Reed Terrie L, Kaufman-Rivi Diana
FDA's Center for Devices and Radiological Health, Office of Surveillance and Biometrics, USA.
Biomed Instrum Technol. 2010 May-Jun;44(3):248-56. doi: 10.2345/0899-8205-44.3.248.
The broad array of medical devices and the potential for device failures, malfunctions, and other adverse events associated with each device creates a challenge for public health device surveillance programs. Coding reported events by type of device problem provides one method for identifying a potential signal of a larger device issue. The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) Event Problem Codes that are used to report adverse events previously lacked a structured set of controls for code development and maintenance. Over time this led to inconsistent, ambiguous, and duplicative concepts being added to the code set on an ad-hoc basis. Recognizing the limitation of its coding system the FDA set out to update the system to improve its usefulness within FDA and as a basis of a global standard to identify important patient and device outcomes throughout the medical community.
In 2004, FDA and the National Cancer Institute (NCI) signed a Memorandum of Understanding (MOU) whereby NCI agreed to provide terminology development and maintenance services to all FDA Centers. Under this MOU, CDRH's Office of Surveillance and Biometrics (OSB) convened a cross-Center workgroup and collaborated with staff at NCI Enterprise Vocabulary Service (EVS) to streamline the Patient and Device Problem Codes and integrate them into the NCI Thesaurus and Meta-Thesaurus. This initiative included many enhancements to the Event Problem Codes aimed at improving code selection as well as improving adverse event report analysis. LIMITATIONS & RECOMMENDATIONS: Staff resources, database concerns, and limited collaboration with external groups in the initial phases of the project are discussed.
Adverse events associated with medical device use can be better understood when they are reported using a consistent and well-defined code set. This FDA initiative was an attempt to improve the structure and add control mechanisms to an existing code set, improve analysis tools that will better identify device safety trends, and improve the ability to prevent or mitigate effects of adverse events associated with medical device use.
种类繁多的医疗设备以及与每种设备相关的设备故障、失灵和其他不良事件的可能性，给公共卫生设备监测计划带来了挑战。按设备问题类型对报告的事件进行编码，为识别更大设备问题的潜在信号提供了一种方法。美国食品药品监督管理局（FDA）的设备与放射健康中心（CDRH）用于报告不良事件的事件问题代码，以前缺乏用于代码开发和维护的结构化控制集。随着时间的推移，这导致在临时基础上向代码集添加了不一致、模糊和重复的概念。认识到其编码系统的局限性，FDA着手更新该系统，以提高其在FDA内部的实用性，并作为全球标准的基础，以识别整个医学界重要的患者和设备结果。
2004年，FDA与美国国家癌症研究所（NCI）签署了一份谅解备忘录（MOU），据此NCI同意向所有FDA中心提供术语开发和维护服务。根据这份谅解备忘录，CDRH的监测与生物统计学办公室（OSB）召集了一个跨中心工作组，并与NCI企业词汇服务（EVS）的工作人员合作，简化患者和设备问题代码，并将其整合到NCI词库和元词库中。该倡议包括对事件问题代码的许多改进，旨在改善代码选择以及改进不良事件报告分析。局限性与建议：讨论了项目初始阶段的人员资源、数据库问题以及与外部团体的有限合作。
当使用一致且定义明确的代码集报告与医疗设备使用相关的不良事件时，可以更好地理解这些事件。FDA的这项举措旨在改进现有代码集的结构并添加控制机制，改进能够更好地识别设备安全趋势的分析工具，以及提高预防或减轻与医疗设备使用相关的不良事件影响的能力。
