Liebel Teresita C, Daugherty Tara, Kirsch Alexandra, Omar Sharifah A, Feuerstein Tara
Biomed Instrum Technol. 2020 May/Jun;54(3):178-188. doi: 10.2345/0899-8205-54.3.178.
This article provides recommendations to manufacturers on using the Food and Drug Administration's MAUDE (Manufacturer and User Facility Device Experience) and Medical Device Recall databases to identify unknown use issues, discover design opportunities, and improve one's risk management file. These recommendations are based on the experiences of researchers who have spent time analyzing and working with both database systems and have developed a methodology for each. Manufacturers can leverage the suggested practices described in this article to address regulatory requirements.
本文就制造商如何利用美国食品药品监督管理局的MAUDE（制造商和用户设施设备经验）及医疗器械召回数据库来识别未知的使用问题、发现设计机会并完善自身的风险管理档案，向制造商提供了相关建议。这些建议是基于研究人员的经验，他们花费时间分析并使用这两个数据库系统，且针对每个系统都开发了一种方法。制造商可以利用本文所述的建议做法来满足监管要求。
