UM-101 sphygmomanometer – PMS Instruments

Measurements Made Easy

The demise of the mercury sphygmomanometer in clinical practice has been discussed and debated for over 10 years.

Until recently they could still be sold for professional use in the healthcare sector. However, since 10 April 2014 and the implementation of EU Commission regulation no 847/2012 the sale of mercury-containing sphygmomanometers to the healthcare sector, is now prohibited.

The exception is where new sphygmomanometers will be used in ongoing epidemiological studies or as reference standards in clinical validation studies of mercury-free sphygmomanometers.

Despite this and as recently as December 2013, the MHRA were still recommending that calibrated, non-mercury devices, which are not automatic, should be made available in all clinical areas.

They should be used to check automatic device results and should also be used in clinical conditions where automatic monitors may be inappropriate e.g. arrhythmia, pre-eclampsia or specific vascular disease.

This presents the Practice Manager and Clinician with a potential dilemma. How do they comply with the MHRA guidelines?

Fortunately for Clinicians with the right training and skillset, there are a number of manual devices available which include shock resistant aneroid sphygmomanometers (ERKA Switch) and manual electronic devices like the A&D Medical UM-101A which have the same look and feel as Mercury.

Assuming Clinicians are comfortable using the Auscultation (manual) technique of recording blood pressure with a stethoscope, then a new generation of hybrid devices like the Omron HBP-1300 are now also available.

These new devices are designed specifically with the professional user in mind. During an automatic measurement if the Irregular Pulse Wave symbol feature is indicated, the user can switch to manual mode and use a stethoscope to verify a reading is accurate without having to change device or cuff.

This is in line with MHRA recommendations.

Conclusion

Mercury sphygmomanometers have not been banned but new ones cannot now be purchased for general clinical use. That doesn’t mean the end of manual readings which in certain clinical situations may be required.

Suitable alternative clinically validated mercury free sphygmomanometers are available, so clinicians do still have a choice.

New hybrid automatic and manual blood pressure monitors specifically designed for the professional market are now available. They offer the advantage of a clinically validated automatic measurement or back up of a manual measurement where circumstances dictate.

PMS algorithm for blood pressure measurement

The CG127 2011 NICE Hypertension guidelines includes generic guidance on the measurement of blood pressure, including the key recommendation that 24 hour ambulatory blood pressure measurement be used before anti-hypertensive treatment is initiated. However out of the entire 317 page document, there is only one 6 page section on measuring blood pressure.

This section focuses on the different ways and methods of measuring blood pressure and the different types of devices available. The question is could the selection of the latest devices streamline the blood pressure measurement process and save time, as well as clinical resources?

Is there a case for developing a suggested PMS algorithm for blood pressure measurement and what form should this take?

Step One Use a Waiting Room BP Monitor

Monitors like the TM-2655P waiting room monitor for patient self-measurement have been available for some time. They are convenient, easy to use and cost effective. They can be effective opportunistic screening devices and may identify patients with undiagnosed Hypertension.

Many also provide additional clinical information such as whether an Irregular Heartbeat is present. Many GP practices utilize them as part of a drop in service as they allow patients to monitor their own BP without making an appointment. This frees up clinicians for other duties. As with any BP monitor, it is important to check the monitor is listed on the BHS web site (www.bhsoc.org). Monitors that measure from the upper arm are recommended.

Step 2 Confirmation with a manual measurement

If it is felt that a reading from a waiting room blood pressure monitor needs clarification, an additional measurement should be taken. The BHS provide “best practice” guidance on the correct way to record blood pressure using an automatic or manual device. Most clinicians will rely on a clinically validated automatic monitor.

Most of these low cost devices like the UA-1010 feature an irregular heartbeat indicator and some have a “Tricheck” feature, which will automatically repeat a measurement three times, in accordance with BHS recommendations.

For patients identified with an irregular heartbeat, non-Mercury manual devices like the UM-101 are available.

Step 3 Use ABPM – The Gold Standard

The cost of ambulatory blood pressure monitors has fallen considerably over the last few years. Like spirometers and ECG machines, the latest models such as the Meditech ABPM-05 feature software that provides automatic analysis of the results for consistent, time saving reporting to NICE Guidelines.