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Healthcare workers handling antineoplastic drugs (ADs) in preparation units run the risk of occupational exposure to contaminated surfaces and associated mutagenic, teratogenic, and oncogenic effects of those drugs. To minimise this risk, automated compounding systems, mainly robots, have been replacing manual preparation of intravenous drugs for the last 20 years now, and their number is on the rise. To evaluate contamination risk and the quality of the working environment for healthcare workers preparing ADs, we applied the Failure Mode Effects and Criticality Analysis (FMECA) method to compare the acceptable risk level (ARL), based on the risk priority number (RPN) calculated from five identified failure modes, with the measured risk level (MRL). The model has shown higher risk of exposure with powdered ADs and containers not protected by external plastic shrink film, but we found no clear difference in contamination risk between manual and automated preparation. This approach could be useful to assess and prevent the risk of occupational exposure for healthcare workers coming from residual cytotoxic contamination both for current handling procedures and the newly designed ones. At the same time, contamination monitoring data can be used to keep track of the quality of working conditions by comparing the observed risk profiles with the proposed ARL. Our study has shown that automated preparation may have an upper hand in terms of safety but still leaves room for improvement, at least in our four hospitals., Zdravstveni radnici koji rukuju antineoplastičnim lijekovima u posebnim jedinicama za njihovu pripremu izlažu se zagađenim površinama i riziku od s njima povezanim mutagenim, teratogenim i onkogenim učincima. Da bi se smanjio taj rizik, u posljednjih se 20-ak godina ručna priprema intravenskih lijekova sve više zamjenjuje automatiziranom. Da bismo ocijenili rizik od zagađenja i kakvoću radnog okoliša zdravstvenih radnika koji pripremaju antineoplastične lijekove, oslonili smo se na metodu analize mogućih pogrešaka u postupcima I kritičnosti njihovih posljedica (engl. failure mode effects and criticality analysis, krat. FMECA) radi usporedbe prihvatljive razine rizika (engl. acceptable risk level, krat. ARL), koja je zbroj ocjena prioriteta rizika (eng. risk priority number, krat. RPN) pet utvrđenih načina pogreške s izmjerenom razinom rizika (engl. measured risk level, krat. MRL). Taj nam je model pokazao da antineoplastični lijekovi u prahu i spremnicima koji nisu zaštićeni vanjskim plastičnim omotačem donose povećani rizik, ali nismo utvrdili dosljednu razliku u riziku od zagađenja između ručne i automatizirane pripreme. Ovaj pristup može biti koristan u procjeni i kontroli rizika od profesionalne izloženosti u zdravstvenih radnika rezidualnim citotoksičnim spojevima, bilo da se radi o postojećim ili tek planiranim/novoosmišljenim postupcima pripreme lijekova. Podatci dobiveni redovitim nadzorom (monitoringom) istodobno mogu poslužiti za praćenje kakvoće radnih uvjeta tako što će se usporediti s predviđenim profilom rizika koji je utvrđen ARL-om. Iako je naše istraživanje pokazalo da automatizirana priprema ima prednost nad ručnom u smislu sigurnosti, prostora za njezino poboljšanje ima podosta, naročito u našim četirima bolnicama koje su sudjelovale u istraživanju.

Clinical Systems Engineering: New Challenges for Future Healthcare covers the critical issues relating to the risk management and design of new technologies in the healthcare sector. It is a comprehensive summary of the advances in clinical engineering over the past 40 years, presenting guidance on compliance and safety for hospitals and engineering teams. This contributed book contains chapters from international experts, who provide their solutions, experiences, and the successful methodologies they have applied to solve common problems in the area of healthcare technology. Topics include compliance with the European Directive on Medical Devices 93/42/EEC, European Norms EN 60601-1-6, EN 62366, and the American Standards ANSI/AAMI HE75: 2009. Content coverage includes decision support systems, clinical complex systems, and human factor engineering. Examples are fully supported with case studies, and global perspective is maintained throughout. This book is ideal for clinical engineers, biomedical engineers, hospital administrators and medical technology manufacturers.Presents clinical systems engineering in a way that will help users answer many questions relating to clinical systems engineering and its relationship to future healthcare needsExplains how to assess new healthcare technologies and what are the most critical issues in their managementProvides information on how to carry out risk analysis for new technological systems or medical softwareContains tactics on how to improve the quality and usability of medical devices

Clinical Systems Engineering: New Challenges for Future Healthcare covers the critical issues relating to the risk management and design of new technologies in the healthcare sector. It is a comprehensive summary of the advances in clinical engineering over the past 40 years, presenting guidance on compliance and safety for hospitals and engineering teams. This contributed book contains chapters from international experts, who provide their solutions, experiences, and the successful methodologies they have applied to solve common problems in the area of healthcare technology. Topics include compliance with the European Directive on Medical Devices 93/42/EEC, European Norms EN 60601-1-6, EN 62366, and the American Standards ANSI/AAMI HE75: 2009. Content coverage includes decision support systems, clinical complex systems, and human factor engineering. Examples are fully supported with case studies, and global perspective is maintained throughout. This book is ideal for clinical engineers, biomedical engineers, hospital administrators and medical technology manufacturers.Presents clinical systems engineering in a way that will help users answer many questions relating to clinical systems engineering and its relationship to future healthcare needsExplains how to assess new healthcare technologies and what are the most critical issues in their managementProvides information on how to carry out risk analysis for new technological systems or medical softwareContains tactics on how to improve the quality and usability of medical devices

Clinical Systems Engineering: New Challenges for Future Healthcare covers the critical issues relating to the risk management and design of new technologies in the healthcare sector. It is a comprehensive summary of the advances in clinical engineering over the past 40 years, presenting guidance on compliance and safety for hospitals and engineering teams. This contributed book contains chapters from international experts, who provide their solutions, experiences, and the successful methodologies they have applied to solve common problems in the area of healthcare technology. Topics include compliance with the European Directive on Medical Devices 93/42/EEC, European Norms EN 60601-1-6, EN 62366, and the American Standards ANSI/AAMI HE75: 2009. Content coverage includes decision support systems, clinical complex systems, and human factor engineering. Examples are fully supported with case studies, and global perspective is maintained throughout. This book is ideal for clinical engineers, biomedical engineers, hospital administrators and medical technology manufacturers.Presents clinical systems engineering in a way that will help users answer many questions relating to clinical systems engineering and its relationship to future healthcare needsExplains how to assess new healthcare technologies and what are the most critical issues in their managementProvides information on how to carry out risk analysis for new technological systems or medical softwareContains tactics on how to improve the quality and usability of medical devices

This chapter presents an overview of HTA methods aiming to inform the research and development of new medical devices, here defined as early stage HTA methods. First, standard HTA methods are briefly introduced and their limits and weaknesses are discussed, with specific regards to medical devices assessment, particularly during research and development phases. Finally, three methods for early stage HTA are introduced: four stages Markov Models, which aims to estimate the cost-effectiveness of new technology when very limited evidence is available; the Headroom, which aims to predict the max reimbursable cost for a medical devices, at least in the best case; the Analytic Hierarchic Process (AHP), which aims to estimate how an innovative healthcare technology meets the main user needs in specific scenarios.

This chapter presents an overview of HTA methods aiming to inform the research and development of new medical devices, here defined as early stage HTA methods. First, standard HTA methods are briefly introduced and their limits and weaknesses are discussed, with specific regards to medical devices assessment, particularly during research and development phases. Finally, three methods for early stage HTA are introduced: four stages Markov Models, which aims to estimate the cost-effectiveness of new technology when very limited evidence is available; the Headroom, which aims to predict the max reimbursable cost for a medical devices, at least in the best case; the Analytic Hierarchic Process (AHP), which aims to estimate how an innovative healthcare technology meets the main user needs in specific scenarios.

This chapter presents an overview of HTA methods aiming to inform the research and development of new medical devices, here defined as early stage HTA methods. First, standard HTA methods are briefly introduced and their limits and weaknesses are discussed, with specific regards to medical devices assessment, particularly during research and development phases. Finally, three methods for early stage HTA are introduced: four stages Markov Models, which aims to estimate the cost-effectiveness of new technology when very limited evidence is available; the Headroom, which aims to predict the max reimbursable cost for a medical devices, at least in the best case; the Analytic Hierarchic Process (AHP), which aims to estimate how an innovative healthcare technology meets the main user needs in specific scenarios.

This chapter presents an overview of HTA methods aiming to inform the research and development of new medical devices, here defined as early stage HTA methods. First, standard HTA methods are briefly introduced and their limits and weaknesses are discussed, with specific regards to medical devices assessment, particularly during research and development phases. Finally, three methods for early stage HTA are introduced: four stages Markov Models, which aims to estimate the cost-effectiveness of new technology when very limited evidence is available; the Headroom, which aims to predict the max reimbursable cost for a medical devices, at least in the best case; the Analytic Hierarchic Process (AHP), which aims to estimate how an innovative healthcare technology meets the main user needs in specific scenarios.

This chapter presents an overview of HTA methods aiming to inform the research and development of new medical devices, here defined as early stage HTA methods. First, standard HTA methods are briefly introduced and their limits and weaknesses are discussed, with specific regards to medical devices assessment, particularly during research and development phases. Finally, three methods for early stage HTA are introduced: four stages Markov Models, which aims to estimate the cost-effectiveness of new technology when very limited evidence is available; the Headroom, which aims to predict the max reimbursable cost for a medical devices, at least in the best case; the Analytic Hierarchic Process (AHP), which aims to estimate how an innovative healthcare technology meets the main user needs in specific scenarios.