Designed to enhance clinical practice by providing complete visualization of the fluid path, the MaxPlus Clear positive-displacement needleless access device was introduced to the market by Medegen Inc. (Ontario, CA; www.medegen.com) in March 2008. Seven months later, the Centers for Medicare & Medicaid Services (CMS) imposed changes to reimbursement policies related to hospital-acquired infections--many of which stem from catheter-related bloodstream infections.

"That movement created a big stir in the community that we sell to in [terms of] coming up with enhancements to further our infection-prevention efforts," recalls Kerry Edgar, Medegen vice president of marketing and clinical affairs. "We thought that this would be a perfect opportunity to take an already great product and enhance it by adding an antimicrobial."

Seeking an agent that could be impregnated rather than applied in coating form, Medegen opted for an antimicrobial ceramic powder developed by Agion Technologies Inc. (Wakefield, MA; www.agion-tech.com). Once compounded and processed, the technology is engineered to release silver ions over time to minimize bacterial colonization on the end device. It does so through a trimodal approach: The antimicrobial prevents bacterial cell metabolism, inhibits cell division, and disrupts cell wall transport. "Our powder has a particular property of being able to deliver silver very gradually over time," explains Jeff Trogolo, Agion's CTO. "There are other silver technologies; but once that silver is out, all silver is the same. There is no 'different silver.' It's the way it's delivered that is the critical part of any antimicrobial technology based on silver."

Determining the most advantageous grade and formulation for the new MaxGuard connector was a delicate balancing act, Trogolo notes, because the company was tasked with retaining the original properties of the material while providing the desired antimicrobial performance. As it turned out, the key to finding that balance was the lab testing that Agion was able to perform in-house.

In its analytical lab, the company ran tests to characterize the silver concentration in test solutions and evaluated the rate at which the silver was released. It also analyzed performance of the antimicrobial throughout a model lifetime with a determined volume of liquid flowing through the product, according to Trogolo. An in-house microbiology lab then allowed Agion to assess the technology's performance against select bacteria identified by Medegen. These internal testing capabilities ultimately contributed to a smoother 510 (k) submission process, according to Medegen.

As a result of the partnership, the MaxGuard device has demonstrated, on average, a 5-log reduction of bacteria, or about 99.999%, according to Edgar. However, as Trogolo comments, "Infection control and reducing colonization on devices is a multifaceted effort. It's in the handling by healthcare providers, it's in the design of the device, it's in the materials--that's where we come in--and it's in the hygienic practices of the healthcare facilities."

For more engineering solutions case studies, go to devicelink.com/mpmn/engineering