Towards medical device certification: A colored Petri Nets model of a surface electrocardiography device

Abstract

Electrocardiography devices are used to perform biomedicai signal acquisition from the cardiac electrical activity. Regulatory agencies, such as Food and Drug Administration (FDA) on the USA and National Agency for Sanitary Vigilance (ANVISA) in Brazil, classify Electrocardiography devices as medium risk Class 2 devices. Manufacturers must certify medical devices before commercialization according to some requirements. Prescriptive standards and clinical tests are examples of these requirements. However, problems are still common, and can cause injuries or death to patients. FDA recorded 1.210 computer-related recalls between 2006 and 2011, being 90.5 percent of Class 2. In this context, we are concerned with the use of formal methods to increase the confidence on these medical devices. This paper presents a Colored Petri Nets (CPN) model of a surface Electrocardiography device in order to aid manufacturers to increase the confidence during the devices' development and the certification process.