Tremaine Anne Marie, Avram Mathew M
Department of Dermatology and Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, Boston, 02114, Massachusetts; Laser Skin Care Center, Long Beach, 90807, California.
Lasers Surg Med. 2015 Feb;47(2):133-40. doi: 10.1002/lsm.22328. Epub 2015 Feb 4.
It is essential for physicians to be fully informed regarding adverse events and malfunctions associated with medical devices that occur in routine practice. There is limited information on this important issue in the medical literature, and it is mostly based on initial studies and case reports. More advanced knowledge regarding device adverse events is necessary to guide physicians towards providing safe treatments. The FDA requires that manufacturers and device users submit medical device reports (MDRs) for suspected injuries from device use or malfunction. The database of MDRs, entitled Manufacturer and User Facility Device Experience (MAUDE) enables the FDA to monitor device performance and identify potential safety issues.
STUDY DESIGN/MATERIALS AND METHODS: We employed the following search strategy to identify reported adverse events. We searched the MAUDE electronic database on the FDA website in December 2013: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm We collected all reported cases between 1991 and December 2013. The search terms utilized included a comprehensive list of device manufacturers, specific product names, and the wavelengths/technology of the devices used in the field of dermatology.
Our search yielded 1257 MDRs. Forty-five MDRs were excluded due to insufficient data. The data is broken down into the adverse events observed, such as, but not limited to: blistering, burns, scarring, dyschromia, fat loss, and nerve palsy. The MDRs describe the adverse event and attempt to determine if it was related to device malfunction versus operator error. Radiofrequency devices, diode lasers, and intense pulsed light devices were the most commonly reported devices related to injuries.
1257 MDRs, from a myriad of devices used in dermatology, have been reported to the FDA as of December 2013. Despite the underreporting of adverse events, the MAUDE database is an untapped resource of post-market surveillance of medical devices. The database can offer additional information, which combined with the initial device studies and published case reports from our colleagues, will help raise awareness and improve patient safety.
对于医生而言，全面了解日常医疗实践中发生的与医疗设备相关的不良事件和故障至关重要。医学文献中关于这一重要问题的信息有限，且大多基于初步研究和病例报告。需要更先进的设备不良事件知识来指导医生提供安全的治疗。美国食品药品监督管理局（FDA）要求制造商和设备使用者提交有关因使用设备或设备故障导致的疑似伤害的医疗设备报告（MDR）。名为制造商和用户设施设备经验（MAUDE）的MDR数据库使FDA能够监测设备性能并识别潜在的安全问题。
研究设计/材料与方法：我们采用以下搜索策略来识别报告的不良事件。2013年12月，我们在FDA网站上搜索了MAUDE电子数据库：http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm 我们收集了1991年至2013年12月期间所有报告的病例。使用的搜索词包括设备制造商的综合列表、特定产品名称以及皮肤科领域使用的设备的波长/技术。
我们的搜索产生了1257份MDR。由于数据不足，排除了45份MDR。数据按观察到的不良事件进行分类，例如但不限于：水疱、烧伤、瘢痕形成、色素沉着异常、脂肪流失和神经麻痹。MDR描述了不良事件，并试图确定其与设备故障还是操作人员失误有关。射频设备、二极管激光器和强脉冲光设备是报告中与伤害相关最常见的设备。
截至2013年12月，已向FDA报告了1257份来自皮肤科使用的各种设备的MDR。尽管不良事件报告不足，但MAUDE数据库是医疗设备上市后监测的未开发资源。该数据库可以提供额外信息，与我们同事的初始设备研究和已发表的病例报告相结合，将有助于提高认识并改善患者安全。
