Analysis of reasons causing development of malfunctioning software in medical equipment

• Autorzy: Drewniok L. , Piekar E. , Stasiak M. , Maniura R.
• Języki publikacji: EN

Abstrakty

EN

In the world today, the vast majority of medical electronic equipment contains software. Very often even the computer software is classified as an independent medical part. Because of the ease of making changes to the element of a large functional complexity, there is a high risk of introducing errors in the modified software. For example, just entering the wrong one filter parameter can make the biomedical signal processing circuit work incorrectly. As noted in [5], "the lessons learned from … disasters can do more to advance engineering knowledge than all the successful machines and structures in the world". This statement is also true in the software domain. The main goal of this paper is - basing on a database of medical devices with software defects - to draw conclusions and guidance for the design and maintenance of software for new medical equipment.

Słowa kluczowe

EN

FDA; medical software; recall; safety of medical devices

PL

oprogramowanie medyczne; bezpieczeństwo wyrobów medycznych

• Wydawca: University of Silesia, Institute of Informatics, Computer Systems Department
• Czasopismo: Journal of Medical Informatics & Technologies
• Rocznik: 2012
• Tom: Vol. 21
• Strony: 57--63
• Opis fizyczny: Bibliogr. 7 poz., rys., tab.

Twórcy

autor

Drewniok L.

• Department of electrostimulation techniques, Institute of Medical Technology and Equipment, Zabrze, Poland

autor

Piekar E.

autor

Stasiak M.

autor

Maniura R.

Bibliografia

• [1] CRUMPLER S., SNIPES CH., GODZIEMSKI A., General Principles of Software Validation; Final Guidance for Industry and FDA Staff, U.S. Department Of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, 2002.
• [2] http://www.fda.gov/Training/CDRHLearn/ucm209125.htm.
• [3] IEC 62304:2006, Medical device software - Software life cycle processes.
• [4] LINDHOLM CH., Software Development and Risk Management in the Safety Critical Medical Device Domain, Licentiate Thesis, Department of Computer Science Lund University Faculty of Engineering, 2009.
• [5] PETROSKI H., To Engineer Is Human, Vintage Books of Random House, Inc., 1992, New York.
• [6] http://www.urpl.gov.pl/komunikaty-wyroby-medyczne.
• [7] WALLACE D., KUHN R., Lessons from 342 Medical Device Failures, Information Technology Laboratory National Institute of Standards and Technology Gaitersburg.