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FDA Warns Public of Contaminated Syringes Manufactured by AM2 PAT, Inc. Containing Heparin and Saline Pre-filled Flush Syringes

Posted On Feb 2, 2008 @ 04:36 PM by SEO Admin

The U.S. Food and Drug Administration (FDA) announced on January 25, 2008, a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, N.C. Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death, and have in fact caused blood infections in patients. These syringes are manufactured by AM2 PAT under the brand names Sierra Pre-filled, Inc. and B. Braun. They are sold in fill sizes of 3mL, 5mL and 10mL and syringe sizes of 6mL and 12mL. Consumers and health care facilities with any of the recalled, pre-filled Heparin Lock or Normal Saline IV Flush syringes should stop using the product immediately. Health care facilities should immediately quarantine the products in their inventory and return them to their distributor. Individual consumers should return them to the location from which they were received, such as a pharmacy or hospital. They should a

National Transportation Safety Board Finds that Faulty Design Led to Minnesota Bridge Collapse; Dozens of Claims Filed

Posted On Jan 30, 2008 @ 08:53 AM by SEO Admin

The National Transportation Safety Board said earlier this month that undersized gusset plates in the Interstate 35-W bridge in Minneapolis were "the critical factor" in the bridge collapse of August 1, 2007, that killed 13 people and injured 100. Chairman Mark Rosenker said the plates, which connected steel beams, were roughly half (1/2 inch rather and 1 inch) the thickness they should have been because of a design error. Investigators found 16 fractured gusset plates from the bridge's center span, he said. The NTSB's final report is expected this fall. This past Sunday marked the 180 day deadline for filing a notice that a lawsuit is going to be brought against the state of Minnesota. The deadline for wrongful death filings is one year from the date of accident. Damages recoverable from the state are capped by law at $1,000,000.00. Lawmakers are considering a compensation fund that would offer more

Study Finds that Waiting Time in the ER More than Doubled; Possible Violations of Federal Law (EMTALA)

Posted On Jan 27, 2008 @ 10:26 PM by SEO Admin

An analysis by researchers at the Cambridge Health Alliance and Harvard Medical School found that the median waiting time to see a physician in hospital emergency departments jumped from 22 minutes in 1997 to 30 minutes in 2004, a 36% increase. Ominously, according to results published in the journal Health Affairs, wait times more than doubled for the sickest heart attack patients. In 1997, half of them got to see a doctor within eight minutes; in 2004 it took 20 minutes. For a quarter of the heart attack patients, the wait reached 50 minutes or more - a particularly disturbing lag because chances of surviving a heart attack are known to worsen when treatment is delayed. Such improper care can be grounds for a claim under the federal Emergency Medical Treatment and Active Labor Act (EMTALA). Under the EMTALA, a hospital and doctor must follow the standard screening practices of the hospital to attempt to identify an emergency medical condition for all patients p

Medical Device Manufacturer's Settlement of Kickback Charges Shows That Even Criminal Fines Can Be "Privatized"

Posted On Jan 25, 2008 @ 09:20 PM by SEO Admin

The U.S. Attorney for New Jersey directed that a no-bid 18-month contract worth $28 million to $52 million contract be awarded to The Ashcroft Group, the consulting firm of former Attorney General John Ashcroft, to monitor a large settlement of criminal accusations against medical device manufacturer Zimmer Holdings and four smaller companies accused of paying kickbacks to doctors who recommended and used the company's knee and hip implants. U.S. Attorney Christopher J. Christie directed that the contract be awarded to his former boss with no public notice. Mr. Christie said the fees were imposed in lieu of fines. If that be so, the practical effect is to force companies prosecuted on taxpayers' money to pay for their criminal acts not by compensating the taxpaying public, but by compensating those connected with the prosecutors. In its filing with the Securities and Exchange Commission, Zimmer said it

Tagged with: Events Medical Devices

MySpace Agrees to Take New Steps to Protect Children from Sexual Predators and Bullies

Posted On Jan 23, 2008 @ 02:03 PM by SEO Admin

MySpace, the country's largest social-networking Web site, has agreed with attorneys general of 49 states to take new steps to protect children from sexual predators and bullies on its site. MySpace also agreed to lead a nationwide effort to develop technology to verify the ages and identities of Internet users. The popular online hangout will create a task force of industry professionals to improve the safety of users, and other social-networking sites will be invited to participate. ''We must keep telling children that they're not just typing into a computer. They're sharing themselves with the world,'' said North Carolina Attorney General Roy Cooper. The exponential growth of sites such as MySpace and Facebook, with teenagers making up a large part of their membership, has created a new potential venue for sexual predators who lie about their age to lure young victims and for cyber bullies who send threatening and anonymous messages. The sites allow any Interne

Drug Makers Release Test Results That Shows That Their Cholesterol Drug Zetia Has No Benefits

Posted On Jan 21, 2008 @ 08:45 PM by SEO Admin

Merck and Schering- Plough, the makers of the popular cholesterol drug, Zetia, announced that Zetia and Vytorin, a pill containing Zetia and Zocor, had failed to benefit patients of a two-year trial which was completed in April of 2006. Merck and Schering-Ploughs press release stated that Zetia not only failed to slow down the accumulation of fatty plaque in the arteries, it contributed to the formation of plaque. Patients taking Vytorin to reduce the growth of fatty plaque in the arteries actually experienced a growth of plaque in their arteries twice as fast as those taking Zetia alone. This was the second time in just over a year that a clinical trial found that LDL reduction did not translate into measurable medical benefits. The first time involved Pfizer's experimental cholesterol drug torcetrapib, whose development was stopped in December of 2006, when a trial involving 15,000 patients showed that the med

New NY Public Health Law Tightens Oversight Over Office-Based Surgeries

Posted On Jan 19, 2008 @ 10:55 AM by SEO Admin

A new public health law that took effect on January 14, 2008, is tightening oversight over outpatient medical facilities that provide office-based surgeries. Office-based surgery refers to any invasive process outside of a hospital where moderate or severe sedation or general anesthesia is used. Experts have found that more than half of medical procedures, including surgeries, endoscopies, colonoscopies, rhinoplasty, and breast augmentation/reductionoccur in offices and clinics, many of which are not accredited. This has resulted in many improper surgeries andnegligent medical care. Many patients have suffered accordingly from this mistreatment. The new law requires all ambulatory surgery centers that use moderate or heavy sedation to be accredited by one of three national groups or the doctor will lose his license. Facilities have until July 14, 2009 to become accredited. All centers must also report "adverse events, " including death and unplanned transf

Construction Workers Fatal 42 Story Fall Latest Problem for Bovis Lend Lease

Posted On Jan 16, 2008 @ 08:33 AM by SEO Admin

A construction worker who was pouring concrete at Trump SoHo, a condominium hotel in SoHo, fell 42 floors to his death on the afternoon of January 14, 2008, when a wooden mold used to set the concrete collapsed. Another worker was thrown from the 42nd floor, but was caught in a safety net that extends outward from the 40th floor, fire officials said. He was brought to safety in a construction bucket and hospitalized for injuries that the authorities said were not life threatening. Two other workers were treated for minor injuries. The cause of the collapse was unclear. Officials said their initial analysis indicated that the project's crane was not involved in the accident, but several people who said they witnessed the accident from the street described the crane as swaying dangerously and crashing into the side of the upper two floors. Trump SoHo is a sleek gray tower that is to rise 45 stories at the northwest corner of Spring Street and Varick Street, near Avenue of

Report on Medicare/Medicaid Overbilling and Fraud in 2007 Focuses on Nursing Homes/Rehab Centers, Pharmaceuticals and Boutique Hospitals

Posted On Jan 15, 2008 @ 01:45 AM by SEO Admin

Americas Watchdog and its Corporate Whistleblower Center have just released the results of its third annual study focused on Medicare & Medicaid fraud. The report continues to show widespread Medicare/Medicaid billing abuse and fraud involving all aspects of health care. The Corporate Whistle Blower Center has just reported its 2007 year end findings on the state of Medicare/Medicaid over billing/fraud in the United States. The report included three areas where Medicare/Medicaid are being over-billed or defrauded; nursing homes/rehab centers, pharmaceuticals, and boutique hospitals, not for profits hospitals, or hospitals owned by doctors/investor groups. 1. Most Nursing Homes/Rehab Centers continue to not provide anything close to mandatory time/hours per day with patients under their care. Nursing homes, rehab centers, and in some cases hospitals are required by Medicare/Medicaid to spend minimum hours per d

Technology Being Introduced to Cut Risk of Surgical Sponges Being Left in Patients

Posted On Jan 13, 2008 @ 12:57 PM by SEO Admin

Last month's $10 million settlement of a suit brought by a woman who underwent surgery for diverticulitis of the colon wherin a surgical sponge was left behind is a reminder of how frequent this complication occurs and of how potentially dangerous it can be. A 2003 study in the New England Journal of Medicine reported that sponges and other foreign objects were left behind after abdominal surgeries at a rate of 1 for every 1,000 to 1,500 such operations. Several medical-products companies say sponges are the most common foreign objects left behind in surgeries. Sponges are made of gauze and are used to soak up blood and protect organs during surgery, but if left inside the body they can cause potentially deadly infections. Retrieving a sponge in a further surgery can cost $50,000 or more. In the case of the woman, she was on a ventilator and had signs of abdominal poisoning. Although she underwent a second surgery to remove the sponge, her kidneys failed. Over the next s

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