Literature Review on Evaluation Methods of Infusion Pumps

Abstract:

According to many negative reports collected by FDA, the reliability and safety of infusion pumps is continuously challenged by software defects, user interface issues, and mechanical and electrical failures. The focus of human factors engineering (HFE) and usability engineering (UE) is to improve safety and effective of human-machine interaction by identifying and removing use-related problems and hazards, which are recommended to assess and reduce risks associated with medical device use. The objective of this report is to review methods that used to evaluate infusion pump or other medical devices. This report begins with defining clinical evaluation and purpose of clinical evaluation in guides from ISO, FDA, European commission and CFDA. HFE and UE, a recommended tool of evaluation, meet the requirement of clinical evaluation and the nature and approaches related to these principles were briefly presented. Then, two main methods of HFE/UE, heuristic evaluation and user testing were investigated. Besides, this report also reviews satisfaction and safety which were not acquiring enough awareness in previous evaluation. Finally, the approaches of Multicriteria decision analysis (MCDA) are investigating, which provide a basis in developing a comprehensive evaluation framework to integrate above evaluation methods. In general, this study supposes to be a preliminary work to form a comprehensive scheme for medical device evaluation and making decisions on medical devices.