Legal Medicine, Department of Molecular Medicine, University of Padua, Via G. Falloppio 50, 35121 Padua, Italy.
Int J Environ Res Public Health. 2020 Oct 7;17(19):7328. doi: 10.3390/ijerph17197328.
: (MC) is of recent origin and belongs to the large family of non-tuberculous mycobacteria. In recent years, it has shown a high infectious capacity via the aerosol produced by operating room equipment, such as heater-cooler units (HCU). The infection has a long latent period and high mortality rate. Genetic and epidemiological studies have shown that there is a clear link between the infection and a specific HCU model manufactured by LivaNova/Sorin. There is, therefore, a strong possibility that contamination occurs during device construction. The objective of this article is to describe the characteristics of this particular infection in view of the medico-legal implications on professional liability, specifically focusing on current evidence regarding contamination prevention. : we have analyzed the clinical characteristics and data from the autopsic investigations performed on a patient who died as a result of MC infection, in addition to analyzing all pertinent recommendation documents available internationally. We searched for all articles in the literature available on MEDLINE between 1995 and 30 July 2020, using the search words "Mycobacterium chimaera". We then analyzed those articles and reported only those that provide useful information regarding prevention techniques for containing dissemination and contamination. : the literature review produced 169 results that highlight the need to develop systems to mitigate and eliminate the risk of MC infection in operating rooms such as physical containment measures, e.g. device replacement, use of safe water, providing patients with information, and training healthcare professionals. : from a medico-legal viewpoint, this particular situation represents a new frontier of professional liability, which includes manufacturers of electromedical equipment. In order to comprehend the true extent of this silent global epidemic, the development of an organic, preventative monitoring system is essential.
(MC) 是一种新近出现的病原体,属于非结核分枝杆菌大家族。近年来,它通过手术室设备(如热交换器)产生的气溶胶表现出很强的传染性。这种感染潜伏期长,死亡率高。遗传和流行病学研究表明,感染与利瓦诺瓦/索林公司生产的特定 HCU 模型之间存在明确联系。因此,在设备制造过程中污染的可能性很大。本文旨在根据对职业责任的医学法律影响,描述这种特殊感染的特征,特别是关注目前关于污染预防的证据。
我们分析了一名因 MC 感染而死亡的患者的临床特征和尸检调查数据,以及国际上所有相关的推荐文件。我们在 MEDLINE 数据库中搜索了 1995 年至 2020 年 7 月 30 日期间的所有文献,使用的关键词是“分枝杆菌 chimaera”。然后,我们对这些文章进行了分析,只报告了那些提供了有关遏制传播和污染的预防技术有用信息的文章。
文献综述产生了 169 项结果,强调需要开发系统来减轻和消除手术室中 MC 感染的风险,例如物理遏制措施,例如设备更换、使用安全水、向患者提供信息和培训医疗保健专业人员。
从医学法律的角度来看,这种特殊情况代表了职业责任的一个新前沿,其中包括医疗电子设备制造商。为了了解这种无声的全球流行的确切范围,必须制定一个有机的、预防性的监测系统。