An initiative by FDA to Regulate External DefibrillatorsManufacturers

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Description:  Initiative became necessary in view of increased complaints about these devices

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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