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

MERCURY
Why Are We Concerned ?

Chemical Forms of Mercury

Elemental
Liquid metal

Inorganic salts
Mercuric chloride

Organic
Methyl, ethyl, dimethyl Phenyl organic groups

Acute Health Effects of Elemental Mercury

Acute exposure to high levels of elemental Hg

tremors, slowed motor nerve functions, memory loss

Acute inhalation of high amounts of elemental Hg

chest pains, acute renal failure, shortness of breath

Mercury in the Environment

Mercury cycle
Emitted from human activities & natural sources Circulates in the atmosphere from 6 months to 1 years Deposited back into land or bodies of water

Converted into insoluble forms, settling into sediment

Converted by bacteria into methyl mercury and enters the food chain

Source: New York State Department of Environmental Conservation

Chronic Exposure to High Levels of Methyl Mercury

Minamata disease: 2,265 cases confirmed in Minamata, Japan as of March 2001 Effects:
Constriction of visual fields Irregular gait Loss of muscular coordination Loss of speech, hearing, and taste Emotional disturbance Living wooden dolls

Photo: William Eugene Smith

Minimata 2011

Mercury: Effects of Low Dose Prenatal Exposure

Children with low prenatal mercury << 15 15 g/l exposure
40

g/l
15-300

15-30 g/l

30-50

30-50 g/l

Children with high prenatal >>50 50 g/l mercury exposure

% Faroe Island Children with Per cent of children with low test scores age 7 years lowest scores at at age 7 years

30

Percent of Children with Low Scores

20

10

0 ATTENTION MOTOR VISUOSPATIAL LANGUAGE MEMORY

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

The Significance of Small Effects:

EFFECTS OF A SMALL SHIFT IN IQ DISTRIBUTION IN A POPULATION OF 300 MILLION
mean 100

7.0 million "mentally disabled"

7.0 million "gifted"

40

60

80

100

120

140

160

70

I.Q.

130

5 Point Decrease in Mean IQ

Mean 95

57% INCREASE
IN

"Mentally Disabled Population 11 million "mentally disabled

40 60 80 100 120 140

4 million "gifted"
160

70

I.Q.

130

Public Health and Economic Consequences of Methyl Mercury Toxicity to the Developing Brain
Leonardo Trasande, Philip J. Landrigan, and Clyde Schechter Mount Sinai School of Medicine, New York, New York, USA Environ Health Perspect 113:590596 (2005).

$1.3 billion
each year is attributable to mercury emissions from U.S. power plants.
Photo: Illinois State Geological Survey

Sources of mercury in health care

Thermometers Sphygmomanometers Dental amalgam Gastrointestinal tubes Laboratory chemicals Pharmaceutical products Electrical applications Medical waste incineration, open burning, burning in barrels, gasification, pyrolysis, etc.

Fever Thermometers

WHO/OMS

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 glass gallium-indium-tin thermometers. Other alternatives include ear canal thermometers and flexible forehead thermometers. These alternatives can be as accurate as mercury thermometers, and are easier to read.

(grams mercury per person per year)

Mercury Use Per Capita

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 thermometer manufacturers in China. 40.3% was exported. In 2002, 25.579 metric tons of mercury was consumed by the one medical thermometer manufacturer in Russia .

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

Lowell University Center Report for UNEP, 2009

Mercury Thermometers

Breakage

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 in a in a 15 square meter, three meter high room. China's provision of mercury maximum allowable concentration in indoor 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 2 weeks exposure to mercury vapor from a bedroom carpet after a single thermometer broke.
Poisindex, 2010

http://www.noharm.org/europe/issues/toxins/mercury/resources.php

Fever Thermometers

WHO/OMS

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 glass gallium-indium-tin thermometers. Other alternatives include ear canal thermometers and flexible forehead thermometers. These alternatives can be as accurate as mercury thermometers, and are easier to read.

Mercury Free Thermometers

Xueyu Li , Global village of Beijing: 12-20-2007

Lowell Center for Sustainable Production University of Lowell Massachusetts

Accuracy Issues

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

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

Cost Issues

Hospital So Luiz in So 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 the savings on maintenance and calibration would pay back the initial 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 with mercury instruments far exceeds this cost difference [with nonmercury instruments] in addition to the extra environmental and occupational 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

Mercury Free Thermometers

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

Sphygmomanometers

WHO/OMS

Use: Sphygmomanometers are manometers used to measure human blood pressure.

Mercury content: Content can vary from 20 to 60 grams of mercury. Alternatives: Alternatives to mercurial sphygmomanometers are aneroid and digital products. Both are reliable, accepted as standard, and comparable to mercurial sphygmomanometers

The largest amount of mercury is used in mercury sphygmomanometers (80 to 100g/unit)

The largest mercury reservoir in the healthcare setting.

Accuracy of Replacements Why I Am Concerned

Cook County Hospital has always been open to all patients, generally poor or destitute, andimmigrants arrived in the city.
Raffensperger, John G., and Louis G. Boshes, eds. The Old International Healthcare Ethics, vol. 3. 1997.

Cook County Hospital:

Internal Medicine Residency: 1975 1978 Attending Physician Internal Medicine: 1979 Emergency Room: 1979 1980 Inpatient Internal Medicine: 1975 - 2009 Outpatient Internal Medicine: 1975 President of the Medical Staff: 2001-2005 Professor of Internal Medicine Fellow American College of Physicians Officer County and State Medical Societies

Lady on Harrison Street: Cook County Hospital, 18331995.

Hypertension

Recommendations for Blood Pressure Measurement in Humans

American Heart Association Council on High Blood Pressure Research

It is surprising that nearly 100 years after it was first discovered, and the subsequent recognition of its limited accuracy, the Korotkoff technique for measuring blood pressure has continued to be used without any substantial improvement.

Circulation. 2005;111:697-716

Gold Standard?
mm Hg = mm Hg BP measurement with Hg = Accurate BP

??

Recommendations for Blood Pressure Measurement in Humans

American Heart Association Council on High Blood Pressure Research

The gold standard for clinical blood pressure measurement has always been readings taken by a trained health care provider using a mercury sphygmomanometer and the Korotkoff sound technique, but there is increasing evidence that this procedure may lead to the misclassification of large numbers of individuals as hypertensive and also to a failure to diagnose blood pressure that may be normal in the clinic setting but elevated at other times in some individuals.

Circulation. 2005;111:697-716

Scipione Riva-Rocci. 1863 1937

THE GOLD STANDARD

A survey of blood pressure devices used in a large teaching hospital in London in 2000 (n=469 devices) 10% 18% 3 8% 35% - the markings were difficult to read - either an obscured mercury column or faded markings, - were leaking mercury. - had worn out, damaged, or split cuffs - velcro cuffs did not stick well enough to resist bursting apart on inflation above 180 mmHg - cuffs contained the wrong size bladder for the size of the cuff.

Markandu et al, 2000

THE GOLD STANDARD

Electronic pressure gauges are more accurate and better for Y Tube calibration:
Mercury sphygmomanometers Electronic pressure devices

3 mm Hg variation

0005 mmHg variation

Coleman AJ, 2005

Non Device Factors in BP Measurement Inaccuracy

The Health Care Provider

End-digit preference in general practice:

a comparison of the conventional auscultatory and electronic oscillometric methods.
Burnier M, Gasser UE. Service de Nephrologie et Consultation d'Hypertension, CHUV, Lausanne et Universite de Lausanne, and ClinResearch Ltd, Aesch, Switzerland.

Very marked digit preferences were observed for both the conventional and the automatic measurements, being most prominent for the digit "0" (52% and 25%, respectively) followed by a preference for the digit "5" (19% and 15%).

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

Non Device Factors in BP Measurement Inaccuracy

The Patient

Automated blood pressure measurement in routine clinical Practice

University of Toronto, Toronto, Ontario, Canada

Martin G. Myers

Results: The mean initial automated reading (mmHg)

taken with the observer present (162 27/85 12)

was similar to the mean manual blood pressure taken in duplicate (163 23/86+ 12).

Both values were higher (P< 0.001) than the mean of the next five readings taken with the
automated recorder when the patient was resting quietly alone (142 21/80 12).

Women exhibited a greater fall in blood pressure

Blood Pressure Monitoring 2006, 11:5962

Clinical Experience

The experiences of using mercury free blood pressure equipment in the Swedish health care sector.
by Kemi & Milj AB for the Swedish Chemicals Inspectorate. 1992

Since 1992 thermometers and other measuring instruments containing mercury may not be commercially manufactured or sold in Sweden.
All heads of department of clinical physiology in Swedish hospitals were contacted and asked to report their experiences from the phase out of mercury in blood pressure equipment.

There are no problems in diagnosing any condition

Studies

Accuracy of aneroid sphygmomanometer blood pressure recording compared with digital and mercury measurements in
Gill G, Ala L, Gurgel R, Cuevas L. Liverpool School of Tropical Medicine, UK.

Brazil

Digital, mercury and aneroid blood pressure measurements were carried out in 400 South American adults. There was slight under-reading of the aneroid instrument (hypertension prevalence 30%, compared with 32% for digital and mercury) Its robustness and simplicity makes it a suitable alternative to mercury machines in tropical field conditions.

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

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 reference pressure sensor.

Blood Pressure Monitoring 2005, 10:181188

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

RESULTS:

17.9% of all surveyed devices gave errors exceeding the +/-3 mmHg threshold. 53.2% of aneroid devices were found to be reading in error by more than +/-3 mmHg compared with 7.8% of the combined population of mercury and automated devices.

Significant differences in the performance of specific models of aneroid, mercury and automated devices were also identified.

Blood Pressure Monitoring 2005, 10:181188

Automated non-invasive blood pressure devices: 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 pressure device. 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 suitability and claims for clinical validation.

Conclusions:

A majority of models available on the European Union market were not validated by clinical trial to one of the recognized protocols

Blood Pressure Monitoring 2005, 10:275281

Criteria for Validating Devices

BMJ 2001, 322:531-536

In Development Coming Soon

Both mercury and aneroid sphygmomanometers have been in use for about 100 years, and when working properly, either gives accurate results. Aneroid sphygmomanometers provide accurate pressure measurements when a proper maintenance protocol is followed.

Must Be Checked Regularly To Avoid Errors.

Both Aneroid And Mercury Sphygmomanometers

Clinical Use of Non Hg Sphygmomanometers

SUMMARY

Gold Standard Accurate BP Greatest Inaccuracies = Measurer

Techniques Hearing Position of Cuff Size of Cuff Digit Preference

Greatest Variability = Patient

Position of Patient Stress Effect Time of Day

Product Accuracy = Manufacturer

When Maintained and Calibrated Properly Nearly All Inter-Device Variability 4mm Hg

Clinical Use of Non Hg Sphygmomanometers Conclusion: Aneroid sphygmomanometers are safe and accurate substitutes for hg devices in clinical practice. The oscillometric method is perhaps the best device for office measurement

SUMMARY

ACKNOWLEGEMENTS
Slides Developed From
Materials of WHO, HCWH, UNEP Colleagues at University of Illinois Postings on the Internet

Thanks to all these colleagues who permitted their slides and materials to be edited by me for presentation
And for support from the:
The United Nations Development Programme Global Environment Facility Global Project on Healthcare Waste