What’s the future for manual blood pressure measurement devices?

Since 10 April 2014 and the implementation of EU Commission regulation no 847/2012 the sale of new Mercury sphygmomanometers to the healthcare sector has been banned.

The alternative? Electronic manual sphygmomanometers like the A&D UM-102A mimic the Mercury sphygmomanometer but have none of the inherent disadvantages. These devices blend the best of modern, reliable vertical LCD technology, with the traditional advantage and reassurance of a manual measurement whilst listening to Korotkoff sounds with a stethoscope.

Unlike Mercury sphygmomanometers, devices like the A&D UM-102A sphygmomanometer don’t require routine cleaning or maintenance and can be used at any angle with a wide range of cuffs sizes and on patients with arrhythmias.

There is no oxidisation of the LCD which could alter the dynamic response and readings can be read to a single digit mm/Hg. Most importantly, if a product like the A&D UM-102A gets dropped you won’t end up with a contaminated treatment room and an expensive and time consuming mercury spill to clean up!

Alternative clinically validated Mercury free sphygmomanometers are available, so clinicians do still have a choice as to whether they use a manual method to record blood pressure with a stethoscope or an automatic device.

Manual devices, like the A&D UM-102A, are more tactile to use and can provide the clinician with additional useful information, like regularity or strength of pulse, provided they are used correctly and users have proper training.

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Does anyone still use Mercury Sphygmomanometers?

The UM-102A is the latest second generation Mercury free sphygmomanometer from Japanese company A&D Medical. It builds on the reliability and accuracy of the previous model, which it replaces, but now features a new ergonomic, modern, lightweight design.

Designed for professional use, it allows clinicians to record accurate blood pressure measurements using the “Gold Standard” Auscultatory measurement technique whilst listening for Korotkoff sounds with a stethoscope.

An extensive range of latex free compatible cuffs, with “quick fit” connectors and inflation bulbs already attached, make swapping cuffs quick and simple.

The adjustable, clear, anti-glare LCD screen is graduated just like Mercury so it is easy to read from any angle.

Sales of new Mercury sphygmomanometers were banned in the UK in 2014, but the UM-102A is an alternative clinically validated modern interpretation of the traditional Mercury sphygmomanometer.

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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.

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No More New Mercury Sphygmomanometers

The confusion that has surrounded the use of Mercury in medical devices has been rumbling on for several years. It’s use was restricted in thermometers some years ago but 2014 now finally sees the banning of it in new Mercury sphygmomanometers for environmental reasons.

The sale of Mercury Sphygmomanometers is now banned under EU directive no 847/2012 which also bans the use of Mercury strain gauges.

Alternatives to the Mercury sphygmomanometer and Mercury strain gauge are widely available, in the case of strain gauges they now use Indium Gallium.

The highly popular validated A&D UM-101A offers Auscultatory manual blood pressure measurement without Mercury in a compact design it even looks like a Mercury sphygmomanometer! Hybrid automatic and manual sphygmomanometers like the Omron HBP-1100 and HBP-1300 are also available.

Interestingly enough the directive does allow the use of Mercury as a reference standard for the validation of new blood pressure monitors and for research. So the Gold Standard still lives on since it’s invention over 130 years ago in 1881!

 

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