Human errors in medical device use account for a large portion of medical errors. Most of these errors are due to inappropriate designs for user interactions, rather than mechanical failures. Evaluating and predicting patient safety in medical device use is critical for developing interventions to reduce such errors either by redesigning the devices or, if redesign is not an option, by training...

The issue of women's security has emerged as a significant concern in many countries. Surveys indicate that approximately 25,000 crimes against women are reported India each year. Sexual harassment and abuse have been on the rise for past 10 years. It is now essential to create strategy protects from becoming victims lowers such assaults. This project aims design implement highly dependable sys...

CONTEXT Ensuring the safety of medical devices challenges current surveillance approaches, which rely heavily on voluntary reporting of adverse events. Automated surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety. OBJECTIVE To determine whether automated safety surveillance of clinical registries using a computerized tool can p...

OBJECTIVE We aimed to determine whether patent foramen ovale closure reduces the risk of stroke, also assessing some safety outcomes. INTRODUCTION The clinical benefit of closing a patent foramen ovale after a cryptogenic stroke has been an open question for several decades, so that it is necessary to review the current state of published medical data in this regard. METHODS MEDLINE, EMBASE...

This report summarizes what the computing research community knows about the role of trustworthy software for safety and effectiveness of medical devices. Research shows that problems in medical device software result largely from a failure to apply well-known systems engineering techniques, especially during specification of requirements and analysis of human factors. Recommendations to increa...

Medical devices play a vital role in diagnosing, treating, and preventing diseases and are an integral part of the health-care system. Many devices, including implantable medical devices, enter the market through a regulatory pathway that was not designed to assure safety and effectiveness. Several recent studies and high-profile device recalls have demonstrated the need for well-designed, vali...

The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health [1]. Through consideration of benefit-risk principles for the evaluation of medical devices, CDRH decisions seek an appropriate balance between protection of the US public and encouragement of innovation directed toward improvement in health outcomes [2,3]. Within the regulatory fram...