A Trans-Atlantic Perspective on Stagnation in Clinical Translation of Antimicrobial Strategies for the Control of Biomaterial-Implant-Associated Infection

Henk J. Busscher, Volker Alt, Henny C. van der Mei*, Paul H. Fagette, Werner Zinunerli, T. Fintan Moriarty, Javad Parvizi, Gerhard Schmidmaier, Michael J. Raschke, Thorsten Gehrke, Roger Bayston, Larry M. Baddour, Lynn C. Winterton, Rabih O. Darouiche, David W. Grainger

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

13 Citations (Scopus)

Abstract

Current regulatory requirements impede clinical translation and market introduction of many new antimicrobial combination implants and devices, causing unnecessary patient suffering, doctor frustration, and costs to healthcare payers. Regulatory requirements of antimicrobial combination implants and devices should be thoroughly revisited and their approval allowed based on enrichment of benefit demonstrations from high-risk patient groups and populations or device components to facilitate their clinical translation. Biomaterial implant and devices equipped with antimicrobial strategies and approved based on enrichment claims should be mandatorily enrolled in global registry studies supervised by regulatory agencies for a minimum five-year period or until statistically validated evidence for noninferiority or superiority of claims is demonstrated. With these recommendations, this trans-Atlantic consortium of academicians and clinicians takes its responsibility to actively seek to relieve the factors that stagnate downward clinical translation and availability of antimicrobial combination implants and devices. Improved dialogue between the various key players involved in the current translational blockade, which include patients, academicians and doctors, policymakers, regulatory agencies, manufacturers, and healthcare payers, is urgently needed.

Original languageEnglish
Pages (from-to)402-406
Number of pages9
JournalACS Biomaterials Science & Engineering
Volume5
Issue number2
DOIs
Publication statusPublished - Feb-2019

Keywords

  • biomaterial-associated infection
  • downward clinical translation
  • prosthesis
  • enrichment
  • benefit assessment
  • risk assessment
  • biomaterials
  • surface modification
  • KNEE ARTHROPLASTY
  • UNITED-STATES
  • THERAPIES
  • BURDEN
  • HIP

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