Safety Management of Dialysis Fluid in Japan: Important Duties and Responsibilities of Clinical Engineers.

Dialysis therapy is the predominant choice for renal failure in Japan, and almost 30% of the patients with renal failure have been treated for 10 years or more. Dialysis became the standard procedure to treat renal failure nationwide in the 1980s. However, at that time, managing the increased number of patients on maintenance hemodialysis as well as operating and maintaining the newly developed advanced medical technologies at extensive numbers of clinical sites proved problematic. To help address this, the clinical engineer system was established in 1987 and certain aspects of the clinical engineers' role remain unique to Japan today. For the last 30 years, clinical engineers have worked as frontline medical personnel not only operating dialysis-related devices but also placing their hands directly on patients when providing care, routinely performing puncture, and administering drugs through the blood circuit under physicians' instructions. As part of their work, they crucially maintain the use of central dialysis fluid delivery systems (CDDSs) - also unique to Japan - which prepare and deliver a large quantity of dialysis fluid through a central circuit to individual dialysis consoles. CDDSs are widely used because they effectively alleviated the early confusion at clinical sites caused by the rapidly increasing hemodialysis population and the serious shortage in medical personnel. Moreover, clinical engineers alone have the technical ability to provide safe dialysis fluids adjusted to strict standards at clinical sites. In this review article, we focus on the crucial roles that clinical engineers have in maintaining the safety of dialysis-related medical devices and the preparation and delivery of dialysis fluid at many dialysis facilities across the country.