Multidisciplinary Evaluation for Severity of Hazards Applied to Hemodialysis Devices

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.

Patients’ experiences of safety during haemodialysis treatment – a qualitative study

“…During haemodialysis, a machine partly replaces the kidney function by circulating the patient's blood through an artificial kidney (Himmelfarb & Ikizler 2010). Various aspects of the treatment cause it to be complex, for instance, the use of advanced technical equipment (Lodi et al 2010) and the associated risk of vascular accessrelated infections (Klevens et al 2005).…”

Dialysate‐induced hypocalcemia presenting as acute intradialytic hypotension: A case report, safety review, and recommendations

“…Although there are multiple reports of accidental dialysis‐associated toxic exposures, this is the first reported case of iatrogenic acute hypocalcemia during dialysis, and is an example of technical error involving dialysate concentrate delivery . It is noteworthy that a large, retrospective cohort study of incenter hemodialysis units that converted to predominantly using dialysate calcium concentrations <2.5 mEq/L, reported significantly greater rates of hospitalization for hypocalcemia and intradialytic hypotension …”

“…Many severe hemodialysis‐associated risks are reduced markedly by physical control and alarm systems inherent to the hemodialysis machine . These include air detectors, pressure monitors, heat and blood leakage detectors, conductivity monitors and ultrafiltration control systems.…”

Statistical Challenges for Quality Assessment of Smart Medical Devices

“…The paper [11] provides an in-depth analysis of this process. A complex example of its application for hemodialysis devices is shown in [12]. [13] discuss the quality evaluation of mobile patient monitoring systems and present a framework for their comparison.…”