Eu Mercury phase out in Measuring and Control Equipment - EEB

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REPORT FROM THE CONFERENCE “EU MERCURY PHASE OUT IN MEASURING AND CONTROL EQUIPMENT”majority of blood pressure monitors are being used by patients at home, and the guideline bythe European Society of Hypertension is that these should be electronic. Thus, the vast majorityof blood pressure monitors in the community are electronic. He further pointed out that the bestmethod to assess blood pressure is using 24-hour ambulatory blood pressure monitoring, whichalso is almost exclusively performed using electronic devices. Therefore, what is left are theoffice measurements. It is debatable whether time has come to ban mercury devices only or getrid of the auscultatory technique altogether. He noted that the auscultatory devices areproblematic in the office (due to poor performance of physicians in applying the auscultatorytechnique), therefore a change should take place which is not only necessarily related tomercury.V. Technical Panel DiscussionAre Hg sphygmomanometers needed for calibration? Are there special cases wereHg sphygmomanometers are still needed? Are non-mercury devices validated?13. Perspective by a mercury-free hospital(Presentation by Dr Heikki Terio, Research Manager, Karolinska University Hospital)The speaker is a medical engineer and has been working in hospitals since 1983. KarolinskaUniversity Hospital is one of the largest in Europe. It has 1700 beds and 1,3 million visits per year.There are different quality systems – one of which is used in the clinical physiology which iscertified by the Swedish Board for Accreditation and Conformity Assessment (SWEDAC).According to the certification Karolinska University hospital has measurement methods which areaccredited and the Swedish authorities control these systems. They have the international normswhich are used by the Swedish authorities for calibration. These are used to calibrate their ownmain norm in their hospitals. This working norm is used weekly or when it is needed to calibrate theactual aneroid blood pressure equipment or the automatic equipment. The accreditation that is usedis ISO 17025. Karolinska hospital has the following measurement quantities that are accredited for:MassPhotometryTemperatureRotation velocity of centrifugesPressureDuring a static calibration of an aneroid blood pressure instrument, there is a check of tubing and ofthe manometer and also a leakage test. It takes about 30 minutes and costs about 30 Euros – theseare internal costs of which the clinic is charged for.In the hospital there is a certain procedure to calibrate the main norm, going from 0 to 300 mm ofmercury and then again down from 300 to 0. There should be control tags when it is calibrated andwhen it needs to be calibrated again and this should appear in the inventory system. These systemsare calibrated by external companies or the Swedish authorities. The procedure is almost the sameas the one that is used for the working norms.The calibration of the automatic or the electronic blood pressure measurement equipment isconducted in the same way. The difference is that there is a certain pulse rate that is used and goeson several levels to the systolic and diastolic pressures so that one can control that the algorithmthat it really works and gives the right answer. Of course the pulse rate can also be changed, whichmeans that it is possible to simulate arrhythmia cases.45
REPORT FROM THE CONFERENCE “EU MERCURY PHASE OUT IN MEASURING AND CONTROL EQUIPMENT”Calibration of blood pressure machine14. Manufacturer’s perspective(Presentation by Thomas Grant, Director, Regional Category Management, Welch Allyn,producer of Mercury-Free Sphygmomanometers)Three questions will be addressed: Are there special cases were mercury sphygmomanometers are still needed? Are non-mercury devices validated – specifically aneroids? Are mercury sphygmomanometers needed for calibration?What are the relative advantages of mercury free devices? Taking blood pressure is a system – it isnot just the manometer. As the American Heart Association suggested in a task force around 1990,the errors derive from: faulty equipment observer bias the failure to standardize measurement technique.What are the potential causes for error? There is a lot of confusion around this point.Mercury is not a magic pressure meter. It is possible to get errors with mercury if the mercury is notat zero level or if the column is not vertical. Further, the manometer needs to be at eye level toprevent error due to parallax effect. Mercury manometers often suffer from lack of regularmaintenance and can introduce error due to plugged filters and oxidized mercury.Aneroid devices are also subject of error if they go out of calibration.Automated devices have their own issues. For example, patient movement can be problematic,especially for devices that are of lower cost/quality. Further, loose cuff applications and usertechniques are sources of error. Arrhythmia, pre-eclampsia can also cause errors.46
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Eu Mercury phase out in Measuring and Control Equipment - EEB

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