1. What forms the basis for the impedance mammography in diagnostics of breast disease?
A living organism does not only generate bioelectricity, but passively conducts the current, which occurs in it or is applied from outside. Electrical conductivity depends on the histological structure of the organ, its molecular and, finally, its elementary composition (structure and number of free electrical charges, their mobility). Electrical properties of many malignant formations considerably differ from the healthy tissues, surrounding them. If X-ray and ultrasound methods of diagnostics construct images using the level of contrast between healthy and malignant tissue, which amounts to several percent and less, in case of impedance diagnostics the electrical conductivity of such tissues might amount to several hundreds of percent. This phenomenon is used in detection and localization of tumours and other breast disease.
2. What is impedance?
It is a physical value, which characterizes the electrical resistance of the system (from Latin impedire — “to cause hindrance”. Electrical impedance is a total resistance of the electrical circuit to the alternative current passing through it. In general, it is a geometrical sum of active resistance of the electrical circuit and reactive resistance (reactance), measured in Om.
3. What parameters of electrical current can be used in medicine, and in mammology in particular?
In medical diagnostics, particularly in electroimpedance mammography, the alternative current of a rather high frequency is used (as a rule, over 1 kHz). Due to high polarization degree of the intercellular membranes and the working electrodes electrical conductivity, measurements of biological systems, using direct current, is extremely difficult. The permissible value of the current is limited by its biological impact on the cells of living tissue; the former grows with the frequency increase. The current used for scanning in the electroimpedance computer mammography “MEIK”® (5th version) is within the range of 0,5 mA, frequency 50 kHz. These parameters of the measurement systems are absolutely harmless for patients.
4. What are the outlooks for utilizing the multi-frequency scanning?
We studied possibilities of the multi-frequency scanning for visualization of mammary tumor. ("Electro-impedance mammography testing at some physiological woman's periods". A.Karpov, O.Trochanova, XI international conference on electrical bio-impedance. Oslo, Norway, 2001; �Changes in electrical conductivity of mammary gland at multi-frequency measurement�, A.Karpov, O.Trochanova, XVIII scientific and practical conference. Yaroslavl, 2001). But application of the current with frequency within the range of β- dispersion ( 102 � 108 Hz) for breast scanning failed to bring the expected results. The 5th version of �MEIK� comprises this possibility. We recommend using it only as a tool for research only.
5. How painful is the examination?
The examination, being absolutely painless during the diagnostics and after it, lasts about 30 seconds.
6. What are the indications for impedance mammography?
The electrical impedance can be utilized in the whole range of the breast diseases, namely: benign and malignant neoplasms, mastopathies, mastitis and so on. In addition electrical impedance can be used for dynamic monitoring of women, comprising a risk group, in order to check efficiency of treatment. The examination, done with the help of MIEK during pregnancy as well as after birth, supplies doctors with valuable information concerning particulars of lactation period. This method of screening is widely used for women who take oral contraceptives and undergo substitutive hormonotherapy in climacterical stages.
7. Do any contraindications exist for using the method of impedance mammography?
Impedance mammography is absolutely harmless for a human being; this is why it can be used at any age period, inclusive lactation and pregnancy.
8. How often can impedance mammography be used?
The examination can be used without time limitations, since it is not accompanied by any radiation exposure and is safe for patients. The examination can be carried out when recommended by the physician at any time intervals. It can be used during a menstrual cycle in order to define breast functional particulars (so called dynamic mammography). In perimenopause it should be done at least one a year.
9. Who should conduct the examination in question?
The examination, connected with impedance mammography, should be performed by doctors, familiar with breast anatomy, physiology and pathology, namely: mammologists, obstetricians, or specialists in radiodiagnostics. When carrying out the examination it is preferable to have a nurse�s assistance, since it speeds up the procedure and increases efficiency.
10. Is it possible to diagnose breast malignant growth?
Due to the difference in electrical conductivity of malignant and healthy tissues existing from the initial stage of the tumour process, the device is capable of performing early detection of the oncology pathologies.
11. What minimal size of a tumour can be detected with the help of impedance mammography?
According to the existing statistic data the smallest detected tumours were 3-5 mm.
12. What are the operational characteristics of impedance mammography (sensitivity, specificity, etc)?
Sensitivity amounts to.92%, specificity-.99%, prognostication of positive - 73%, prognostication of negative result - 99%.
13. What method should be used for detection of malignant diseases? — for benign diseases?
It is not correct to discuss preferences any method in detecting any disease. There are no 100% results in diagnostics either in case of benign or malignant diseases of breast anywhere in the world. When choosing the appropriate method one should be guided by the criteria of safety and appropriateness. Taking into account high degree of sensitivity and specificity of the impedance mammography and at the same time its absolute safety, we can recommend starting examination with this method in particular. It case of necessity a more detailed examination can be recommended.
14. Is it recommendable to use the method in question for screening purposes?
The method of impedance mammography meets all demands of screening: safety, affordability, comprehensiveness; it can be performed within a short period of time in a room with limited sizes.
15. Does impedance mammography examination require any special condition?
The impedance mammography doesn�t need any special procedures. The examination is carried out at a room temperature, in rooms with average humidity. The patient takes a lying position on the examination couch.
16. How long does the examination last?
The length of examination procedure is 30 - 35 seconds. The process of diagnostic examination from the moment of obtaining the case history to establishing a conclusion amounts to 15 minutes. Screening examination lasts about 5 minutes.
17. What is the cost of the examination procedure?
When comparing the cost of various equipment, utilized for the same purposes, it is possible to say that the examination in question is cheaper than X-ray mammography and ultrasound examination.
18. Can the impedance mammography provoke any complications?
We have never witnessed any complications after impedance mammography.
Copyright © 2008 OOO PKF “SIM-technika”
Developed by “Bondarenko & Voronov” studio
Saturday, February 28, 2009
Development of electrical impedance tomography
The works on development of electrical impedance tomography started in Russia in the 90s of the last century. A group of scientists from the Institute of Radiotechnology and Electronics of the Russian Academy of Science (director — an academician, professor, an honoured worker of science and technology, Doctor of Physico-Mathematical Science Guliaev Yu. V.) comprising Doctor of Science (Physics and Mathematics) Cherepenin V.A., Candidate of science (Physics and Mathematics) Korzhenevskiy A.V., Candidate of science (Physics and Mathematics) Kornienko V.A. and others in 1997 — 1998 were able to solve a mathematical problem of imaging internal tissues of human body utilizing electrical impedance tomography.
Their efforts resulted in development of a pilot model of the device for diagnostics of the mammary gland, which was later handed over to Karpov A.Yu,, doctor of the higher category, head of the perinatal department of the Clinical Hospital # 9 in Yaroslavl, whose painstaking work allowed him to develop medical basics of electrical impedance mammography.
Head of the medical department
of the OOO PKF “SIM-technika” (ltd),
originator of the medical principles
of the electrical impedance
mammography Karpov A.Yu.
The first variant of the diagnostic device was called “The Electrical Impedance computer Mammograph EIM-003 “Korvet”. The electrical impedance mammograph “MEIK” was covered by the patent of the Russian Federation No. 2153285 and No. 2127075, as well as the USA patent No. 6,167,300 and No. 6,236,886. The invention, which forms the basis of the device, was awarded a golden medal at the World�s Fair of Inventions in Brussels at the exhibition “Eureka '99”.
In 2003 PKF “SIM-technika” on the basis of the OAO “Yaroslavl Radio Works” set up commercial production and manufactured the first batch of the electrical impedance computer mammograph “MEIK” (version 3.0).
The device underwent a successful period of testing and trials at the All-Russia Research Centre for X-ray and Radiology of the Ministry of Public Health in Moscow and at the Regional Oncology Centre of the 9th clinical hospital of Yaroslavl..
After obtaining the relevant approval documentation, starting from 2003 the electrical impedance mammography “MEIK”® has been used in medical practice at various medical institutions of Russia, the CIS, as well as in the countries of Europe and Asia.
Scientific and research work conducted by the PKF “SIM-technika” with involvement of mathematicians for the Yaroslavl State Demidov University as well as programmers and specialists in electronics from the Scientific and Production Enterprise “Spetspribor” enabled SIM-technika to start production from April 2007 of the 5th version of the device. This version differs from the previous modes by high degree of protection from noise and interference, perfect circuit design, high reliability in operation; in addition a fundamentally new software was developed as well, which was highly appreciated by doctors.
The electronics of the devices underwent principle alterations (the electrical circuit, isolation of printed circuit boards, power supply of active components; a block for preliminary filtration of signals from interference, noises and stray conductor-to-conductor flow of current; in addition, thanks to gold electroplating of the circuit boards and current-carrying parts, the jump potentials on the boarder of dissimilar metals was minimized).
As the production testing of the pilot batch of “MEIK”® proved, the abovementioned steps facilitated achievements of the following positive effects:
1. Elimination of noises and disturbances, which overlaying the main signal, led to deterioration of the obtain mammograms resolution capability, sometimes completely degrading the image.
2. Absence of need for calibration since stability of the obtained images and their numeric derivative characteristics are inbuilt into the electronic circuit itself.
3. Existence of independent channels (injecting and measuring) with individual power supply from the secondary sources DC-DC of the THI type with high insulation resistance and low level of interference make the device extremely reliable and electrically safe.
The software for the device (version 5.0) enables the user to perform the following:
to monitor correct positioning of the electrode matrix on the breast;
to control the procedure of measurement, data processing and archiving;
to change the image parameters (colour scale, contrasting, noise filtering, image softening, a 3-D layer-specific image);
to analyze electrical conductivity distribution, frequency distribution of electrical conductivity;
to assist the doctor in the process of diagnostics (automatic prompting).
Copyright © 2008 OOO PKF “SIM-technika”
Developed by “Bondarenko & Voronov” studio
Their efforts resulted in development of a pilot model of the device for diagnostics of the mammary gland, which was later handed over to Karpov A.Yu,, doctor of the higher category, head of the perinatal department of the Clinical Hospital # 9 in Yaroslavl, whose painstaking work allowed him to develop medical basics of electrical impedance mammography.
Head of the medical department
of the OOO PKF “SIM-technika” (ltd),
originator of the medical principles
of the electrical impedance
mammography Karpov A.Yu.
The first variant of the diagnostic device was called “The Electrical Impedance computer Mammograph EIM-003 “Korvet”. The electrical impedance mammograph “MEIK” was covered by the patent of the Russian Federation No. 2153285 and No. 2127075, as well as the USA patent No. 6,167,300 and No. 6,236,886. The invention, which forms the basis of the device, was awarded a golden medal at the World�s Fair of Inventions in Brussels at the exhibition “Eureka '99”.
In 2003 PKF “SIM-technika” on the basis of the OAO “Yaroslavl Radio Works” set up commercial production and manufactured the first batch of the electrical impedance computer mammograph “MEIK” (version 3.0).
The device underwent a successful period of testing and trials at the All-Russia Research Centre for X-ray and Radiology of the Ministry of Public Health in Moscow and at the Regional Oncology Centre of the 9th clinical hospital of Yaroslavl..
After obtaining the relevant approval documentation, starting from 2003 the electrical impedance mammography “MEIK”® has been used in medical practice at various medical institutions of Russia, the CIS, as well as in the countries of Europe and Asia.
Scientific and research work conducted by the PKF “SIM-technika” with involvement of mathematicians for the Yaroslavl State Demidov University as well as programmers and specialists in electronics from the Scientific and Production Enterprise “Spetspribor” enabled SIM-technika to start production from April 2007 of the 5th version of the device. This version differs from the previous modes by high degree of protection from noise and interference, perfect circuit design, high reliability in operation; in addition a fundamentally new software was developed as well, which was highly appreciated by doctors.
The electronics of the devices underwent principle alterations (the electrical circuit, isolation of printed circuit boards, power supply of active components; a block for preliminary filtration of signals from interference, noises and stray conductor-to-conductor flow of current; in addition, thanks to gold electroplating of the circuit boards and current-carrying parts, the jump potentials on the boarder of dissimilar metals was minimized).
As the production testing of the pilot batch of “MEIK”® proved, the abovementioned steps facilitated achievements of the following positive effects:
1. Elimination of noises and disturbances, which overlaying the main signal, led to deterioration of the obtain mammograms resolution capability, sometimes completely degrading the image.
2. Absence of need for calibration since stability of the obtained images and their numeric derivative characteristics are inbuilt into the electronic circuit itself.
3. Existence of independent channels (injecting and measuring) with individual power supply from the secondary sources DC-DC of the THI type with high insulation resistance and low level of interference make the device extremely reliable and electrically safe.
The software for the device (version 5.0) enables the user to perform the following:
to monitor correct positioning of the electrode matrix on the breast;
to control the procedure of measurement, data processing and archiving;
to change the image parameters (colour scale, contrasting, noise filtering, image softening, a 3-D layer-specific image);
to analyze electrical conductivity distribution, frequency distribution of electrical conductivity;
to assist the doctor in the process of diagnostics (automatic prompting).
Copyright © 2008 OOO PKF “SIM-technika”
Developed by “Bondarenko & Voronov” studio
EIT system overview
Three-dimensional EIT imaging of breast tissues: system design and clinical testing
Cherepenin, V.A.; Karpov, A.Y.; Korjenevsky, A.V.; Kornienko, V.N.; Kultiasov, Y.S.; Ochapkin, M.B.; Trochanova, O.V.; Meister, J.D.
Medical Imaging, IEEE Transactions on
Volume 21, Issue 6, June 2002 Page(s):662 - 667
Digital Object Identifier 10.1109/TMI.2002.800602
Summary:Results of development and testing of the new medical imaging system are described. The system uses a planar array consisting of 256 electrodes and enables obtaining images of the three-dimensional conductivity distribution in regions below the skin's surface up to several centimeters deep. The developed measuring system and image reconstruction algorithm can be used for breast tissue imaging and diagnostics, in particular for malignant tumor detection. Examples of tomographic images obtained in vivo during clinical tests are presented. The mammary gland, being an organ-target, alters at the background with such physiological events as menstrual cycle, pregnancy, lactation, and postmenopause. The objectives of this paper include estimation of the possibilities of electrical impedance mammography for investigation of mammary glands' state among women with different hormonal status. We found that electrical impedance mammograms from different groups had clear visual distinctions and statistically significant differences in mammary glands' conductivity. Our data on conductivity distribution in the mammary gland during different physiological periods will allow us to use it as normal values in the future, to continue this research on mammary glands with different pathology.
» View citation and abstract
Cherepenin, V.A.; Karpov, A.Y.; Korjenevsky, A.V.; Kornienko, V.N.; Kultiasov, Y.S.; Ochapkin, M.B.; Trochanova, O.V.; Meister, J.D.
Medical Imaging, IEEE Transactions on
Volume 21, Issue 6, June 2002 Page(s):662 - 667
Digital Object Identifier 10.1109/TMI.2002.800602
Summary:Results of development and testing of the new medical imaging system are described. The system uses a planar array consisting of 256 electrodes and enables obtaining images of the three-dimensional conductivity distribution in regions below the skin's surface up to several centimeters deep. The developed measuring system and image reconstruction algorithm can be used for breast tissue imaging and diagnostics, in particular for malignant tumor detection. Examples of tomographic images obtained in vivo during clinical tests are presented. The mammary gland, being an organ-target, alters at the background with such physiological events as menstrual cycle, pregnancy, lactation, and postmenopause. The objectives of this paper include estimation of the possibilities of electrical impedance mammography for investigation of mammary glands' state among women with different hormonal status. We found that electrical impedance mammograms from different groups had clear visual distinctions and statistically significant differences in mammary glands' conductivity. Our data on conductivity distribution in the mammary gland during different physiological periods will allow us to use it as normal values in the future, to continue this research on mammary glands with different pathology.
» View citation and abstract
What is the role of Electrical Impedance Tomography (EIT) in Early Detection of Breast Cancer?
What is the role of Electrical Impedance Tomography (EIT) in Early Detection of Breast Cancer?
An online interview with Alexander Hartov PhD, Thayer School of Engineering, Dartmouth College, Hanover, USA. 27 Jan 2006
About Alexander Hartov
Alexander Hartov is an electronics and biomedical engineer by training. He is the Research Associate Professor of Engineering at Dartmouth College in the USA, where he works in collaboration with physicians. His area of specialisation concerns instrumentation for medical application and more specifically the use of impedance measurements to screen for cancer. He also works in the field of image guided surgery. His involvement with electrical impedance tomography started in 1996 when he joined the faculty at Dartmouth.
Alexander Hartov in this online interview speaks from the view point of a scientist and Radiology Malaysia thanks him for sparing time to talk about his research in EIT.
The views expressed are his and does not necessarily represent or reflect the views or policies of the institution where he works. The content in this article does not replace consultation with your health professional.
Question: In Malaysia, EIT appears to have invaded the market, and used even in beauty and slimming saloons as part of their package of value added services for women. Advertisements alluding to “breast cancer screening” without pain and radiation have surfaced. Younger women, even in their late teens (from 15 years) have been included in the group that can benefit from Breast EIT.
Hartov: I concur with your outrage at screening wantonly women as young as 15. This is preposterous, no matter how innocuous the technology. In the US the recommended age for starting screening with mammography is somewhere between 40 and 50 years. Of course family history and other factors indicating a predisposition may require starting screening mammograms at a younger age. Screening the 20-40 years group is simply a waste of time if no indications exist. I will add that it's a waste of resources from a public health policy perspective, but it's also lucrative from the provider's perspective, which explains why it is offered as part of packages by businesses such as beauty and slimming salons.
Question: What exactly is electrical impedance tomography, especially with reference to the breast? I note there are a variety of terms used for the scans – T scan, Electrical Impedance scanning, Electrical impedance tomography. Is there a difference between these various types of “equipment used”?
Hartov: Here is a brief explanation of electrical impedance and how it relates to breast cancer screening. All tissue exhibit electrical properties which affect how well they conduct electrical currents (conductivity) and how well they can retain electrical charge (permittivity). This is not a special attribute of tissues, all materials have those properties and their magnitude qualifies them as conductors (very high conductivity) or isolators (very low conductivity). Materials with very high permittivity are used in the electronics industry to make capacitors, for example.
By applying a current on a person's skin, one can measure the effective impedance of the tissue traversed by the current. The impedance represents the effect of both conductivity and permittivity on the current flow. By applying many electrodes to a patient's breast (for example) and measuring the currents flowing through each electrode, it is possible to reconstruct a "map" of the tissue impedance variation. This image can reveal areas of high conductivity, which in the breast are associated with tumors. The whole process is non-invasive and innocuous, since the currents are too small to cause any harm and no radiation is involved.
There remain quite a few issues regarding the use of impedance measurements. First it has not been established clinically that it can discriminate reliably between benign (non cancerous) and malignant (cancerous) abnormalities in the breast. It is clear from direct invasive in-vivo (within a living organism) measurements that differences exist that may be used for screening. However, when making measurements non-invasively, the spatial resolution and sensitivity may not be sufficient to discriminate reliably. We are precisely in the process of conducting such clinical studies.
There are a few techniques to perform the measurements and the reconstruction of the impedance maps. We use a tomographic reconstruction approach. The Russian device uses a much simpler approach in which the electrode array is presented the way it looks spatially with the impedance magnitude reading represented in a gray scale image. A light spot (high conductivity) is considered an anomaly.
The T-scan device belongs in the same category, although its reconstruction method is somewhat more sophisticated in that it can reconstruct planes parallel to the electrode array at various depths. The thing to know about those planar array devices, the T-scan in particular is that they are not approved for screening by themselves (in the US). The studies that have been conducted with these devices were based on coupling the use of the T-scan with mammography. When used in this manner, that is the T-scan is used only on patients with an abnormal mammographic finding, the combination of mammo + T-scan improves the overall accuracy of screening. By itself, it does not qualify as a screening device.
Question: There has been some reports – eg Electrical Impedance Scanning for the Early Detection of Breast Cancer in Young Women: Preliminary Results of a Multicenter Prospective Clinical Trial, Journal of Clinical Oncology, Vol 23, No 12 (April 20), 2005: pp. 2703-2715 & Technology review: The use of electrical impedance scanning in the detection of breast cancer, Breast Cancer Res 2004, 6:69-74. There may be a role for young women with dense breasts. What are your comments?
Hartov: Also important, as I'm sure you know, is the fact that x-ray mammography is far from perfect and results in significant numbers of false positives and a few false negatives, which is why people are striving to find better screening methods. Not much in the way of improvement has been found to date. One category of patients in which it fails at an even higher rate is those women with denser breasts. It is thought that EIT may constitute to improve screening in that group.
Question: Does this problem of misleading advertisements (to the best of your knowledge and experience) exist in other countries? If so, what steps are being done elsewhere to curb misleading claims and what legislation or rules are there in place.
Hartov: As for curbing unsubstantiated claims, lying and cheating to make a buck is going to be with us for some time, I'm afraid. Strong legislation regarding devices for medical use does help, when it comes to public health policies.
Question: Perhaps, you have at take home message for Malaysians on the issue of electrical impedance?
Hartov: My take home message for people considering undergoing EIT is that it's still experimental. If your local beautician is offering it, you should ask yourself what are that person's qualifications to operate such a device and interpret the results it produces. I would recommend you change beautician and talk to a bona fide health care worker about your needs for screening. If you are under 40 and no one in you family has had breast cancer, you most likely don't need to worry about it yet.
Have your say! Discuss this at the Radiology Malaysia Forum
An online interview with Alexander Hartov PhD, Thayer School of Engineering, Dartmouth College, Hanover, USA. 27 Jan 2006
About Alexander Hartov
Alexander Hartov is an electronics and biomedical engineer by training. He is the Research Associate Professor of Engineering at Dartmouth College in the USA, where he works in collaboration with physicians. His area of specialisation concerns instrumentation for medical application and more specifically the use of impedance measurements to screen for cancer. He also works in the field of image guided surgery. His involvement with electrical impedance tomography started in 1996 when he joined the faculty at Dartmouth.
Alexander Hartov in this online interview speaks from the view point of a scientist and Radiology Malaysia thanks him for sparing time to talk about his research in EIT.
The views expressed are his and does not necessarily represent or reflect the views or policies of the institution where he works. The content in this article does not replace consultation with your health professional.
Question: In Malaysia, EIT appears to have invaded the market, and used even in beauty and slimming saloons as part of their package of value added services for women. Advertisements alluding to “breast cancer screening” without pain and radiation have surfaced. Younger women, even in their late teens (from 15 years) have been included in the group that can benefit from Breast EIT.
Hartov: I concur with your outrage at screening wantonly women as young as 15. This is preposterous, no matter how innocuous the technology. In the US the recommended age for starting screening with mammography is somewhere between 40 and 50 years. Of course family history and other factors indicating a predisposition may require starting screening mammograms at a younger age. Screening the 20-40 years group is simply a waste of time if no indications exist. I will add that it's a waste of resources from a public health policy perspective, but it's also lucrative from the provider's perspective, which explains why it is offered as part of packages by businesses such as beauty and slimming salons.
Question: What exactly is electrical impedance tomography, especially with reference to the breast? I note there are a variety of terms used for the scans – T scan, Electrical Impedance scanning, Electrical impedance tomography. Is there a difference between these various types of “equipment used”?
Hartov: Here is a brief explanation of electrical impedance and how it relates to breast cancer screening. All tissue exhibit electrical properties which affect how well they conduct electrical currents (conductivity) and how well they can retain electrical charge (permittivity). This is not a special attribute of tissues, all materials have those properties and their magnitude qualifies them as conductors (very high conductivity) or isolators (very low conductivity). Materials with very high permittivity are used in the electronics industry to make capacitors, for example.
By applying a current on a person's skin, one can measure the effective impedance of the tissue traversed by the current. The impedance represents the effect of both conductivity and permittivity on the current flow. By applying many electrodes to a patient's breast (for example) and measuring the currents flowing through each electrode, it is possible to reconstruct a "map" of the tissue impedance variation. This image can reveal areas of high conductivity, which in the breast are associated with tumors. The whole process is non-invasive and innocuous, since the currents are too small to cause any harm and no radiation is involved.
There remain quite a few issues regarding the use of impedance measurements. First it has not been established clinically that it can discriminate reliably between benign (non cancerous) and malignant (cancerous) abnormalities in the breast. It is clear from direct invasive in-vivo (within a living organism) measurements that differences exist that may be used for screening. However, when making measurements non-invasively, the spatial resolution and sensitivity may not be sufficient to discriminate reliably. We are precisely in the process of conducting such clinical studies.
There are a few techniques to perform the measurements and the reconstruction of the impedance maps. We use a tomographic reconstruction approach. The Russian device uses a much simpler approach in which the electrode array is presented the way it looks spatially with the impedance magnitude reading represented in a gray scale image. A light spot (high conductivity) is considered an anomaly.
The T-scan device belongs in the same category, although its reconstruction method is somewhat more sophisticated in that it can reconstruct planes parallel to the electrode array at various depths. The thing to know about those planar array devices, the T-scan in particular is that they are not approved for screening by themselves (in the US). The studies that have been conducted with these devices were based on coupling the use of the T-scan with mammography. When used in this manner, that is the T-scan is used only on patients with an abnormal mammographic finding, the combination of mammo + T-scan improves the overall accuracy of screening. By itself, it does not qualify as a screening device.
Question: There has been some reports – eg Electrical Impedance Scanning for the Early Detection of Breast Cancer in Young Women: Preliminary Results of a Multicenter Prospective Clinical Trial, Journal of Clinical Oncology, Vol 23, No 12 (April 20), 2005: pp. 2703-2715 & Technology review: The use of electrical impedance scanning in the detection of breast cancer, Breast Cancer Res 2004, 6:69-74. There may be a role for young women with dense breasts. What are your comments?
Hartov: Also important, as I'm sure you know, is the fact that x-ray mammography is far from perfect and results in significant numbers of false positives and a few false negatives, which is why people are striving to find better screening methods. Not much in the way of improvement has been found to date. One category of patients in which it fails at an even higher rate is those women with denser breasts. It is thought that EIT may constitute to improve screening in that group.
Question: Does this problem of misleading advertisements (to the best of your knowledge and experience) exist in other countries? If so, what steps are being done elsewhere to curb misleading claims and what legislation or rules are there in place.
Hartov: As for curbing unsubstantiated claims, lying and cheating to make a buck is going to be with us for some time, I'm afraid. Strong legislation regarding devices for medical use does help, when it comes to public health policies.
Question: Perhaps, you have at take home message for Malaysians on the issue of electrical impedance?
Hartov: My take home message for people considering undergoing EIT is that it's still experimental. If your local beautician is offering it, you should ask yourself what are that person's qualifications to operate such a device and interpret the results it produces. I would recommend you change beautician and talk to a bona fide health care worker about your needs for screening. If you are under 40 and no one in you family has had breast cancer, you most likely don't need to worry about it yet.
Have your say! Discuss this at the Radiology Malaysia Forum
CANCER SOCIETY OF SABAH (CSS)
Homepages of Member Organisations of
Sabah Council of Social Services
--------------------------------------------------------------------------------
CANCER SOCIETY OF SABAH (CSS)
Formation
Aims & Objectives
Membership
Membership Application Form
Management Committee
Activities
Activities
MAIN ACTIVITIES OF THE SOCIETY
1. Public Forum and education.
This is carried out regularly to disseminate information about cancer, its risks factors and ways of prevention. This is usually done by giving public lectures and the display of posters depicting various types of cancer.
2. Rural Health Clinics
This is one of our major activities. A group of volunteers consisting of doctors, nurses and other volunteers go to the rural areas to promote awareness of cancer amongst the rural people. During these visits talks on cancer in the local dialect as well as screening for cancer, e.g. Pap smear, are carried out. Sometimes difficult terrain have to be negotiated in order to reach these rural people who are living in isolated areas.
3. Breast Cancer Support Group
This self-help group initiated by members of the Society deals with women who have breast cancer or who have had breast cancer operation. This group works closely with the surgeons at our General Hospital. They will visit patients prior to breast cancer surgery and share personal experiences with one another. The trust and rapport established during these visit to patients whilst in hospital as well as in their homes make affected women emotionally and physically prepared.
4. Home Hospice Programme
This is a project which we have added to our on-going programme. It was formed in March 1993, with the aim of providing palliative care to patients with advanced cancer in their own homes. There are three tiers of volunteers involved in this programme, and consists of doctors, nurses and lay volunteers. They are all under the co-ordination of a Nurse Co-ordinator who arranges groups of volunteers to visits patients in their homes. These volunteers administer care and support to the patients after appropriate training, e.g. a nurse may administer injectable morphine. Due to the non-cooperation of one or two surgeons in Q.E.H. no patients were referred to the Society recently and so this programme has stagnated. The Societ is depending on self referrals and referrals from Private Practitioners.
5. FINANCIAL AID
The Cancer Society of Sabah also provide financial aid to needy patients and their relatives. This occurs when cancer patients from the rural areas have to come to Kota Kinabalu for Radiotherapy or for the administration of anti-cancer drugs. Financial Aid is usually used to pay for transport or to buy food for the relatives who accompany these patients. In some cases financial aid is also given to buy a special device such as a chemoport.
6. CANCER SCREENING CLINIC
A regular cancer screening clinic is held on every Saturday afternoon in our Society's office. The aim of this is to provide an avenue for people who are worried about cancer to be examined and to be counselled on the ways to prevent cancer. The clinic is usually manned by a doctor with the assistance of a nurse.
--------------------------------------------------------------------------------
K.J.Joseph cansab@tm.net.my , rijo@pc.jaring.my
Sabah Council of Social Services
--------------------------------------------------------------------------------
CANCER SOCIETY OF SABAH (CSS)
Formation
Aims & Objectives
Membership
Membership Application Form
Management Committee
Activities
Activities
MAIN ACTIVITIES OF THE SOCIETY
1. Public Forum and education.
This is carried out regularly to disseminate information about cancer, its risks factors and ways of prevention. This is usually done by giving public lectures and the display of posters depicting various types of cancer.
2. Rural Health Clinics
This is one of our major activities. A group of volunteers consisting of doctors, nurses and other volunteers go to the rural areas to promote awareness of cancer amongst the rural people. During these visits talks on cancer in the local dialect as well as screening for cancer, e.g. Pap smear, are carried out. Sometimes difficult terrain have to be negotiated in order to reach these rural people who are living in isolated areas.
3. Breast Cancer Support Group
This self-help group initiated by members of the Society deals with women who have breast cancer or who have had breast cancer operation. This group works closely with the surgeons at our General Hospital. They will visit patients prior to breast cancer surgery and share personal experiences with one another. The trust and rapport established during these visit to patients whilst in hospital as well as in their homes make affected women emotionally and physically prepared.
4. Home Hospice Programme
This is a project which we have added to our on-going programme. It was formed in March 1993, with the aim of providing palliative care to patients with advanced cancer in their own homes. There are three tiers of volunteers involved in this programme, and consists of doctors, nurses and lay volunteers. They are all under the co-ordination of a Nurse Co-ordinator who arranges groups of volunteers to visits patients in their homes. These volunteers administer care and support to the patients after appropriate training, e.g. a nurse may administer injectable morphine. Due to the non-cooperation of one or two surgeons in Q.E.H. no patients were referred to the Society recently and so this programme has stagnated. The Societ is depending on self referrals and referrals from Private Practitioners.
5. FINANCIAL AID
The Cancer Society of Sabah also provide financial aid to needy patients and their relatives. This occurs when cancer patients from the rural areas have to come to Kota Kinabalu for Radiotherapy or for the administration of anti-cancer drugs. Financial Aid is usually used to pay for transport or to buy food for the relatives who accompany these patients. In some cases financial aid is also given to buy a special device such as a chemoport.
6. CANCER SCREENING CLINIC
A regular cancer screening clinic is held on every Saturday afternoon in our Society's office. The aim of this is to provide an avenue for people who are worried about cancer to be examined and to be counselled on the ways to prevent cancer. The clinic is usually manned by a doctor with the assistance of a nurse.
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K.J.Joseph cansab@tm.net.my , rijo@pc.jaring.my
Laws on healthcare devices in the works
Sunday April 6, 2008
Laws on healthcare devices in the works
I REFER to the letter, The need to protect consumers of healthcare services (Your Say, StarMag March 23).
In that letter, Ms Ranjit Kaur, president of the Malaysian Breast Cancer Council, called upon the Ministry of Health (MOH) to protect the consumers by regulating medical devices and non-evidence-based approaches.
The MOH is well aware of the issues associated with medical devices in this country. These include, among others, the following:
1. The absence of pre-market controls to assess safety, effectiveness, and quality of medical devices prior to making these devices available on our market.
2. Inadequate information to guide the public and health professionals in making informed choices about medical devices that can be used safely and effectively to diagnose and treat illnesses.
3. The absence of a formal post-market reporting system to identify and monitor medical devices with problems in the market for follow-up action.
The MOH recognises the need to develop and implement a medical device regulatory system to address and manage these and other issues associated with medical devices.
In 2005, a proposal to develop and implement such a system in Malaysia was presented by the MOH to the Cabinet, which agreed to the proposal.
The proposed system is aimed at protecting the public as well as ensuring the safety of such devices, while, at the same time, facilitating trading activities to allow for the timely availability of beneficial new technologies to the medical community and the public.
The regulatory system encompasses the following components:
1. Medical Devices Act and its subsidiary legislations to provide legislative support for the medical device regulatory system.
2. An appropriate agency to implement and enforce the regulatory system.
3. Appropriate infrastructure and mechanisms for effective and efficient implementation of the regulatory system.
4. Medical Devices Registration and Surveillance/Vigilance System.
The ministry is currently in the midst of developing a medical device regulatory system based on international practices and standards.
As an initial step towards a regulated environment, the ministry initiated in 2006 a voluntary registration scheme for companies dealing with medical devices in Malaysia. The ministry has also started a reporting system for problematic devices on the market.
Voluntary registration of medical device products will start by the middle of this year.
With the implementation and full enforcement of the regulatory system, only medical devices that have met essential safety and performance requirements will be permitted in the market.
At the same time, the MOH has been actively conducting health technology assessments and technology reviews of new technologies since 1995. Health technology assessments are the systematic evaluation of the properties, effects or other impacts of technology, using evidence-based processes.
More importantly, this systematic evaluation will be benchmarked with international health technology assessment groups such as the International Networking Agencies of Health Technology Assessment, etc.
The MOH has also developed evidence-based Clinical Practice Guidelines (CPGs) since 2001. This is to ensure technologies used in our facilities are safe, cost-effective, and evidence-based.
We have so far produced 42 health technology assessment reports, 133 technology review reports and 43 evidence-based CPGs. All these reports can be accessed at the MOH website at moh.gov.my.
We also update the CPGs from time to time. A version of the CPG for patients has also been initiated.
With all these initiatives, we hope consumers will not only have access to evidence-based information on new technologies and practices but also that all medical devices introduced in this country will be safe and of high quality, and used only after stringent appraisal based on scientific evidence.
Tan Sri Dr Mohd Ismail Merican
Director General of Health
Malaysia
Laws on healthcare devices in the works
I REFER to the letter, The need to protect consumers of healthcare services (Your Say, StarMag March 23).
In that letter, Ms Ranjit Kaur, president of the Malaysian Breast Cancer Council, called upon the Ministry of Health (MOH) to protect the consumers by regulating medical devices and non-evidence-based approaches.
The MOH is well aware of the issues associated with medical devices in this country. These include, among others, the following:
1. The absence of pre-market controls to assess safety, effectiveness, and quality of medical devices prior to making these devices available on our market.
2. Inadequate information to guide the public and health professionals in making informed choices about medical devices that can be used safely and effectively to diagnose and treat illnesses.
3. The absence of a formal post-market reporting system to identify and monitor medical devices with problems in the market for follow-up action.
The MOH recognises the need to develop and implement a medical device regulatory system to address and manage these and other issues associated with medical devices.
In 2005, a proposal to develop and implement such a system in Malaysia was presented by the MOH to the Cabinet, which agreed to the proposal.
The proposed system is aimed at protecting the public as well as ensuring the safety of such devices, while, at the same time, facilitating trading activities to allow for the timely availability of beneficial new technologies to the medical community and the public.
The regulatory system encompasses the following components:
1. Medical Devices Act and its subsidiary legislations to provide legislative support for the medical device regulatory system.
2. An appropriate agency to implement and enforce the regulatory system.
3. Appropriate infrastructure and mechanisms for effective and efficient implementation of the regulatory system.
4. Medical Devices Registration and Surveillance/Vigilance System.
The ministry is currently in the midst of developing a medical device regulatory system based on international practices and standards.
As an initial step towards a regulated environment, the ministry initiated in 2006 a voluntary registration scheme for companies dealing with medical devices in Malaysia. The ministry has also started a reporting system for problematic devices on the market.
Voluntary registration of medical device products will start by the middle of this year.
With the implementation and full enforcement of the regulatory system, only medical devices that have met essential safety and performance requirements will be permitted in the market.
At the same time, the MOH has been actively conducting health technology assessments and technology reviews of new technologies since 1995. Health technology assessments are the systematic evaluation of the properties, effects or other impacts of technology, using evidence-based processes.
More importantly, this systematic evaluation will be benchmarked with international health technology assessment groups such as the International Networking Agencies of Health Technology Assessment, etc.
The MOH has also developed evidence-based Clinical Practice Guidelines (CPGs) since 2001. This is to ensure technologies used in our facilities are safe, cost-effective, and evidence-based.
We have so far produced 42 health technology assessment reports, 133 technology review reports and 43 evidence-based CPGs. All these reports can be accessed at the MOH website at moh.gov.my.
We also update the CPGs from time to time. A version of the CPG for patients has also been initiated.
With all these initiatives, we hope consumers will not only have access to evidence-based information on new technologies and practices but also that all medical devices introduced in this country will be safe and of high quality, and used only after stringent appraisal based on scientific evidence.
Tan Sri Dr Mohd Ismail Merican
Director General of Health
Malaysia
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