Medical devices: promoting a safe migration into the home.
Medical device use in the home environment has grown in volume and complexity. Because of this, the Food and Drug Administration (FDA) needs to ensure that these products are safe and effective for use in this environment. The FDA must develop a partnership with home healthcare providers in areas of patient education, monitoring device adverse events that occur in the home environment, and communicating problems to the manufacturer.
Weick-Brady
Mary D
MD
Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, Rockville, MD 20850, USA. Mary.Brady@hhs.fda.gov
Lazerow
Robert N
RN
D003152:Community Health Nursing / Q000458:organization & administration; D004868:Equipment Failure; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000009:adverse effects / Q000592:standards* / Q000706:statistics & numerical data; D006804:Ergonomics; D006699:Home Care Services / Q000458:organization & administration*; D006801:Humans; D007373:Interinstitutional Relations; D024802:Nurse's Role; D010353:Patient Education as Topic / Q000458:organization & administration; D011358:Product Surveillance, Postmarketing; D017751:Safety Management / Q000458:organization & administration*; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*