Skip to main content

Advertisement

SpringerLink
Log in

Biomaterials Evaluation: Conceptual Refinements and Practical Reforms

  • Product Safety: Review
  • Published:
Therapeutic Innovation & Regulatory Science Aims and scope Submit manuscript

Abstract

Regarding the widespread and ever-increasing applications of biomaterials in different medical fields, their accurate assessment is of great importance. Hence the safety and efficacy of biomaterials is confirmed only through the evaluation process, the way it is done has direct effects on public health. Although every biomaterial undergoes rigorous premarket evaluation, the regulatory agencies receive a considerable number of complications and adverse event reports annually. The main factors that challenge the process of biomaterials evaluation are dissimilar regulations, asynchrony of biomaterials evaluation and biomaterials development, inherent biases of postmarketing data, and cost and timing issues. Several pieces of evidence indicate that current medical device regulations need to be improved so that they can be used more effectively in the evaluation of biomaterials. This article provides suggested conceptual refinements and practical reforms to increase the efficiency and effectiveness of the existing regulations. The main focus of the article is on strategies for evaluating biomaterials in US, and then in EU.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Tathe A, Ghodke M, Nikalje AP. A brief review: biomaterials and their application. Int J Pharm Pharm Sci. 2010;2:19–23.

    CAS  Google Scholar 

  2. Williams DF. The Williams Dictionary of Biomaterials. Liverpool: Liverpool University Press; 1999.

    Book  Google Scholar 

  3. Williams DF. On the nature of biomaterials. Biomaterials. 2009;30:5897–5909.

    Article  CAS  PubMed  Google Scholar 

  4. Ratner BD, Hoffman AS, Schoen FJ, Lemons JE. Biomaterials Science: An Introduction to Materials in Medicine. Amsterdam: Elsevier; 2013.

    Google Scholar 

  5. Vats A, Tolley NS, Polak JM, Gough JE. Scaffolds and biomaterials for tissue engineering: a review of clinical applications. Clin Otolaryngol. 2003;28:165–172.

    Article  CAS  PubMed  Google Scholar 

  6. Qi C, Yan X, Huang C, Melerzanov A, Du Y. Biomaterials as carrier, barrier and reactor for cell-based regenerative medicine. Protein Cell. 2015;6:638–653.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  7. Medical Device User Fee Amendments 2017 (MDUFA IV). https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm454039.htm.

  8. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. https://publications.europa.eu/en/publication-detail/-/publication/83bdc18f-315d-11e7-9412-01aa75ed71a1/language-en/format-PDF/source-58036705.

  9. Williams DF. On the mechanisms of biocompatibility. Biomaterials. 2008;29:2941–2953.

    Article  CAS  PubMed  Google Scholar 

  10. ASTM F756-00. Standard practice for assessment of hemolytic properties of materials. Philadelphia: American Society for Testing and Materials, 2000.

    Google Scholar 

  11. Dobrovolskaia MA, Clogston JD, Neun BW, Hall JB, Patri AK, McNeil SE. Method for analysis of nanoparticle hemolytic properties in vitro. Nano Lett. 2008;8:2180–2187.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  12. Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process 10993-1. International Organization for Standardization. ISO, 2009.

  13. Biological evaluation of medical devices—Part 2: Animal welfare requirements 10993-2. International Organization for Standardization. ISO, 2006.

  14. Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity 10993-3. International Organization for Standardization. ISO, 2014.

  15. Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood 10993-4. International Organization for Standardization. ISO, 2002.

  16. Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity 10993-5. International Organization for Standardization. ISO, 2009.

  17. Biological evaluation of medical devices—Part 6: Tests for local effects after implantation 10993-6. International Organization for Standardization. ISO, 2016.

  18. Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals 10993-7. International Organization for Standardization. ISO, 2008.

  19. Biological evaluation of medical devices—Part 8: Selection and qualification of reference materials for biological tests 10993-8. International Organization for Standardization. ISO, 2001.

  20. Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products 10993-9. International Organization for Standardization. ISO, 1999.

  21. Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization 10993-10. International Organization for Standardization. ISO, 2010.

  22. Biological evaluation of medical devices—Part 11: Tests for systemic toxicity 10993-11. International Organization for Standardization. ISO, 2006.

  23. Biological evaluation of medical devices—Part 12: Sample preparation and reference materials 10993-12. International Organization for Standardization. ISO, 2012.

  24. Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices 10993-13. International Organization for Standardization. ISO, 1998.

  25. Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics 10993-14. International Organization for Standardization. ISO, 2001.

  26. Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys 10993-15. International Organization for Standardization. ISO, 2000.

  27. Biological evaluation of medical devices—Part 16: Ioxicokinetic study design for degradation products and leachables 10993-16. International Organization for Standardization. ISO, 1997.

  28. Biological evaluation of medical devices—Part 17: Establishment of allowable limits for leachable substances 10993-17. International Organization for Standardization. ISO, 2002.

  29. Biological evaluation of medical devices—Part 18: Chemical characterization of materials 10993-18. International Organization for Standardization. ISO, 2005.

  30. Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials 10993-19. International Organization for Standardization. ISO, 2006.

  31. Biological evaluation of medical devices—Part 20: Principles and methods for immunotoxicology testing of medical devices 10993-20. International Organization for Standardization. ISO, 2006.

  32. Biological evaluation of medical devices—Part 22: Guidance on nanomaterials 10993-22. International Organization for Standardization. ISO, 2017.

  33. Biological evaluation of medical devices—Part 33: Guidance on tests to evaluate genotoxicity 10993-33 (Supplement to ISO 10993-3). International Organization for Standardization. ISO, 2015.

  34. Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes 5840-2. International Organization for Standardization. ISO, 2015.

  35. Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques 5840-3. International Organization for Standardization. ISO, 2013.

  36. Center for Devices and Radiological Health (CDRH). https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/.

  37. FDA Medical Devices Classification. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm.

  38. Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Arch Intern Med. 2011;171:1006–1011.

    PubMed  Google Scholar 

  39. Amato SF, Ezzell RM. Regulatory Affairs for Biomaterials. Philadelphia, PA: Elsevier; 2015.

    Google Scholar 

  40. Guidelines on medical devices—Clinical evaluation: a guide for manufacturers and notified bodies. http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_7_1rev_3_en.pdf.

  41. Medical devices guidance document: classification of medical devices. http://ec.europa.eu/consumers/sectors/medicaldevices/files/meddev/2_4_1_rev_9_classification_en.pdf.

  42. Kramer DB, Xu S, Kesselheim AS. How does medical device regulation perform in the United States and the European Union? A systematic review. PLoS Med. 2012;9:1–10.

    Article  Google Scholar 

  43. Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act. Guidance for Industry and Food and Drug Administration Staff. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm268141.pdf.

  44. Jaffe R, Strauss BH. Late and very late thrombosis of drug-eluting stents: evolving concepts and perspectives. J Am Coll Cardiol. 2007;50:119–127.

    Article  CAS  PubMed  Google Scholar 

  45. US Food and Drug Administration. Medical Device Reporting (MDR). http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/ucm2005291.htm.

  46. US Food and Drug Administration. Medical product safety information. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm.

  47. US Food and Drug Administration. List of device recalls. What is a Medical Device Recall? http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/.

  48. Global Unique Device Identification Database (GUDID). Guidance for Industry and Food and Drug Administration Staff. http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm369248.pdf.

  49. EUDAMED: European Database on Medical Devices. http://ec.europa.eu/idabc/en/document/2256/5637.html.

  50. Guidelines on a Medical Devices Vigilance System—MEDDEV 2.12/1 rev8. https://ec.europa.eu/docsroom/documents/15506/attachments/1/translations/en/renditions/pdf.

  51. ANSM Report: PIP Breast Implants. 2013. http://ansm.sante.fr/var/ansm_site/storage/original/application/ea94f5f3532f4f831d6a923ef553a77e.pdf.

  52. Greco C. The poly implant Prothèse breast prostheses scandal: embodied risk and social suffering. Soc Sci Med. 2015;147:150–157.

    Article  PubMed  Google Scholar 

  53. Cohen D. Out of joint: The story of the ASR. BMJ. 2011;342:1–7.

    Google Scholar 

  54. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide: AOA; 2007.

    Google Scholar 

  55. FDA Report: Challenge and Opportunity on the Critical Path to New Medical Products. http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/UCM113411.pdf. Published 2004.

  56. Baim DS, Wahr D, George B, et al. Randomized trial of a distal embolic protection device during percutaneous intervention of saphenous vein aorto-coronary bypass grafts. Circulation. 2002;105:1285–1290.

    Article  PubMed  Google Scholar 

  57. Webb JG, Carere RG, Virmani R, et al. Retrieval and analysis of particulate debris after saphenous vein graft intervention. J Am Coll Cardiol. 1999;34:468–475.

    Article  CAS  PubMed  Google Scholar 

  58. Reeve L, Baldrick P. Biocompatibility assessments for medical devices—evolving regulatory considerations. Expert Rev Med Devices. 2017;14:161–167.

    Article  CAS  PubMed  Google Scholar 

  59. FDA Manufacturer and User Facility Device Experience (MAUDE). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM.

  60. Improving America’s health V: a survey of the working relationship between the life sciences industry and FDA. PwC. https://www.pwc.com/jp/ja/japan-nowledge/archive/assets/pdf/archive_improving_americas_health.pdf. Published 2010.

  61. Fargen KM, Frei D, Fiorella D, Mcdougall CG. The FDA approval process for medical devices: an inherently flawed system or a valuable pathway for innovation? J NeuroIntervent Surg. 2013;5:269–275.

    Article  Google Scholar 

  62. Bekerman E, Einav S. Combating emerging viral threats. Science. 2015;348:282–283.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  63. Karageorgiou V, Kaplan D. Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials. 2005;26:5474–5491.

    Article  CAS  PubMed  Google Scholar 

  64. Morais JM, Papadimitrakopoulos F, Burgess DJ. Biomaterials/tissue interactions: possible solutions to overcome foreign body response. AAPS J. 2010;12:188–196.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  65. Ratner BD. A pore way to heal and regenerate: 21st century thinking on biocompatibility. Regen Biomate. 2016;3:107–110.

    Article  CAS  Google Scholar 

  66. Global harmonization task force (GHTF). http://www.who.int/medical_devices/collaborations/force/en/.

  67. CDRH Innovation: Innovation Pathway. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/InnovationPathway/ucm283511.htm.

  68. Helmus MN, Gibbons DF, Cebon D. Biocompatibility: meeting a key functional requirement of next-generation medical devices. Toxicol Pathol. 2008;36:70–80.

    Article  CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Dental Biomaterials Department, School of Dentistry, Tehran University of Medical Sciences, North Karegar Ave, Tehran, Iran

    Reza Masaeli PhD, DDS

  2. Department of Life Sciences Engineering, Faculty of New Sciences and Technologies, University of Tehran, Tehran, Iran

    Kavosh Zandsalimi MSc

  3. School of Dentistry, Marquette University, Milwaukee, WI, USA

    Lobat Tayebi PhD

  4. Department of Engineering Science, University of Oxford, Oxford, United Kingdom

    Lobat Tayebi PhD

Authors
  1. Reza Masaeli PhD, DDS
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Kavosh Zandsalimi MSc
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Lobat Tayebi PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Reza Masaeli PhD, DDS.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Masaeli, R., Zandsalimi, K. & Tayebi, L. Biomaterials Evaluation: Conceptual Refinements and Practical Reforms. Ther Innov Regul Sci 53, 120–127 (2019). https://doi.org/10.1177/2168479018774320

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1177/2168479018774320

Keywords

Search

Navigation