There are over two million healthcare-associated infections (HAIs) every year which costs the U.S. healthcare system $28-45 billion annually1, of which the CDC estimates 90% of cases could be avoided through implementation of improved infection controls.2 About 50-70% of HAIs can be attributed to microbial colonization of indwelling implants.3,4 The resulting device-related infections (DRIs) create a staggering financial burden, with costs ranging from $30,000 to treat a catheter infection to over $150,000 to address an infected total joint prosthesis. The risk of patient morbidity and death with DRIs is also alarmingly high.
For example, a recent review by Kurtz et al. demonstrated that the 5-year survival rate for an infected total knee implant is lower than the 5-year survival rate for breast or prostate cancer.5
To address this problem, healthcare has evolved to include pre-operative, peri-operative and post-operative infection control procedures,6 but one significant remaining gap is a strategy specifically designed to protect the surface of implantable medical devices. Addressing this gap is particularly urgent because numerous studies have shown that when a foreign body such as an implant is present in a wound site, it takes approximately 1000x fewer bacteria to generate an infection.7-12
Once bacteria adhere to a device surface, they can further develop into a biofilm, becoming embedded within a self-produced matrix composed of polysaccharides and other cellular materials. This biofilm creates both a physical and metabolic barrier that significantly reduces antibiotic penetration and activity, making antimicrobial treatments largely ineffective at eliminating the infection.
In response to this need, Orthobond® Corporation has developed a covalent, non-eluting surface that has rapid, broad-spectrum antibacterial activity (Ostaguard®). Ostaguard is the first and only FDA De Novo-cleared permanent antibacterial implant surface proven to protect against MRSA and 8 other strains of bacteria that have shown to contribute to implant contamination.
The financial and clinical toll of implant contamination is well-documented—and largely preventable. As the evidence continues to mount on the limitations of systemic antibiotics and post-operative protocols alone, the need for a surface-level solution has never been clearer. Ostaguard represents a fundamental shift in how the medical device industry can approach implant-contamination risk by protecting the device surface from the moment of implantation.
With FDA De Novo clearance, a growing body of clinical experience, and expanding applications across specialties, Ostaguard is positioned to help medical device manufacturers close the most critical remaining gap in contamination control. The opportunity to protect patients starts at the surface.
