Risk Management in the New Frontier of Professional Liability for Nosocomial Infection: Review of the Literature on Mycobacterium Chimaera

Background: Mycobacterium chimaera (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. Methods: 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. Results: 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. Conclusions: 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.