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Health technology assessment methods guidelines for medical devices : how can we address the gaps? The International Federation of Medical and Biological Engineering perspective
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Polisena, Julie, Castaldo, Rossana, Ciani, Oriana, Federici, Carlo, Borsci, Simone, Ritrovato, Matteo, Clark, Daniel and Pecchia, Leandro (2018) Health technology assessment methods guidelines for medical devices : how can we address the gaps? The International Federation of Medical and Biological Engineering perspective. International Journal of Technology Assessment in Health Care, 34 (3). pp. 276-289. doi:10.1017/S0266462318000314 ISSN 0266-4623.
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Official URL: http://dx.doi.org/10.1017/S0266462318000314
Abstract
Objectives
Current health technology assessment (HTA) methods guidelines for medical devices may benefit from contributions by biomedical and clinical engineers. Our study aims to: (i) review and identify gaps in the current HTA guidelines on medical devices, (ii) propose recommendations to optimize the impact of HTA for medical devices, and (iii) reach a consensus among biomedical engineers on these recommendations.
Methods
A gray literature search of HTA agency Web sites for assessment methods guidelines on devices was conducted. The International Federation of Medical and Biological Engineers (IFMBE) then convened a structured focus group, with experts from different fields, to identify potential gaps in the current HTA guidelines, and to develop recommendations to fill these perceived gaps. The thirty recommendations generated from the focus group were circulated in a Delphi survey to eighty-five biomedical and clinical engineers.
Results
Thirty-two panelists, from seventeen countries, participated in the Delphi survey. The responses showed a strong agreement on twenty-seven of thirty recommendations. Some uncertainties remain about the methods to accurately assess the effectiveness and safety, and interoperability of a medical device with other devices or within the clinical setting.
Conclusions
As medical devices differ from drug therapies, current HTA methods may not accurately reflect the conclusions of their assessment. Recommendations informed by the focus group discussions and Delphi survey responses aimed to address the perceived gaps, and to provide a more integrated approach in medical device assessments in combining engineering with other perspectives, such as clinical, economic, patient, human factors, ethical, and environmental.
Item Type: | Journal Article | ||||||||||||
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Subjects: | R Medicine > R Medicine (General) | ||||||||||||
Divisions: | Faculty of Science, Engineering and Medicine > Engineering > Engineering | ||||||||||||
Library of Congress Subject Headings (LCSH): | Biomedical engineering, Medical instruments and apparatus | ||||||||||||
Journal or Publication Title: | International Journal of Technology Assessment in Health Care | ||||||||||||
Publisher: | Cambridge University Press | ||||||||||||
ISSN: | 0266-4623 | ||||||||||||
Official Date: | June 2018 | ||||||||||||
Dates: |
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Volume: | 34 | ||||||||||||
Number: | 3 | ||||||||||||
Page Range: | pp. 276-289 | ||||||||||||
DOI: | 10.1017/S0266462318000314 | ||||||||||||
Status: | Peer Reviewed | ||||||||||||
Publication Status: | Published | ||||||||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||||||||
Date of first compliant deposit: | 20 June 2018 | ||||||||||||
Date of first compliant Open Access: | 21 June 2018 | ||||||||||||
RIOXX Funder/Project Grant: |
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