Regulator to overhaul BP monitoring
The Government's drug regulator has recommended a massive overhaul of blood pressure monitoring devices, writes Nerys Hairon.
GPs should scrap oscillometric blood pressure monitors that have not had recognised clinical validation and buy new equipment, an expert committee has advised.
The report, prepared by the Medicines and Healthcare Products Regulatory Agency's committee on blood pressure monitoring in clinical practice, warned oscillometric devices were often inaccurate.
It said GPs should not assume oscillometric devices with a CE mark were automatically suitable for diagnosis of hypertension.
An audit published earlier this year of 45 GP practices in inner London found 48 per cent used oscillometric devices, 22 per cent used aneroid sphygmos and the remainder mercury devices.
Committee chair Professor Andrew Shennan, professor of obstetrics at King's College London, said: 'If you've got a device that has not passed one of these protocols you should not be using it. I really think people don't appreciate the thing they've bought with the CE mark [can be] so awful.
'If people look at the device they have within their surgeries, it's more than likely the device will not have been adequately validated, so my advice is to stop using it and get one that is validated. The concern is about diagnostic accuracy.'
Professor Shennan said the committee had requested the Department of Health set up a group to enforce the recommendations.
Dr Peter McCartney, a committee member and a GP in Bristol, said: 'GPs should think about what machines they have got and whether they are approved by the British Hypertension Society.'
Summary of recommendations
· Maintain safety procedures such as spillage kits while mercury devices still used and decommission according to appropriate regulations
· Do not assume CE-marked oscillometric devices are suitable for hypertension diagnosis
· Use alternative devices for clinical conditions where oscillometric devices are unsuitable eg arrhythmia, pre-clampsia and certain vascular diseases
· Aneroid guages should be regularly checked based on manufacturers' recommendations
· NHS to only purchase devices that meet MHRA standards