Safety concerns on the devices that treat abnormal heart rhythms also to be addressed
The U.S. Food and Drug Administration today announced a program aimed at facilitating the development of safer, more effective automated external defibrillators (AED).
There are about 40,000 cardiac arrests in Canada every year — that's about one every 12 minutes, according to the Heart and Stroke Foundation. 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.
There are about 40,000 cardiac arrests in Canada every year — that's about one every 12 minutes, according to the Heart and Stroke Foundation. 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.
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. Manufacturers conducted dozens of recalls involving hundreds of thousands of the devices.
In the past five years Health Canada has received 524 reports concerning defibrillators. Of these reports, 41 involved recalls of defibrillators. Manufacturers and importers are required to report medical device problems to Health Canada. Problems may include deficiencies in device design, defects arising from the manufacturing or inadequacy or errors in labelling such as directions for use.
In February 2009, Health Canada issued a corrective action notice on a ZOLL AED that would not operate properly if left unused for more than three years. The device would prompt to change batteries during use and fail to deliver therapy. Health Canada ordered to change the batteries every three years and affix a battery replacement label with indicating the next replacement date.
In 2008, the LIFEPAK CR Plus and the LIFEPAK EXPRESS automated external defibrillators manufactured between November 2006 and March 2008 were recalled by Health Canada due to an internal flex cable that may be susceptible to failure and could cause a short, preventing the AED from powering on.
Many of the types of problems that CDRH has identified are preventable, correctable, and can impact patient safety. These problems include engineering design and manufacturing practices related to the adequate control of components bought from other suppliers.
“These devices play an important role in health care,” said CDRH director Jeffrey Shuren. “The purpose of our initiative is to improve these technologies so we can save more lives.”
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 these devices and facilitate the development of their next generation.
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.
