Shows & Panels
- AFCEA Answers
- Ask the CIO
- The Big Data Dilemma
- Carrying On with Continuity of Operations
- Connected Government
- Constituent Servicing
- Continuous Monitoring: Tools and Techniques for Trustworthy Government IT
- The Cyber Imperative
- Cyber Solutions for 2013 and Beyond
- The Data Privacy Imperative: Safeguarding Sensitive Data
- Expert Voices
- Federal Executive Forum
- Federal IT Challenge
- Federal Tech Talk
- Mission-critical Apps in the Cloud
- The Modern Federal Threat Landscape
- The Path from Legacy Systems
- The Real Deal on Digital Government
- The Reality of Continuous Monitoring... Is Your Agency Secure?
- Veterans in Private Sector: Making the Transition
Shows & Panels
FDA proposes new rules for heart defibrillators
Friday - 3/22/2013, 12:28pm EDT
WASHINGTON (AP) -- The Food and Drug Administration will require makers of heart-zapping defibrillators to submit more data on their safety and effectiveness following years of recalls of the emergency devices.
Defibrillators use electric shocks to jolt the heart back to normal after patients collapse from cardiac arrest. Once used exclusively in emergency rooms, they are now found in schools, office buildings and other public places.
The devices have been plagued by design and manufacturing flaws for years. The FDA says it has received 45,000 reports of problems with defibrillators between 2005 and 2012.
Currently the FDA approves defibrillators through a fast-track process reserved for devices similar to ones already on the market.
The FDA proposal, when finalized, will require manufacturers to submit more extensive testing documentation before new defibrillators can be marketed.
Copyright 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.