FDA'sNov 2010 InitiativetoRegulate Manufacturers ofExternal Defibrillators
Introduction
External defibrillators are medical devices designed to
diagnose life-threatening abnormal heart rhythms and treat them by delivering
electrical energy to the heart in order to restore its normal rhythm. If these
devices swing into action within the first few minutes following a cardiac arrest,the
person’s life can be saved.
External defibrillators are widely used to treat sudden
cardiac arrest. Automated external defibrillators (AEDs) are found in many public
settings such as airports and office buildings as well as in homes.
In the wake of increased reports of external defibrillator
failures received by the Center for Devices and Radiological Health (CDRH),
Food and Drug Administration (FDA) in November 2010 has launched an initiative
to regulate manufacturers of external defibrillators
Background
During the past five years, the CDRH has received over 28,000
reports related to the failures of external defibrillators. Dozens of recalls have
been conducted involving hundreds of thousands of the devices.
According to CDHR, Many of the problems are preventable,
correctable, and can impact patient safety. Some of the problems were engineering
design; inadequate quality control of components which reflects on the
company’s manufacturing practices.
Initiative Goals
1. Promote innovation of next generation external
defibrillators in order tobetter address the increased safety and effectiveness
requirements
2. Make the process of identifying potential problems and
responding to them faster both on the part of FDA as well as the company to
ensure potential safety risks are addressed quickly and effectively.
3.. FDA aims at designating
premarket regulations for automatic external defibrillators in order to
ensure that the best practices for design and testing are followed.
Action Point -External Defibrillator Improvement Initiative
The FDA has launched this initiative in order to promote and
support the development of safer and more effective external defibrillators.
The FDA aims at bringing about design improvements and improvements in the
manufacturing practices especially quality control. CDRH has released a whitepaper that describes
the actions taken by the center to improve the safety of external
defibrillators.
This initiative will begin with a public meeting on Dec.
15-16, 2010, at the FDA headquarters in Silver Spring, Maryland. Here the
industry leaders as well as external stakeholders are expected to discuss ways
to improve these devices.
In collaboration with the University of Colorado, the FDA is
planning on setting up local emergency services in different cities, which will
automatically respond by dispatching emergency rescue team when an AED is used.
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