Have you ever heard of GE? Of course you have surely, we all have. It's the common name for the General Electric company, a global giant. The following release from the US Food and Drug Administration (FDA) is a timely reminder that big brand names alone are certainly not sufficient guarantee that quality and safety systems are in place when manufacturing critical medical equipment. It's worth remembering if you are tempted to believe in the self-claimed virtues of the medical system that it can only be as good as its weakest part. Unfortunately, there are many weak parts.

The U.S. Food and Drug Administration (FDA) today announced that GE OEC Medical Systems, Inc., its parent company, the General Electric Company doing business as GE Healthcare, and two of their top executives have signed a consent decree of permanent injunction related to X-ray surgical imaging systems manufactured by GE OEC Medical Systems.  The consent decree prohibits the manufacturing and distribution of specified GE OEC Medical Systems X-ray surgical imaging systems at facilities in Salt Lake City, Utah, and Lawrence, Massachusetts, until the devices and facilities have been shown to be in compliance with FDA's current good manufacturing practice (CGMP) requirements as set forth in the Quality System (QS) regulation for devices.

The Centers for Disease Control and Prevention (CDC) issued a Morbidity and Mortality Weekly Report (MMWR) article (January 12, 2007 / 56(01);1-4) describing three deaths in U.S. infants aged less than 12 months associated with cough and cold medications. These medications were determined by medical examiners or coroners to be the underlying cause of death. The cases described in this report underscore the need for clinicians to use caution when prescribing and caregivers to use caution when administering cough and cold medications to children aged less than 2 years.

Cough and cold medications that contain nasal decongestants, antihistamines, cough suppressants, and expectorants commonly are used alone or in combination in attempts to temporarily relieve symptoms of upper respiratory tract infection in children aged <2 years. However, during 2004--2005, an estimated 1,519 children aged <2 years were treated in U.S. emergency departments for adverse events, including overdoses, associated with cough and cold medications.

The U.S. Food and Drug Administration (FDA) is proposing to limit the materials used in some medical products in order to keep them free of the agent thought to cause mad cow disease, also known as bovine spongiform encephalopathy or BSE. This is the latest in a series of BSE safeguards that would bar material that has been found to harbor the highest concentrations of this fatal agent in infected cattle.  These materials would be prohibited from use as ingredients in medical products or elements of product manufacturing.

It would be better if the potentially contaminated products were themselves not used at all as this would be much more effective. This bureaucratic system will certainly afford increased consumer protection but, like all similar systems, it will have its failures. The effects of these will be compounded by the false sense of security the system provides.

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