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POSTS TAGGED "FDA"

Special Codes for Medical Devices Should Help Reduce Safety Problems

 When you buy something at the grocery store, it has a bar code that can be used to track it. This is particularly helpful when you purchase a faulty product or when companies are doing recalls of food items.

If it is so simple to do this with most consumer goods, then why don't medical devices have their own barcodes so recalls can be easily tracked...especially when a life-saving medical device is arguably more important to your health than a box of cereal.

Well, the U.S. Food and Drug Administration (FDA) has now proposed a rule that would require unique codes for tracking purposes. The riskiest devices, such as pacemakers, defibrillators and other implantable devices, would have to have a special code, known as a unique device identifier (UDI).

Surgical Fires Occur Too Often, Says the FDA

 The 68-year-old man went in for what he thought would be a rather routine surgery: implanting a pacemaker in his chest. He came out of surgery with second-degree burns to his upper body when he started on fire.

A cauterizing tool, fueled by the patient's oxygen mask, caused a 29-year-old woman's face to erupt in flames while she lay on the operating table. She had been in surgery to have three cysts on her head removed.

A 52-year-old patient received severe burns after a minor explosion occurred in the operating room. A New York surgeon had been performing a tracheotomy when the electronic scalpel sparked, igniting the oxygen supply.

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