Risk Management and Biomedical Devices

Robson, JS; Yeo, Pei Hoon.; Riches, Mark D.; Carlisle, Tara; Kitto, N.

doi:10.1109/iembs.2005.1616368

Cited by 3 publications

(2 citation statements)

References 1 publication

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“…However, during time, clinical engineers have become deeply involved in quality improvement and risk management activity. The healthcare technology management aims to optimize the acquisition and utilization of medical technology to achieve maximum beneficial impact on health outcomes ( 56 , 57 ). In particular, proper maintenance implementation can prevent failure or breakdown that affects the healthcare operations and may cause severe injury to the patients ( 44 ).…”

Section: Discussionmentioning

confidence: 99%

The digitization process and the evolution of Clinical Risk Management concept: The role of Clinical Engineering in the operational management of biomedical technologies

Verga

Viganò

Capuzzo

et al. 2023

Front. Public Health

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IntroductionDigital transformation and technological innovation which have influenced several areas of social and productive life in recent years, are now also a tangible and concrete reality in the vast and strategic sector of public healthcare. The progressive introduction of digital technologies and their widespread diffusion in many segments of the population undoubtedly represent a driving force both for the evolution of care delivery methods and for the introduction of new organizational and management methods within clinical structures.MethodsThe CS Clinical Engineering of the “Spedali Civili Hospital in Brescia” decided to design a path that would lead to the development of a software for the management of biomedical technologies within its competence inside the hospital. The ultimate aim of this path stems from the need of Clinical Engineering Department to have up-to-date, realistic, and systematic control of all biomedical technologies present in the company. “Spedali Civili Hospital in Brescia” is not just one of the most important corporate realities in the city, but it is also the largest hospital in Lombardy and one of the largest in Italy. System development has followed the well-established phases: requirement analysis phase, development phase, release phase and evaluating and updating phase.ResultsFinally, cooperation between the various figures involved in the multidisciplinary working group led to the development of an innovative management software called “SIC Brescia”.DiscussionThe contribution of the present paper is to illustrate the development of a complex implementation model for the digitization of processes, information relating to biomedical technologies and their management throughout the entire life cycle. The purpose of sharing this path is to highlight the methodologies followed for its realization, the results obtained and possible future developments. This may enable other realities in the healthcare context to undertake the same type of pathway inspired by an accomplished model. Furthermore, future implementation and data collection related to the proposed Key Performance Indicators, as well as the consequent development of new operational management models for biomedical technologies and maintenance processes will be possible. In this way, the Clinical Risk Management concept will also be able to evolve into a more controlled, safe, and efficient system for the patient and the user.

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Section: Discussionmentioning

confidence: 99%

The digitization process and the evolution of Clinical Risk Management concept: The role of Clinical Engineering in the operational management of biomedical technologies

Verga

Viganò

Capuzzo

et al. 2023

Front. Public Health

View full text Add to dashboard Cite

show abstract

“… 9 Keeping records of the risk management process is similarly essential to show the fulfillment of safety regulations. 10 …”

Section: Introductionmentioning

confidence: 99%

Risk Management Assessments and Recommendations Among Students, Staffs, and Health Care Workers in Educational Biomedical Laboratories

AlShammari

Alhussain

Rizk

2021

RMHP

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Gerenciamento de tecnologia para saúde: classificação de equipamentos médico-hospitalares

Silveira

Oshiyama

Bassani

2007

IV Latin American Congress on Biomedical Engineering 2007, Bioengineering Solutions for Latin America Health

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Neste trabalho foi descrito o desenvolvimento e a aplicação de um método para classificação de equipamentos médicos considerando dados de manutenção corretiva. O método foi desenvolvido para auxiliar os engenheiros clínicos no gerenciamento das tecnologias médicas. Os três indicadores utilizados foram tempo gasto com manutenção corretiva (TMc), custo de manutenção corretiva ($Mc) e número de manutenções corretivas (NCc). Os indicadores foram obtidos da base de dados do Centro de Engenharia Biomédica (CEB) da Universidade Estadual de Campinas (UNICAMP) no período de 2004 a 2006. Foram estudados os seguintes grupos de equipamentos: 1) Bomba de infusão tipo seringa; 2) Bomba de infusão de uso geral; 3) Monitores cardíacos e multiparamétricos; 4) Ventiladores pulmonares e 5) grupo heterogêneo composto por diferentes grupos de equipamentos, participando todos dos grupos de 1 a 5, incluindo aparelhos de anestesia, unidades eletrocirúrgicas e desfibriladores/cardioversores. O método baseia-se na hipótese de que a idade do equipamento é um fator determinante para o aumento dos três indicadores estudados. Os resultados confirmam essa hipótese e a classificação revelou diferenças importantes entre marcas/modelos dos equipamentos de um determinado grupo. Além disso, o método mostrou-se aplicável para grupos homogêneos ou heterogêneos de equipamentos. A classificação proposta pode ser utilizada na gestão de equipamentos médicos, gerando alertas que contribuam para a tomada de decisão pelo engenheiro clínico e a fiscalização por parte de agências reguladoras governamentais.

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Risk Management and Biomedical Devices

Cited by 3 publications

References 1 publication

The digitization process and the evolution of Clinical Risk Management concept: The role of Clinical Engineering in the operational management of biomedical technologies

The digitization process and the evolution of Clinical Risk Management concept: The role of Clinical Engineering in the operational management of biomedical technologies

Risk Management Assessments and Recommendations Among Students, Staffs, and Health Care Workers in Educational Biomedical Laboratories

Gerenciamento de tecnologia para saúde: classificação de equipamentos médico-hospitalares

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