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Applying Insights from Industry Applications to Improve the Reliability of Medical Devices

By Mary Capelli-Schellpfeffer

A new approach to product reliability, known as Prognostics and Health Management (PHM), has found increasing application in a wide range of technical areas. Now IEEE members are exploring its use in the medical field.

IEEE members are working to apply reliability concepts pioneered in other technical areas to the field of medical devices. Their application of ‘Prognostics and Health Management’ (PHM) may lead to improved reliability of implanted devices, for instance. (Note – in this context, ‘Health Management’ refers to the state of health of the physical device, not the clinical health of a patient) PHM is a process of using monitoring to track the ‘health’ of a product and thereby being able to predict its remaining useful life. It is an alternative to the handbook-based reliability prediction methods widely used in industry. In recent years, Prognostics and Health Management (PHM) has revolutionized the perception of product reliability and has resulted in a broad range of applications.

At the first Medical Equipment Diagnostic-Prognostic Panel of the IEEE Reliability Society’s annual International Conference on Prognostics and Health Management held June 21, 2012 (1) in Denver, Colorado, industry application approaches to electrical failures provided insights for prognostics research and mitigation strategies relevant to medical devices and life sciences. Application of prognostics to medical devices poses difficulties, however, because of the complexity of the biological/clinical environment and the variability in medical device applications. This complicates the determination of the data elements necessary for PHM analysis and monitoring.

I presented a case study(2) during the panel comparing an electrical fault in a high voltage power installation to the occurrence of an electrical fault in an implanted medical device. The case study included considerations of the critical features of medical electronics use and uncertainties attributable to the medical device’s patient “host” as well as the healthcare environment.

Regarding the panel, Dennis R. Hoffman, President of the IEEE Reliability Society said, “The [IEEE] Reliability Society is engaged in assuring reliability in the engineering disciplines of hardware, software, and human factors. Technologies that enable modern healthcare span from systems and processes to devices and products. The panel organized by Dr. Peter Ghavami offered a terrific opportunity to bring together reliability engineering, general industry, and patient care perspectives.”

“Safety is a highly developed focus within the Industry Applications Society, leading this year to the formation of the Electrical Safety Committee as one of the Society’s full-fledged technical committees”, Bruno Lequesne, President of the IEEE Industry Applications Society recently noted. “A key strategy of the committee is to link professionals in engineering, industry, academia, government, and medicine to accelerate advancements.”

“As the number of sensors, devices, and data sources increase, potential benefits for clinical care decisions and research are also increasing”, said Dr. Ghavami, Director, Informatics at the University of Washington Harborview Medical Center. “The IEEE Life Sciences Initiative encourages the broad collaboration within engineering, healthcare, and life sciences that this first panel suggests is immediately possible across IEEE Technical Societies.”

For Further Reading

1. “2012 IEEE International Conference on Prognostics and Health Management.”.

2. M. Capelli-Schellpfeffer, “Scale Considerations in Medical Device Prognostics“.

3. M. Pecht and J. Gu, “Health Assessment and Prognostics of Electronic Products: An Alternative to Traditional Reliability Prediction Methods”.

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August 2012 Contributors

Olaf SuchOlaf Such is currently the Global Head of Clinical Science, Magnetic Resonance Imaging Systems, Philips Healthcare, based in Best, the Netherlands. Read more

Atam DhawanAtam P. Dhawan, Ph.D., obtained his bachelor's and master's degrees from the Indian Institute of Technology, Roorkee, and Ph.D. from the University of Manitoba, in Electrical Engineering. Read more

Mary Capelli-SchellpfefferMary Capelli-Schellpfeffer, MD, MPA, is Medical Director of Loyola University Health System's Occupational Health Services, and Associate Professor, Department of Medicine... Read more