SYSTEM AND METHOD FOR MEDICAL DEVICE SECURITY, DATA TRACKING AND OUTCOMES ANALYSIS

摘要

The present invention creates an objective methodology of quantitative accountability for medical device manufacturers, vendors, clinical providers, patients, and payers. In one embodiment, the standardized data received and stored in the medical device database can in turn be used for a variety of applications related to decision support (e.g., medical device selection), education and training (e.g., procedural performance), cost efficacy, evidence based medicine and best practice guidelines, personalized medicine, and comparative performance/safety analytics.

主权项

1. A computer-implemented method of providing ensuring medical device position and functionality, comprising:
providing a medical device for internal use within a patient during a medical procedure, said medical device having sensors or biomarkers disposed therein for providing data on said medical device and said patient; confirming said medical device data integrity and device functionality by receiving said data from said medical device into a database of a computer system and performing an analysis of said data using a processor of said computer system; and confirming, using said processor, a position of said medical device within said patient using an imaging device or a positional analysis of positional data from said data from said medical device; wherein predetermined changes in said position of said medical device are monitored for indication of an adverse event.