Evidence-based recommendations on the CoaguChek XS system for self-monitoring coagulation status in adults and children. The recommendations originally included the InRatio2 PT/INR, but this was withdrawn from the market in October 2016 and is not currently available.
NICE has also published a medtech innovation briefing on microINR for anticoagulation therapy. Medtech innovation briefings provide information on new technologies and do not make recommendations to the NHS.
Is this guidance up to date?
We reviewed the evidence in November 2017. The recommendations were updated because the InRatio2 PT/INR is no longer available. We found nothing else that affects the recommendations in this guidance. The CoaguChek XS system has been updated since the guidance was published and we have summarised the main changes. The guidance applies to the updated system.
Next review: The guidance will be reviewed if there is new evidence that is likely to change the recommendations.
Guidance development process
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.