New Safety Plan for Drugs and Medical Devices

Federal health agencies have announced a new initiative aimed at improving patient safety and better ensuring the quality of medication and medical devices.

The Sentinel Initiative - A National Strategy for Monitoring Medical Product Safety is described as "a national electronic safety system capable of tracking the performance of a drug or medical product, beginning with the earliest stages of clinical research through its effects on millions of Americans who use it to treat or to recover from an illness or condition." The initiative is a joint effort of the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA). The Washington Post reports that the Sentinel Initiative will allow federal health agencies "to try to identify drug- and device-related problems sooner than does the current system, which relies primarily on voluntary reporting by individual doctors."

• The Sentinel Initiative - A National Strategy for Monitoring Medical Product Safety
• HHS Press Release on the Sentinel Initiative
• Washington Post: Program Aims for Drug, Device Safety
• Medical Product and Device Defects (FindLaw)
• Pharmaceutical Drug Liability (FindLaw)