Assessment of the impact of medical devices on the quality of care.

Medical technology and medical devices play major roles in the diagnosis and treatment of patients in health care facilities. A facility should use a rational process to reach the decision to acquire a new piece of technology; this process should recognize the importance of both the machine and the user in modern technology. Moreover, each health care facility should assure that a newly acquired technological advance does not pose safety hazards to patients; that the device, when used in the clinical situation, produces the desired results reliably and consistently with its intended purpose; that there are appropriate means of identifying performance defects or opportunities for greater use of the existing device; and that the end of the device's useful life is anticipated so that quality does not decrease and dangers to patients do not increase due to equipment obsolescence. Successfully applying QA principles, consistent with each phase in the life of medical technological devices, should ensure equipment of high quality and thus benefit a health care facility and its patients.