Posted on December 15, 2012 in Defective Medical Devices

Researchers that are from the Cincinnati Children's Hospital Medical Center have studied children that either have a pacemaker (40 patients) or an implanted defibrillator (133 patients). The researchers have been assessing the patients' quality of life compared to other children that have congenital heart disease and children that are healthy.

The children in the study, ages 8 to 18 years old, and their parents were each asked to complete a quality of life questionnaire. Children with heart devices and parents who have children with heart devices, when compared to the children and parents without heart devices, were reported to have significantly lower quality of life scores. Similarly, these parents' and children's scores were also lower than the scores for children and parents with children that have more severe heart disease, but no device.

Major factors that affect the quality of life for children, included things like self-perception, self-worth, and athletic capability.

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 Posted on December 12, 2012 in Defective Medical Devices

A medical device is defined as a product which is used for medical purposes in patients, in diagnosis, in therapy, or in surgery, according to an online definition. Although medical devices are meant to aid medical professionals in improving the health of their patients, hundreds of medical devices are recalled each year.

Whether a manufacturer was overeager to put their device on the market and rushed the production without putting it through adequate tests first, or the instructions were poorly written and the device was too commonly misused, there are defective medical device injuries every day. However, if you find a problem with your medical device, it is critical that you report it not only to your doctor, but also to the FDA.

The FDA has a website called MedWatch that is specifically for reporting these injuries and defects, and it contains information on exactly how to report them. The website states, “In order to keep effective medical products available on the market, the FDA relies on the voluntary reporting of these events.”

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