Klonoff David C, Reyes Juliet S
Mills-Peninsula Health Services, San Mateo, California, USA.
J Diabetes Sci Technol. 2009 Mar 1;3(2):396-402. doi: 10.1177/193229680900300224.
Diabetes Technology Society convened a panel of insulin pump experts in Bethesda, Maryland, on November 12, 2008, at the request of the Food and Drug Administration. The group consisted of physicians, nurses, diabetes educators, and engineers from across the United States. The panel members (1) discussed safety features of insulin pump therapy and (2) recommended adjustments to current insulin pump design and use to enhance overall safety. Software and hardware features of insulin pumps were analyzed from engineering, medical, nursing, and pump-user perspectives. The meeting was divided into four sections: (1) Engineering Safety-Designing Software and Hardware for Insulin Pump Therapy; (2) Patient Safety-Selecting Patients and Clinical Settings for Insulin Pump Use; (3) Clinical Safety-Determining and Delivering Insulin Dosages Using Insulin Pump Therapy; and (4) Personal Experiences-A Panel Discussion about Insulin Pump Safety. Six aspects of insulin pump technology were noted to present potential safety problems: (1) software, (2) wireless communication, (3) hardware, (4) alarms, (5) human factors, and (6) bolus-dose calculation. There was consensus among meeting participants that insulin pump therapy is beneficial in patients of all ages and that insulin pump safety must be assured through careful regulation.
应美国食品药品监督管理局的要求，糖尿病技术协会于2008年11月12日在马里兰州贝塞斯达召集了一个胰岛素泵专家小组。该小组由来自美国各地的医生、护士、糖尿病教育工作者和工程师组成。小组成员（1）讨论了胰岛素泵治疗的安全特性，（2）建议对当前胰岛素泵的设计和使用进行调整，以提高整体安全性。从工程、医学、护理和泵使用者的角度分析了胰岛素泵的软件和硬件特性。会议分为四个部分：（1）工程安全——为胰岛素泵治疗设计软件和硬件；（2）患者安全——选择使用胰岛素泵的患者和临床环境；（3）临床安全——使用胰岛素泵治疗确定和输送胰岛素剂量；（4）个人经验——关于胰岛素泵安全的小组讨论。胰岛素泵技术的六个方面被指出存在潜在的安全问题：（1）软件，（2）无线通信，（3）硬件，（4）警报，（5）人为因素，（6）大剂量计算。与会者一致认为，胰岛素泵治疗对所有年龄段的患者都有益，必须通过仔细监管来确保胰岛素泵的安全。
