Health technology asessment methods guidelines for medical devices: How can we address the gaps? The International Federation of Medical and Biological Engineering Perspective

Julie Polisena (Corresponding Author), Rossana Castaldo, Oriana Ciani, Carlo Federici, Simone Borsci, Matteo Ritrovato, Leandro Pecchia

    Research output: Contribution to journalReview articleAcademicpeer-review

    14 Citations (Scopus)
    97 Downloads (Pure)

    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.
    Original languageEnglish
    Pages (from-to)276-289
    Number of pages14
    JournalInternational journal of technology assessment in health care
    Volume34
    Issue number3
    DOIs
    Publication statusE-pub ahead of print/First online - 18 Jun 2018

    Keywords

    • UT-Hybrid-D

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