Evidence-based recommendations on lead-I electrocardiogram (ECG) devices (imPulse, Kardia Mobile, MyDiagnostick and Zenicor-ECG) for detecting symptomatic atrial fibrillation using single time point testing in primary care.
This guidance covers devices that are used to record and analyse a single time point lead-I ECG for people in primary care with symptoms of atrial fibrillation and an irregular pulse. Using the devices for taking ECGs other than a single time point lead-I ECG reading, or for screening for atrial fibrillation in people without symptoms, was outside the scope of the assessment.
NICE is aware that there are wearable devices for detecting irregular heart rhythms available on the market. These devices are consumer devices and are not intended for use by healthcare professionals in diagnosing atrial fibrillation. It is expected that healthcare professionals would use clinical judgement and provide standard care following clinical guidelines when investigating an irregular heart rhythm and a potential diagnosis of atrial fibrillation. Findings from a consumer wearable device are one of many factors which may lead a patient to seek an appointment with a healthcare professional.
One of the 5 lead-I ECG devices in the scope, the RhythmPad GP (Cardiocity Ltd), was removed from this guidance after consultation. This was because the company informed NICE that, following a change in the CE mark, the device is no longer intended for detecting atrial fibrillation in people with signs or symptoms using single time point testing in primary care.
Is this guidance up to date?
Next review: May 2022
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.