Brazilian clinical engineering regulations: health equipment management and conditions for professional exercise

Abstract Introduction In Brazil, professionals, scientific community, and members of regulatory bodies have not yet achieved a consensus regarding who can legally perform the professional duties of a clinical engineer. We aim at clarifying this aspect, based on a detailed analysis of the pertinent regulations. Methods We acted on three fronts: (i) reviewing the current legislation regarding the clinical engineering exercise; (ii) visiting hospitals and working as trainee to understand how this exercise is implemented on Brazil’s Federal District; (iii) one of the authors participated in virtual discussion groups of clinical engineering professionals, monitoring collective understanding of regulations, checking consistency of proper knowledge, and acting as an active opinion leader in the subject among peers. Results We try to make a formal definition of clinical engineer and indicate their characteristic activities. We propose a synthesis of the regulation regarding healthcare products’ integrity protection and health technology management, identifying the engineering activities necessary to achieve those legal requirements. We analyze the legal constraints and conditions to exert engineering, indicating the necessary professionals’ attributions and the way to obtain them. Finally, we provide a brief analysis of the technical requirements presented by the Brazilian Consumer Protection Code and of the 15.943 Brazilian Standard (NBR). Discussion We conclude that, despite the lack of consensus about the Clinical Engineering activity, there exists in Brazil a Clinical Engineering regulation, but it is spread in complex laws and normative resolutions, defining compulsory responsibilities and attributions, as well as conditions and prerequisites for role performance.

摘要 研究背景：在巴西，专业从业者、科学界人士及监管机构成员尚未就“何人可合法履行临床工程师（Clinical Engineer）职业职责”这一问题达成共识。本研究旨在通过对相关法规的详细剖析，厘清该模糊地带。
方法 本研究从三个维度展开：（1）梳理现行临床工程执业相关法律法规；（2）走访医院并以实习生身份参与工作，以了解巴西联邦特区内临床工程执业的实际落地模式；（3）本研究的一名作者参与了临床工程师专业群体的虚拟讨论小组，监测业界对法规的集体认知情况，核查专业认知的一致性，并作为该议题的活跃意见领袖在同行中发挥引导作用。
结果 本研究对临床工程师进行了正式定义，并明确了其典型执业活动。我们梳理了医疗产品完整性保护与健康技术管理相关的法规体系，识别出满足这些法定要求所需的工程类活动。我们分析了开展工程执业的法律约束与准入条件，明确了必要的专业人员职责及获取相应资质的路径。最后，我们简要分析了《巴西消费者保护法》提出的技术要求，以及巴西国家标准15.943（NBR 15.943）。
讨论 本研究得出结论：尽管巴西国内对于临床工程执业活动尚未形成统一共识，但该国已存在临床工程监管法规，只是这些法规分散于复杂的法律与规范性决议之中，明确了法定职责与执业权限，以及开展该岗位工作的条件与前置要求。