Medical Safety & Global Health
Open Access

Abstract

Software Safety Analysis for Clinical Programming Software of Cochlear Implant System

Umamaheswararao B and Seetharamaiah P

Computer based bio-electronic systems are used for replacement of damaged human parts such as Bionic-ear for deafness, Bionic-eye for blindness, Deep Brain Stimulator for diseases of the brain, and Bionic-arm for arm prostheses. Algorithms for controlling bionic system are based on the specific bionic devices like bionic ear with sound processing software and bionic eye with image processing software. A lot of research is going on to improve the performance of bionic systems in respect of achieving near 100% functionality, low cost and smaller sizes with higher reliability and safety. As the use of software in medical devices has improved, the need for specific regulations for healthcare system software has improved. Software for medical systems has to deal with the Health software lifecycle identified by safety analysis in order to make the system safe. The focus of this paper is defining two approaches such as Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA) techniques to identify potentially hazardous software faults and development of software safety for clinical programming software (CPS) as medical device software. CPS software to operate on Digital Speech Processor System (DSPS), Impedance Telemetry Monitoring System (ITMS), Implantable Receiver Stimulator (IRS) that is Connections are made from PC to ITMS Unit and ITMS Unit to Receiver Stimulator. A custom built Database Application (DA) for medical development of Bionic Ear is developed under Visual Studio software environment using MS-Access database.