The Effect of New Standards on the Global Movement Toward Usable Medical Devices

摘要

Ergonomics and usability do not only pertain to computer work places. More and more they are becoming an important factor in the process of ensuring safety, efficacy, and a return on investment. Especially in the medical field, the increasing life expectancy requires among other things continually new methods of therapy and diagnosis. Triggered by competition and higher functionality of the devices medical products becomes more and more complex. The growing density of achievements in the public health care system such as DRG's, as well as the larger number of various medical devices imply for physicians and nursing staff a heavy burden that can deteriorate therapy quality and safety. The rapidly changing user requirements have a high pressure also on products' development. The critical questions refer equally to an efficient development combined with reduced expenses for development time and costs, as to an optimized use of the products by the customer with reduced process costs and an increased user satisfaction and safety for the welfare of patients and users. In order to guarantee the safe use of medical devices, a usability engineering process (UEP) should be integrated into a medical device development program. This article describes challenges and possible solutions for medical devices' manufacturers seeking to do so.