Clinical performance and quality health care
-
Clin Perform Qual Health Care · Apr 1999
How do regulatory agencies ensure the release of a safe medical device?
This article describes the current regulatory activities of the Food and Drug Administration (FDA), in particular the FDA techniques for regulating medical-device approvals, medical-device reporting, and medical-device-company inspections. Also discussed are the FDA Modernization Act and the methods the FDA is using to implement the act.
-
Clin Perform Qual Health Care · Apr 1999
Comparative StudyEmergence of highly antibiotic-resistant Pseudomonas aeruginosa in relation to duration of empirical antipseudomonal antibiotic treatment.
This study examines antibiotic resistance in Pseudomonas aeruginosa in hospitalized patients in relation to prior empirical antibiotic therapy. ⋯ Duration of empirical antipseudomonal antibiotic treatment influences selection of resistant strains of P aeruginosa; the longer the duration, the broader the pattern of resistance.
-
Clin Perform Qual Health Care · Apr 1999
The psychological and physiological effects of an intensive-care unit environment on healthy individuals.
The ideal inpatient environment would be one in which patient stress and anxiety are alleviated, but current inpatient hospital settings often do not seem to take this fact into consideration. To date, the effects of the actual hospital environment itself on patients is poorly understood. The purpose of the present study was to investigate the types of psychological and physiological changes that people undergo in response to being placed in an inpatient setting. ⋯ The findings of increased feelings of depression attributable solely to being in an ICU setting are inconsistent with the type of environment generally considered necessary to alleviate patient anxiety and tension in a critical-care-ward environment. The negative perception of this environment strongly suggests room for improvement. Efforts in this regard should focus on improving the five senses, particularly sight, sound, and taste within the ICU.