ASA Adjudication on Datel Group plc

Ad

An ad for a digital wrist Blood Pressure Monitor was broadcast on Max TV. The female presenter explained “… Do you worry about blood pressure? No? Well, maybe you should. Because high blood pressure affects over 16 million people in the UK and the higher your blood pressure the greater your risk of stroke, heart attack and heart failure. The problem is that high blood pressure rarely has any symptoms. The only way to know if you actually have high blood pressure is to have it measured. Now obviously you can have that done at the doctors but what do you do between doctor visits? ... Spotting high blood pressure early means that you can get it checked by your doctor quickly and start to do something about it straight away. For pregnant mums, your blood pressure is checked every time you go and see your mid-wife and this is because high blood pressure in pregnancy can be one of the signs of pre-eclampsia, which is a potentially dangerous condition if left undetected. So, if detection of high blood pressure is the key, then surely being able to check it yourself, at home, in a matter of seconds is by far the best option. And then, if you do find that your blood pressure is a bit high, you can go to the doctor quickly and have it checked out and hopefully put your mind at rest … Do you have a friend or a relative that you worry may be a candidate for high blood pressure? Or perhaps they have already been told they need to keep an eye on their blood pressure. If that is the case then, for just £19.99, this piece of equipment could give you the reassurance that you want …”. On-screen demonstrations included men and women sitting down, wearing the wrist blood pressure monitor, with their wrist elevated to heart height. Another demonstration, repeated twice, showed a lorry driver wearing the monitor with his wrist at waist height.

Issue

Monitoring staff challenged whether:

1.   evidence substantiated the efficacy of the device in diagnosing high blood pressure;  

2.   the ad implied that medical advice was not necessary because it encouraged consumers to self-diagnose;

3.   the ad implied the wrist blood pressure monitor could be used in more than one position.

BCAP TV Code

Response

Max TV did not explain why they believed the ad was acceptable.  They provided evidence relating to the devices CE marking and a copy of the instruction manual. They stopped broadcasting the ad during the investigation.

Assessment

1. Upheld

The ASA took expert advice. The expert said the CE marking information related to the blood pressure monitor being an electronic device with a CE Certificate of Conformity for Electromagnetic Compatibility.  The device was not CE marked as a Medical Device and the absence of information on a clinical evaluation study confirmed that.  The expert explained the main problem with the device was one of safety.  Because few wrist blood pressure monitors had passed clinical evaluation studies, the accuracy of the devices measurements could not be guaranteed and those devices were not generally recommended.  The expert advised that although it should not be advertised as a diagnostic device, the device was safe to promote to those specifically wanting to keep fit or interested in sport as a means of encouraging lifestyle changes to reduce blood pressure.  

We considered that, because we had seen no evidence to demonstrate the wrist blood pressure monitors efficacy in diagnosing high blood pressure, the ad was misleading.

The ad breached CAP (Broadcast) TV Advertising Standards Code 5.1 (Misleading advertising), 5.2.1 (Evidence).

2. Upheld

Although the ad told viewers they should contact their GP or hospital if they discovered an unusual reading, we considered that, with phrases such as "if detection of high blood pressure is the key, then surely being able to check it yourself, at home ... is by far the best option" and "this piece of equipment could give you the reassurance that you want", the ad implied the device could be used as an independent diagnostic device and encouraged consumers to self-diagnose.  

We noted that, as well as high blood pressure, the ad referred to serious medical conditions such as pre-eclampsia, stroke and heart attacks. We noted the expert advised that, because clinical trials had not been conducted on the efficacy of the wrist blood pressure monitor as a diagnostic device, to encourage consumers to measure their blood pressure was not safe because of the potential risk of being given an inaccurate reading.  That might lead to a wrong self-diagnosis and discourage people from seeking advice from a suitably qualified medical professional.  

We considered that the ad breached the Code.    

The ad breached CAP (Broadcast) TV Advertising Standards Code 6.7 (Health and Safety) and 8.2.6 (Conditions requiring medical attention).

3. Upheld

We noted that although the instruction manual content was accurate, the English was poorly translated.  The instructions advised that, when using the device, the wrist should be elevated to heart height.  We noted that some of the demonstrations in the ad reflected that advice others did not.  The expert was concerned that the presenter did not explicitly advise how the wrist blood pressure monitor should be used.  We were concerned that, because of the inaccurate on-screen demonstrations, the ad wrongly implied the monitor could be used in more than one position.  

The ad breached CAP (Broadcast) TV Advertising Standards Code 5.1 (Misleading advertising) and 6.7 (Health and Safety).

Action

The ad must not be broadcast again in its present form.  References to serious medical conditions, implications that the device could be used for diagnostic purposes and demonstrations using the device at waist height should be removed.

Adjudication of the ASA Council (Broadcast)