On the universality of medical device regulations: the case of Benin

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. Supplementary Information The online version contains supplementary material available at 10.1186/s12913-022-08396-2.


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Personal Information
This section asks some general questions about your personal information.

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Mark only one oval. Mark only one oval. Less  In the hospital where you work, do you ask patients to sign a document before a surgery (i.e., informed consent)? If the patient is not able to understand the treatment they will undergo, do you provide for the consultation of someone who clarifies all aspects of the treatment?
Has it ever happened that a patient sued the hospital or a doctor for misconduct in the communication of the therapy/surgery?

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Tick all that apply. According to the local culture, whose is the decision to undergo a treatment / intervention / trial? According to the laws of the Republic of Benin, is staff required to comply with a Code of Conduct (Deontologic)?
Is a Code of Ethics complied with by health personnel?

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Medical Devices Regulations
This section aim to clarify the Regulations adopted by Republic of Benin about Medical Devices

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How much does the ethical behavior of a doctor / nurse depend on their religion / culture / personal ethics ?
In your opinion, how good do you consider the role of ethics in the Beninese national healthcare system?
Are local Medical Device Regulations complied with in Benin?

30.
Mark only one oval. Have they ever proposed regulatory internal changes for their own country?
Have they ever proposed regulatory changes to Europe?

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Gender biases 40.

41.
Mark only one oval. Is there a department of biomedical engineering or clinical engineering or health technology management in this hospital?
What is the relation between women and science in this country?
How is a woman involved in biomedical engineering perceived in this country?

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45.
What is the percentage of female biomedical engineers in this country?
What is the percentage of female biomedical engineers in this hospital?
Who mainly takes care of a medical device maintenance in a hospital?
In this hospital, who is in charge of medical device maintenance?

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Mark only one oval. Do you believe that, given the role of the Beninese woman, traditionally linked to home and family maintenance, even medical devices maintenance is considered a "woman's business"?
How important is medical device maintenance, in your opinion?
In your opinion, on a scale from 1 (Not degrading) to 5 (Very degrading), how degrading can a job based solely on maintenance be perceived?
What do you think if the state took actions aimed at fostering the role of women in biomedical engineering?

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What is the biggest problem of medical device maintenance in Benin?
How good do you consider medical devices in Benin?
How good do you consider medical devices in this hospital?
How are medical devices perceived by the rural population? 54.

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ethical committee members doctors nurses other Do you think that the local population has some reticence about the use of technology and prefers the traditional form of care?
Who should introduce the rural population to the use of health technologies?