Development of a Methodology for the Implementation of Wearable Electrocardiogram Devices as Part of a Telemedicine System Supported by Medical Assistance for Cardiovascular Diseases

In Peru, nearly 16% of people over 20 years old suffer from a cardiovascular disease (CVD), which represents the third cause of mortality around the country. The National Statistic and Informatic Institute (INEI) demonstrates that the ratio between the number of patients per doctor is insufficient with 16.8 doctors per 10 thousand inhabitants, whereas it should be near to 23 doctors per 10 thousand inhabitants. A similar situation is replicated in Pontifical Catholic University of Peru (PUCP) medical center, with a ratio of one cardiologist per 37,000 members of the university community. For this reason, it is designed a health-telemonitoring implementation system for electrocardiograph wearable medical devices, based in life-cycle management, in order to prevent pathologies related to CVD, such as critical ischemic symptoms and heart failure. PulseBit Ex (PEX) was used as the wearable electrocardiograph commercial device, while PUCP community and medical center were a reference for the definition of clinical requirements. The results include protocols for performance, electrical safety and usability tests for validation and maintenance stages; the operation and support flowchart consisting of five phases: admission, induction, monitoring, patient report and treatment follow-up; training, preventive and corrective maintenance, and device end of life protocols as well as a website prototype which its function is to connect the device’s interface with the health personnel. Feedback obtained from PUCP Health Center during the validation of the system implementation methodology, allowed to obtain results that suggest the scalability of the project to other Peruvian health centers. In this sense, the present work achieves the objectives initially set and leaves a precedent for possible future research, in local and international context.