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

1 Citation (Scopus)
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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

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Bioengineering
Biomedical Technology
Biomedical Technology Assessment
Guidelines
Equipment and Supplies
Focus Groups
Uncertainty
Economics
Safety
Drug Therapy

Keywords

  • UT-Hybrid-D

Cite this

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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.",
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Health technology asessment methods guidelines for medical devices : How can we address the gaps? The International Federation of Medical and Biological Engineering Perspective. / Polisena, Julie (Corresponding Author); Castaldo, Rossana; Ciani, Oriana; Federici, Carlo; Borsci, Simone ; Ritrovato, Matteo; Pecchia, Leandro.

In: International journal of technology assessment in health care, Vol. 34, No. 3, 18.06.2018, p. 276-289.

Research output: Contribution to journalReview articleAcademicpeer-review

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T1 - Health technology asessment methods guidelines for medical devices

T2 - How can we address the gaps? The International Federation of Medical and Biological Engineering Perspective

AU - Polisena, Julie

AU - Castaldo, Rossana

AU - Ciani, Oriana

AU - Federici, Carlo

AU - Borsci, Simone

AU - Ritrovato, Matteo

AU - Pecchia, Leandro

N1 - Cambridge University Press deal

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Y1 - 2018/6/18

N2 - 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.

AB - 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.

KW - UT-Hybrid-D

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DO - 10.1017/S0266462318000314

M3 - Review article

VL - 34

SP - 276

EP - 289

JO - International journal of technology assessment in health care

JF - International journal of technology assessment in health care

SN - 0266-4623

IS - 3

ER -