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On the universality of medical device regulations : the case of Benin
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Maccaro, Alessia, Piaggio, Davide, Leesurakarn, Saveethika, Husen, N., Sekalala, Sharifah, Rai, Shirin and Pecchia, Leandro (2022) On the universality of medical device regulations : the case of Benin. BMC Health Services Research, 22 (1). 1031 . doi:10.1186/s12913-022-08396-2 ISSN 1472-6963.
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Official URL: http://dx.doi.org/10.1186/s12913-022-08396-2
Abstract
Background
Regulatory frameworks surrounding medical devices (MDs) and medical locations are of utter importance for safeguarding patients and users, and for granting a universal access to healthcare.
Currently, as the main existing regulatory frameworks are drafted by high-income countries, they pretend to be general and applicable globally, but fail to understand particular contexts, specifically those in low-resource settings (LRSs), resulting, therefore, inapplicable. In particular, LRSs present a varied situation, with legal transplants of guidelines from their previous colonial regimes. This apparently theoretical issue, is, effectively, a tangible and rising matter of concern, given the ever-increasing number of MD patent applications per year, as well as the appearance of low- and middle-income countries (LMICs) on the MD market itself.
This article will focus on the European Regulation on MDs 745/2017 and its applicability in LRSs, specifically presenting the case of Benin, a Sub-Saharan African country.
Methods
This work is based on a field study conducted in 2019 in Benin, which is particularly exemplar to show the complexity of the “legal transplantation” concept. A multidisciplinary approach, comprising the standard tools and methods of ethics, law, and biomedical engineering, was used to draft a heuristic hermeneutic framework, and to analyse related bioethical issues concerning Medical Device Regulations (MDRs) in LRSs, the role of Maintenance, and other sociological questions; as well as the rural population’s perception on MDs and health technologies, and the role of ethics in the hospitals of LRSs.
Results
The definition of these themes helped approach the local perspective and define the research questions. Downstream of the analysis of the Medical Devices Regulations, the Maintenance and other bioethical issues in Benin, the heuristic hermeneutic framework was created to guide a shift in the paradigm of law and regulation making, so as to make them more contextualised and inclusive, globally.
Conclusion
This article proposes a framework that will help policymakers take into account the particularism of each context, especially those of the most vulnerable countries, when drafting and issuing regulatory frameworks, promoting an ever-evolving model of universalism
| Item Type: | Journal Article | |||||||||
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| Subjects: | R Medicine > R Medicine (General) | |||||||||
| Divisions: | Other > Institute of Advanced Study Faculty of Science, Engineering and Medicine > Engineering > Engineering Faculty of Social Sciences > Politics and International Studies |
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| Library of Congress Subject Headings (LCSH): | Medical instruments and apparatus -- Standards, Medical instruments and apparatus -- Safety regulations, Medical instruments and apparatus -- Quality control | |||||||||
| Journal or Publication Title: | BMC Health Services Research | |||||||||
| Publisher: | Biomed central | |||||||||
| ISSN: | 1472-6963 | |||||||||
| Official Date: | 12 August 2022 | |||||||||
| Dates: |
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| Volume: | 22 | |||||||||
| Number: | 1 | |||||||||
| Article Number: | 1031 | |||||||||
| DOI: | 10.1186/s12913-022-08396-2 | |||||||||
| Status: | Peer Reviewed | |||||||||
| Publication Status: | Published | |||||||||
| Access rights to Published version: | Open Access (Creative Commons) | |||||||||
| Date of first compliant deposit: | 15 August 2022 | |||||||||
| Date of first compliant Open Access: | 15 August 2022 | |||||||||
| RIOXX Funder/Project Grant: |
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