FDA issues new requirements to improve defibrillator safety
WASHINGTON (AP) — The Food and Drug Administration is requiring makers of heart-zapping defibrillators to submit more data on the emergency care devices after years of recalls and manufacturing problems.
Regulators say companies must now submit new testing data on battery life, adapters, electrodes and other components before receiving approval to sell the products.
Defibrillators use electric shocks to jolt the heart back to normal after patients suffer heart attacks or other cardiovascular problems. 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 72,000 reports of defibrillator problems between 2005 and September 2014. Since 2005, manufacturers have issued 111 recalls involving more than 2 million defibrillators.