#USA #Carlsbad #HAI Solutions #QIKCAP System #UVC Technology

HAI Solutions' Innovative Leap in Medical Technology

HAI Solutions, a pioneering force in ultraviolet (UVC) microbial reduction technology, announced a significant milestone with the granting of a De Novo classification by the U.S. Food and Drug Administration (FDA) for their QIKCAP System. This system stands out as the first and unique UVC-based microbial reduction device designed for needleless IV connectors, marking the establishment of a new Class II medical device category.

A Closer Look at the QIKCAP System

The QIKCAP System consists of two key components: the QIKCAP Device and the single-use QIKCAP Cap. Together, these elements are engineered to enhance existing manual disinfection practices for luer-activated valves used in intravenous (IV) applications. The QIKCAP Device administers precise, targeted UVC irradiation to the connector's septum, achieving a rapid 10-second microbial reduction. Meanwhile, the QIKCAP Cap serves as a protective physical barrier, safeguarding the connector against environmental contamination for up to seven days when not in use.

This innovation positions HAI Solutions at the forefront of medical device technology aimed at microbial safety in healthcare settings. The company's growing portfolio is further strengthened through strategic collaborations, particularly with Intellego Technologies, which focuses on a specialized chromatic dosimeter tailored for UVC applications.

Commitment to Safety and Efficacy

The company has expressed strong support for FDA's regulatory framework surrounding UVC devices in healthcare, emphasizing the necessity of stringent standards to guarantee both patient safety and device efficacy. Nick Perrenoud, CEO of HAI Solutions, remarked on the significance of the De Novo Grant, calling it a "HUGE accomplishment" for their team. He further highlighted the critical need for advancements in IV connector maintenance and protection, which the QIKCAP Technology promises to fulfill.

Collaboration with the FDA

In developing the QIKCAP System, HAI Solutions collaborated closely with the FDA, ensuring compliance with both general and specialized controls that mandated comprehensive performance testing under some of the most challenging conditions. This robust testing process was designed to validate the device’s functionality and reliability within clinical environments. Results showed that utilizing the QIKCAP Device along with a cleaning regimen of 3.15% CHG/70% IPA wipes for five seconds led to four-log reductions in several harmful bacteria, including Staphylococcus aureus and Klebsiella pneumoniae. However, the device did not significantly impact fungal organisms, and there remains no established correlation with clinical infection-related outcomes.

The Future of IV Therapy Solutions

Located in Carlsbad, California, HAI Solutions is dedicated to advancing IV therapy solutions that effectively tackle contamination issues within the demanding environments of hospitals—specifically in operating rooms, intensive care units, and emergency departments. Their commitment to developing innovative products reflects their focus on improving healthcare delivery methods and patient safety.

For continual updates on their latest innovations and solutions, visit www.HAI-Solutions.com.

To learn more about the QIKCAP System and its impact on medical technology, get in touch or access their latest press releases through their corporate communication channels.