Quality assurance of electrosurgical devices: a manufacturer's view

The safe and effective use of electrosurgical devices is a complex activity dependent on a wide array of people and factors. Among the significant factors involved is the quality designed and built into the products. Quality assurance of electrosurgical devices includes the well-known quality control functions of inspection and test, in addition to a host of other activities: requirements definition, product design, assembly, product evaluation, regulatory compliance, product information, user training, and customer service. This article delineates some of the mechanisms that a manufacturer employs to ensure that the products he or she offers to the health care customer are safe and effective and possess the high quality level that their intended use requires.