Medical devices such as catheters now feature antimicrobial technology to protect devices against microbial contamination and reduce the risk of biofilm buildup.

The rise in healthcare associated infections (HAIs) has placed a major burden on the healthcare industry. Approximately 1.7 million cases of HAIs occur in the US each year. These account for an estimated 99,000 deaths and $45 billion in added healthcare costs annually.^{1, 2}

In the past, the industry did not have a good grasp on the factors that contributed to these infections due to vague definitions of what constituted an HAI, discrepancies in HAI categorization, and inconsistent reporting. But in recent years, legislation pertaining to HAIs on the state and federal levels has placed increased pressure on healthcare providers to take a closer look at what is driving the HAI epidemic.

Thirty states now have laws that require healthcare facilities to report certain HAIs, and as of October 2008, Medicare reduced reimbursements for services associated with some of the most prevalent HAIs, including surgical site infections, vascular catheter-associated infections, and catheter-associated urinary tract infections.

With improvements in HAI reporting and data quality, the industry is obtaining a clearer picture of the factors that contribute to these infections. A major contributing factor that has emerged is the use of medical devices on or within the body, with at least one-half of all HAI cases being medical device related.³

To protect their devices against microbial contamination and reduce the risk of biofilm buildup, an increasing number of medical device manufacturers are designing devices that feature antimicrobial technology. This article presents background on the use of antimicrobials in medical devices and explores design considerations when selecting an antimicrobial, including manufacturing and regulatory requirements.

Understanding antimicrobials

Conventional medical devices cannot fight off microbes, so they are prone to biofilm buildup. Biofilm is an organized community of bacteria protected by a slime layer that is highly resistant to antibiotic treatment.

Silver ion antimicrobial technology employs a ceramic zeolite carriers in which the silver ions are encapsulated. In the presence of bacteria these silver ions will move to the surface of a treated device to inhibit microbial growth.”
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The objective of an antimicrobial protected device is to break this cycle of bacterial contamination by preventing microbial colonization and subsequent biofilm formation. While hand washing and other active hygiene measures are primary lines of defense against device contamination, antimicrobial technology provides a passive yet effective means by which to protect the device against microbes during its use on or within the body.

Antimicrobial protected devices on the market today include those devices most closely associated with HAIs, including urinary catheters, central venous catheters and wound care products. Certain medical devices that incorporate antimicrobial technology have gone through clinical trials and gained FDA 510(K) clearance for their capacity to reduce infections.

Choosing antimicrobial technology

There are a wide variety of antimicrobial technologies on the market today, all with their own active ingredients, modes of operation, safety profiles and application requirements. A manufacturer can narrow down the list of possible choices by evaluating only those technologies that are compatible with its manufacturing process and meet the requirements of its device’s intended use.

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