FDA Sets Tighter Standards For Medical Devices

By JDavis | 5/12/10 9:25 AM

Among the wide range of medical devices currently in use, the infusion pump has become one of the most commonplace--and most problematic. Over two million pumps currently operate in clinical settings, and hundreds of thousands more can be found in private homes. Over the last five years some 700 deaths have been linked to infusion pumps, and more than 40,000 related complaints have been made in that time. Because these devices administer the delivery of drugs and vital substances to patients, their risk of malfunction has become an industry concern. Although many of these incidents can be attributed to user error, the FDA has decided it's not taking any chances on critical medical devices, and has issued a new set of guidelines requiring manufacturers to supply test data on their products.

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