Ji Hangyu, Wang Shaoli, Gong Yang
China Academy of Chinese Medical Sciences Guang'anmen Hospital, Beijing, People's Republic of China.
School of Biomedical Informatics, University of Texas Health Science Center at Houston, Texas, United States.
J Dig Endosc. 2021 Jun;12(2):71-77. doi: 10.1055/s-0041-1731960. Epub 2021 Jul 30.
The malfunction of capsule endoscopy (CE) devices is a significant reason for the failure of CE procedures, which could hinder and prevent diagnosis. Unfortunately, malfunction-related adverse events (AEs) caused by CE devices are rarely reported in publications. Although most malfunction-related AEs could not lead to physical harm, they could reduce the efficiency of medical care and increase medical costs. The manufacturer and user facility device experience (MAUDE) database, a publicly accessible resource for patient safety, contains not only the common complications of CE but also valuable malfunction-related AEs, which have been underutilized. Therefore, the study aims to discover and analyze the possible AEs associated with CE and demonstrate the utility of the MAUDE reports to promote patient safety.
We acquired MAUDE reports of CE systems from January 01, 2008, to July 31, 2020, through a systematic search strategy. We utilized the manufacturers, brand names, and product codes as search terms from which medical device reports including structured data and narrative texts were extracted, followed by a manual review of the narrative texts, reporter occupation, device involved, event type and the phase of the event; finally, patient outcomes were recorded and analyzed as per CE categories and characteristics.
A total of 377 CEs medical device reports were retrieved, and 342 reports were included after reviewing. There were 327 mandatory reports (96%) and 15 voluntary reports (4%). These reports referred to capsule endoscope ( = 213), sensing system ( = 66), patency capsule ( = 38), and capsule delivery device ( = 26). A total of 349 CE-related AEs were identified, including complications ( = 228), malfunction-related AEs ( = 109), and other events ( = 12). The composition of AEs was not the same for the CE devices. Complications were major AEs of capsule endoscope and patency capsule, but malfunction-related AEs were the most common in AEs of sensing systems and capsule delivery devices.
MAUDE serves as an invaluable data source for investigating malfunction-related AEs. In addition to common complications, malfunction of CE devices could threaten patient safety in CE procedures. Improving awareness of the malfunction of CE devices and raising adequate training for staff working in gastrointestinal (GI) endoscopic units could be critical and beneficial in preventing malfunction-related AEs.
胶囊内镜（CE）设备故障是CE检查失败的重要原因，可能会阻碍和妨碍诊断。不幸的是，由CE设备引起的与故障相关的不良事件（AE）在出版物中很少被报道。虽然大多数与故障相关的AE不会导致身体伤害，但它们会降低医疗效率并增加医疗成本。制造商和用户设施设备经验（MAUDE）数据库是一个可公开获取的患者安全资源，不仅包含CE的常见并发症，还包含未得到充分利用的与故障相关的宝贵AE。因此，本研究旨在发现和分析与CE相关的可能AE，并展示MAUDE报告在促进患者安全方面的作用。
我们通过系统检索策略获取了2008年1月1日至2020年7月31日期间CE系统的MAUDE报告。我们将制造商、品牌名称和产品代码用作检索词，从中提取包括结构化数据和叙述性文本的医疗器械报告，随后对叙述性文本、报告者职业、涉及设备、事件类型和事件阶段进行人工审核；最后，根据CE类别和特征记录并分析患者结局。
共检索到377份CE医疗器械报告，审核后纳入342份报告。其中有327份强制报告（96%）和15份自愿报告（4%）。这些报告涉及胶囊内镜（=213）、传感系统（=66）、通畅性胶囊（=38）和胶囊输送装置（=26）。共识别出349起与CE相关的AE，包括并发症（=228）、与故障相关的AE（=109）和其他事件（=12）。不同CE设备的AE构成不同。并发症是胶囊内镜和通畅性胶囊的主要AE，但与故障相关的AE在传感系统和胶囊输送装置的AE中最为常见。
MAUDE是调查与故障相关AE的宝贵数据源。除常见并发症外，CE设备故障可能会威胁CE检查过程中的患者安全。提高对CE设备故障的认识并加强对胃肠（GI）内镜科室工作人员的适当培训，对于预防与故障相关的AE可能至关重要且有益。
