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U.S. Department of Health and Human Services

About FDA

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Laboratory of Infection Control

Laboratory leader: Victoria Hichins 301.796.0258 victoria.hitchins@fda.hhs.gov

Healthcare-associated infections (HAI) are one of the top 10 causes of death in the U.S. Of the approximately 1.7 million HAI in the U.S. annually, at least 1/3rd are associated with medical devices. These devices are found in homes, hospitals, and healthcare facilities, and can range in complexity from contact lenses to implanted infusion pumps. Understanding how device materials and designs influence infections can lead to innovations in device design and testing. Given the enormity of device-associated infections in the U.S., modest improvements in device design and testing could potentially have a significant impact on public health.   The project goals are develop methods to detect, identify and improve tests to assure the safety of single- and reusable-medical devices such as contact lens solutions, urinary catheters, needleless connectors, and endoscopes and their accessories.  Specific aims are to develop clinically relevant test soils to validate cleaning of complex medical devices, establish sensitive and quantitative assays to detect biofilm and patient soils in “cleaned” devices, and to identify device designs and materials that favor biofilm formation and debris retention within devices that may hinder adequate disinfection and sterilization of reusable devices.

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