The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing hemodialysis treatment.
The device includes a blood sensor incorporated into a sensor patch. The sensor monitors potential blood leakage from the venous needle blood access via a light signal and will alarm if blood leakage is detected by the device’s sensor.
All use must be administrated under physician’s prescription, and must be observed by a trained and qualified person considered to be competent in the use of this device by the prescribing physician.
Redsense may be use together with all cleared hemodialysis equipment. Its cleared for sale in the USA by FDA.
The Redsense device is an alarm system for monitoring the venous needle during hemodialysis in clinic or at home. Redsense device is CE marked and quality approved according to European standards.
Implementing Redsense is in alignment with the EU directive
Council directive 93/42/EEC concerning medical devices
” The solutions adopted by the manufacturer for the design and construction of the device must confirm to safety principles, taking account of the generally acknowledged state of the art.
In selection of the most appropriate solutions, the manufacturer must apply the following principles in the following order:
- eliminate or reduce risks as far as possible (inherent design and construction)
- where appropriate take adequate protection measures including alarms if necessary, in relation to the risks that cannot be eliminated,
- Inform the user on the user of the residual risks due to any shortcomings of the measures adopted.”1
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1)
US Goverment Department of
Veteran Affairs, mandate Redsense
As of November 2010, Veteran Affairs Patient Safety Alert mandate the use of Redsense alarm.
Renal Physicians Association recognizes VND to be one of the top areas needing improvement and is part of the program ”Keeping Kidney Patients Safe” www.kidneypatientsafety.org
Review includes the following publications:
- 93/42 EEC, from 14 June 1993: Page No L 169/13