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Archive for August, 2008

Number of Medical Errors At Indiana Hospitals Increases

Monday, August 25th, 2008

Indiana hospitals and surgery centers reported 105 serious medical errors in 2007, according to a report released on August 25, 2008 by the state Department of Health.

The report showed 105 cases of severe bedsores, 24 cases of foreign objects being left in the body of a surgery patient and 23 cases of a surgery being performed on the wrong body part.

Clarian Health which runs Methodist Hospital, Indiana University Hospital and Riley Hospital For Children, all in Indianapolis reported the most errors of any hospital in the state with 10, according to the report.

Among other Indianapolis-area hospitals, St. Vincent Hospital in Indianapolis reported five errors, Wishard Hospital in Indianapolis reported three errors and St. Vincent Heart Center in Carmel each reported three errors and St. Vincent Carmel Hospital and Community North Hospital in Indianapolis each reported one error.

This is the second-annual report of the Medical Error Reporting System (MERS), which was called for by Gov. Mitch Daniels.

The 2006 report revealed 77 serious medical errors, although health officials had said they expected the number of errors reported to rise over the next few years as hospitals learn more about the program.

“MERS is a valuable tool to help improve patient safety. The data we get from this report will help reduce the frequency of medical errors by promoting awareness of patient safety, revealing causes of medical errors and identifying statewide trends,” said State Health Commissioner Dr. Judy Monroe in a press release on August 25, 2008.

The reporting system requires hospitals, surgery centers, abortion clinics and birthing centers to report any errors in categories including surgical, products or devices, patient protection, care management, environmental and criminal.

The Department of Health began collecting the information in 2005 following an executive order by Daniels, and in 2006 approved permanent regulations requiring hospitals to report the mistakes.

Atico International USA Recalls Personal Blenders Due to Laceration Risk

Thursday, August 21st, 2008

On August 7, 2008, the U.S. Consumer Product Safety Commission, in cooperation with the firm named below, announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Signature Gourmet™ and Crofton® Personal Blenders

Units: About 124,000

Importers: Atico International USA Inc., of Fort Lauderdale, Fla. (for the Crofton® model) and East West Distributing Co., of Deerfield Ill. (for the Signature Gourmet™ model)

Hazard: While placing the cup on or off the base of the blender, the blender can be inadvertently turned on, activating the blade. This can pose a serious laceration hazard to consumers.

Incidents/Injuceries: The firm has reived 14 reports of lacerations, including 11 that required medical treatment and stitches.

Description: This recall involves the Signature Gourmet™ (item number W14A3691) and the Crofton® (model number SB-19) personal blenders. The blenders are white and have 3 components parts – a base containing a power button, a blade assembly, and a blending cup. Signature Gourmet™ or Crofton® is printed on the front of the base of the unit. “SB-19” or “W14A3691” is located on a label at the bottom of the unit.

Sold at: The Signature Gourmet™ blenders were sold at Walgreens stores nationwide from July 2006 through March 2008 for about $16. The Crofton® blenders were sold at Aldi stores nationwide from May 2007 through March 2008 for about $13.

Manufactured in: China

Remedy: Consumers should stop using the recalled blenders immediately and call Atico International USA for instructions on returning the product for a full refund.

Consumer Contact: Consumers should call Atico International USA toll-free at (877) 546-4835 between 9 a.m. and 5 p.m. ET Monday through Friday or visit the company’s website at www.aticousa.com

Zimmer Suspends Sales of Durom Cup Hip Device

Tuesday, August 19th, 2008

On July 24, 2008, Zimmer Holdings, the nation’s biggest producer of orthopedic devices, announced it would suspend sales of an artificial hip component that some doctors have complained was failing at a high rate.

In recent months, several doctors have complained that the device, a hip socket known as the Durom cup, was failing in their patients, who then had to undergo replacement surgery.

Zimmer said its investigation had determined that the product was not defective. But it stated that even some experienced surgeons had found it difficult to implant. The company said it expected to resume sales once specialized training for doctors had begun.

Since it was first sold in the United States in 2006, the Durom cup has been implanted in over 12,000 patients. Zimmer said it expected the overall need for early replacement in patients would be low. But Zimmer data and interviews with doctors suggest that hundreds of patients might need such procedures in coming years.

Some doctors said their patients had not had problems with the cup.

“They had given hints that there would not be a recall but this came as a surprise,” Mr. Nudell said.

The issue with the device surfaced in April when a surgeon in Los Angeles, Dr. Lawrence Dorr, publicly warned other orthopedists about cup failures his patients were experiencing. In response, Zimmer said it would start an investigation but said it saw no reason to take added action like halting sales.

At the time, Zimmer also cited European data showing that the device was doing well there. But the version of the device used outside the United States is slightly different from the one used here. Also, while doctors here use it in traditional hip replacement, surgeons in other countries used it in a relatively new kind of hip surgery known as resurfacing, which involves somewhat different surgical techniques.

Zimmer, which announced the sales suspension late Tuesday, said that its investigation found that using the cup required a higher degree of precision.

Dr. Dorr, who said he had stopped using the device last year, said he did not plan to start reusing it.

“It is a bad design,” he said.

As a result of halting sales, Zimmer said that it was also suspending United States premarketing trials of its system for resurfacing, the process that is used in Europe. That decision will put it further behind competitors that already have such products on the American market.

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