VA Eastern Colorado Health Care System, Department of Medicine, CART Coordinating Center, University of Colorado Denver, Denver, CO 80220, USA.
Med Care. 2013 Mar;51(3 Suppl 1):S57-61. doi: 10.1097/MLR.0b013e31827da819.
Timely identification and reporting of medical device problems is critical to postmarket device surveillance programs to maximize patient safety. Cardiac catheterization laboratories are high-device utilization areas well suited for device surveillance.
To demonstrate the feasibility of the national VA Clinical Assessment, Reporting, and Tracking (CART) system, embedded in the electronic health record of all 76 VA cardiac catheterization laboratories, to document unexpected problems with medical devices at the point of care.
We evaluated 260,258 consecutive cardiac catheterization and/or percutaneous coronary intervention procedures on 175,098 Veterans between August 2006 and February 2012. Unexpected device problems (UDPs) encountered for any equipment used during a procedure were entered by clinicians at the point of care as part of regular care documentation. All UDPs were reviewed in collaboration with the FDA to ascertain the likelihood of a device defect (eg, in manufacture or design) and/or contributing to a procedural complication (level I, unlikely; level II, possibly; level III, likely).
Of the 260,258 procedure reports, 974 (0.37%) UDP's were reported by 71 (92.2%) of the 76 VA hospitals. After triage, 739 (75.9%) were deemed level I, 196 (20.1%) level II, and 39 (4.0%) level III. Of the 39 level III reports, 12 (30.7%) are in the submission phase as a FDA MedWatch report. The number of monthly UDP reports increased significantly from 2006 to 2012 (P<0.001).
Leveraging a clinical application embedded in the electronic health record and in collaboration with FDA, a proactive national cardiac device surveillance program has been successfully implemented in the VA.
及时识别和报告医疗器械问题对于最大限度地提高患者安全性的上市后设备监测计划至关重要。心脏导管实验室是高设备使用率的区域，非常适合进行设备监测。
展示国家 VA 临床评估、报告和跟踪（CART）系统的可行性，该系统嵌入在所有 76 个 VA 心脏导管实验室的电子健康记录中，以记录在护理点医疗器械的意外问题。
我们评估了 2006 年 8 月至 2012 年 2 月期间 175098 名退伍军人的 260258 例连续心脏导管检查和/或经皮冠状动脉介入治疗。在进行手术过程中使用的任何设备遇到的意外设备问题（UDP）由临床医生在护理点作为常规护理文件的一部分输入。所有 UDP 都与 FDA 合作审查，以确定设备缺陷（例如制造或设计缺陷）的可能性和/或是否导致手术并发症（一级，不太可能；二级，可能；三级，很可能）。
在 260258 份手术报告中，有 974 份（0.37%）UDP 是由 76 家 VA 医院中的 71 家（92.2%）报告的。经过分诊，739 份（75.9%）被认为是一级，196 份（20.1%）是二级，39 份（4.0%）是三级。在 39 份三级报告中，有 12 份（30.7%）正在作为 FDA MedWatch 报告提交阶段。2006 年至 2012 年，每月 UDP 报告数量显著增加（P<0.001）。
利用嵌入电子健康记录的临床应用程序并与 FDA 合作，VA 成功实施了一项积极主动的国家心脏设备监测计划。
