OBJECTIVE Exposure of healthcare personnel to bloodborne pathogens (BBPs) can be prevented in part by using safety-engineered sharp devices (SESDs) and other safe practices, such as double gloving. In some instances, however, safer devices and practices cannot be utilized because of procedural factors or the lack of a manufactured safety device for the specific clinical use. In these situations...

IEC 62304 [1] is an international standard (hereafter referred to as the Standard) that specifies software development life cycle processes to improve the safety of medical devices. It defines a series of activities and tasks that are required for medical device software engineering. We will discuss how MathWorks tools for Model-Based Design, which have been used to create high-integrity softwa...

In the proposed study, a medical device maintenance management system (MEDEMAS) is designed and implemented which provides a data pool of medical devices, the maintenance protocols and other required information for these devices. The system also contains complete repair and maintenance history of a specific device. MEDEMAS creates optimal maintenance schedule for devices and enables the servic...

Indwelling medical devices are increasingly used in long-term care facilities (LTCFs). These devices place residents at a heightened risk for infection and colonization and infection with multidrug-resistant organisms. Understanding the risk and pathogenesis of infection associated with commonly used medical devices can help facilitate appropriate therapy. Programs to minimize unnecessary use o...

PURPOSE Medical devices are used to monitor, replace, or modify anatomy or physiological processes. They are important health care innovations that enable effective treatment using less invasive techniques, and they improve health care delivery and patient outcomes. Devices can also introduce risk of harm to patients. Our objective was to propose a surveillance system framework to improve the s...

The effect of medical errors and unsafe systems of care has had a profound effect on the practice of obstetrics and gynecology. From 1975 to 2000, medical malpractice costs for obstetrician–gynecologists have risen nearly four-fold higher than that of other medical costs. In addition, it has been estimated that defensive medicine may cost society $80 billion per year. Most importantly, many obs...