title: The Safe Medical Device Act: nursing implications.
abstract: The Safe Medical Device Act places a legal responsibility on health care practitioners to assess and report malfunctioning medical equipment. As a result of this law, the Food and Drug Administration (FDA) will for the first time have direct regulatory authority over hospitals. Today's complex and technological critical care setting requires that the nurse understand the legal and professional responsibilities imposed by this Act.
authors.forename: K A
authors.initials: KA
authors.lastname: Singleton
authors.forename: R
authors.initials: R
authors.lastname: Dever
authors.forename: T A
authors.initials: TA
authors.lastname: Donner
mesh_terms: D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D003422:Critical Care; D004869:Equipment Safety; D006801:Humans; D016365:Liability, Legal; D009741:Nursing Staff, Hospital / Q000331:legislation & jurisprudence*; D014481:United States