Medical device accident reporting: does it improve patient safety?

A significant number of patient injuries and deaths are associated with the use of medical devices. After several decades of experience in device evaluation and accident investigation, ECRI believes that many of these adverse effects could not be predicted in advance, even with the most sophisticated design validation techniques. Reporting networks with investigational capability that identify problem devices and provide feedback about adverse effects to manufacturers and medical device users are essential to meet the health communities obligation to provide safe and effective products and patient care.

The health care professional's workstation: a call to action.

The environment of health care delivery is changing dramatically, matched by design trends in the organizations that are responsible for care delivery, whether at the hospital or the national level. However, the emerging goals of these organizations have a certain amount of uniformity independent of background, cultural assumptions or organizational size: they are all committed to the delivery of services that maximize satisfaction of system beneficiaries at a minimum of expense. Achievement of these goals will in part require the development of a management and delivery coordination infrastructure that links the key resource utilizers and administrative operators at the point of production. Merged computer and telecommunications systems connecting at user interface nodes called workstations represent a critical enabling technology for meeting the organizational goals described above. Future delivery systems will need to provide compassionate care, retaining the most highly regarded traditions of medical practice without ignoring considerations of cost, clinical outcome and financial sustainability. This paper describes some of the limitations of the current delivery system, and attempts to identify key design concepts and paradigms that might serve to guide future system development.