• This product is a new “needle dislodgment and blood leakage detection device” specifically designed for sensing blood leakage during hemodialysis. Its primary function is to help medical personnel promptly detect any bleeding situation and thus prevent unnecessary complications, enabling effective preventive healthcare and truly reducing medical risks.

• By integrating “flexible substrates” with “array-based sensing” technology, and applying a “multi-point adherence” design concept, the device addresses various clinical needs. It incorporates innovative features such as “multiple fluid leakage detection,” “large-area, multi-point sensing,” “array-level graded alarms,” “no sensation of needle compression,” “multi-bed patient care monitoring,” and “wearable alerts for healthcare providers.”

• Through these advancements, the device assists medical staff in quickly identifying blood leakage, preventing unnecessary complications, implementing effective preventive care, and substantially lowering healthcare risks.

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Manufacturer: AcuSense BioMedical Technology Corp.
Manufacturing Facility Registration: 94A00445
Quality Management System: ISO13485

• This detection device has obtained multiple regulatory certifications, including ISO 13485, 14971, 10993-X, 11137-X, 11607-1, IEC 60601-1-X, 62304, and 62366. Its safety, system stability, and reliability have been verified through standard laboratory testing and simulated patient trials. Designed to meet medical regulatory standards and ensure wearer comfort, it excels as a safe and compliant medical device.

• In a trial with 544 participants, there were 73 instances (7.4%) of blood seepage or leakage, and the device successfully issued warnings in 67 cases (an accuracy rate of 91.7%). These results demonstrate that the device achieves over 90% detection accuracy with zero incidence of adverse events.

The dialysis needle dislodgment and blood leakage detection device is designed for patients prone to bleeding or agitation during their dialysis sessions. By using this device during treatment, it helps prevent the risk of severe bleeding and allows for timely intervention to stop blood loss if a needle dislodgement occurs. Overall, this device achieves a detection accuracy of 90% and has a zero adverse event rate. From a healthcare cost perspective, employing this detection device is more cost-effective than managing complications related to arteriovenous fistulas (such as low hemoglobin levels or fistula reconstruction surgeries), ultimately ensuring patient safety and providing a more economical solution.

This product has undergone all relevant preclinical tests, including biocompatibility and system safety evaluations. In addition to passing EMC/EMI testing, the ISO 10993 biocompatibility results confirmed that it passed both skin sensitization and irritation tests, with no evidence of cytotoxicity.

This product is not intended for commercial marketing or sale; therefore, no post-market sales surveillance mechanism is applicable. To date, the product has successfully passed nine relevant certifications/accreditation reviews. Continuous improvements and optimizations have been implemented based on review findings to ensure its stability, quality, and safety in use.

• Du, Y. C., Lim, B. Y., Ciou, W. S., & Wu, M. J. (2016). Novel wearable device for blood leakage detection during hemodialysis using an array sensing patch. Sensors, 16(6), 849.

• Lin, C. H., Chen, W. L., Li, C. M., Wu, M. J., Huang, P. T., & Chen, Y. S. (2016). Assistive technology using integrated flexible sensor and virtual alarm unit for blood leakage detection during dialysis therapy. Healthcare Technology Letters, 3(4), 290-296.

• Ou, Y. K., Wu, M. J., Ciou, W. S., & Du, Y. C. (2019). A clinical trial of the effect of a blood leakage detection device for patients during hemodialysis. International journal of environmental research and public health, 16(13), 2388.

• Du, Y. C., Chen, W. T., Chuang, C. H., & Wu, M. J. (2016, October). A wearable conductivity sensor for sweat and blood leakage monitoring during hemodialysis. In 2016 IEEE SENSORS (pp. 1-3). IEEE.

• Hu, H. W., Yi-Chun, D., & Ming-Jui, W. (2019). FP555 Multiple alert threshold of blood leakage detector in hemodialysis to increase the economic benefits of care. Nephrology Dialysis Transplantation, 34(Supplement_1), gfz106-FP555.

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