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 Accuracy of Mercury Free Devices in Health Care Asia Regional Conference on Mercury-Free Health Care Manila, Philippines March 15, 2011 Prof. Peter Orris, MD, MPH, FACP, FACOEM Chief, Ocupational & Environmental Medicine University of Illinois at Chicago Medical Center Great Lakes Centers For Environmental & Occupational Safety and Health World Health Organization Collaborating Center 
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Accuracy of Mercury Free Devices

in Health CareAsia Regional Conference

on

Mercury-Free Health Care

Manila, PhilippinesMarch 15, 2011

Prof. Peter Orris, MD, MPH, FACP, FACOEMChief, Ocupational & Environmental Medicine

University of Illinois at Chicago Medical Center

Great Lakes Centers For Environmental & Occupational Safety and HealthWorld Health Organization Collaborating Center

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MERCURY

Why Are We Concerned ?

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Chemical Forms of

MercuryElemental – Liquid metal

Inorganic salts – Mercuric chloride

Organic – Methyl, ethyl, dimethyl – Phenyl organic groups

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Acute Health Effects of Elemental Mercury

Acute exposure to high levels of elementalHg – tremors, slowed motor nerve functions, memory

loss

Acute inhalation of high amounts of elemental Hg – chest pains, acute renal failure, shortness of

breath

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Mercury in the Environment

Mercury cycle – Emitted from human activities& natural sources

– Circulates in the atmospherefrom 6 months to 1½ years

– Deposited back into land or bodies of water

– Converted into insoluble forms, settling into sediment

– Converted by bacteria into methyl mercury and entersthe food chain Source: New York State Department of Environmental Conservation

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Chronic Exposure to High Levelsof Methyl Mercury

Minamata disease : 2,265 cases confirmed inMinamata, Japan as of March 2001

Effects: – Constriction of visual fields – Irregular gait

– Loss of muscular coordination – Loss of speech, hearing, andtaste

– Emotional disturbance – “Livin wooden dolls”

Photo: William Eugene Smith

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Minimata 2011

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Mercury: Effects of Low Dose Prenatal Exposure

Grandjean, et. al., Neurotoxicology & Teratology, 19:6, 1997

P e r c e n t o f c h i l d r e n w i t

h l o w t e s t

s c o r e s a t a g e

7 y e a r s

40

30

20

10

0

MOTORATTENTION

VISUOSPATIAL

LANGUAGE

MEMORY

> 50 g/l

30-50 g/l15-300 g/l< 15 g/l

Children with low prenatal

mercuryexposure < 15 >50 30-50 15-30

Children with highprenatalmercury

exposure

% F a r o

e I s l a n d C h i l d r e n w

i t h

l o w e s t s c o r e s a t a g e

7 y e a r s

µg/l

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The Significance of Small Effects:EFFECTS OF A SMALL SHIFTIN IQ DISTRIBUTION IN A

POPULATION OF 300 MILLION

160 140 120 100 80 60 40

70 130 I.Q.

mean 100

7.0 million

"gifted"

7.0 million

"mentally disabled"

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5 Point Decrease in Mean IQ

160 140 120 100 80 60 40

Mean 95

70 130

4 million

" gifted " 11 million " mentally disabled”

57% INCREASE IN

"Mentally Disabled” Population

I.Q.

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$1.3 billioneach year is attributable

tomercury emissions from

U.S. power plants.

Leonardo Trasande, Philip J. Landrigan, and Clyde SchechterMount Sinai School of Medicine, New York, New York, USA

Environ Health Perspect 113:590 –596 (2005).

Public Health and EconomicConsequences of Methyl Mercury Toxicityto the Developing Brain

Photo: Illinois State Geological Survey

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Sources of mercury in health care

ThermometersSphygmomanometersDental amalgamGastrointestinal tubesLaboratory chemicals

Pharmaceutical productsElectrical applicationsMedical waste incineration, open burning,

burning in barrels, gasification, pyrolysis, etc.

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WHO/OMSFever Thermometers

Use: Fever thermometers measure human body temperature including oral,rectal, or auxiliary (armpit).

Mercury content: Content ranges from 0.5 to 3 grams.

Alternatives: Mercury-free alternatives include digital, alcohol, and glassgallium-indium-tin thermometers. Other alternatives include ear canalthermometers and flexible forehead thermometers. These alternatives can beas accurate as mercury thermometers, and are easier to read.

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Mercury Use Per Capita(grams mercury per person per year)

Russia (0.180) and China (0.152):highest level per capita in grams of mercury per person per year

– In 2005, 200.9 tons of mercury was consumed by medical thermometermanufacturers in China. 40.3% was exported.

– In 2002, 25.579 metric tons of mercury was consumed by the one medicalthermometer manufacturer in Russia .

Chile, Romania, and Belarus reported between 0.074 to 0.086 grams.

Lowell University Center Report for UNEP, 2009

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Mercury Thermometers

Breakage

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Thermometer Breakage An example glass thermometer containing 1 gram of mercury

A broken thermometer will release mercury which will evaporate

and to a concentration of 22.2 mg/m3 in the air measured ina in a 15 square meter, three meter high room.

China's provision of mercury maximum allowable concentration inindoor air is 0.01 mg/m3 and in US workplaces the PEL is 0.1

mg/M3 & STEL is 0.03 mg/M3 .Xueyu Li , Global village of Beijing: 12-20-2007

Young Children have been poisoned after less than 2weeks exposure to mercury vapor from a bedroom carpet after asingle thermometer broke.

Poisindex, 2010

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WHO/OMSFever Thermometers

Use: Fever thermometers measure human body temperature including oral,rectal, or auxiliary (armpit).

Mercury content: Content ranges from 0.5 to 3 grams.

Alternatives: Mercury-free alternatives include digital, alcohol, and glassgallium-indium-tin thermometers. Other alternatives include ear canalthermometers and flexible forehead thermometers. These alternatives can beas accurate as mercury thermometers, and are easier to read.

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Mercury Free Thermometers

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Accuracy IssuesLowell Center for Sustainable Production

University of Lowell Massachusetts

http://www.sustainablehospitals.org/cgi-bin/DB_Report.cgi?px=W&rpt=Cat&id=15

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STUDY OF NON MERCURY

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STUDY OF NON-MERCURY ALTERNATIVES AS AN ENVIRONMENTAL

ATTRIBUTE

Detailed Study of Non-Mercury Alternatives 8 U.S. Army Corps of Engineers, Baltimore District as an Environmental Attribute HQ Defense Logistics Agency January 2005

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Cost Issues

Hospital São Luiz in São Paulo, Brazil – A 116 bed hospital found that if they were to replace all

sphygmomanometers, wall thermometers and clinical

thermometers in the hospital with alternative devices, that thesavings on maintenance and calibration would pay back theinitial capital investment of more than U.S. $9,000 in five years,while saving another U.S. $2,000 a year after that.

In India, Toxics Link

– “a study in four hospitals has shown that the recurring cost withmercury instruments far exceeds this cost difference [with non-mercury instruments] in addition to the extra environmental andoccupational hazard cost.”

Toward The Tipping Point | WHO-HCWH Global Initiative to Substitute Mercury-Based Medical Devices in Health Care A Two-Year Progress Report Published by the World Health Organization and Health Care Without Harm (Discussion Draft ) - 2010

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Mercury Free Thermometers

Reducing Mercury in Health Care Setting: A case study of Four Hospitals in Delhi, India, Toxics Link 2009

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WHO/OMSSphygmomanometers

Use: Sphygmomanometers are manometers used to measure human bloodpressure.

Mercury content: Content can vary from 20 to 60 grams of mercury.

Alternatives: Alternatives to mercurial sphygmomanometers are aneroid anddigital products. Both are reliable, accepted as standard, and comparable tomercurial sphygmomanometers

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The largest amount of mercury is used inmercury sphygmomanometers (80 to100g/unit)

The largest mercury reservoir in the health-care setting.

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Accuracy of ReplacementsWhy I Am Concerned

Cook County Hospital:

Internal Medicine Residency: 1975 – 1978 Attending Physician Internal Medicine: 1979 – Emergency Room: 1979 – 1980Inpatient Internal Medicine: 1975 - 2009Outpatient Internal Medicine: 1975 -

President of the Medical Staff: 2001-2005

Professor of Internal MedicineFellow American College of PhysiciansOfficer County and State Medical Societies Hypertension

Cook County Hospital has alwaysbeen open to all patients,generally poor or destitute,and…immigrants arrived in the city .

Raffensperger, John G., and Louis G. Boshes, eds. The Old Lady on Harrison Street: Cook County Hospital, 1833 – 1995. International Healthcare Ethics, vol. 3. 1997.

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h

Recommendations for Blood Pressure

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Recommendations for Blood PressureMeasurement in Humans American Heart Association Council on

High Blood Pressure Research

It is surprising that nearly 100 years after it was firstdiscovered, and the subsequent recognition of its limitedaccuracy, the Korotkoff technique for measuring blood

pressure has continued to be used without anysubstantial improvement.

Circulation. 2005;111:697-716

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Gold Standard?

mm Hg = mm HgBP measurement with Hg = Accurate BP

??

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Recommendations for Blood Pressure Measurement inHumans

American Heart Association Council onHigh Blood Pressure Research

The gold standard for clinical blood pressure measurement has alwaysbeen readings taken by a trained health care provider using a mercurysphygmomanometer and the Korotkoff sound technique, but there isincreasing evidence that this procedure may lead to themisclassification of large numbers of individuals ashypertensive and also to a failure to diagnose blood pressurethat may be normal in the clinic setting but elevated at othertimes in some individuals.

Circulation. 2005;111:697-716Scipione Riva-Rocci. 1863 – 1937

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“THE GOLD STANDARD”

A survey of blood pressure devices used in a largeteaching hospital in London in 2000 (n=469 devices)

– 10% - the markings were difficult to read – 18% - either an obscured mercury column or faded markings, – 3 - were leaking mercury. – 8% - had “worn out”, damaged, or split cuffs – 35% - velcro cuffs did not stick well enough to resist bursting

apart on inflation above 180 mmHg – 7 - cuffs contained the wrong size bladder for the size of

the cuff.

Markandu et al, 2000

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“THE GOLD STANDARD” Electronic pressure gauges are more accurate andbetter for Y Tube calibration:

Mercury sphygmomanometers 3 mm Hg variationElectronic pressure devices

0·005 mmHg variation

– Coleman AJ, 2005

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Non Device Factors inBP Measurement Inaccuracy

The Health Care Provider

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End-digit preference in general practice:a comparison of the conventional auscultatory and electronic

oscillometric methods.

Very marked digit preferences were observed for both the

conventional and the automatic measurements, being mostprominent for the digit "0" (52% and 25%, respectively) followedby a preference for the digit "5" (19% and 15%).

Burnier M, Gasser UE.Service de Nephrologie et Consultation d'Hypertension, CHUV, Lausanne et Universitede Lausanne, and ClinResearch Ltd, Aesch, Switzerland.

Blood Press. 2008;17(2):104-9.

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Non Device Factors inBP Measurement Inaccuracy

The Patient

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Automated blood pressure measurement in routineclinical Practice

Martin G. MyersUniversity of Toronto, Toronto,

Ontario, Canada

Results:The mean initial automated reading (mmHg)taken with the observer present (162 ± 27/85± 12)was similar to the mean manual bloodpressure taken in duplicate (163± 23/86+ 12).

Both values were higher (P< 0.001) than themean of the next five readings taken with theautomated recorder when the patient was resting

quietly alone (142± 21/80± 12).

Women exhibited a greater fall in blood pressure

Blood Pressure Monitoring 2006, 11:59 – 62

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Clinical Experience

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The experiences of using mercury free blood pressureequipment

in the Swedish health care sector. by Kemi & Miljö AB for the Swedish Chemicals Inspectorate.

1992

Since 1992 thermometers and other measuring instrumentscontaining mercury may not be commerciallymanufactured or sold in Sweden.

All heads of department of clinical physiology in Swedishhospitals were contacted and asked to report theirexperiences from the phase out of mercury in bloodpressure equipment .

There are no problems in diagnosingany condition

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Studies

Accuracy of aneroid sphygmomanometer blood

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Accuracy of aneroid sphygmomanometer bloodpressure recording compared

with digital and mercury measurements inBrazil

Gill G, Ala L, Gurgel R, Cuevas L.Liverpool School of Tropical Medicine, UK.

Digital, mercury and aneroid blood pressuremeasurements were carried out in 400 South

American adults.There was slight under-reading of the aneroidinstrument (hypertension prevalence 30%, comparedwith 32% for digital and mercury)

Its robustness and simplicity makes it asuitable alternative to mercury machines intropical field conditions.

Trop Doct. 2004 Jan;34(1):26-7

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Accuracy of the pressure scale of

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Accuracy of the pressure scale of sphygmomanometers in clinical use within

primary care Andrew J. Coleman, Stephen D. Steel, Mark Ashworth,

Sarah L. Vowler and Andrew Shennan

45 general practices within Lambeth, Southwark and Lewisham.

A total of 279 sphygmomanometers.Calibrated using an accurate electronic referencepressure sensor.

Blood Pressure Monitoring 2005, 10:181 – 188

Accuracy of the pressure scale of

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y psphygmomanometers in clinical use within

primary care Andrew J. Coleman, Stephen D. Steel, Mark Ashworth,

Sarah L. Vowler and Andrew Shennan

RESULTS:17.9% of all surveyed devices gave errors exceedingthe +/-3 mmHg threshold.

53.2% of aneroid devices were found to be reading inerror by more than +/-3 mmHg compared with

7.8% of the combined population of mercury andautomated devices.

Significant differences in the performance of specificmodels of aneroid, mercury and automated deviceswere also identified.

Blood Pressure Monitoring 2005, 10:181 – 188

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Automated non-invasive blood pressuredevices: are they suitable for use?

Andrew J. Sims, Julian A. Menes, Derek R. Bousfield, Christopher A.

Reay and Alan Murray

Results: – 86 companies were found to be actively involved in the supply of

158 different models of automated non-invasive blood pressuredevice.

– 54 devices for use on the arm and 62 for use on the wrist – We received responses for 61% of the main category arm and wrist

devices and 80% of these provided claims for CE marking.

– Inconsistencies were found between claims for diagnostic suitabilityand claims for clinical validation.

Conclusions: – A majority of models available on the European

Union market were not validated by clinical trial toone of the recognized protocols

Blood Pressure Monitoring 2005, 10:275 – 281

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Criteria for Validating Devices

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BMJ 2001, 322:531-536

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In DevelopmentComing Soon

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Both mercury and aneroid sphygmomanometershave been in use for about 100 years, and when

working properly, either gives accurate results.

Aneroid sphygmomanometers provide accuratepressure measurements when a proper

maintenance protocol is followed.

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Both Aneroid And Mercury Sphygmomanometers

Must Be Checked RegularlyTo Avoid Errors.

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SUMMARY Clinical Use of Non – Hg Sphygmomanometers

Gold Standard ≠ Accurate BP Greatest Inaccuracies = Measurer

TechniquesHearingPosition of Cuff Size of Cuff Digit Preference

Greatest Variability = PatientPosition of Patient

Stress EffectTime of DayProduct Accuracy = Manufacturer

When Maintained and Calibrated Properly Nearly AllInter- Device Variability ≤ 4mm Hg

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SUMMARY Clinical Use of Non – Hg Sphygmomanometers

Conclusion:

• Aneroid sphygmomanometers are safe and

accurate substitutes for hg devices inclinical practice.• The oscillometric method is perhaps the best

device for office measurement

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Slides Developed FromMaterials of

WHO, HCWH, UNEPColleagues at University of IllinoisPostings on the Internet

Thanks to all these colleagues who permitted their slides and mat

edited by me for presentationAnd for support from the:The United Nations Development ProgrammeGlobal Environment Facility Global Project on Healthcare Waste

ACKNOWLEGEMENTS