A silver ion-based antimicrobial material that reduces surgical site infections (SSIs) in spinal procedures will be built into a spinal implant. The material, Cleanfuze from Difusion Technologies Inc, Austin, Texas, (difusiontech.com) has successfully completed laboratory tests that show its effectiveness. The company says tests validate the controlled release of ionic silver and its antimicrobial efficacy, by producing a 5 log reduction in bacteria counts, meaning it is 99.999% effective. No antibiotic works this well, says the firm. Hospital-acquired infections are among the top ten leading causes of death in the U.S., accounting for an estimated 1.7 million infections and 99,000 associated deaths in 2002. SSIs occur within spinal surgery from 2.5 to 13% of the time.

Material for the spinal interbody cage is PEEK capable of stopping biofilm formation for up to four weeks in a bone-graft site and thereby postoperatively eliminating 650 types of bacteria, including antibiotic-resistant bacteria such as MRSA. The infection-fighting material used in Cleanfuze is a ‘super silicate’ molecule composed of silver ions added to the plastic spinal interbody cage. With the implant in place, silver ions exchange with naturally occurring sodium ions in the bloodstream and diffuse silver ions.

Orthopedic surgeons will not have to alter currently accepted surgical techniques to use the material nor use new instruments. And hospital and insurance carriers will not be required to implement new procedure codes.

The company says the development will lower infection rates and save patients from additional surgery, weeks of IV antibiotics, and, in some extreme cases life-long exposure to antibiotics or amputation.