Background: The complexity of health care systems, the development of clinical approaches, and both scientific and technological advancements give rise to new requirements in clinical risk management. An expedient risk management is expected to deal with as many risks as possible to ensure patient safety. A prerequisite for a clinical risk management is a well-functioning error-reporting culture in health care organizations. The present study analysed the relationship between the Critical Incident Reporting System (CIRS) and patient safety. In particular, the aim of this work is to evaluate whether data from available sources provide sufficient evidence for the utility of CIRS and to derive recommendations for both theorists and practitioners. On paper, CIRS is expected to be useful in clinical settings because it allows the identification of weak spots, hazards, and critical situations such as 'near misses'. However, neither a general CIRS database based on clinical reports exists nor a universal CIRS policy or CIRS direction has been established so far, which can be attributed to the inhomogeneity of the literature and the variability of approaches. Therefore, ordering and analysis of clinical reports are highly desirable. Methods: First, inclusion criteria, exclusion criteria, and keywords were defined to collect studies, reviews, and other sources on CIRS from official databases. After the collection of appropriate articles, a description of the individual data is given. Then, data are classified into different sections based on their respective central statements, and a brief description is given. Finally, the reports are analysed in order to detect patterns and differences. Results: There is a close correlation between the establishment of CIRS in a health care organization and patient safety, although a quantitative relationship between reporting systems and safety is still unproven. CIRS allows the identification and implementation of appropriate actions and strategies toward patient safety. Several prerequisites were identified: top management commitment, transparency, training, anonymity, incentives, and an open error-reporting culture. Personnel have an important impact on the reduction of risk and on the development of safety. The leadership should accept the implementation of a "no blame" error and feedback culture and the security of an absolutely anonymous reporting system. The position of a risk or safety manager is highly recommended. Conclusion: As immediate recommendations, health care organizations are encouraged to adopt CIRS. On the other hand, several research topics were identified, such as the quantitative relationship between CIRS and safety or the development of reliable incident-reporting indices and the ways on how to deal with them. Intensified empirically based research may help in answering open questions concerning CIRS.