Pre-clinical validation and risk management of autonomous tumor prosthesis using FMEA approach
Abstract
Keywords
Full Text:
PDFReferences
S. Kocaoğlu and E. Akdoğan, “Design and development of an intelligent biomechatronic tumor prosthesis,” Biocybern. Biomed. Eng., vol. 39, no. 2, pp. 561–570, 2019.
T. Gaamangwe, A. Krivoy, and P. Kresta, “Applying risk management principles to medical devices performance assurance program - Defining the process,” Biomed. Instrum. Technol., vol. 42, no. 5, pp. 401–406, 2008.
X. Zhao and X. Bai, “The application of FMEA method in the risk management of medical device during the lifecycle,” 2010 2nd Int. Conf. E-bus. Inf. Syst. Secur. EBISS2010, pp. 455–458, 2010.
R. D. Wilkins and L. K. Holley, “Risk management in medical equipment management,” 1998, vol. 20, no. 6, pp. 3343–3345.
F. McCaffery, J. Burton, and I. Richardson, “Improving software risk management in a medical device company,” 2009 31st Int. Conf. Softw. Eng. - Companion Vol. ICSE 2009, pp. 152–162, 2009.
S. M. Donn, “Medical liability, risk management, and the quality of health care,” Semin. Fetal Neonatal Med., vol. 10, no. 1, pp. 3–9, 2005.
R. Masterton, L. Teare, and J. Richards, “Hospital Infection Society/Association of Medical Microbiologists ‘Towards a Consensus II’ Workshop I Hospital-acquired infection and risk management,” J. Hosp. Infect., vol. 51, no. 1, pp. 17–20, 2002.
S. McRoberts, “Risk management of product safety,” 2005 IEEE Symp. Prod. Saf. Eng., vol. 2005, pp. 65–71, 2005.
A. Pillay and J. Wang, “Modified failure mode and effects analysis using approximate reasoning,” Elsevier Ocean Eng. Ser., vol. 7, no. C, pp. 149–177, 2003.
D. H. Stamatis, Failure Mode and Effect Analysis: FMEA from Theory to Execution. Milwakuee: American Society for Qualiity, Quality Press, 2003.
L. Wang, Y. P. Hu, H. C. Liu, and H. Shi, “A linguistic risk prioritization approach for failure mode and effects analysis: A case study of medical product development,” Qual. Reliab. Eng. Int., vol. 35, no. 6, pp. 1735–1752, 2019.
G. Faiella et al., “Expanding healthcare failure mode and effect analysis: A composite proactive risk analysis approach,” Reliab. Eng. Syst. Saf., vol. 169, no. August 2017, pp. 117–126, 2018.
H. C. Liu, L. E. Wang, Z. Li, and Y. P. Hu, “Improving risk evaluation in FMEA with cloud model and hierarchical TOPSIS method,” IEEE Trans. Fuzzy Syst., vol. 27, no. 1, pp. 84–95, 2019.
P. Chemweno, L. Pintelon, A. M. De Meyer, P. N. Muchiri, A. Van Horenbeek, and J. Wakiru, “A Dynamic Risk Assessment Methodology for Maintenance Decision Support,” Qual. Reliab. Eng. Int., vol. 33, no. 3, pp. 551–564, 2017.
H. Selim, M. G. Yunusoglu, and Ş. Yilmaz Balaman, “A Dynamic Maintenance Planning Framework Based on Fuzzy TOPSIS and FMEA: Application in an International Food Company,” Qual. Reliab. Eng. Int., vol. 32, no. 3, pp. 795–804, 2016.
M. Yazdi, “Improving failure mode and effect analysis (FMEA) with consideration of uncertainty handling as an interactive approach,” Int. J. Interact. Des. Manuf., vol. 13, no. 2, pp. 441–458, 2019.
H. Sayyadi Tooranloo, A. S. Ayatollah, and S. Alboghobish, “Evaluating knowledge management failure factors using intuitionistic fuzzy FMEA approach,” Knowl. Inf. Syst., vol. 57, no. 1, pp. 183–205, 2018.
M. Baghery, S. Yousefi, and M. J. Rezaee, “Risk measurement and prioritization of auto parts manufacturing processes based on process failure analysis, interval data envelopment analysis and grey relational analysis,” J. Intell. Manuf., vol. 29, no. 8, pp. 1803–1825, 2018.
K. Kölle, A. L. Fougner, M. A. Lundteigen, S. M. Carlsen, R. Ellingsen, and Ø. Stavdahl, “Risk analysis for the design of a safe artificial pancreas control system,” pp. 311–328, 2019.
I. F. Warsito, C. Pahl, E. Supriyanto, and A. Soesanto, “Risk Analysis of Transesophageal Echocardiography Telemanipulator in Catheterization Laboratory,” vol. 11, pp. 48–54, 2017.
T. Kitano, S. Koyama, N. Koike, and H. Kanebako, “Development of EVAHEART LVAS to Enhance SSafety During Home Care,” Trans. Japanese Soc. Med. Biol. Eng., vol. 52, pp. 84–85, 2014.
S. M. Patel, P. E. Allaire, H. G. Wood, A. L. Throckmorton, C. G. Tribble, and D. B. Olsen, “Methods of Failure and Reliability Assessment for Mechanical Heart Pumps,” Artif. Organs, vol. 29, no. 1, pp. 15–25, 2005.
K. Bramstedt, “Failure Mode and Effects Analysis as an Informed Consent Tool for Investigational Cardiothoracic Devices,” Am. Soc. Artif. Organs J., vol. 48, no. 3, pp. 293–295, 2002.
M. Cv and B. Gs, “Failure mode and effect analysis of chitra heart valve prosthesis,” pp. 3–4, 1995.
I. Chou, H. Hsueh, and R. Lee, “Example For Mobile Ecg Holter Design Using FMEA Model,” vol. 21, no. 1, pp. 61–70, 2009.
B. Y. P. Kazanzides, G. Fichtinger, G. D. Hager, A. M. Okamura, L. L. Whitcomb, and R. H. Taylor, “Surgical and Interventional Robotics,” no. June, 2008.
C. M. Zapanta et al., “Durability Testing of a Completely Implantable Electric Total,” Am. Soc. Artif. Organs J., vol. 51, no. 3, pp. 214–223, 2005.
M. Fischer, M. Schönegg, J. Schöchlin, and A. Bolz, “Development of a Current-Controlled Deeffirillator for Clinical Tests,” Biomed. TTechnik, vol. 47, no. 1, pp. 800–802, 2002.
C. A. Cipriano, I. S. Gruzinova, R. M. Frank, S. Gitelis, and W. W. Virkus, “Frequent complications and severe bone loss associated with the repiphysis expandable distal femoral prosthesis,” Clin. Orthop. Relat. Res., vol. 473, no. 3, pp. 831–838, 2015.
A. J. Schwartz, J. M. Kabo, F. C. Eilber, F. R. Eilber, and J. J. Eckardt, “Cemented distal femoral endoprostheses for musculoskeletal tumor: Improved survival of modular versus custom implants,” Clin. Orthop. Relat. Res., vol. 468, no. 8, pp. 2198–2210, 2010.
M. D. Neel, R. M. Wilkins, B. N. Rao, and C. M. Kelly, “Early Multicenter Experience With a Noninvasive Expandable Prosthesis,” Clin. Orthop. Relat. Res., vol. 415, no. 415, pp. 72–81, 2003.
S. Verkerke, G. J., “Design of a lengthening element for a modular femur endoprosthetic system,” J. Eng. Med., vol. 203, pp. 97–102, 1989.
G. Delepine, N. Delepine, J. C. Desbois, and D. Goutallier, “Expanding prostheses in conservative surgery for lower limb sarcoma,” Int. Orthop., vol. 22, no. 1, pp. 27–31, 1998.
T. D. E. C. Module et al., “1-Q-EC Amplifier Summary DEC Module 24 / 2 1-Q-EC Amplifier DEC Module 50 / 5 1-Q-EC Amplifier maxon motor control 1-Q-EC Amplifier Data maxon motor control,” 2017. .
“Re-chargeable Lithium-ion batteries.” [Online]. Available: http://www.arpae-summit.com/paperclip/exhibitor_docs/13AE/Quallion_LLC_36.pdf. [Accessed: 22-Apr-2020].
“Medical equipment batteries.” [Online]. Available: http://www.enersys.com/WorkArea/DownloadAsset.aspx?id=25769803876. [Accessed: 22-Apr-2020].
DOI: http://dx.doi.org/10.21533/pen.v8i2.1292
Refbacks
- There are currently no refbacks.
Copyright (c) 2020 SITKI KOCAOGLU, ERHAN AKDOGAN
This work is licensed under a Creative Commons Attribution 4.0 International License.
ISSN: 2303-4521
Digital Object Identifier DOI: 10.21533/pen
This work is licensed under a Creative Commons Attribution 4.0 International License