Posted on February 20 2015
Recent reports from the United States Food and Drug Administration reveal a significant need to increase the quality of Automated External Defibrillators. These devices can mean the difference between life and death for those in cardiac arrest, but over the last decade, 72,000 reports of device failure have been reported. The FDA is planning to step up regulations and mandatory approvals to increase device quality and reliability.
AED devices detect irregular heart rhythms and provide a shock to help restore normal functioning. These devices can provide an affected individual with additional time before emergency personnel are able to arrive to stabilize and treat the patient. Use of these devices has greatly reduces cardiac arrest related deaths and are now found in most public and many private buildings.
Reports of device failure have been alarmingly high over the last decade and have sparked the implementation of a safety review and approval process by the FDA. Under these new guidelines, the facilities and units will be inspected to ensure safe and reliable use. This will be coupled with yearly review of usage and updates to be provided should any critical design elements be changed. Regulations