The European Commission - Mercury Sphygmomanometers in Healthcare and the feasibility of Alternatives, 23 September 2009.

Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), Mercury Sphygmomanometers in Healthcare and the feasibility of Alternatives, 23 September 2009.

The European Commission, Directorate-General for Health & Consumers has released it’s report :Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), Mercury Sphygmomanometers in Healthcare and the feasibility of Alternatives, 23 September 2009.

This multinational collaborative study included 17 committee members and an additional 6 External Experts, from 5 E.U. member countries.

Amongst the key conclusions they found:

"It is recommended that mercury sphygmomanometers remain available as a reference standard for clinical validation of existing mercury-free blood-pressure measurement devices. Therefore, the mercury sphygmomanometer should remain available as a reference standard until an alternative device is recognized as such."

"For certain patient groups, blood pressure measurement by a trained observer, using mercury sphygmomanometers or a validated auscultatory alternative, remains the most accurate and reliable form of indirect blood pressure measurement."

"Blood pressure measurement is vital for the prevention and treatment of blood pressure related diseases, and for monitoring of cardiovascular homeostasis. Based on long-term experience, blood pressure measurement using a mercury sphygmomanometer is currently regarded as the gold standard for indirect measurement of blood pressure."

"There are a number of physiological and pathological states that may influence the ability of an oscillometric (automated) device to obtain and equivalent reading to a mercury sphygmomanometer. Oscillometric measurements are dependant on movement, and changes in amplitude of this movement, in the artery, and therefore maybe altered. Oscillometric measurements cannot be relied on it patients with arrhythmias, some valvuar heart disease such as aortic incompetence. Other patients with altered vascular compliance, such as diabetics, or the elderly, could have less accurate blood pressure readings using oscillometric measurement. Changes in vascular compliance may also be confounded by oedema, intravascular volume, hyperdynamic circulation and by changes in cardiac output such as pre-eclampsia, in which oscillometric (automated) readings frequently underestimate the blood pressure."

Mercury Sphygmomanometers Shouldn't Be Abandoned

"Although both aneroid and electronic instruments have some advantages of portability and ease of use, few of these instruments have had adequate validation. Still fewer of these instrument's are calibrated regularly. To be sure, these instruments have a place in patient management, particularly with respect to their use as home monitoring devices. However most of these instruments have not been adequately validated over a wide range of blood pressures, ages, and clinical conditions to warrant routine use in hospitals and outpatient settings."

Hypertension magazine, Vol. 37, no. 2 (February 2001)

European Union Rejects Restrictions On Mercury

"... In a nine-page chapter on medical devices, the [European Commission's] report on mercury concludes that while there are risks linked to the substance's use in devices, benefits outweigh those risks."

-FDAnews.com, 8/6/02

Cuff Controversy: Opinions Mixed Over Accuracy of Blood-Pressure Devices

"To subject a patient to a lifetime of treatment based on measurement from a device which may be inaccurate is bad medicine and bad public policy."

ABCnews.com, 6/20/02

Inaccurate Blood Pressure Readings Can Pose Health Risk

(NAPS)-You look good, even feel good-but not so fast. The best measure of true health may be the numbers inside your body-and of those numbers, doctors say blood pressure ranks among the top. According to the American Heart Association, 50 million Americans over age 6 (one out of five) suffer from high blood pressure. Almost a third of them don't know it. High blood pressure, or hypertension, can cause heart and kidney disease, stroke, even death. Within the past ten years, deaths from high blood pressure have risen almost 50 percent.

Doctors agree that getting an accurate reading of your blood pressure is very important for managing your health. There are three different types of instruments used to measure blood pressure: aneroid (circular), digital (electronic) and mercurygravity (column) manometers. Recently, doctors have questioned the accuracy of some of these devices.

"The gold standard for accurate blood pressure measurement is mercury," says Dr. Paul Thompson, director of preventive cardiology and cardiovascular research at Hartford Hospital and professor of medicine at the University of Connecticut. "Over time," he continues, "digital and aneroid devices can become decalibrated or fall out of balance due to metal fatigue and other sources of variability.Because the weight of mercury and the effect of gravity never change, we know a mercury-gravity reading is always accurate."

Doctors rely on mercury-gravity manometers for scientifically accurate readings. "When you go to your doctor's office, the first thing you should do is look to see how your blood pressure is being measured," advises Dr. Thompson. "If it's with a mercury-gravity manometer, you can relax. If it's being measured with an aneroid or digital instrument, simply ask: 'When was the last time this machine was calibrated for accuracy? 'A lot of doctors' offices never calibrate their devices."

Doctors recommend the next time you have your blood pressure taken, ask when the device was last calibrated. High blood pressure can't be cured, but in most cases it can be controlled. Having your pressure accurately measured is one way to keep on track to good health.

For the original article in PDF Format please click here.

Experts: New Blood Pressure Devices Unreliable, Old Mercury Gauges Often More Accurate

"Across the nation, hospitals and doctors' offices are returning blood pressure cuffs to their manufacturers to comply with a federal environmental initiative to cut down on the use of mercury, a toxic metal that can pollute the air and water when disposed of improperly. But leading medical experts, joined by the American Heart Association and the National Heart, Lung, and Blood Institute, say the mercury gauges are being replaced by newer devices that may be unreliable, and they warn that inaccuracies may be leading to false diagnoses and inappropriate treatments."

The New York Times, 06/16/02

The Mercury in Your Mouth.

"There's no evidence that even potentially vulnerable populations, such as pregnant women and young children, are at any risk from the low levels of mercury vapor from amalgams. Given low doses, the human body can rid itself of toxic agents such as mercury or render them harmless."

Consumer Reports, May 1991

Checking Up on Blood Pressure Monitors

Measuring a person's blood pressure is a routine part of every physical exam. The results can predict long-term health risks, assess suitability for certain physical activities, help manage many types of medical problems, and determine eligibility for insurance. The procedure is done to screen for high blood pressure (hypertension), a major risk factor for serious conditions, such as stroke, kidney failure, and the leading killer in the United States--cardiovascular disease.

The safety of the current "gold standard" instrument used to measure blood pressure--the mercury-filled sphygmomanometer--however, is being called into question due to the environmental health risks associated with mercury. At the same time, medical experts fear that the mercury gauges may be replaced by less accurate devices without consideration for the health risks that could follow.

Although the environmental concerns are serious, the Food and Drug Administration believes that mercury sphygmomanometers are still useful medical devices.

The most accurate means for measuring blood pressure is directly within an artery (intra-arterial) using a catheter. But because this method is invasive, it is neither practical nor appropriate for repeated measurements in non-hospital settings, or for large-scale public health screenings. In addition, different methods for measuring blood pressure can produce different readings. The guidelines for diagnosing and treating hypertension are based upon measurements made using the mercury-filled sphygmomanometer, not upon intra-arterial measurement of blood pressure.

The usual method of measurement, therefore, is a noninvasive means that uses a sphygmomanometer, which includes either a column of mercury or pressure-registering gauge. With this technique, the flow of blood is temporarily stopped by an inflated cuff that is wrapped around the upper arm and that puts pressure on the main artery in the arm. Blood flow is then gradually restarted as the user slowly deflates the cuff.

An examiner uses a stethoscope to listen for sounds, called Korotkoff sounds, that can be heard when the blood begins flowing again through the artery and that change in tone and volume while the cuff is deflated. Blood pressure is typically measured in units of millimeters of mercury, and represents the force of blood against the blood vessel wall. The first number, called the systolic pressure, represents the highest blood pressure that occurs each time the heart beats. The second number, called the diastolic pressure, is the lowest pressure that occurs when the heart relaxes between two beats. The Korotkoff sounds are used to identify a person's systolic and diastolic blood pressure readings.

Both numbers are important because when either is elevated, so is the risk of developing heart and blood problems. According to the National Heart, Lung, and Blood Institute, a blood pressure reading consistently higher than 140/90 is a sign that the blood pressure needs to be brought under control. The typical adult blood pressure is 120/80 or lower, but readings vary depending on age and other factors.

The mercury sphygmomanometer is simple, easy to read, and requires no readjustment.It has been validated in many clinical circumstances against the direct method of measurement through the artery.

The push to replace mercury sphygmomanometers began in June 1998, when the Environmental Protection Agency and the American Hospital Association agreed to limit the amount of mercury waste from hospitals as much as possible by 2005. Other organizations, over time, have joined the effort.

Mercury is a silver-colored metallic element that is liquid at room temperature and tends to break into tiny, highly mobile droplets when spilled. These droplets vaporize and can contaminate the atmosphere. Precautions must be taken to limit the inhalation, ingestion or absorption of mercury in case of a spill or breakage. Exposure to mercury from sphygmomanometers used in health-care settings is extremely rare. Modern mercury sphygmomanometers are available in models that prevent accidental spillage of mercury. And, there have been only a few isolated cases of illness in children from mercury toxicity related to broken glass thermometers.

The FDA, which regulates blood pressure devices, requires companies to show that new monitors are substantially equivalent to models already on the market. They also must demonstrate accuracy through a clinical validation study.

There are two alternative types of blood pressure measuring instruments being marketed. Aneroid devices, which have no liquid, use metal that acts like a spring to measure blood pressure. These have a round compass-like face that is attached to a cuff and accompanied by a stethoscope, and are commonly used in physicians' offices. Electronic devices measure pressure by converting the readings into measurable electronic waves.

Electronic instruments include in-home blood pressure monitoring devices as well as the small stations often seen at drug stores where people place their arms through a mechanical cuff. These use physical measurements and mathematical formulas to calculate pressure. Electronic monitors were originally designed for use during surgery and in emergency room settings. They are not commonly used by U.S. physicians to diagnose or to monitor hypertension.

The two crucial considerations for substituting aneroid and electronic units for mercury instruments are calibration and validation. Calibration is a way to make sure that measurements begin from zero--much like when a scale is balanced before it is stepped on to measure body weight. If the starting mark is above or below zero, the final measurement will be inaccurate. Validation ensures that the instrument can take accurate measurements over a wide range of blood pressures, ages and clinical conditions.

The FDA also is concerned that aneroid and electronic devices may not be regularly calibrated, potentially making these devices prone to erroneous readings.

Regardless of the type of device used to measure blood pressure, selecting appropriately sized cuffs is critical. The appropriate cuff width is based on the diameter of the upper arm. Taking blood pressure measurement with a cuff that's too narrow could overestimate blood pressure, while too wide a cuff can underestimate the pressure. Inappropriately low blood pressure, or clinical shock, is a medical emergency. Inappropriately high blood pressure can indicate hypertension.

The American Heart Association (AHA) says that physicians who are involved in the management of patients with blood pressure problems must accept responsibility for ensuring that adequate instruments are available. They need to educate themselves on the instruments available for use in their clinics, and encourage the general use of mercury sphygmomanometers as the instrument of choice until others have been better validated.

Where aneroid or electronic devices are used, the AHA recommends validation through the Association for the Advancement of Medical Instrumentation or a similar organization and a program of regular maintenance.

The FDA recommends the following guidelines for in-home monitors: * Read the labeling to familiarize yourself with its operation. * Have the device calibrated/validated according to the manufacturer's instructions. * Look for a statement that says the unit was validated against the direct method of measurement. * Make no changes in medications based on at-home findings.

FDA experts say it's important to remember that home monitors are not an appropriate substitute for the regular measurement of blood pressure during physician visits.

Inez E. Fuller, R.N.

Ms. Grace Lancia
W.A. Baum Co., Inc.
620 Oak St.
Copiague, N.Y. 11726

September 26, 2002

Re: Receipt of flat cover spring

Dear Mrs. Lancia:

Thank you very much for your immediate response to my request for a flat cover spring for a desk model Baumanometer U6 79 56. Installation was quick and simple to do.

You may be interested in knowing that my family physician, member of a large group of medical doctors, has just replaced all late model dial-faced blood pressure apparatuses with wall mounted mercury column Baumanometers. Many thanks for still being there! I, personally, feel more confident in the readings.

Very truly yours,
Inez E. Fuller, R.N.
Raleigh, NC

Jon L. Vickery, M.D.

Mr. James Baum
Vice-President of Marketing and Sales
W.A. Baum Company Incorporated
Copiague, NY 11726-3292

January 29, 1990

Dear Mr. Baum:

I read, with interest, your letter of January 17, 1990, and am writing to you to thank you for your expeditious repair of my Baumanometer instrument, serial #208154. I was also delighted to receive the photocopy of the ledger entry indicating that this was shipped to my grandfather, Dr. Lee Otis Vickery, of Lena, IL, on September 2, 1936.

You may be interested to know that this blood pressure unit has been in continual service since that time with the exception of the years that my father served in WWII. It took 50 years of continual operation before requiring repair.

I acquired the instrument from my father when he retired from general practice in mid-1984, at the same time that I began my neurology practice here in Camp Hill, PA. I have on a number of occasions spot-checked it for accuracy with another unit, and have found it extremely reliable. I enjoy having and using the instrument, not only because of its reliability, but also because it serves as a reminder of my medical heritage.

Again, thank you for your attention to it, and I too feel it has many miles to go before it sleeps.

Sincerely,
Patterson, Yanofsky, Vickery & Levin, LTD.
Associates in Neurology
Camp Hill, Pennsylvania

Marianne Farrar, R.N.

W.A. Baum Company Incorporated
Copiague, NY 11726-3292

March 20, 1995

Dear Sirs,

Several years ago I purchased a desk model Baumanometer, model number 0661-0120. I have used this model every day and it has been reliable and trustworthy. Unfortunately, from using it so often the latch in the bottom of the case which allows the cover to become stationary in the upright position, has broken. Since this latch is non-functioning there is no way to keep the cover upright. Consequently, I am unable to use the Baumanometer without taping it in place.

The latch appears to be soldered in place. The portion of the latch which has a bend in it, allowing the cover to snap in place, has broken off. How can this be repaired? There is nothing wrong with the rest of the unit.

This unit is essential for my work. I run health clinics in public housing every day and am lost without my trusty Baumanometer. Can you advise me what to do? I desperately need your help.

Respectfully,
Marianne Farrar, R.N.
Manchester Housing & Redevelopment Authority
Manchester, N.H.

Sue Morse, R.N.

W.A. Baum Incorporated
Copiague, NY 11726-3292

November 24, 1999

Dear Sirs,

I'm so disappointed to have to return these. I know I had the best instruments, but my county board is so paranoid and so afraid of our union they will do anything to prevent a lawsuit over a Hg spill even if it prevents us from giving good nursing care.

Thank God I'm retiring in three months. I've worked here over 34 years and the political and bureaucratic nonsense just escalates day by day.

Keep trying to educate people.

Thanks,

Sue Morse, R.N.
Administrator
Grundy County Home
Morris, IL