The FDA (Food and Drug Administration) announced today that safety concerns about defibrillators need to be addressed, and has announced a program to encourage the development of safer and more effective devices. The focus is mainly on external defibrillators, which are designed to diagnose potentially fatal heart rhythm abnormalities and treat them by literally shocking the heart with electricity in order to restore regular rhythm. External defibrillators can save lives if they are used early enough after a sudden cardiac arrest (heart suddenly stops pumping blood into the body).
AEDs (automated external defibrillators) are commonly located in public places, such as train stations, airports and some office buildings. They are becoming more common in homes too. They have been effectively used hundreds of thousands of times to treat sudden cardiac arrest.
Hospitals have more sophisticated and complex defibrillators which are used by trained staff.
Up to 300,000 people in the USA each year collapse because their heart suddenly stops pumping blood into the body. If their heart rhythms are not restored back to normal rapidly, their chances of survival drop dramatically. Survival from sudden cardiac arrest depends on a sequence of events that need to occur in succession promptly, one of which is the successful delivery of electric shock to the heart from an external defibrillator.
The FDA’s Center for Devices and Radiological Health (CDRH) has received over 28,000 reports of external defibrillators going wrong over the past five years. Manufacturers have subsequently issued dozens of recalls.
The CDRH says that many of the problems it identified are unnecessary and correctable. Improvements in engineering design and manufacturing practices related to the proper control of the components bought from other suppliers would go a long way to sorting out the current problems.
Jeffrey Shuren, M.D., director of CDRH, said:
- “These devices play an important role in health care. The purpose of our initiative is to improve these technologies so we can save more lives.”
CDHR says it is currently liaising with users, experts, and manufacturers, the aim is to make sure the next generation of external defibrillators have addressed the current problems.
CDRH says it will release a White Paper, describing its actions to improve the safety of these medical devices, as part of its External Defibrillator Improvement Initiative.
The initiative has the following aims:
- To steer innovation towards safety and effectiveness
- Make it easier and faster for the FDA and industry to respond to problems that exist with current devices
- Set out an appropriate premarket regulatory pathway for automated external defibrillators that encourages good design and testing practices
A public meeting on December 15-16 at FDA headquarters in Silver Spring, Maryland, will mark the start of the Initiative. Together with the University of Colorado’s Department of Emergency Medicine, the FDA says it will define enhancements which should improve ease of use and outcomes.
Source: FDA
Written by Christian Nordqvist