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医院设备代表:商业动机是否正在左右临床决策?

Device representatives in hospitals: are commercial imperatives driving clinical decision-making?

机构信息

School of Pharmacy, The University of Sydney, Sydney, NSW, Australia.

Charles Perkins Centre, The University of Sydney, Sydney, NSW, Australia.

出版信息

J Med Ethics. 2018 Sep;44(9):589-592. doi: 10.1136/medethics-2018-104804. Epub 2018 Jul 4.

Abstract

Despite concerns about the relationships between health professionals and the medical device industry, the issue has received relatively little attention. Prevalence data are lacking; however, qualitative and survey research suggest device industry representatives, who are commonly present in clinical settings, play a key role in these relationships. Representatives, who are technical product specialists and not necessarily medically trained, may attend surgeries on a daily basis and be available to health professionals 24 hours a day, 7 days a week, to provide advice. However, device representatives have a dual role: functioning as commissioned sales representatives at the same time as providing advice on approaches to treatment. This duality raises the concern that clinical decision-making may be unduly influenced by commercial imperatives. In this paper, we identify three key ethical concerns raised by the relationship between device representatives and health professionals: (1) impacts on healthcare costs, (2) the outsourcing of expertise and (3) issues of accountability and informed consent. These ethical concerns can be addressed in part through clarifying the boundary between the support and sales aspects of the roles of device representatives and developing clear guidelines for device representatives providing support in clinical spaces. We suggest several policy options including hospital provision of expert support, formalising clinician conduct to eschew receipt of meals and payments from industry and establishing device registries.

摘要

尽管人们对医疗专业人员与医疗器械行业之间的关系存在担忧,但这个问题相对较少受到关注。目前缺乏流行数据;然而,定性研究和调查研究表明,医疗器械行业的代表,他们通常出现在临床环境中,在这些关系中扮演着关键角色。这些代表是技术产品专家,不一定接受过医学培训,他们可能每天都要参加手术,并在每天 24 小时、每周 7 天的时间内为医疗专业人员提供建议。然而,医疗器械代表具有双重角色:既是委托销售代表,同时又提供有关治疗方法的建议。这种双重角色引发了人们的担忧,即临床决策可能会受到商业利益的不当影响。在本文中,我们确定了医疗器械代表与医疗专业人员之间关系引发的三个关键伦理问题:(1)对医疗保健成本的影响;(2)专业知识的外包;(3)问责制和知情同意的问题。通过明确医疗器械代表角色中支持和销售方面的界限,并为在临床环境中提供支持的医疗器械代表制定明确的准则,可以在一定程度上解决这些伦理问题。我们提出了几种政策选择,包括医院提供专家支持、规范医生的行为以避免接受行业的餐饮和付款,并建立医疗器械登记处。

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