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Why Sterility Matters

Wed, 05/15/2013 - 10:21am
by Kim LaFreniere, PhD., Clinical Affairs, Associate Research Fellow

One might assume that all unit-of-use alcohol and povodine-iodine products are sterile. However, it has become abundantly clear that this is not always the case.

Product sterility – the assurance that your product is not contaminated – is critical to delivering better patient outcomes and ensuring the safety of a medical team. Clinical infections associated with a variety of approved products have been reported to the Center for Disease Control, U.S. Food and Drug Administration, and journals. As a result of these reports, a number of product recalls have ensued. The reported outcomes range from localized infections at injection sites to systemic infections resulting in death.

The reports implicate all commonly used antiseptic categories. Examples include alcohol, iodophors, chlorhexidinegluconate, and quaternary ammonium products. Some potentially pathogenic organisms, such as Bacillus cereus, Burkholderiacepacia, Pseudomonas aeruginosa, and Serratiamarcescens, have been implicated in one or more recent outbreak.

Several recent incidences of product contamination have led to tragic outcomes: Contamination of antiseptic drug products may occur either  during manufacturing (intrinsic contamination) or during manipulations by the end user (extrinsic contamination). Although PVP-I manufacturers rely on complex water purification systems that sanitize the water used in formulating PVP-I solution, bacteria can colonize in water distribution pipes, filters, and pumps.
Once affixed, many organisms can form a biofilm. The biofilm can randomly become dislodged and travel with the PVP-I solution to the finished product during packaging. Since the dislodging of the bacterial biofilm cannot be predicted, the most effective way to address this accidental contamination is through a validated terminal sterilization process that renders the solution and applicator (if present) sterile until the package is opened or damaged. The terminal sterilization process eliminates the chance that any viable organisms would be delivered to the patient via the antiseptic agent. This includes prep pads, swabsticks, and pouches.

Extrinsic contamination can arise from dilution of the product with non-sterile water or from storage in non-sterile containers. Users should also be aware that microbial contamination can occur when they are opening containers or diluting and storing solutions under non-sterile conditions. 

* Responsible organisms are listed only for cases in which genetic-fingerprinting methods have confirmed the source of contamination.

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