Abstract
BACKGROUND AND OBJECTIVES: Risk analysis for medical devices is a crucial process to grant adequate levels of safety. Identification of device exposure-related hazards is one of the main objectives. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Hazard analysis for hemodialysis devices has been performed by a multidisciplinary team involving engineers and clinical experts. A potential harm list was identified from clinical and technical experience, postproduction information, and literature. Various hazardous situations (circumstances when the use of the dialysis device may lead to described harms) were described. Such hazardous situations were correlated to the extent of the deviation of a specific device parameter from expected ranges. The clinical severity that was relevant to any specific harm was categorized for each hazardous situation using a descriptive and numerical scale with five levels (from negligible [i.e., discomfort only] to catastrophic [i.e., potentially lethal]). RESULTS: Harms in which the deviation of a parameter strictly coincides with the clinically measured effect on the patient are defined as "direct." Otherwise, when another clinical parameter must be involved to quantify severity, the related harm is considered "indirect." Two complete examples of multidisciplinary evaluation for severity of hazards (MESH) are given for a direct harm (air embolism) and for an indirect harm (hypothermia). For other harms, the maximum value of severity involved is provided. CONCLUSIONS: MESH represents a possible example of risk management for dialysis equipment in which, although the manufacturer is directly responsible, a multidisciplinary task force may contribute to a better link between engineering and clinical perspectives.