implantable devices

The Food and Drug Administration recently proposed to substantially alter the approval process for many medical devices

In 2011, some widely used implantable heart defibrillators, designed to correct potentially fatal irregular heart rhythms, developed cracked insulation on their high-voltage electrical wires. The result was that in some cases they caused severe shocks, and even deaths.

Implantable devices, such as hip replacements and heart valves, are a central part of medical treatment today. Americans receive about 370,000 cardiac pacemakers and about 1 million total hip and knee replacements per year. Despite how common the use of implantable devices is, little information is…