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The Safe Medical Device act and its impact on clinical practice
1Lehigh Valley Hospital, Allentown, PA 18105-1556, USA.
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.