FDA proposes Submission of Extensive Data of safety and Effectiveness of Defibrillators

FDA proposes Submission of Extensive Data of safety and Effectiveness of Defibri

Past few years have shown a number of recalls of the emergency devices which has led the Food and Drug Administration to issue a new safety requirement.

As per the novel proposal from the side of the FDA, makers of heart-zapping defibrillators will be required to submit extensive data on safety and effectiveness of the equipment. Defibrillators, which were once found only in emergency rooms, can now be found only in schools, office buildings and other public places.

It has been said that the devices have been found to be plagued by a number of flaws either due to manufacturing or design flaws. If to go as per the FDA statement then it has received 45,000 complaints with defibrillators from
2005 to 2009.

For now, the FDA proposal has not been active yet, but once it gets active then manufacturers will be required to submit increased amount of amount of data to get sure about the safety and effectiveness of the device.

Dr. William Maisel, Chief Scientist in Center for Devices and Radiological Health, FDA, said, "These devices are critically important and serve a very important public health need. The importance of early defibrillation for patients who are suffering from cardiac arrest is well-established".


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