Developing safety critical software is a complex process. Due to the fact that medical device software failure can lead to catastrophic consequences, numerous standards have been developed which govern software development in the medical device domain. Risk management has an important role in medical device software development as it is important to ensure that safe software is developed. Demon...

introduction: health care organizations, especially hospitals, must focus on patient safety as their main strategy. cultural change is the most important challenge that they are faced with in creating a safe system. the present article aims to improve the patient safety culture with an assessment of the safety in fatemeh zahra hospital, najafabad, iran. methods: this descriptive and cross-secti...

introduction: disaster occurs almost daily in the world and increases the issue of it because of high volume of population, industrialization and acts of terrorism, my country is one of the most unexpected event areas of the world. health care systems encounter special challenges in disaster management, that they include triage and treatment a large number victims and also victims' information ...

introduction: nowadays, more than 10,000 different types of medical devices can be found in hospitals. this way, medical electrical equipment is being employed in a wide variety of fields in medical sciences with different physiological effects and measurements. hospitals and medical centers must ensure that their critical medical devices are safe, accurate, reliable and operational at the requ...

patients and methods a questionnaire was developed by a departmental checklist focus group, which aimed to identify the perception of health care checklists in general as well as specific checklists for routine and crisis situations in anesthesia. furthermore participants were asked regarding their perception of performing routine anesthesia and managing crisis situations without any cognitive ...

OBJECTIVES This paper suggests the experimental guidelines to evaluate the electro-mechanical safety of belt type equipment. The electro-mechanical safety was determined by using the International Electrotechnical Commission guidelines, which are widely used as important factors for assessing the electro-mechanical safety of belt type equipment. However, the local guidelines on wearable healthc...

Background Medical devices are used widely for virtually every disease and condition. Although devices are subject to regulation, the number of recalls, the clinical data requirements for regulation and the impact on patient safety are poorly understood. Methods The authors defined a device using European directives and used publicly available information on the Medicines and Health Regulatory...

PROBLEM Significant deficiencies exist in the knowledge and skills of medical students and residents around health care quality and safety. The theory and practice of quality and safety should be embedded into undergraduate medical practice so that health care professionals are capable of developing interventions and innovations to effectively anticipate and mitigate errors. APPROACH Since 20...