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FDA Targets Defective Defibrillators

Nov 16, 2010 | Parker Waichman LLP

 


 

A new Food & Drug Administration (FDA) report on external defibrillators finds that the devices malfunction far too often, and that such malfunctions can prove fatal. Yesterday, the agency announced that it has launched an initiative aimed at facilitating the development of safer, more effective external defibrillators.

According to the FDA, early 300,000 Americans collapse each year when the heart stops pumping blood to the body (sudden cardiac arrest). Those who experience the condition 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 external defibrillator. Automated external defibrillators (AEDs) are found in public settings and increasingly in homes, airports and office buildings. More complex external defibrillators are used in hospitals by trained health care professionals. 

During the past five years, the FDA’s Center for Devices and Radiological Health (CDRH) has received more than 28,000 medical device reports associated with the failures of external defibrillators. According to FDA data, from January 1, 2005 to July, 10, 2010, there were 68 recalls of external defibrillators, exhibiting an increase from nine (in 2005) to 17 (in 2009, the last complete year for which data are available). During this period, the FDA received over 28,000 medical device report, which also exhibited an increase from 4,210 (in 2005) to 7,807 (in 2009, the last complete year for which data are available). The FDA conducted multiple inspections of all external defibrillator manufacturers throughout this time period.

Many of the types of problems the FDA identified are preventable, correctable, and impact patient safety. The agency has concluded that there are numerous problems with industry practices for designing and manufacturing defibrillators, handling user complaints, conducting recalls, and communicating with users. The FDA said its analysis demonstrates that there are problems with how well firms control how they purchase and accept components used in the manufacture of external defibrillators. Finally, the agency said its analysis demonstrates problems with how changes to the device are evaluated before being implemented.

As a part of a broad initiative, CDRH is taking steps to work with manufacturers, users and experts in the field to improve the engineering design and manufacturing practices of external defibrillators, 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 premarket regulatory pathway for AEDs that promotes best practices for design and testing.

The program will start with a public meeting December 15th and 16th at the FDA’s headquarters in Silver Spring, Md., to bring together representatives from companies and others to discuss ways to improve the devices. The agency also is working with the University of Colorado’s Department of Emergency Medicine to develop improvements that will make it easier to use the devices more effectively.

The FDA is also is sending a letter to the manufacturers of external defibrillators encouraging them to meet with the agency early in the device development process to discuss ways in which they can avoid common problems in the design and manufacturing of these devices.

Help filing claims and other legal assistance for victims of faulty external defibrillators and other defective medical devices is available at the www.yourlawyer.com.


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