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The increasing complexity of software in implantable medical devices such as cardiac pacemakers and defibrillators accounts for over 40% of device recalls. Testing remains the principal means of verification in the medical device certification regime. Traditional software test generation techniques, where the tests are generated independently of the operational environment, are not effective as the...
Designing bug-free medical device software is challenging, especially in complex implantable devices that may be used in unanticipated contexts. Safety recalls of pacemakers and implantable cardioverter defibrillators due to firmware problems between 1990 and 2000 affected over 200, 000 devices. This encompasses 41% of the devices recalled and continues to increase in frequency. There is currently...
Artificial pacemakers are one of the most widely-used implantable devices today, with millions implanted worldwide. The main purpose of an artificial pacemaker is to treat bradycardia, or slow heart beats, by pacing the atrium and ventricles at a faster rate. While the basic functionality of the device is fairly simple, there are many documented cases of death and injury due to device malfunctions...
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