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The Accuracy of Alternatives to Mercury Sphygmomanometers OCTOBER 2009

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The Accuracy of Alternatives to Mercury Sphygmomanometers OCTOBER 2009 HEALTH CARE RESEARCH COLLABORATIVE The Accuracy of Alternatives to Mercury Sphygmomanometers OCTOBER 2009 A U T H O R : Susan Buchanan, MD, MPH Health Care Without Harm has initiated a research collaborative coordinated by faculty of the University of Illinois at Chicago School of Public Health, with support from the Pioneer Portfolio of the Robert Wood Johnson Foundation, aimed at stimulating collaborative research around health and safety improvements in health care. This collaborative is designed to increase the evidence base concerning the human health and environmental impacts of materials, products and practices within health care. In partnership with the Global Health and Safety Initiative (GHSI), the Research Collaborative is engaged in research directed at the intersection of environmental, patient, and worker safety issues related to building and operating health care institutions. This paper is the third in a series of papers in which the Collaborative provides research and analysis of factors influencing patient, worker and environmental safety and sustainability in the healthcare sector. The editors of this series are Peter Orris, MD, MPH and Susan Kaplan, JD. TABLE OF CONTENTS Executive Summary .......................................................................................................................................3 I. Introduction .........................................................................................................................................4 II. Methods ...............................................................................................................................................7 III. Results .................................................................................................................................................8 Studies comparing mercury with aneroid devices ...............................................................................................8 Studies comparing digital pressure gauges with mercury and aneroid devices .....................................................9 Studies of calibrated aneroid devices .................................................................................................................10 Study of mercury devices ...................................................................................................................................10 Studies of oscillometric devices ..........................................................................................................................11 Studies of oscillometric devices compared with mercury and aneroid devices ..................................................11 Additional studies and independent evaluations of specific products ...............................................................12 IV. Discussion ..........................................................................................................................................13 Uncalibrated mercury sphygmomanometers ......................................................................................................13 Uncalibrated aneroid sphygmomanometers .......................................................................................................13 Calibrated aneroid and mercury sphygmomanometers ......................................................................................13 Oscillometric sphygmomanometers ....................................................................................................................13 Sphygmomanometer independent reviews and recommendations ....................................................................14 Clinical considerations and observer inaccuracy ...............................................................................................14 Oscillometric devices ..........................................................................................................................................15 V. Conclusions ........................................................................................................................................16 References ...................................................................................................................................................17 Acknowledgements Health Care without Harm funded this work via a grant from the Robert Wood Johnson Foundation. Our Author: Susan Buchanan, MD, MPH Clinical Assistant Professor Environmental and Occupational Health Sciences University of Illinois at Chicago School of Public Health 835 S. Wolcott, Suite E-144, MC 684 Chicago, Illinois 60612 Telephone: 312-996-0806 Fax: 312-413-8485 Email: [email protected] Design & Layout: Kieran Daly & Parisa Damian of Winking Fish EXECUTIVE SUMMARY The mercury sphygmomanometer was first introduced Although most professional organizations still require over 100 years ago and has not changed much since mercury for validation protocols, electronic pressure then. Due to the move towards removal of mercury gauges offer superior accuracy and should be substituted from health care settings, alternatives to the mercury for mercury manometers for calibration and validation. sphygmomanometer are in common use in many hospi- Organizations that publish validation and calibration tals and clinics. Concern has been voiced regarding the protocols should immediately re-evaluate their recom- accuracy of these alternative devices. This monograph mendations regarding the use of mercury devices. comprises a review of the medical literature that evalu- ates the accuracy of mercury, aneroid, and oscillometric blood pressure devices. Articles published between 1995 and 2009 were included. Seventeen articles met the inclusion criteria. Mercury sphygmomanometers were not as unfailingly accurate as often expected. Failure rates using various validation, calibration and inspection protocols ranged from 1% to 28%. Aneroid sphygmomanometer accu- racy also varied widely, failing calibration tests between 4 and 61% of the time in this literature. Both the mer- cury and aneroid sphygmomanometers evaluated in the studies had not undergone the recommended regular maintenance and calibration. As to potential substi- tution of aneroid for mercury devices, recent articles reported that when aneroid devices were calibrated and maintained appropriately, they performed equally or better than mercury devices. Oscillometric devices were understudied and their performance was variable. Proprietary algorithms to calculate systolic and diastolic pressure from the mean arterial pressure confound the assessment of these devices. However, validated oscillometric devices with digital displays have been demonstrated to be accurate and provide the possibility of removing inter-observer differences in blood pressure measurement. While early data is promising, as yet these devices have not been validated for all clinical conditions. The Accuracy of Alternatives to Mercury Sphygmomanometers 3 IINTRODUCTION. The accurate measurement and control of blood The first indirect blood pressure device utilizing a pressure are key elements in the prevention of car- mercury manometer was developed by Italian physician diovascular disease and stroke. Mercury sphygmo- Scipione Riva-Rocci in 1896 (Roguin 2006). In 1905, manometers, first developed over 100 years ago and Nikolai Korotkoff introduced the auscultory technique, largely unchanged since, are used in both hospital and which replaced arterial palpation and established the ambulatory settings. They have been considered the presence of the diastolic pressure. Indirect blood pressure ‘gold standard’ blood pressure measuring devices from monitoring has not changed much since that time. Mer- which treatment guidelines are developed (O’Brien et cury sphygmomanometers are of relatively simple design, al. 2003a, Pickering et al. 2005). consisting of a column of mercury connected by rubber tubing to a manually inflated cuff. Blood pressure is read However, mercury has been using the auscultatory technique, using Korotkoff sounds A typical mercury sphygmomanometer found to be a potent human I and V to identify systolic and diastolic pressure readings. neurotoxin. Environmental mercury pollution, mainly from The two commonly A typical sphygmomanometer aneroid industrial sources such as coal- used alternatives to fired power plants and trash mercury sphygmo- incineration, enters waterways manometers are the via industrial run-off or settling aneroid and oscil- of airborne particulate matter. lometric devices. It is metabolized by microor- Aneroid (meaning ganisms into methyl mercury, “without fluid”) which then accumulates in fish. sphygmomanom- In the United States, this has eters use mechani- contaminated 30% of U.S. lakes and wetlands, causing cal parts to transmit 44 states to issue fish advisories recommending limits the pressure in the on the ingestion of locally caught fish by pregnant and cuff to a dial. As the cuff pressure rises, a thin brass nursing women and children. (USEPA 2009) As health corrugated bellows expands, triggering movement of a care facilities contribute to mercury pollution via breaks pin resting on the bellows. This movement is amplified and spills and the burning of medical waste, an inter- by a series of gears and transmitted to the dial where national effort has developed over the last several years the blood pressure is read. As with mercury devices, the to eliminate the most common health care sources of cuff is inflated and deflated
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