Cardiovascular technology: THE SAFE MEDICAL DEVICE ACT

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Abstract

The Safe Medical Devices Act of 1990 and subsequent federal Food and Drug Administration (FDA) regulations provide a new dimension in the regulation of health care institutions. For the first time, the FDA has the power to require many health care facilities to investigate, document, and report serious events related to all medical devices, from ventricular assist devices, to catheters, to sutures. The FDA also has the power to require facilities to track certain devices from receipt, through patient use, to disposal. Staff must be trained, procedures implemented, and compliance achieved. Lack of compliance may carry civil and criminal penalties in the future, affect liability and risk management, and influence accreditation.

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