Implementing the FDA performance standard on electrode lead wires and patient cables in hospitals.
The U.S. Food and Drug Administration (FDA) Performance Standard on Electrode Lead Wires and Patient Cables became mandatory for all relevant devices on May 9, 2000. The standard requires that any lead wire or patient cable that has contact, temporary or permanent, with a patient, should not allow the connection of the patient to the earth or possibly hazardous voltages. This article advises those hospitals and other healthcare facilities that have not completed the upgrades of wires and cables on how to complete this task.
Tsitlik
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JE
Clinical Engineering Department, Service-Master Management Services Company, Downers Grove, Illinois, USA.
Rose
D C
DC
Baumann
R C
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D001698:Biomedical Engineering / Q000295:instrumentation / Q000592:standards; D004556:Electric Injuries / Q000517:prevention & control; D004560:Electricity; D004566:Electrodes / Q000592:standards*; D004867:Equipment Design; D004869:Equipment Safety; D004865:Equipment and Supplies, Hospital / Q000592:standards*; D006801:Humans; D017751:Safety Management; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*