Safety and Performance of Intra- and Extra-Vascular Direct Measurement Blood Pressure Transducers and Access Catheters

摘要

The objectives of this task were (1) to gather and analyze available information about safety and performance characteristics of the subject devices, and (2) to generate a list of specific recommendations on safety, performance and labeling requirements that would eliminate or reduce the patient and user hazard associated with those devices. Identified problems included nosocomial infections, accidental blood loss, catheter tip occlusion from thrombus formation, embolization, and calibration and connector nonstandardization. A bibliography of 483 citations is appended to the report.