Archive for the 'Medical Device' Category

FDA and Medicare Work Together to Improve Medical Products

Tuesday, May 27th, 2008

On May 22, it was announced that the U.S. Food and Drug Administration (FDA) will be working in conjunction with the Centers for Medicare & Medicaid Services (CMS).

Both organizations working together will attempt to increase the capacity of the FDA to monitor the effectiveness of medical products. The proposed system is being called the Sentinel Initiative. It will create a new electronic system that will allow the FDA to query information through CMS that will allow them to monitor possible adverse effects of medical products.

The electronic system will maintain strict privacy. The information gathered will only be used to monitor the effectiveness of prescription drugs and medical devices. The intent is to be able to quickly determine if a product is dangerous.

Defective drug attorneys are working on cases in which serious effects of prescription drugs have caused life-long disability or fatality.

Medical Device Recalled Due to Heparin Concerns

Tuesday, May 13th, 2008

On May 12th, Atrium Medical Corporation recalled specific lots of Hydraglide Brand Heparin-Coated Thoracic Drainage Catheters. The Heparin-Coated Catheters are being recalled because of concerns about contaminated Heparin.

The Heparin-Coated catheters are used during heart bypass surgery for autotransfusion.

Heparin was recalled in January because of contamination. Since 2007, Heparin has been linked to about 100 fatalities. Many of those fatalities, in addition to hundreds of adverse reactions, have been linked to contaminated Heparin. Baxter International recalled almost all lots of Heparin in order to prevent further illnesses and death.

The contamination was traced to a manufacturing facility in China. The adverse reactions were caused by over-sulfated chondroitin sulfate that could not be detected during testing because of its similarities to Heparin.

Atrium is voluntarily recalling its Heparin-Coated catheters because it was discovered that they were manufactured with contaminated Heparin.

The manufacturers of prescription drugs can be found liable if the products are found to be defective because of negligence. Defective drug attorneys are working on cases in which serious illness or fatality has resulted from faulty prescription medications.

Prescription Drug Tracking Delayed in California

Wednesday, April 2nd, 2008

On March 25th, California regulators delayed the electronic tracking of prescription drugs for two years. The California State Board of Pharmacy voted 12-0 to allow prescription drug manufacturers, distributors and pharmacies an additional two years to begin electronically tracking prescription drugs from the manufacturer to the patient.The requirement was already delayed by the California State Legislation in 2007. Now, the pharmaceutical industry has until January 1, 2011. The delay is intended to allow the pharmaceutical industry time to set up computer systems that would comply with the first ever requirement to track prescriptions.

The requirement was instituted in California after a recall of fake Lipitor.

There are defective drug attorneys currently working on cases that involve the serious and fatal illnesses that result from defective drugs.