HAI Solutions has received De Novo classification from the U.S. Food and Drug Administration (FDA) for its QIKCAP System, marking the first FDA-approved ultraviolet (UVC) light-based microbial reduction device for luer-activated valves and establishing a new Class II medical device category.
Based in Carlsbad, California, HAI Solutions focuses on advanced intravenous therapy solutions aimed at reducing IV contamination in hospital environments such as operating rooms, intensive care units, and emergency departments.
The system, comprising the QIKCAP Device and single-use QIKCAP Cap, is designed to supplement manual disinfection of needle-free luer connectors in intravascular applications. The QIKCAP Device delivers targeted UVC irradiation to the connector septum, achieving rapid microbial reduction in just 10 seconds, while the QIKCAP Cap provides a protective barrier that shields connectors from environmental contamination for up to seven days when not in use.
HAI Solutions developed the device in collaboration with the FDA, conducting extensive performance testing under worst-case conditions to ensure clinical reliability and safety. Combined with 3.15% CHG/70% IPA wipes applied for five seconds, the system achieved 4-log reductions in bacterial species including Staphylococcus aureus, Klebsiella pneumoniae, Staphylococcus epidermidis, and Enterobacter cloacae. The device has not shown significant activity against fungal organisms, and a correlation to clinical infection-related outcomes has not been established.
The QIKCAP System adds to the company’s growing portfolio, which includes a partnership with Intellego Technologies to develop a chromatic dosimeter specifically for UVC applications, positioning HAI Solutions as a leader in UVC microbial reduction medical devices.
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