News & Technology
FDA Launches Initiative to Develop Innovative External Defibrillators
The Food and Drug Administration recently announced a program aimed at facilitating the development of safer, more effective external defibril‐ lators used to treat abnormal heart rhythms through improved design and manufacturing practices.
External defibrillators are medical devices designed to diagnose life‐ threatening abnormal heart rhythms and treat them by delivering electrical energy to the heart to restore its nor‐ mal rhythm. When used in the first few minutes following a cardiac arrest, they can save lives.
External defibrillators are used suc‐ cessfully thousands of times each year to treat sudden cardiac arrest. Automated external defibrillators (AEDs) are found in public settings and increasingly in homes, airports and office buildings. Trained health care professionals use more complex exter‐ nal defibrillators in hospitals. Nearly 300,000 Americans collapse each year when the heart stops pump‐ ing blood to the body (sudden cardiac arrest). Those who experience the con‐ dition may die if normal rhythms are not restored quickly. Survival depends
on a rapid sequence of rescue events that can include the successful delivery of a high‐energy shock from an exter‐ nal defibrillator.
During the past five years, the FDA’s Center for Devices and Radiological Health (CDRH) has received more than 28,000 medical device reports associat‐ ed with the failures of external defibril‐ lators and manufacturers conducted dozens of recalls involving hundreds of thousands of the devices.
Many of the types of problems that CDRH has identified are preventable, correctable, and can impact patient safety. These problems include engi‐ neering design and manufacturing practices related to the adequate con‐ trol of components bought from other suppliers.
“These devices play an important role in health care,” said CDRH Director Jeffrey Shuren, M.D. “The purpose of our initiative is to improve these tech‐ nologies so we can save more lives.” As a part of a broad initiative, CDRH is taking steps to work with manufac‐ turers, users and experts in the field to improve the engineering design and manufacturing practices of these
devices, and facilitate the development of their next generation.
CDRH intends to release a white paper that describes the actions the Center is taking to improve the safety external defibrillators used today and to foster the development of safer, more effective technologies in the near future as part of its External Defibrillator Improvement Initiative.
Goals of the initiative include:
• Promoting the innovation of next‐ generation external defibrillators to improve safety and effectiveness
• Enhancing the ability of industry and the FDA to identify and resolve problems with devices currently on the market to address safety risks more quickly and effectively
• Designating an appropriate pre‐ market regulatory pathway for AEDs that promotes best prac‐ tices for design and testing. The initiative kicks off with a public meeting on Dec. 15‐16, 2010, at the FDA headquarters in Silver Spring, Maryland where industry and other external stakeholders will discuss ways to improve these devices. The FDA is also collaborating with the University of Colorado’s Department of Emergency Medicine to define the enhancements that will improve ease of use and out‐ comes, such as conducting a multi‐city pilot of connecting AEDs with local emergency medical services so that when an AED is used an emergency res‐ cue team is rapidly dispatched. EMS
12 EMS PRO Magazine
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