Ensign Lisa Garnsey, Cohen K Bretonnel
University of Colorado, Anschutz Medical Campus.
University of Colorado, Denver, School of Medicine.
EGEMS (Wash DC). 2017 Jun 14;5(1):12. doi: 10.5334/egems.221.
The US Food and Drug Administration (FDA)'s Manufacturer and User Facility Device Experience (MAUDE) database is a publicly available resource providing over 4 million records relating to medical device safety. Using downloadable MAUDE files avoids limitations of the online MAUDE search interface. However, naive file usage can result in errors, while independent discovery of the nuances required to correctly work with the database can be time-consuming. Practical information is provided to shorten this learning curve and obtain accurate results when using the MAUDE database files.
The MAUDE database consists of 135 fields in four primary (Master Event, Device, Patient, Text) and two supplemental (Device Problems and Problem Code Descriptions) file types. When combined, these six files provide a detailed account of an adverse event or product problem report. Website instructions for joining the files are incomplete. Comprehensive details are provided to enable precise file linking.
MAUDE files have irregularities that must be understood to download and work with the data efficiently. Accurate results depend upon combining the files correctly and understanding the difference between report and event denominators. Appreciating data availability can facilitate successful MAUDE investigations.
The MAUDE database can provide key insights about medical device safety. Detailed information is provided about the structure, content and interrelationships of the MAUDE database files to enable investigators to use this valuable resource more quickly and accurately.
美国食品药品监督管理局（FDA）的制造商和用户设施设备经验（MAUDE）数据库是一个公开资源，提供了超过400万条与医疗器械安全相关的记录。使用可下载的MAUDE文件可避免在线MAUDE搜索界面的局限性。然而，单纯使用文件可能会导致错误，而独立发现正确使用该数据库所需的细微差别可能会很耗时。本文提供了实用信息，以缩短这一学习曲线，并在使用MAUDE数据库文件时获得准确结果。
MAUDE文件描述：MAUDE数据库由四种主要（主事件、设备、患者、文本）和两种补充（设备问题和问题代码描述）文件类型中的135个字段组成。这六个文件结合起来，详细说明了不良事件或产品问题报告。网站上关于合并文件的说明不完整。本文提供了全面的详细信息，以实现精确的文件链接。
MAUDE文件存在一些不规则之处，必须了解这些不规则之处才能有效地下载和处理数据。准确的结果取决于正确合并文件并理解报告分母和事件分母之间的差异。了解数据可用性有助于成功进行MAUDE调查。
MAUDE数据库可以提供有关医疗器械安全的关键见解。本文提供了有关MAUDE数据库文件的结构、内容和相互关系的详细信息，以使研究人员能够更快、更准确地使用这一宝贵资源。
