Heart defibrillators are intended to be life-saving devices. However, despite
their widespread use, defibrillators may be prone to defects. In response
to growing concerns about their safety, the Federal Drug Administration
(FDA) is recommending a stricter approval process.
The tighter regulation is aimed at curbing design and manufacturing flaws.
Over the last five years, according to a new agency report, there have been
68 recalls and more than 22,000 reports of malfunctioning devices.
In fact, the FDA believes that
some of the flaws may have led to severe injuries or even deaths.
Currently, makers of defibrillators are approved through an accelerated
approval pathway designed for low-risk devices, which range from hospital
beds to artificial hips. The so-called 510(k) system allows speedy approval
of devices that are similar to products already on the market.
Regulators only inspect the companies’ manufacturing facilities if
they have cause to suspect a problem.
Companies, including Philips Healthcare, Cardiac Science Corporation, Defibtech,
and others, have petitioned the FDA to keep their devices approved at
this standard. However, the FDA argues that stricter testing is warranted
because manufacturers have consistently failed to address reports of malfunction.
Under the FDA’s proposal, device manufacturers would be subject to
regular inspections and could be required to submit additional clinical
data before launching a new version of their defibrillator, as is required
for other high-risk devices such an internal defibrillators and heart valves.
The Law Offices of Robert Vaage is currently pursuing a product liability
case involving a defective medical device approved under the 510(k) system.