Under the agency’s proposal posted online Friday, makers of external defibrillators would need to submit more data and undergo manufacturing inspections before launching a new product.
The tighter regulation is aimed at curbing design and manufacturing flaws with the devices, which are found everywhere from hospitals to schools to airports. Medical device manufacturers have issued 68 recalls of defibrillators in the last five years, according to the FDA. And the agency has received more than 23,000 reports of device malfunctions, “including some where the device failure occurred during a rescue attempt and may have contributed to patient harm or death.”
The changes would not apply to implantable defibrillators, which are pacemaker-like devices given to patients with heart problems.
- FDA wants stricter testing for defibrillators (seattletimes.nwsource.com)
- Summary Box: FDA eyes tougher defibrillator rules (seattletimes.nwsource.com)