Study finds hospital safety still lacking.
In a front-page study, the New York Times (11/25, A1 Grady) reported efforts "to make hospitals safer for patients are falling short, researchers report in the first large study in a decade to analyze harm from medical care and to track it over time." The study, "conducted from 2002 to 2007 in 10 North Carolina hospitals, found that harm to patients was common and that the number of incidents did not decrease over time. The most common problems were complications from procedures or drugs and hospital-acquired infections." The study, which is "being published on Thursday in The New England Journal of Medicine," is "one of the most rigorous efforts to collect data about patient safety since a landmark report in 1999 found that medical mistakes caused as many as 98,000 deaths and more than one million injuries a year in the United States."
Bloomberg News (11/29, Olmos) reports the study found "almost one in five hospital patients was injured by their care," and researchers "found little improvement from industry and government efforts to improve safety." The "six-year study of 2,341 hospital admissions in North Carolina found that 18 percent of patients suffered at least one safety-related incident, ranging from minor injuries with little harm to life-threatening mistakes and fourteen deaths." The North Carolina hospitals "were chosen because the state is considered a leader in efforts to improve patient safety."
The Boston Globe (11/29, Cooney) reports Dr. Christopher Landrigan, "a patient safety researcher at both Children's Hospital Boston and Brigham and Women's Hospital, led a team that studied a sample of more than 2,300 patient admissions to 10 hospitals in North Carolina between 2002 and 2007." They "picked the state because of its active role in safety training programs. To see if those efforts were paying off, they used a tool designed by the Cambridge-based Institute for Healthcare Improvement to detect cases in which care went wrong." Overall, "there were 588 instances of harm suffered by nearly 1 in 5 patients admitted to all 10 hospitals." Modern Healthcare (11/29) reports "the rate of harm -- 25 instances per 100 hospital admissions -- did not change significantly during the study's five-year span from 2002 to 2007, they said. And of the instances of patient harm they detected, 50 were life-threatening and 14 patient deaths were attributable to medical errors."
Monday, November 29, 2010
Tuesday, November 23, 2010
Volvo recalls 2010 XC60
Volvo recalls models over airbag errors, fire-prone navigation units.
Cars.com writer Colin Bird reported in the Chicago Tribune (11/22) that "Volvo is recalling the 2010 XC60 over airbag concerns." According to Bird, "58 XC60s are being recalled for side curtain airbags that may have been misassembled. The error may cause the airbags not to deploy correctly or possibly not at all, which could increase the risk of injury in a crash." The automaker also issued a separate recall for several models containing faulty Garmin 760 GPS units, "which can potentially overheat, possibly causing a fire in the car."
Cars.com writer Colin Bird reported in the Chicago Tribune (11/22) that "Volvo is recalling the 2010 XC60 over airbag concerns." According to Bird, "58 XC60s are being recalled for side curtain airbags that may have been misassembled. The error may cause the airbags not to deploy correctly or possibly not at all, which could increase the risk of injury in a crash." The automaker also issued a separate recall for several models containing faulty Garmin 760 GPS units, "which can potentially overheat, possibly causing a fire in the car."
Friday, November 19, 2010
Depuy Orthopedics ASR Hip Implant Recall
In 2005, DePuy, a division of Johnson & Johnson, introduced the ASR and ASR XL hip replacement systems in the US after winning “510(k) clearance” from the Food and Drug Administration (FDA). This type of clearance meant that the product was approved without having to pass clinical trials to ensure it was safe. In 2008, The British equivalent to the FDA recognized “evidence of genetic damage in patients with certain metal hip implants,” such as the ASR system. Also in 2008, the FDA received higher than expected complaints from patients who received ASR hips. In 2009, DePuy voluntarily withdrew the ASR system from the Australian market due to higher than expected failure rates. In early 2010, DePuy notified physicians that the ASR system would be phased out by the end of the year. It was not until August 24, 2010, that DePuy recalled the ASR hip replacement system in the US and worldwide.
DePuy Orthopedics, Inc., and Johnson & Johnson are working hard to control the problems created by the DePuy ASR hip prosthesis. Part of this effort includes using physicians to ask patients to sign waivers and authorizations allowing DePuy access to patient records. DePuy is using Broadspire to manage this process. While DePuy promises to cover certain medical expenses associated with revision surgery, there remain a number of important concerns patients should have regarding this process. First, when a patient signs the waivers and authorizations, the manufacturer is given access to private medical information. Second, once the manufacturer gets copies of private medical records and the parts of the prosthesis removed during revision surgery, the manufacturer may not preserve that information properly. Third, while the manufacturer has promised to pay certain costs, the manufacturer is not volunteering to compensate for harm suffered as a result of the defective prosthesis. To be fully compensated for all of the injuries caused by the defective prosthesis, a patient may need to sue the manufacturer.
DePuy Orthopedics, Inc., and Johnson & Johnson are working hard to control the problems created by the DePuy ASR hip prosthesis. Part of this effort includes using physicians to ask patients to sign waivers and authorizations allowing DePuy access to patient records. DePuy is using Broadspire to manage this process. While DePuy promises to cover certain medical expenses associated with revision surgery, there remain a number of important concerns patients should have regarding this process. First, when a patient signs the waivers and authorizations, the manufacturer is given access to private medical information. Second, once the manufacturer gets copies of private medical records and the parts of the prosthesis removed during revision surgery, the manufacturer may not preserve that information properly. Third, while the manufacturer has promised to pay certain costs, the manufacturer is not volunteering to compensate for harm suffered as a result of the defective prosthesis. To be fully compensated for all of the injuries caused by the defective prosthesis, a patient may need to sue the manufacturer.
Thursday, November 18, 2010
Window Shades and Blinds Recalled amid Safety Review
WASHINGTON — The death of a toddler who strangled in a window shade cord spurred a huge recall Wednesday, even as the industry crafts a better standard to make window coverings in American homes safer for children.
The Consumer Product Safety Commission says Hanover Direct, of Weehawken, N.J., has agreed to recall about 495,000 roman shades and some 28,500 blinds. Hanover is the parent company for Domestications, The Company Store, and Company Kids.
CPSC says the 22-month-old boy in Cedar Falls, Iowa, became trapped in the pull cord of a roman shade in May. He was found hanging by his neck and was rescued by his father, but died later at a hospital.
The commission estimates that one child dies every month after strangling on the cords of blinds or roman shades.
Consumer safety groups have complained that the government and industry have been slow over the last two decades to cut child deaths from blinds. More recently, however, CPSC has stepped up its efforts to get safer window coverings on the market.
At a meeting of industry officials and consumer advocates at CPSC headquarters in Bethesda, Md., this week, the head of the commission urged manufacturers to move swiftly to approve new safety rules.
"Chart a new course today," said Chairman Inez Tenenbaum, "a course that promises to eliminate, not just mitigate, the risk of harm to children."
While there have been millions of blinds and shades recalled in the past several years, safety advocates say fatality rates haven't improved much and the process for moving safer designs to the market has been sluggish.
The problem is the cord on the blinds and shades that rolls them up and down. Young children can get tangled and trapped in the cords, leading to injuries and deaths. Since 1990, CPSC estimates that nearly 250 infants and young children have died from accidentally strangling on window cords.
Ralph Vasami, executive director of the Window Covering Manufacturers Association, says blinds and shades can be used by most people with no problem at all. "But there is a hidden risk to children," he said in an interview.
Vasami says manufacturers are pressing ahead to revise the current voluntary safety rules on the books, standards developed by industry. He expects to have new rules ready for a vote by next October.
Current standards for roman shades, Vasami says, call for them to be cordless; have cords that are inaccessible to children; or if the cord is in reach of a child, then it cannot be able to form a hazardous loop that could trap a child's head. That standard would likely serve as a model and be expanded to cover blinds in the new writing of standards underway.
Wednesday's recall involving Hanover is an expansion of a previous recall from October 2009 of about 90,000 roman shades. Thousands more roman shades as well as roller and roll-up blinds are now being called back. The products were sold through the company nationwide from January 1996 through October 2009.
Consumers can contact the firm at 800-453-1106 or http://www.domestications.com and http://www.hanoverdirect.com for more information.
The Consumer Product Safety Commission says Hanover Direct, of Weehawken, N.J., has agreed to recall about 495,000 roman shades and some 28,500 blinds. Hanover is the parent company for Domestications, The Company Store, and Company Kids.
CPSC says the 22-month-old boy in Cedar Falls, Iowa, became trapped in the pull cord of a roman shade in May. He was found hanging by his neck and was rescued by his father, but died later at a hospital.
The commission estimates that one child dies every month after strangling on the cords of blinds or roman shades.
Consumer safety groups have complained that the government and industry have been slow over the last two decades to cut child deaths from blinds. More recently, however, CPSC has stepped up its efforts to get safer window coverings on the market.
At a meeting of industry officials and consumer advocates at CPSC headquarters in Bethesda, Md., this week, the head of the commission urged manufacturers to move swiftly to approve new safety rules.
"Chart a new course today," said Chairman Inez Tenenbaum, "a course that promises to eliminate, not just mitigate, the risk of harm to children."
While there have been millions of blinds and shades recalled in the past several years, safety advocates say fatality rates haven't improved much and the process for moving safer designs to the market has been sluggish.
The problem is the cord on the blinds and shades that rolls them up and down. Young children can get tangled and trapped in the cords, leading to injuries and deaths. Since 1990, CPSC estimates that nearly 250 infants and young children have died from accidentally strangling on window cords.
Ralph Vasami, executive director of the Window Covering Manufacturers Association, says blinds and shades can be used by most people with no problem at all. "But there is a hidden risk to children," he said in an interview.
Vasami says manufacturers are pressing ahead to revise the current voluntary safety rules on the books, standards developed by industry. He expects to have new rules ready for a vote by next October.
Current standards for roman shades, Vasami says, call for them to be cordless; have cords that are inaccessible to children; or if the cord is in reach of a child, then it cannot be able to form a hazardous loop that could trap a child's head. That standard would likely serve as a model and be expanded to cover blinds in the new writing of standards underway.
Wednesday's recall involving Hanover is an expansion of a previous recall from October 2009 of about 90,000 roman shades. Thousands more roman shades as well as roller and roll-up blinds are now being called back. The products were sold through the company nationwide from January 1996 through October 2009.
Consumers can contact the firm at 800-453-1106 or http://www.domestications.com and http://www.hanoverdirect.com for more information.
GM recalls Buick Lucerne and Cadillac DTS after fire reports
GM recalls 13,780 vehicles after fire reports; Chrysler recalls 16,000 Jeep Libertys
DETROIT -- General Motors Co. is recalling 13,780 Buick Lucerne and Cadillac DTS cars in the United States because of a flaw that can cause power-steering fluid to leak and ignite a fire in the engine.
Chrysler, meanwhile, said it plans to recall 16,000 Jeep Liberty SUVs to fix faulty windshield wiper systems, according to The Associated Press.
The company is targeting model year 2010 and 2011 Lucerne and DTS vehicles following reports of two fires related to electrical arcing triggered by leaking fluid coming into contact with the starter or alternator cable, according to a letter on the National Highway Traffic Safety Administration's Web site today.
No injuries were reported in the fires, Alan Adler, a spokesman for Detroit-based GM, said in an interview.
The automaker concluded the starter and alternator cables were incorrectly installed so they touch a power-steering line, it said in the letter to NHTSA, the U.S. auto-safety regulator.
GM will repair the cars, which are under warranty, free of charge to owners. The recall totals 14,245 cars worldwide, GM said in a statement on its Web site.
The company this year has recalled 1.53 million cars and trucks for a windshield-wiper flaw that may cause fires, and 303,100 Impala cars in the U.S. because seat belts in the front seat may not be properly anchored and may fail to restrain passengers in a crash.
Wiper problems
In the Chrysler recall, the automaker said the wiper problem involves certain 2008 Jeep Liberty SUVs, the AP said. Chrysler said water could get into the windshield wiper motor of the Jeeps and stop the wipers.
Chrysler said no crashes or injuries have been tied to the recalls, the AP reported.
Jeep dealers will replace the windshield wiper motor free of charge, according to the report, and the recall is expected to begin this month.
DETROIT -- General Motors Co. is recalling 13,780 Buick Lucerne and Cadillac DTS cars in the United States because of a flaw that can cause power-steering fluid to leak and ignite a fire in the engine.
Chrysler, meanwhile, said it plans to recall 16,000 Jeep Liberty SUVs to fix faulty windshield wiper systems, according to The Associated Press.
The company is targeting model year 2010 and 2011 Lucerne and DTS vehicles following reports of two fires related to electrical arcing triggered by leaking fluid coming into contact with the starter or alternator cable, according to a letter on the National Highway Traffic Safety Administration's Web site today.
No injuries were reported in the fires, Alan Adler, a spokesman for Detroit-based GM, said in an interview.
The automaker concluded the starter and alternator cables were incorrectly installed so they touch a power-steering line, it said in the letter to NHTSA, the U.S. auto-safety regulator.
GM will repair the cars, which are under warranty, free of charge to owners. The recall totals 14,245 cars worldwide, GM said in a statement on its Web site.
The company this year has recalled 1.53 million cars and trucks for a windshield-wiper flaw that may cause fires, and 303,100 Impala cars in the U.S. because seat belts in the front seat may not be properly anchored and may fail to restrain passengers in a crash.
Wiper problems
In the Chrysler recall, the automaker said the wiper problem involves certain 2008 Jeep Liberty SUVs, the AP said. Chrysler said water could get into the windshield wiper motor of the Jeeps and stop the wipers.
Chrysler said no crashes or injuries have been tied to the recalls, the AP reported.
Jeep dealers will replace the windshield wiper motor free of charge, according to the report, and the recall is expected to begin this month.
Ford Winstar Minivans Need to be Fixed
NHTSA: only fraction of recalled minivans repaired.
The AP (11/17) reported, "The government is urging owners of recalled Ford Motor Co. minivans to get their vehicles fixed." According to the National Highway Traffic Safety Administration, "only about 75,000 of the minivans had been fixed by the recall, leaving a large number of vehicles still to be repaired." Concerns "that the rear axles could corrode and potentially break" prompted the August recall of nearly 575,000Ford Windstar models.
The AP (11/17) reported, "The government is urging owners of recalled Ford Motor Co. minivans to get their vehicles fixed." According to the National Highway Traffic Safety Administration, "only about 75,000 of the minivans had been fixed by the recall, leaving a large number of vehicles still to be repaired." Concerns "that the rear axles could corrode and potentially break" prompted the August recall of nearly 575,000Ford Windstar models.
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