The Safe Medical Device act and its impact on clinical practice.
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.
Deacon
Vera L
VL
Lehigh Valley Hospital, Allentown, PA 18105-1556, USA.
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