Qualitative System Dynamics Methods to Assist with Safety Management on Medical Devices

被引:0
|
作者
Pan, Erdun [1 ]
Mi, Xianqiang [1 ]
Wang, Cong [1 ]
Chen, Jie
机构
[1] Shanghai Univ Sci & Technol, Coll Med Device & Food Engn, Shanghai 201800, Peoples R China
关键词
Qualitative System Dynamics; Risk Management; Medical Device;
D O I
暂无
中图分类号
C93 [管理学];
学科分类号
12 ; 1201 ; 1202 ; 120202 ;
摘要
There are two basic concerns related to medical devices, safety and performance. To improve product safety, risk management needs to be applied throughout the total product lifecycle. However, most manufacturers in China will not emphasize the job of risk management and the statutory requirements are relatively low. To analyze this problem and seek for ways to improve, a group from the medical device school of USST turned to system dynamics and a qualitative method as QSD. They interviewed medical device companies and discussed with the experts, and finally completed the model with two key actions concluded.
引用
收藏
页码:111 / 115
页数:5
相关论文
共 50 条
  • [21] Thermal Management System for In Vitro Evalution of Circulatory Assist Devices at In Vivo Temperatures
    Richard, Joshua
    Jeansonne, Ryan
    Hebert, Jordan
    Stoute, Garth
    King, Jacob M.
    Taylor, Charles E.
    2016 32ND SOUTHERN BIOMEDICAL ENGINEERING CONFERENCE (SBEC), 2016, : 153 - 154
  • [22] SAFETY MONITORING OF MEDICAL DEVICES
    MULLER, H
    BIOMEDIZINISCHE TECHNIK, 1990, 35 (03): : 41 - 43
  • [23] SAFETY OF MEDICAL ELECTRONIC DEVICES
    ARONOW, S
    IEEE TRANSACTIONS ON RELIABILITY, 1973, R 22 (01) : 51 - 51
  • [24] Editorial: Management of right ventricular failure: pathophysiology, medical treatment and use of ventricular assist devices
    Soriano-Colome, Toni
    Barrabes, Jose Antonio
    Gevaert, Sofie
    Sambola, Antonia
    FRONTIERS IN CARDIOVASCULAR MEDICINE, 2023, 10
  • [25] System dynamics methods in complex project management
    Cooper, KG
    MANAGING AND MODELLING COMPLEX PROJECTS, 1997, 17 : 89 - 108
  • [26] Applying Rigorous Methods To Advance the Evidence for Safety and Effectiveness of Implantable Medical Devices
    Marinac-Dabic, Danica
    Matheny, Michael
    West, Suzanne
    Steinbuch, Michael
    Sedrakyan, Art
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2011, 20 : S17 - S18
  • [27] Collecting and analyzing qualitative data for system dynamics: methods and models
    Luna-Reyes, LF
    Andersen, DL
    SYSTEM DYNAMICS REVIEW, 2003, 19 (04) : 271 - 296
  • [28] SAFETY OF PATIENTS WITH MEDICAL DEVICES DURING APPLICATION OF MAGNETIC-RESONANCE METHODS
    POHOST, GM
    BLACKWELL, GG
    SHELLOCK, FG
    ANNALS OF THE NEW YORK ACADEMY OF SCIENCES-SERIES, 1992, 649 : 302 - 312
  • [29] Safety of Endoscopy in Patients With Left Ventricular Assist Devices
    Zuchelli, Tobias
    Alsheik, Eva H.
    Griggs, Leah
    Ahmad, Asyia S.
    Kroser, Joyann A.
    GASTROINTESTINAL ENDOSCOPY, 2010, 71 (05) : AB249 - AB250
  • [30] Perioperative management of left ventricular assist devices
    Sanjay, O. P.
    ANNALS OF CARDIAC ANAESTHESIA, 2016, 19 (05) : S9 - S10