Bezpieczeństwo użytkowania wyrobu medycznego a odpowiedzialność karna za błąd organizacyjny w leczeniu pacjenta – studium przypadku
Safety in use of the medical device and criminal liability for organizational medical error – a case study

Summary/Abstract: The phenomenon of distorting the functioning of health care institutions and affecting the safety of the patients hospitalized in them, which may result in criminal liability of employees of these entities is organizational error in conducting medical activity. It includes a series of events related to failure to provide appropriate conditions for the treatment of patients, including irregularities and shortcomings in the management of medical devices. Improper are the purchase and use of equipment and tools do not meet the required safety standards, unpredictable as to the outcome of their application, or incredible in terms of research results using them. Ignoring the rules of safe use of medical devices can take different forms and lead to cause irreparable harm. This type of case is analyzed in this publication. On the basis of the facts concerning the improper use of medical device in the embolization, îe. without its real properties and rules of use in surgical procedures, compiled a catalog of hypothetical unlawful behavior of staff therapeutic entity representing organizational medical error. At the same time the study identifies the criminal liability of individual groups of employees, depending on the causes and course of medical incident. The relevant considerations in this regard while preceded by a presentation of basic issues of security market and use of medical devices.

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