Model-Based Conformance Testing for Implantable Pacemakers

Between 1990 and 2000, over 600,000 implantable cardiac pacemakers and cardioverter defibrillators were recalled. 41% of these devices were recalled due to device software issues. Software-related recalls are increasing with the growing complexity of medical device software, which is responsible for the life-critical operation with the organ. Currently, there are no formal methods to test and verify the safety of implantable cardiac device software. To this effect, a pacemaker-testing platform has been developed to automatically verify if the software in a pacemaker is functioning appropriately and determine if the pacemaker implementation conforms to the device software design specifications. A testing methodology was developed where tests were automatically generated from a model of the pacemaker that satisfied the specifications. These tests checked the software implemented in the physical pacemaker were in conformance with the design specifications and ensured safe operation. This paper outlines the steps used to create this testing platform, as well as the steps used to construct a pacemaker model for testing. By using this test framework as a standard for medical device testing, the US Food and Drug Administration (FDA) will potentially have a more streamlined method to certify the safety of medical device software.