Medical devices range from examination gloves and stethoscopes to more complex products, such as pacemakers and joint replacements. These products are used in hospitals, doctors’ offices and in the home to diagnose, treat, or prevent illness. Many people have benefited from recent advances in medical technology and Americans are increasing reliant upon medical devices.
Medical devices are an essential part of patient care, but if a defective or unsafe product enters widespread use it can have severe consequences. Reports of adverse events related to medical devices—including deaths, serious injuries, and product malfunctions—more than doubled between 2003 and 2007. From 2005 to 2009, medical device firms initiated an average of over 700 recalls per year. In 4 percent of the recalls, the FDA determined that there was a reasonable probability that use of the product would cause serious adverse health consequences or death.
The laws authorizing the Food and Drug Administration (FDA) to regulate medical devices were enacted decades ago. In 2011, the Institute of Medicine (IOM) issued a report recommending that FDA develop a comprehensive strategy to collect, analyze, and act on safety information for medical devices on the market. The Medical Device Initiative project seeks to improve the tracking of medical device safety and to foster innovation that benefits patients through streamlined device approvals.
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The Medical Device Initiative project seeks to improve the tracking of medical device safety and to foster innovation that benefits patients. Project Director Josh Rising has a personal connection to the value of medical devices and he explains the importance of the Initiative.
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Issue Brief
Once implemented by the U.S. Food and Drug Administration and utilized by healthcare professionals, the unique device identification (UDI) system will be the cornerstone for significant improvements in postmarketing surveillance of medical devices.
Full StoryThe FDA announced that it will classify metal-on-metal hip implants as high-risk devices but hundreds of other potentially high-risk medical devices remain in use without what many consider to be adequate testing.
Pew joins other stakeholders in commenting on Health Information Technology Patient Safety Action and Surveillance Plan and urges the adoption of the UDI system for medical devices to improve the safety of medical care for patients.
Allan Coukell
Senior Director, Drugs and Medical Devices
The Pew Charitable Trusts
Josh Rising
Director, Medical Devices
The Pew Charitable Trusts
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