Critical failures in the use of home ventilation medical equipment

Abstract

Home ventilation involves the use of medical devices at patient's home by personnel who are not healthcare practitioners. This implies new potential risks not fully addressed by current standards and guidelines. A methodological approach to investigate potential failures and define improvement actions to address the dangerous potential situations in HV is required.A multidisciplinary team performed an extended version of Failure Mode, Effect and Criticality Analysis (FMECA) to analyse the home ventilation service provided by the Local Healthcare Unit of Naples (ASL NA1) that assisted 60 homebound ventilator dependent patients. The failures were identified in three risk areas: device, electrical system & fire hazard, and indoor air quality. The corrective actions were formulated with two extra steps: identification of critical failures with a threshold applied to the risk priority number and analysis of causes by means of contributory factors (Organization, Technology, Information, and Structure) based on Reason's theory of failures.22 of 86 potential failures were identified as critical. Specific corrective actions were addressed and proposed through contributory factors to improve the overall quality of home ventilation service.The use of this systemic approach oriented the improvements to reduce the harms caused by vulnerabilities in high-risk care service as life support home ventilation.

Risk management of smart healthcare systems: Delimitation, state-of-arts, process, and perspectives

“…48 In the study by Clemente et al, organization is also regarded as one of four types of contributory factors to risks in medical ventilation services. 68…”

“…48 In the study by Clemente et al, organization is also regarded as one of four types of contributory factors to risks in medical ventilation services. 68 In the following Table 1, some examples of hazards in smart healthcare are given. These hazards, together with their causes, events that they can result in, and consequences are categorized.…”

“…Failures are found in three areas: device, electrical system & fire hazard, and indoor air quality, and then are prioritized based on RPNs. 68 Jamshidi et al apply a fuzzy FMEA for identifying risk factors and propose seven miscellaneous dimensions including use-related hazards, age, and utilization in hazards and risks in prioritization of medical devices. 71 Based on the review by Liu et al, FMEA has been widely applied in the risk analysis for healthcare process, hospital management, hospital informatization, and medical equipment and production.…”