Regulatory Affairs Syndicator

Evolving practices of medical equipment. Management following FDA inspections.

J Clin Eng. 1992 Jan-Feb;17(1):49-57

Authors: Hill D

This paper outlines one hospital’s response to the changing needs for: quality of care; risk management; cost control; and regulatory agency requirements. All recall, update, and product safety alerts are now routed to the office of The Director of Materials Management. The director notifies the appropriate department manager, who must reply in writing. The Clinical Engineering Department maintains a historical data file for medical equipment, which includes service costs information. New purchasing forms and terms have been developed for use in purchasing equipment and service. Maintenance of accurate historical data for medical devices begins at purchase, and continues to installation and through ongoing service. This requires the cooperation of the manufacturer, the service vendor, and the clinical department using the device. Because technology management can improve the quality of care and reduce risk, it is worth doing and can also reduce costs.

PMID: 10117003 [PubMed - indexed for MEDLINE]