Use-related risk analysis for medical devices based on improved FMEA

被引：10

作者：

Liu, Long ^{[1
]}

Ma, Shuai ^{[2
]}

Wang, Zhu ^{[2
]}

Li, Ping ^{[3
]}

机构：

[1] Tongji Univ, Coll Design & Innovat, Shanghai 201203, Peoples R China

[2] Tongji Univ, Inst Ind Engn, Shanghai 201203, Peoples R China

[3] Shanghai E Hosp, Shanghai 200120, Peoples R China

来源：

WORK-A JOURNAL OF PREVENTION ASSESSMENT & REHABILITATION | 2012年 / 41卷

关键词：

Use-related risk; medical device; FMEA;

D O I：

10.3233/WOR-2012-0976-5860

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

In order to effectively analyze and control use-related risk of medical devices, quantitative methodologies must be applied. Failure Mode and Effects Analysis (FMEA) is a proactive technique for error detection and risk reduction. In this article, an improved FMEA based on Fuzzy Mathematics and Grey Relational Theory is developed to better carry out use-related risk analysis for medical devices. As an example, the analysis process using this improved FMEA method for a certain medical device (C-arm X-ray machine) is described.

引用

页码：5860 / 5865

页数：6

共 50 条

[41] The organization of a community: Community-based prevention of injecting drug use-related health problems
Carruthers, Susan
SUBSTANCE USE & MISUSE, 2007, 42 (12-13) : 1971 - 1977
[42] Methodology to Assess Medical Processes based on a Failure Mode and Effects Analysis (FMEA)
Sobral, J.
Teixeira, D.
Morais, H.
Neves, M.
2017 IEEE 5TH PORTUGUESE MEETING ON BIOENGINEERING (ENBENG), 2017,
[43] Risk analysis method based on FMEA for transmission line in lightning hazards
1600, International Frequency Sensor Association (171):
[44] FMEA based potential risk analysis of lower cost region sourcing
Zhang, Jie
Zhu, Qiong
2006 IEEE INTERNATIONAL CONFERENCE ON SERVICE OPERATIONS AND LOGISTICS, AND INFORMATICS (SOLI 2006), PROCEEDINGS, 2006, : 158 - +
[45] MedDevRisk: Risk Analysis Methodology for Networked Medical Devices
Seale, Katherine A.
McDonald, J. Todd
Glisson, Willam B.
Pardue, J. Harold
Jacobs, Michael B.
PROCEEDINGS OF THE 51ST ANNUAL HAWAII INTERNATIONAL CONFERENCE ON SYSTEM SCIENCES (HICSS), 2018, : 3271 - 3280
[46] Determination of a Quality Index for Stereotactic Radiosurgery Based On FMEA Risk Analysis
Teixeira, F.
de Almeida, C.
Huq, M.
MEDICAL PHYSICS, 2020, 47 (06) : E738 - E738
[47] Risk-based validation of multilingual medical devices
Crimson Life Sciences Division of TransPerfect Translations
不详
Biomed. Instrum. Technol., 2007, 4 (305-308):
[48] Vague Set based FMEA Method for Risk Evaluation of Safety-Related Systems
Lin, Kuo-Sui
Chiu, Chih-Chung
2018 IEEE CONFERENCE ON DEPENDABLE AND SECURE COMPUTING (DSC), 2018, : 229 - 236
[49] Antimicrobial Use-Related Problems and Predictors among Hospitalized Medical In-Patients in Southwest Ethiopia: Prospective Observational Study
Yadesa, Tadele Mekuriya
Gudina, Esayas Kebede
Angamo, Mulugeta Tarekegn
PLOS ONE, 2015, 10 (12):
[50] Alcohol and cannabis dual use among Black adults: Associations with alcohol use, use-related problems, and race-based discrimination
Buckner, Julia D.
Zvolensky, Michael J.
Scherzer, Caroline R.
AMERICAN JOURNAL ON ADDICTIONS, 2024, 33 (01): : 65 - 70

← 1 2 3 4 5 →