WHY REDSENSEall about redsense blood loss detection

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

eec 3d

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.

Patient-Safety-Alert

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


 

Literature list

Review includes the following publications:

  1. 93/42 EEC, from 14 June 1993: Page No L 169/13