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Hazard and Safety Analysis of the Integra™ UltraVS™ Neonate Valve

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Advances in Human Factors and Ergonomics in Healthcare and Medical Devices (AHFE 2017)

Part of the book series: Advances in Intelligent Systems and Computing ((AISC,volume 590))

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Abstract

The purpose of the research was to perform a hazard and safety analysis on an Integra™ UltraVS™ Neonate Valve. This product is a key component used in a ventriculoperitoneal shunt to aid in the treatment of pediatric patients diagnosed with hydrocephalus. The main objective is to investigate the root cause of both valve and shunt failures and propose potential improvements that may reduce the risk of failure in order to decrease a number of surgeries for pediatrics with this diagnosis. A preliminary hazard analysis, failure mode and effects analysis, and fault tree analysis were used to detect any potential risks and hazards that may cause device failure.

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References

  1. About Hydrocephalus: Pediatric hydrocephalus foundation. http://www.hydrocephaluskids.org/wordpress/?page_id=2. Accessed 02 Dec 2016

  2. Pediatric Hydrocephalus: http://www.columbianeurosurgery.org/conditions/pediatric-hydrocephalus/. Accessed 01 Dec 2016

  3. Hydrocephalus: MedlinePlus. https://medlineplus.gov/hydrocephalus.html. Accessed 30 Oct 2016

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  5. Shunt Systems. http://www.hydroassoc.org/shunt-systems/. Accessed 06 Dec 2016

  6. Health, B.: Brain shunt. http://www.beaumont.edu/neuroscience/neurological-treatments-services/brain-shunt/. Accessed 1 Feb 2017

  7. McGirt, M.J., Zaas, A., Fuchs, H.E., George, T.M., Kaye, K., Sexton, D.J.: Risk factors for pediatric ventriculoperitoneal shunt infection and predictors of infectious pathogens, 01 April 2003. https://academic.oup.com/cid/article/36/7/858/318528/Risk-Factors-for-Pediatric-Ventriculoperitoneal. Accessed 3 Jan 2017

  8. Integra LifeSciences|Medical Device Company - Medical Technologies. http://www.integralife.com/index.aspx?redir=detailproduct&Product=116&ProductName=Integra%99%20UltraVS%99%20Valve&ProductLineName=Hydrocephalus%20Management&ProductLineID=5&PA=neurosurgeon. Accessed 30 Oct 2016

  9. Rausand, M.: Preliminary hazard analysis. https://pdfs.semanticscholar.org/97ea/bafa77429110191e74d8e47012885ebd00a6.pdf. Accessed 12 Nov 2016

  10. Failure Mode Effects Analysis (FMEA). http://asq.org/learn-about-quality/process-analysis-tools/overview/fmea.html. Accessed 06 Dec 2016

  11. Pilot, S.: What is a fault tree analysis? http://asq.org/quality-progress/2002/03/problem-solving/what-is-a-fault-tree-analysis.html. Accessed 3 Jan 2017

  12. Nationwide Children’s Hospital. VP Shunt: Care at Home

    Google Scholar 

  13. Care and management of the child with shunted hydrocephalus. http://www.medscape.com/viewarticle/541771_4. Accessed 10 Mar 2017

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Author information

Authors and Affiliations

  1. Colorado State University-Pueblo, 2200 Bonforte Blvd, Pueblo, CO, 81001, USA

    Amber Torrez

Authors
  1. Amber Torrez
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Correspondence to Amber Torrez .

Editor information

Editors and Affiliations

  1. School of Industrial Engineering, Purdue University, West Lafayette, Indiana, USA

    Vincent Duffy

  2. Center for Applied Systems Engineering, Veterans Affairs, Indianapolis, Indiana, USA

    Nancy Lightner

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Torrez, A. (2018). Hazard and Safety Analysis of the Integra™ UltraVS™ Neonate Valve. In: Duffy, V., Lightner, N. (eds) Advances in Human Factors and Ergonomics in Healthcare and Medical Devices. AHFE 2017. Advances in Intelligent Systems and Computing, vol 590. Springer, Cham. https://doi.org/10.1007/978-3-319-60483-1_61

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  • DOI: https://doi.org/10.1007/978-3-319-60483-1_61

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-60482-4

  • Online ISBN: 978-3-319-60483-1

  • eBook Packages: EngineeringEngineering (R0)

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