A Review of Safety and Hazards Associated with the Artificial Pancreas

被引:18
作者
Ramkissoon C.M. [1 ]
Aufderheide B. [2 ]
Bequette B.W. [3 ]
Vehí J. [1 ]
机构
[1] Institut D'informtica i Aplicacions, Universitat de Girona, Girona
[2] Department of Process Engineering, University of Trinidad and Tobago, Arima
[3] Isermann Department of Chemical and Biological Engineering, Rensselaer Polytechnic Institute, Troy, 12180-3590, NY
关键词
Artificial pancreas (AP); faults; hazards; safety; type; 1; diabetes;
D O I
10.1109/RBME.2017.2749038
中图分类号
学科分类号
摘要
The artificial pancreas (AP) is a closed-loop device with the potential to reduce the complications associated with type 1 diabetes mellitus by maintaining euglycemia in patients. The AP encompasses an algorithm that determines the amount of insulin (and other hormones) to be administered to the patient via a continuous subcutaneous insulin infusion pump using information provided by a continuous glucose monitor and other sensors. As the AP approaches commercialization, special attention must be given to safety within all the individual components, including physiological changes in the patient, as well as safety issues that can arise when these components are combined into a single system. Therefore, we analyzed the specific hazards applicable to the AP with the aim of exposing areas of safety that are yet to be addressed. © 2017 IEEE.
引用
收藏
页码:44 / 62
页数:18
相关论文
共 195 条
[1]  
The Diabetes Control and Complications Trial (DCCT): Design andmethodologic considerations for the feasibility phase, Diabetes, 35, 5, pp. 530-545, (1986)
[2]  
Hybrid Closed Loop Pivotal Trial in Type 1 Diabetes, (2016)
[3]  
Multi-center Trial in Adult and Pediatric Patients with Type 1 Diabetes Using Hybrid Closed Loop System at Home, (2016)
[4]  
Blauw H., Et al., A review of safety and design requirements of the artificial pancreas, Ann. Biomed. Eng., 44, 11, pp. 3158-3172, (2016)
[5]  
Leveson N.G., Engineering a Safer World: Systems Thinking Applied to Safety, (2012)
[6]  
Himmelblau D.M., Fault Detection and Diagnosis in Chemical and Petrochemical Processes, (1978)
[7]  
Leveson N.G., Safeware: System Safety and Computers, (1995)
[8]  
Venkatasubramanian V., Systemic failures: Challenges and opportunities in risk management in complex systems, AIChE J., 57, 1, pp. 2-9, (2011)
[9]  
The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems
[10]  
Code of Federal Regulations Title 21, 8, (2015)