title: The Safe Medical Device act and its impact on clinical practice.
abstract: Hospital patients often require vascular access devices to deliver infusion therapies. These can include peripheral intravenous catheters (PIVs), peripherally inserted central venous catheters (PICCs), triple lumens, ports, and Tesio, Swann-Ganz, and Hickman catheters. Although these products are used in large numbers without significant sequelae, when a device fails, the impact is realized throughout the industry. The infusion clinicians within our institution followed a systematic approach to dealing with the failure of devices that occurred over a 3-month period. This article describes the response process when a device fails and the methods of achieving positive patient outcomes.
authors.affiliation: Lehigh Valley Hospital, Allentown, PA 18105-1556, USA.
authors.forename: Vera L
authors.initials: VL
authors.lastname: Deacon
mesh_terms: D002405:Catheterization, Central Venous / Q000295:instrumentation* / Q000451:nursing; D002406:Catheterization, Peripheral / Q000295:instrumentation* / Q000451:nursing; D002408:Catheters, Indwelling / Q000009:adverse effects*; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D004282:Documentation; D004868:Equipment Failure; D004869:Equipment Safety / Q000592:standards*; D005568:Forms and Records Control; D006801:Humans; D009737:Nursing Records; D017063:Outcome Assessment, Health Care; D010414:Pennsylvania; D012308:Risk Management / Q000458:organization & administration; D017749:Total Quality Management / Q000458:organization & administration; D014481:United States; D014486:United States Food and Drug Administration