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Regulation of Medical Devices and Organizational Behavior in Hospitals.

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    • Abstract:
      This paper analyzes the evolution in regulation of medical devices and the dynamics by which regulation insulates manufacturers of medical devices from effective control by hospitals. Based on a theoretical framework developed by Zald and an exploratory study of the control environment of the medical device industry, three predictions are made to explain this process. These predictions suggest that internal adaptation of hospitals to technological innovation may be a reaction to a historical imbalance of power in relationships between hospitals and manufacturers of medical devices, rather than simply a mechanistic adaptation to technological imperatives. This focus becomes crucial as hospitals are held to higher performance standards by accrediting agencies and legal requirements, making hospitals more dependent upon the quality and reliability of medical devices to meet these standards. [ABSTRACT FROM AUTHOR]
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