<body bgcolor="#ffffff" text="#000000"> <a href="http://hyulo.free-best-hosting.com/?fp=eK5baGYX1ZBAyQ64br6pHEZTEKOS7DeglyE6Rm4ZbuHk6Qe8CY%2Bw%2BXy1WEb8Y393N5I%2BKBz8W4Ec%2BhvLgEJFuA%3D%3D&prvtof=KvHdPQ9KB5eWMj4N49MjCMtVIWBepLu%2Frnd4m3f%2BuLo%3D&poru=2rGga2c1K%2BMoYyXUs4dc6xkRGhPOLa191asFqkhjGdUB9wCNTWXQxp0WHksRjbExhZT8uss2SmRn1a%2FAOrr88MZCuE%2B588P5X1HKvDLLY7G%2B8N3UGBqNHO2O163MG5USzxB%2BmV4I3460MyvLFRJTykCS0rVB4MRFRlx4JY14HLHQXs%2B8jzi7alxfgPHcjnreDGK8I6LARhNytlFNBxpojhAOo3JLFGyNDdmYoVgPX42QeBhmKzUsO%2By5BBW0J4CEkcuBtQ6gABfoJEfWs5isDA%3D%3D&result=aT01NC4yMjQuMi4xMjMmdT1DQ0JvdCUyRjIuMCslMjhodHRwJTNBJTJGJTJGY29tbW9uY3Jhd2wub3JnJTJGZmFxJTJGJTI5Jmg9d3d3LjI0LTctbmV3cy5jb20maHI9d3d3LjI0LTctbmV3cy5jb20lMkZhcmNoaXZlcyUyRjU5MzUmcmY9">Click here to proceed</a>. </body> Heart Devices Top Recall Lists | 24-7-news.com cialis online

Heart Devices Top Recall Lists

AddThis Social Bookmark Button

A recent report reveals cardiovascular devices are the most commonly recalled medical products. The Government Accountability Office (GAO) report is based on recall data from 2005 through 2009 in the U.S. Food and Drug Administration’s (FDA) recall enterprise system. The reviewed data shows cardiac devices are the most common source of FDA device recalls and demonstrates that the agency “could take a more proactive approach to its oversight,” says the report.

Physicians criticize the system saying its obvious tracking device problems and recalls are not a priority. The report is particularly focused on the FDA’s lack of knowledge in using the recall enterprise system (RES).

“Instead of using RES to conduct systemic analyses of recalls…the FDA has used RES primarily for processing and tracking the progress of individual recalls,” the report concluded.

The report says FDA officials may be unaware of the system’s full capacity, specifically the ability to generate summary data. For example, GAO investigators requested RES data but the agency’s staff was unable to extract the data, initially responding that such a task was impossible. However, two months later the FDA completed the request but only with the assistance of an outside contractor, reported theheart.org.

During the four-year period, device manufacturers initiated 3,510 recalls which included “field corrections,” revised labeling and retrieving a device from customers. Of those recalls, 532 were cardio devices and the largest number involved automatic external defibrillators.

The FDA categorizes the recalls and determined 83 percent were class II which indicates “the devices may cause temporary adverse health consequences, says theheart.org. Fourteen percent were classified as class III, which means the device is not likely to cause any adverse consequences; while, four percent were class I recalls because there is a reasonable risk of causing serious adverse consequences or death.

Cardio devices made up 15 percent of all recalls and “40 class-I recalls of cardiovascular devices represented 31% of all class-I recalls in the period,” reported theheart.org.

The GAO report claims device manufactures and the FDA appropriately recall devices in the “initiation and classification phases;” however, the ball is often dropped during the follow-up process when recall-related inspection of the manufacturer’s facility is never initiated.

The report also revealed that despite innovated electronic tracking systems, manufacturers still find it difficult to locate all recalled devices so patients and/or physicians can immediately be notified. For instance, after a pacemaker was recalled the manufacturer could not locate roughly 1,700 of the 23,000 recalled units because there was no implant record.

This is a serious issue since “patients with defective implanted devices are not consistently informed, and medical providers with recalled devices sitting on hospital shelves may be unaware of the potential hazard,” said Dr. Steven Nissen of the Cleveland Clinic.

The GAO made four key recommendations for the FDA and the agency plans to address each.

« »

Leave a Reply

You must be logged in to post a comment.

NEWS CATEGORIES

GOVERNMENT NOTICES

ARCHIVES


Defective Johnson & Johnson Depuy ASR Hip Implants

The Johnson & Johnson Depuy ASR Hip Implant is suppose to last 15 years, but can fail in only a few years after surgery. Victims with faulty hip implants endure excruciating pain, pain in the groin, death of tissue in the hip joint and loss of surrounding bone. GET ALL THE FACTS NOW! CLICK HERE!
defective-hip-replacement.com

CAT Scans Radiation Exposure

If you had a CT or CAT scan and now have a band of missing hair, skin reddening or any other problems possibly related to a radiation overdose, you may have been exposed to much radiation due to incorrect settings on these machines. CONTACT US TODAY!
CAT-Scans-Radiation-Exposure.com

Water Contamination From Fracking

Hydraulic Fracturing of Fracking a way to extract natural gas from shale is contaminating water supplies across the country. Get the facts to keep your drinking water safe for your family.
WaterContaminationFrom Fracking.com

Overexposure to PCBs

Many people unknowingly have been exposed to high levels of PCBs. Recently 3 schools in NY City were found to have dangerous levels of PCBs throughout. Many workers for Monsanto, General Electric, and Westinghouse were exposed to high levels of PCBs. PCBs are a dangerous toxic substance that doesn't break down easily and can cause chloracne, bleeding and neurological disorders, liver damage, spontaneous abortions, malformed babies, cancer, and death. GET THE FACTS!
Overexposure to PCBs.com

Great Photography

Tallis Photo, the number one photographer for great corporate, wedding, and special occasion photos. CONTACT US TODAY!
TallisPhoto.com

Poligrip Lawsuit

Super Poligrip or Fixodent May Cause Nerve Damage. 800-LAW-INFO
Poligrip-Lawsuit.com

Personal Injury Lawyer Nassau County

If you or someone you love was injured CONTACT US TODAY!
Nassau-Personal-Injury-Lawyer-Online.com

Nursing Home Blog

When a loved one is abused at a nursing home, it is time to take action. STOP nursing home abuse!
nursing-home-blog.com

Car Accident Lawyer Nassau County

If you or someone you love was injured in an auto accident CONTACT US TODAY!
www.nassau-car-accident-lawyer-online.com

Suffolk County Auto Accident Lawyer

If you or someone you love was injured in an auto accident in Suffolk County, NY CONTACT US TODAY!
www.suffolk-car-accident-lawyer-online.com

Don't Be Denied Veterans Benefits

If you or someone you love was denied veterans benefits CONTACT US TODAY!
www.veterans-benefits-denial.com

Oil Rig Spills Lawyer

Oil Rig Spills harm the environment and cause heavy losses to coastal game and fishing industries, as well as a loss of waterway usage, resulting in a loss of income to individuals and businesses, and a loss of beach front usage. Don't let a spill cause you harm, CONTACT US TODAY!
www.oil-rig-spills.com

Whistle Blower

Stand up and say what you think is right. See something, say something.
whistlebloweradvisor.com