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

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.

Single‐stage revision of MRSA orthopedic device‐related infection in sheep with an antibiotic‐loaded hydrogel

“…Given the advantages of single‐stage surgery to reduce the surgical burden and costs while not compromising efficacy in appropriately selected patients, 18,39,40 development of bioresorbable delivery vehicles are of increasing importance 16 . Further hurdles will need to be overcome to translate from preclinical to clinical trials and bring this antibiotic‐loaded hydrogel beyond regulatory approval to both prevent and treat both FRI and PJI 41,42 …”

“…16 Further hurdles will need to be overcome to translate from preclinical to clinical trials and bring this antibiotic-loaded hydrogel beyond regulatory approval to both prevent and treat both FRI and PJI. 41,42 5 | CONCLUSION…”

Prevention of Prosthetic Joint Infection: From Traditional Approaches towards Quality Improvement and Data Mining

“…The respective behavior of each of these stakeholders contributes to the overall difficulty, precluding the implementation of smart anti-infective devices in clinical practice. This issue is described in detail elsewhere [184].…”

Antibiotic-loaded amphora-shaped pores on a titanium implant surface enhance osteointegration and prevent infections

“…simply immersing the implant into an antibiotic solution during the operation, has advantages compared to the dropwise application of the solution [ 28 ] or coatings [ [29] , [30] , [31] ]. Even if clinical acceptance is achieved, the hurdles for translation are development costs and, in particular, regulatory approval under applicable legal regulations [ 32 ]. These factors led us to select laser technology , which is environmentally friendly, has a large structuring scale (micro to nano structures), needs no auxiliary materials, is reproducible, and can be automated to structure complex products.…”