Experts see dangers in rules implementing Safe Medical Devices Act.
Final rules for the Safe Medical Devices Act of 1990 have yet to be published, but hospitals now must comply with an interim version of the law. The rules, designed to ensure that equipment is safe and effective, are proving to be controversial: Some say they're too vague and will be too burdensome for providers, while others say complications should be minimal.
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D000573:American Hospital Association; D001294:Attitude to Health; D004869:Equipment Safety; D004865:Equipment and Supplies, Hospital / Q000592:standards*; D007882:Legislation, Hospital; D011358:Product Surveillance, Postmarketing; D012308:Risk Management / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration