中国医学装备2026，Vol.23Issue(5)：113-118,6.DOI:10.3969/j.issn.1672-8270.2026.05.020
基于真实世界数据的发泡胶定位垫不良事件风险研究
Study on risk of adverse events of fixation cushion with Styrofoam on the basis of RWD
摘要
Abstract
Objective:To analyze the types and risk reasons of adverse events of fixation cushion with Styrofoam,and propose corresponding countermeasures for risks,so as to reduce risks of using it.Methods:The data of 174 adverse events of fixation cushion with Styrofoam that were used at The First Affiliated Hospital of Fujian Medical University during January 2018 and June 2025 were retrospectively selected.The 158 adverse events of them occurred in 486 patients(45 cases were at head and neck,and 148 cases were at chest,and 227 cases were at abdomen,and 66 cases were at limbs)who occurred adverse events after the fixation cushion with Styrofoam was used.In addition,16 adverse events occurred in the process that 2 technicians,who conducted clinical operation,made the fixation cushion with Styrofoam.The risk factors of making and using these fixation cushions with Styrofoam were researched and analyzed through these adverse events.Results:Among 486 patients who received radiotherapy,32.51%(158/486)of patients occurred adverse events included skin redness and skin swelling after used fixation cushion with Styrofoam.For different fixation parts,the incidence of adverse events of patients,whose fixation part was head and neck,was the highest[57.78%(26/45)],and the incidences of that at chest,abdomen and limbs were respectively 29.06%(43/148),30.37%(69/227)and 30.30%(20/66).The difference of the incidences of adverse events among different fixation parts was significant(x2=15.84,P<0.01).The differences of the effects of age and gender on incidence of adverse events among different fixation parts were not significant(P>0.05).In 174 adverse events,the ratio of severe reports was 1.15%(2/174),and the ratio of general reports was 98.85%(172/174).The involved main injuries of 174 adverse events included skin redness(90.23%),nasal mucosa irritation(3.45%),contaminated skin(1.15%),and redness and swelling of skin(0.57%).The failure of apparatus mainly included insufficient foaming(4.02%)and explosion of bottle(0.57%).The risk levels of skin redness and explosion of bottle were higher.The reason of occurring risk of fixation cushion with Styrofoam mainly included imperfect user manual of products,products without waterproof bags,Styrofoam liquid with irritant,insufficient foaming,unskilled clinical operation,reasons from patients,and so on.Conclusion:Clinical users and operators of fixation cushion with Styrofoam should fully understand the risks of using it,and strictly implement operation as production process,so as to reduce risks of clinical operation.The registrants of this product should strengthen management for research and risk after the product enters market,and improve the design of product,and promote iteration and upgrading of product,and reduce risk of using it.关键词
发泡胶/发泡胶定位垫/不良事件/风险分析Key words
Styrofoam/Fixation cushion with Styrofoam/Adverse event/Risk analysis分类
医药卫生引用本文复制引用
施丽霞,陈龙建,周瑾,洪金省,郭飞宝,林嵘,陈深..基于真实世界数据的发泡胶定位垫不良事件风险研究[J].中国医学装备,2026,23(5):113-118,6.基金项目
福建省药品监督管理局科技计划项目(2023-11) Science and Technology Program Project of Fujian Medical Products Administration(2023-11) （2023-11）
