Multidisciplinary Evaluation for Severity of Hazards Applied to Hemodialysis Devices
- 1 November 2010
- journal article
- Published by Ovid Technologies (Wolters Kluwer Health) in Clinical Journal of the American Society of Nephrology
- Vol. 5 (11), 2004-2017
- https://doi.org/10.2215/cjn.01740210
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.This publication has 32 references indexed in Scilit:
- Water for Haemodialysis and Related Therapies: Recent Standards and Emerging IssuesBlood Purification, 2010
- Disinfection of the hospital water supply: a hidden risk to dialysis patientsCritical Care, 2009
- Hemodialysis Machine Air Detectors Need Not Detect MicrobubblesArtificial Organs, 2007
- Using a multi-method, user centred, prospective hazard analysis to assess care quality and patient safety in a care pathwayBMC Health Services Research, 2007
- Development of Air Micro Bubbles in the Venous Outlet Line: An In Vitro Analysis of Various Air Traps Used for HemodialysisArtificial Organs, 2007
- Air Bubbles Pass the Security System of the Dialysis Device Without AlarmingArtificial Organs, 2007
- Intradialytic complications during hemodialysisHemodialysis International, 2006
- Effects of ultrapure dialysis fluid on nutritional status and inflammatory parametersNephrology Dialysis Transplantation, 2001
- Patient Safety in End-Stage Renal Disease: How Do We Create a Safe Environment?Advances in Renal Replacement Therapy, 2001
- Mortality Risk by Hemodialyzer Reuse Practice and Dialyzer Membrane Characteristics: Results From the USRDS Dialysis Morbidity and Mortality StudyAmerican Journal of Kidney Diseases, 2001