Tuesday, 8/4/09, patients and doctors testified before the Senate Health, Education, Labor and Pensions Committee in support of the Medical Device Safety Act of 2009 which will restore manufacturer...
Anyone following this topic is aware that the U.S. Supreme Court ruled last year that manufacturers of medical devices, even if the devices are defective, are immune from liability if the product...
Isn't it amazing how liberating the truth is? This morning the Dow Jones Newswires reported that a group of FDA (U.S. Food & Drug Administration) scientists delivered a letter to...
Is it safer to be in the hospital during the day when having a heart attack than in the evening? According to recent research, a higher percentage of heart attack patients get better care during the day at a hospital, than between the hours of 11 pm and 6 am. Apparently, hospitals are better staffed and more attentive to patient needs during the day. Sadly, those who rely upon the staff the...
Postarthroscopic Glenohumeral Chondrolysis, or PAGCL, is a painful condition in the shoulder caused when the cartilage between the humeral head and the ball and socket of your shoulder has broken down to the point where bone meets bone. Recently, studies have shown that pain pumps used after shoulder surgery is a leading cause for this pain. While these products are still available on the...
The FDA has issued a warning stemming from improperly maintained electrical dental equipment. The poorly maintained equipment can result in third degree burns. In fact, some of the patients even needed to undergo plastic surgery as a result. One of the main reason for the alert directed at dental professionals was that the burns may become apparent only after tissue damage has occurred...
Thoratec Corporation has recalled its Implantable Ventricular Assist Devices (IVAD) catalog number 10012-2555-001, serial numbers 488 or higher. The recalled devices were manufactured and distributed from October 1,2 004 through October 22, 2007. These IVAD's are used to help pump blood through the body of a person whose body is too weak to perform that function. The IVAD can be implanted or...
Reports of death and serious cardiopulmonary reactions to the micro-bubble contrast agents used with ultrasounds has caused the FDA to require revisions to the labels of these products. Micro-bubble ultrasound contrast agents are used in the administration of ultrasounds to view the heart. Definity and Optison are the only micro-bubble products approved for use in the USA. The adverse...
Medtronic has issued a product recall for Sprint Fidelis Defibrillator leads because of possible fractures in the lines. The defibrillator leads have been on the market since 2004 and the FDA did not require human testing before gaining approval. The model was close enough to a previous one to not warrent it. Medtronic did perform short-term testing on humans before seeking FDA approval...
A heart assistance device manufactured by Thoratec has been recalled because the device may function incorrectly. The defective medical device has been used at 87 hospitals in the United States and around the world since 2004. The device is surgically implanted in patients and it may become bent. Thoratec notified the hospitals of potential problem in an Oct. 19 recall notification letter,...
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