Human factors engineering for medical devices: European regulation and current issues.

A large proportion of the patient injuries or deaths attributable to medical device (MD) misuse can be eliminated and/or mitigated by adopting an effective human factors and ergonomics (HFE) approach. The implementation of a usability engineering process is now mandatory for MD manufacturers seeking to obtain the European Union's CE Mark. Here, we describe the European Union's HFE regulation and highlight the challenges faced by (i) manufacturers implementing this regulation and (ii) regulatory bodies charged with assessing the compliance of usability files.

New Rules on Patient's Safety and Professional Liability for the Italian Health Service.

Background: The phenomenon of clinical negligence claims has rapidly spread to United States, Canada and Europe assuming the dimensions and the severity of a pandemia. Consequently, the issues related to medical malpractice need to be studied from a transnational perspective since they raise similar problems in different legal systems.

Methods: Over the last two decades, medical liability has become a prominent issue in healthcare policy and a major concern for healthcare economics in Italy.

Patient Safety in Complementary Medicine through the Application of Clinical Risk Management in the Public Health System.

To develop a systematic approach to detect and prevent clinical risks in complementary medicine (CM) and increase patient safety through the analysis of activities in homeopathy and acupuncture centres in the Tuscan region using a significant event audit (SEA) and failure modes and effects analysis (FMEA). SEA is the selected tool for studying adverse events (AE) and detecting the best solutions to prevent future incidents in our Regional Healthcare Service (RHS). This requires the active participation of all the actors and external experts to validate the analysis.