four days a week. The dorms are infested with bed bugs, and shown photographs of the insects, entomologist Dr. Susan C. Jones of Ohio State University confirmed the bed bugs were engorged with blood.
"All labour laws in Jordan, not to mention the International Labour Organization's (ILO) internationally recognized workers' rights standards, are being blatantly violated at the IBG factory," said Kernaghan. "In fact, the Jordanian Ministry of Labour has placed the abusive IBG plant on their 'Golden List' of best factories."
In a single week, from January 28 to February 17, 2010, Nygard imported more than 280,000 women's pants made at the IBG factory, worth $2.5 million. The customs value of the pants -- the total cost of production and transport -- was $9.49. Many of the pants retail for $38, which represents a 300-percent mark-up. The workers were paid nine cents for each pair of pants they sewed.
Kernaghan said workers do not want Nygard and the other companies to cut and run, pulling work from the factory, which would only further hurt the workers who have already suffered enough. All workers are asking is that their legal rights be respected.
The IBG sweatshop in Jordan is owned by G4S, the world's largest security service company, which also operates in the U.S.
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Charles Kernaghan, director of the U.S.-based National Labor Committee, whose report on IBG "Dirty Clothes," is being released today, said that, while sewing Nygard International Ltd.'s Alia, Tan Jay, and Investments labels, the women are forced to work 16-hour shifts, from 7 a.m. to 11 p.m., seven days a week.
"There are also mandatory, all-night 23-hour shifts, from 7 a.m. to 6 a.m. at least once a week," Kernaghan said. "The exhausted workers are at the factory over 110 hours a week, while being cheated of over half the legal wages due them. Instead of earning the 74.5-cents-an-hour minimum wage in Jordan, they are paid just 35 cents an hour." Nygard International's clothing is also sold at Dillard's in the U.S. J.C. Penney and Wal-Mart are beginning production at the IBG plants.
"When workers ask for the return of their passports and to be paid correctly, they are slapped and threatened with forcible deportation," said Kernaghan "There are also serious allegations of sexual harassment, even rape, and of workers being overworked to death."
Workers are housed in filthy primitive dormitories without heat and with only sporadic access to water for two hours, three or four days a week. The dorms are infested with bed bugs, and shown photographs of the insects, entomologist Dr. Susan C. Jones of Ohio State University confirmed the bed bugs were engorged with blood.
"All labour laws in Jordan, not to mention the International Labour Organization's (ILO) internationally recognized workers' rights standards, are being blatantly violated at the IBG factory," said Kernaghan. "In fact, the Jordanian Ministry of Labour has placed the abusive IBG plant on their 'Golden List' of best factories."
In a single week, from January 28 to February 17, 2010, Nygard imported more than 280,000 women's pants made at the IBG factory, worth $2.5 million. The customs value of the pants -- the total cost of production and transport -- was $9.49. Many of the pants retail for $38, which represents a 300-percent mark-up. The workers were paid nine cents for each pair of pants they sewed.
Kernaghan said workers do not want Nygard and the other companies to cut and run, pulling work from the factory, which would only further hurt the workers who have already suffered enough. All workers are asking is that their legal rights be respected.
The IBG sweatshop in Jordan is owned by G4S, the world's largest security service company, which also operates in the U.S.
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Monday, April 12, 2010
Feds Would Face Problems in a Bio Attack Clean-Up
/PRNewswire/ -- Following the 2001 anthrax attacks, the government and private sector undertook the task of cleaning up anthrax-contaminated facilities - a job that had never before been attempted on that scale. Decontaminating congressional office buildings, postal facilities, and media buildings cost hundreds of millions of dollars, and some of the facilities could not be reopened for more than 2 years.
Nine years later, what progress have we made in policy and practice that would make decontamination easier in the event of another attack? A recent assessment, sponsored by the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism (www.preventwmd.gov) and appearing in the journal Biosecurity and Bioterrorism, found that the process of environmental decontamination would still be very difficult and costly and that the lines of responsibility at the federal level are still unclear.
The 2001 anthrax attack is considered to be a small attack, because relatively few facilities were involved and anthrax contamination was limited to indoor environments. But a large-scale biological release could potentially result in hundreds of thousands of illnesses and deaths and could cost trillions of dollars to clean up. An attack on a U.S. city could contaminate both indoor and outdoor areas, including buildings, street, parks, and vehicles.
Researchers from the Center for Biosecurity of UPMC looked at current decontamination policy and technical practices at the federal level to determine what gaps exist that might hamper response to a future large-scale attack with a biological agent. The government agencies with primary responsibility for decontamination are the Environmental Protection Agency (EPA), the Department of Homeland Security (DHS), and the Department of Defense (DoD). Federal roles and responsibilities for decontamination research and response are not clearly spelled out, overlap, and are often underfunded.
The article also describes some of the technical and scientific issues that remain unresolved: After an anthrax release, what is the risk of secondary aerosolization? What is the federal standard for decontamination - or, how clean is clean? How clean is safe?
The authors note that there are too few personnel trained in decontamination among all of the agencies and including private contractors. In the event of an attack, private building owners and government agencies would likely be calling on the same limited pool of experts and contractors to help with remediation.
Among the recommendations the authors propose:
-- DHS should clarify federal roles and responsibilities.
-- Congress should increase funding for decontamination research.
-- In addition to research, additional investment in personnel is needed.
"Environmental Decontamination Following a Large-Scale Bioterrorism Attack: Federal Progress and Remaining Gaps" by Crystal Franco and Nidhi Bouri appears ahead of the June 2010 print issue of Biosecurity and Bioterrorism. The full text is available at http://www.liebertonline.com/toc/bsp/0/0.
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Nine years later, what progress have we made in policy and practice that would make decontamination easier in the event of another attack? A recent assessment, sponsored by the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism (www.preventwmd.gov) and appearing in the journal Biosecurity and Bioterrorism, found that the process of environmental decontamination would still be very difficult and costly and that the lines of responsibility at the federal level are still unclear.
The 2001 anthrax attack is considered to be a small attack, because relatively few facilities were involved and anthrax contamination was limited to indoor environments. But a large-scale biological release could potentially result in hundreds of thousands of illnesses and deaths and could cost trillions of dollars to clean up. An attack on a U.S. city could contaminate both indoor and outdoor areas, including buildings, street, parks, and vehicles.
Researchers from the Center for Biosecurity of UPMC looked at current decontamination policy and technical practices at the federal level to determine what gaps exist that might hamper response to a future large-scale attack with a biological agent. The government agencies with primary responsibility for decontamination are the Environmental Protection Agency (EPA), the Department of Homeland Security (DHS), and the Department of Defense (DoD). Federal roles and responsibilities for decontamination research and response are not clearly spelled out, overlap, and are often underfunded.
The article also describes some of the technical and scientific issues that remain unresolved: After an anthrax release, what is the risk of secondary aerosolization? What is the federal standard for decontamination - or, how clean is clean? How clean is safe?
The authors note that there are too few personnel trained in decontamination among all of the agencies and including private contractors. In the event of an attack, private building owners and government agencies would likely be calling on the same limited pool of experts and contractors to help with remediation.
Among the recommendations the authors propose:
-- DHS should clarify federal roles and responsibilities.
-- Congress should increase funding for decontamination research.
-- In addition to research, additional investment in personnel is needed.
"Environmental Decontamination Following a Large-Scale Bioterrorism Attack: Federal Progress and Remaining Gaps" by Crystal Franco and Nidhi Bouri appears ahead of the June 2010 print issue of Biosecurity and Bioterrorism. The full text is available at http://www.liebertonline.com/toc/bsp/0/0.
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