DataVXACS Biomaterials Science & EngineeringPaper
journal article·2019-02-11Open access

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 Zimmerli, 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

ACS Biomaterials Science & Engineering· Volume 5· Issue 2
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Source abstract

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.
Source: openalex_inverted_index · Quality: baseline

Research context

Biomaterials

OpenAlex topics: Orthopaedic implants and arthroplasty · Orthopedic Infections and Treatments · Medical Device Sterilization and Disinfection

SciVX discovery tags are terminology-based. OpenAlex topics are source-provided classifications.

Affiliations

University of Groningen and University Medical Center Groningen, Department of Biomedical Engineering, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands

Department of Trauma Surgery, University Hospital Giessen-Marburg, Rudolf-Buchheim strasse 7, 35392 Giessen, Germany

Basel University Medical Clinic, Kantonsspital Baselland, Rheinstrasse 26, CH-4410 Liestal, Switzerland

AO Research Institute Davos, Clavadelerstrasse 8, 7270 Davos Platz, Switzerland

Department of Orthopedic Surgery, Rothman Institute at Jefferson, Thomas Jefferson University, Center City Philadelphia, 925 Chestnut Street, Fifth Floor, Philadelphia, Pennsylvania 19107, United States

Department of Orthopedic and Trauma Surgery, University of Heidelberg, Schlierbacher Landstrasse 200a, 69118 Heidelberg, Germany

Department of Trauma, Hand, and Reconstructive Surgery, University of Muenster, Albert-Schweizer-Campus, D-48149 Muenster, Germany

Department of Orthopedic Joint Surgery and Endoprosthetics, HELIOS ENDO-Clinic, Holstenstrasse 2, 22767 Hamburg, Germany

School of Medicine, Queens Medical Center, University of Nottingham, Nottingham NG7 2UH, U.K.

Divisions of Infectious Diseases and Cardiovascular Diseases, Mayo Clinic, 200 First Street SW, Rochester, Minnesota 55905, United States

Better Vision Group, LLC, 808 Sandy Trail, Keller, Texas 76248, United States

Departments of Medicine, Surgery and PM&R, Baylor College of Medicine 1333 Moursund Avenue, Houston, Texas 77030, United States

Departments of Bioengineering, Pharmaceutics, and Pharmaceutical Chemistry, University of Utah, 30 South 2000 East, Salt Lake City, Utah 84112-5820, United States

Funding

Elsevier Foundation · Wolters Kluwer · Jaypee Brothers Medical Publishers Ltd.

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