Improving Safety of Medical Device Use Through Training

Abstract

This chapter addresses the importance of training as a means to control risk associated with Information Technology (IT) embedded in medical devices. Many medical devices use software-driven control systems, for example pumps, ventilators, anesthesia machines, and defibrillators. In contrast to IT systems that handle information only, these software-driven medical devices produce physical outputs in the form of gases, fluids, electrical energy, and heat that can directly affect patients. Because many medical devices are complex, their design for use is not intuitive, and safeguards to protect patients from harm are not always provided, training becomes an important means to assure they are used in a safe manner. The short in-service and the see one, do one, teach one methods of training are not appropriate for qualifying one to use complex equipment with inherent risk. To protect both the safety of patients and their own interests, institutions must assume the burden of providing adequate training to overcome the risk associated with complex, software-driven devices. In this chapter case studies are provided to indicate how training can reduce the potential for harm in the use of a smart infusion pump and a patient controlled anesthesia pump. The need for device training is also supported by a Failure Modes and Effects Analysis conducted on a physiologic monitor. The author offers suggestions on how to select medical equipment to limit the training burden and identifies and briefly describes a method for developing training materials. The importance of competency assessment, often given little attention during in-services, is also addressed.