Advertisement

Risk Assessments for Medical Devices

  • Erica N. RogersEmail author
Chapter
  • 26 Downloads

Abstract

This chapter focuses on providing a brief but thorough summary of risk assessment in relation to medical devices. This chapter is divided into four key sections: (i) Overview of Device Regulation, (ii) Classification of Medical Devices, (iii) Medical Devices and Risk Assessment, and (iv) Case Studies. In the Overview of Device Regulation section, information is provided on the definition of a medical device as it applies to the US Food and Drug Administration (FDA). For the Classification of Medical Devices section, a summary of the key classes of medical devices, as given by the FDA, is discussed. The Medical Devices and Risk Assessment section includes information on set standards as detailed by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), the key steps of human health risk assessment, examples of sources for data retrieval and analysis, and calculation of a tolerable exposure limit with some implementation of uncertainty and/or safety factors as well as determination of whether a device is safe to use. Lastly, this chapter provides two fictious case studies which assist readers in understanding how to apply the steps of human health risk assessment to determine an appropriate TE limit.

Keywords

Medical device Risk assessment Tolerable exposure (TE) Uncertainty factor (UF) 

References

  1. ATSDR. (2005). Toxicological profile for nickel. Agency for Toxic Substances and Disease Registry, Atlanta.Google Scholar
  2. CDRH. (1992). Regulatroy Requirements for Medical Devices: A Workshop Manual. (FDA 92-4165). Center for Device and Radiological Health: HHS Publication.Google Scholar
  3. David, R. M. (2000). Exposure to phthalate esters. Environmental Health Perspectives, 108(10), A440–A440.CrossRefGoogle Scholar
  4. Ecobichon, D. J. (1997). The basis of toxicity testing. CRC press, Boca Raton, FL.Google Scholar
  5. EMA. (2008). Guideline on the specification limits for residues of metal catalysts or metal reagents. European Medicines Agency, London.Google Scholar
  6. Gad, S. C., & Gad-McDonald, S. (2015). Biomaterials, medical devices, and combination products: Biocompatibility testing and safety assessment. CRC Press, Boca Raton, FL.Google Scholar
  7. Gad, S. C., & Schuh, J. C. L. (2018). Toxicologic pathology forum opinion paper: Considerations for Toxicologic pathologists evaluating the safety of biomaterials and finished medical devices. Toxicologic Pathology, 46(4), 366–371.  https://doi.org/10.1177/0192623318768719.CrossRefGoogle Scholar
  8. Geer, L. Y., Marchler-Bauer, A., Geer, R. C., Han, L., He, J., He, S., et al. (2010). The NCBI BioSystems database. Nucleic Acids Research, 38(Database issue), D492–D496.  https://doi.org/10.1093/nar/gkp858.CrossRefPubMedGoogle Scholar
  9. HSDB. (2015). Hazardous substances data bank (Online Database). Available from National Institutes of Health, Health & Human Services TOXNET Retrieved June 29, 2019, from U.S. National Library of Medicine.Google Scholar
  10. ICHQ3D(R1). (2019). Guideline for Elemental Impurities. ICH Harmonised Guideline.Google Scholar
  11. ISO10993-1. (2018). Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. Arlington: Association for the Advancement of Medical Instrumentation.Google Scholar
  12. ISO14971-1. (2019). Medical devices—Application of risk management to medical devices. Arlington: Association for the Advancement of Medical Instrumentation.Google Scholar
  13. Kluwe, W. M. (1982). Overview of phthalate ester pharmacokinetics in mammalian species. Environmental Health Perspectives, 45, 3–9.CrossRefGoogle Scholar
  14. Kurahashi, N., Kondo, T., Omura, M., Umemura, T., Ma, M., & Kishi, R. (2005). The effects of subacute inhalation of di (2-ethylhexyl) phthalate (DEHP) on the testes of prepubertal Wistar rats. Journal of Occupational Health, 47(5), 437–444.  https://doi.org/10.1539/joh.47.437.CrossRefPubMedGoogle Scholar
  15. Leadscope. (2019). Leadscope Enterprise, Inc.Google Scholar
  16. Lu, Z. (2011). PubMed and beyond: a survey of web tools for searching biomedical literature. Database, 2011.Google Scholar
  17. Ma, M., Kondo, T., Ban, S., Umemura, T., Kurahashi, N., Takeda, M., & Kishi, R. (2006). Exposure of prepubertal female rats to inhaled di(2-ethylhexyl)phthalate affects the onset of puberty and postpubertal reproductive functions. Toxicological Sciences, 93(1), 164–171.  https://doi.org/10.1093/toxsci/kfl036.CrossRefPubMedGoogle Scholar
  18. NTP. (2016). Report on carcinogens (14th ed.). National Toxicology Program, Research Triangle Park.Google Scholar
  19. Pohanish, R. P. (2017). Sittig's handbook of toxic and hazardous chemicals and carcinogens. William Andrew, Kidlington, Oxford, United Kingdom; Cambridge, MA, United States.Google Scholar
  20. Rao, M., Yeldandi, A. V., & Subbarao, V. (1990). Quantitative analysis of hepatocellular lesions induced by di (2-ethylhexyl) phthalate in F-344 rats. Journal of Toxicology and Environmental Health, Part A Current Issues, 30(2), 85–89.CrossRefGoogle Scholar
  21. Roberts, G., Myatt, G. J., Johnson, W. P., Cross, K. P., & Blower, P. E. (2000). LeadScope: Software for exploring large sets of screening data. Journal of Chemical Information and Computer Sciences, 40(6), 1302–1314.CrossRefGoogle Scholar
  22. Stark, N. (1997). Case studies: using the world literature to reduce biocompatability testing. Paper presented at the Proceedings of the Medical Design and Manufacturing East 97 Conference and Exposition.Google Scholar
  23. TOXNET. (2019). US National Library of Medicine/Toxicology Data Network.Google Scholar
  24. USFDA. (2017). Learn if a medical device has been cleared by FDA for marketing.Google Scholar
  25. Voss, C., Zerban, H., Bannasch, P., & Berger, M. R. (2005). Lifelong exposure to di-(2-ethylhexyl)-phthalate induces tumors in liver and testes of Sprague–Dawley rats. Toxicology, 206(3), 359–371.CrossRefGoogle Scholar
  26. Wexler, P. (2001). TOXNET: An evolving web resource for toxicology and environmental health information. Toxicology, 157(1–2), 3–10.CrossRefGoogle Scholar
  27. White, R., Cammack, J., Eyre, R., & Wilson, D. (1999). Medical device risk assessment paradigm: Use and case history. International Journal of Toxicology, 18(4), 269–274.CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Gad Consulting ServicesRaleighUSA

Personalised recommendations