Il rischio tecnologico in sanità

An overall risk management process in healthcare should involve the evaluating of potential risk related to medical devices and technology. The importance of this analysis is undelined by many legislative measures of both the Italian Country and the European Community. This article describes the importance of a medical devices vigilance system and the analysis that can be conducted to establish the baseline hazards associated with a device, evaluating its potential hazards. To improve patients safety, the risk analysis should include any risks associated with the manufacture and delivery of the device

Reliability analysis of GEM® Premier™ technology: a multicenter study

This paper describes how specific blood gas analyzer characteristics can support the emerging clinical and organizational user's needs while ensuring patient safety. A oneyear data set from two Italian hospitals was analyzed from 10 different blood gas analyzers. Performance measurements in terms of mean down time (MDT) were calculated to show how technical characteristics declared by the manufacturer compare to the analyzer availability in real clinical settings. Results show a high level of reliability for the analyzed technology, associated with very low MDT of each sensor integrated in the cartridge. Moreover, results show a high level of efficiency in cartridge usage. Such results are consistent with the specification of the GEM® Premier™ maintenance- free technology and are particularly relevant in the point-of-care testing setting.</p

COVIDIAGNOSTIX : health technology assessment of serological tests for SARS-CoV-2 infection.

Abstract Objective In vitro diagnostic tests for SARS-COV-2, also known as serological tests, have rapidly spread. However, to date, mostly single-center technical and diagnostic performance's assessments have been carried out without an intralaboratory validation process and a health technology assessment (HTA) systematic approach. Therefore, the rapid HTA for evaluating antibody tests for SARS-COV-2 was applied. Methods The use of rapid HTA is an opportunity to test innovative technology. Unlike traditional HTA (which evaluates the benefits of new technologies after being tested in clinical trials or have been applied in practice for some time), the rapid HTA is performed during the early stages of developing new technology. A multidisciplinary team conducted the rapid HTA following the HTA Core Model® (version 3.0) developed by the European Network for Health Technology Assessment. Results The three methodological and analytical steps used in the HTA applied to the evaluation of antibody tests for SARS-COV-2 are reported: the selection of the tests to be evaluated; the research and collection of information to support the adoption and appropriateness of the technology; and the preparation of the final reports and their dissemination. Finally, the rapid HTA of serological tests for SARS-CoV-2 is summarized in a report that allows its dissemination and communication. Conclusions The rapid-HTA evaluation method, in addition to highlighting the characteristics that differentiate the tests from each other, guarantees a timely and appropriate evaluation, becoming a tool to create a direct link between science and health management

Health technology assessment of intensive care ventilators for pediatric patients

This paper is aimed at addressing all the critical aspects linked to the implementation of intensive care ventilators in a pediatric setting, highlighting the most relevant technical features and describing the methodology to conduct health technology assessment (HTA) for supporting the decision-making process. Four ventilator models were included in the assessment process. A decision-making support tool (DoHTA method) was applied. Twenty-eight Key Performance Indicators (KPIs) were identified, defining the safety, clinical effectiveness, organizational, technical, and economic aspects. The Performance scores of each ventilator have been measured with respect to KPIs integrated with the total cost of ownership analysis, leading to a final rank of the four possible technological solutions. The final technologies’ performance scores reflected a deliver valued, contextualized, and shared outputs, detecting the most performant technological solution for the specific hospital context. HTA results had informed and supported the pediatric hospital decision-making process. This study, critically identifying the pros and cons of innovative features of ventilators and the evaluation criteria and aspects to be taken into account during HTA, can be considered as a valuable proof of evidence as well as a reliable and transferable method for conducting decision-making processes in a hospital context

Implementation of best practices for emergency response and recovery at a large hospital: A fire emergency case study

<b>Highlights</b>\ud \ud - Crisis response and recovery are crucial phases of emergency management.\ud \ud - In case of emergencies, critical infrastructures are particularly exposed to safety risks.\ud \ud - Complexity of the underlying organizational context is a crucial element.\ud \ud - This research highlights best practices to manage a fire event in a large hospital.\ud \ud - The replication of the best practices enhances the resilience of the affected infrastructures.\ud \ud <b>Abstract</b>\ud \ud This paper illustrates a study conducted into the managerial practices implemented to mitigate the consequences of a major fire emergency and to promptly restore normal business operations at a large pediatric hospital. Stemming from prior research on crisis response and recovery in critical infrastructures, this investigation demonstrates that factors such as the complexity of the underlying stakeholder networks, the vulnerability of the involved actors, and several temporal and spatial constraints, all contribute in hampering the intervention of crisis managers. In these situations, relying on consolidated best practices may enable more rapid response and more adequate recovery.\ud \ud This study adopts a qualitative approach to build a retrospective case study that highlights the crucial issues that healthcare crisis managers are requested to face when exposed to thorny work conditions: presence of numerous actors from the public and the private sector, involvement of organizations with contrasting interests, need for a balance among public health, cost containment and legitimacy, etc. The findings of the present investigation expand the theoretical knowledge on the dynamics that characterize crises occurring at critical infrastructures and provide practical recommendations for healthcare emergency managers to improve their response to, and recovery from, major fire emergencies