INTRODUCTION A fully functional electronic health record (EHR) system that is integrated with other automated medical devices has significant potential to improve the quality, safety, and efficiency of care delivered. These improvements are made possible with the overarching objectives of medical device integration: 1) reduction in errors, 2) access to data, and 3) improved workflows. Most of d...

INTRODUCTION Considering the high cost, volume, and patient safety issues associated with medical devices, monitoring of medical device performance is critical to ensure patient safety and quality of care. The purpose of this article is to describe the Kaiser Permanente (KP) implant registries and to highlight the benefits of these implant registries on patient safety, quality, cost effectivene...

Introduction: The software components of implantable medical devices are becoming increasingly complex and are responsible for the majority of life-critical decisions. From 2008-2012, 15% of all the medical device recalls were due to software issues. Research and regulation efforts have largely focused on verifying whether the device satisfies its specification, which can be achieved with open ...

out being hospitalized. More patients stay at home – or at least outside the reach of health-care providers – for self-treatment, in which they use medical devices, such as dialysis or insulin injector implants. Remote diagnosis and even treatment is already being applied for specific forms of illness, for example cardiac failure problems, in the sense of telemedicine or even telesurgery. Risks...

BACKGROUND The safety and efficacy of the PrePex device for voluntary medical male circumcision (VMMC) has been demonstrated in studies in Rwanda, Uganda, and Zimbabwe, leading to the conditional prequalification of the device for use in adults. Because the majority of VMMC clients in the 14 priority countries are adolescents under 18 years, research to establish the safety and efficacy of the ...

Developing software for the manufacture of medical devices is a sensitive operation from many perspectives, such as: safety and regulatory compliance. Medical Device companies are required to have a well defined development process in place, which includes software development, and be able to demonstrate that they have followed it through the complete life-cycle of the device. With the increasi...

With the current Guidance for Industry and Food and Drug Administration Staff for Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices [1] and for Mobile Medical Applications [2] of the of the U.S. Food and Drug Administration (FDA) the everlasting discussion has been refired: Is (this) software a medical device? If so, in an informatician’s world...

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Defense Alliance for Advanced Medical Terminology (DAAMT). The purpose of the MOU is to enable government agencies to exchange information and jointly pursue research endeavors related to medical device safety and effectiveness.

The World Health Organization has proposed three major challenges in patient safety: healthcare-associated infection (HAI); safe surgery saves lives; and antimicrobial resistance. The first priority for patient safety is to confront HAI, which obviously indicates that HAI has become an important issue in global public health. HAI remains a current challenge in Taiwan. HAI is an important indica...