Diagnostic imaging: A fundamental tool of clinical medicine.

Jan 6, 20236 min read

Updated: Aug 26, 2023

This series of articles will focus on the evolution of medical products. We will explore the history and advancements of different categories of devices and medical technology, their current status and implications within our global society, and future outlook. As these products and technology continue to improve patient health, extend our lifetimes and improve our quality of life, we intend to help the reader better understand and appreciate where we’ve been, where we are, and where we’re heading within this very dynamic and fascinating industry.

It is interesting to wonder if Wilhelm Conrad Roentgen (German physicist) could have imagined a small portion of the legacy he was leaving, or significant impact he was making on the future of medicine, by making the first imaging study in the history of humanity: an X-ray. Roentgen made it of his wife's hand in November 1895, giving birth to the branch of diagnostic medicine known today as medical imaging.

He was awarded the Nobel Prize in physics as well as decorations from the Royal Society of London among others.

Well .... he may have sensed a portion of his legacy when he said: "It is now possible that a hecatomb may be unleashed" when he handed his manuscript to the secretary of the Medical Physics Society of Wuzburg, suggesting the significant sacrifice that was made for this advancement of humanity.

At first disbelieved by his colleagues, until only a couple of days after this presentation, his fellow student and professor of physics at the University of Vienna, Franz Exner told other colleagues about his friend's discovery. That same evening an article about it was written for the Vienna newspaper Die Presse, which was published the next day. And far away from the speed that today's internet and other media provide information, within 5 days it was in the newspapers of the different capitals and cities of the world: New York, London, Paris, Florence and others. In the same year, 49 monographs and more than 1100 special articles on X-rays were published. Rays that allowed seeing through matter (used even in science fiction movies: X-ray vision) were analyzed and studied in a large number of scientific fields, and from an extraterrestrial origin to the impact on internal medicine and surgery, the foundations were laid for bone radiology, angiography, radiotherapy, veterinary radiography, thoracic diagnosis, gastrointestinal radiography, and others. In the same year, the unfavorable effects of X-rays also began to be discovered, so technical solutions to protect against radiation exposure began to be sought.

Radiation regulation - For patients, workers and devices.

Today, extensive progress has been made regarding ionizing radiation, its uses and care, but also (as we will detail later on) in the evolution towards different diagnostic imaging studies. For example, some of the most important entities that regulate radiation-emitting devices, application in practice, and protection of public health, include the following:

- The ICRP International Commission on Radiological Protection, founded in 1928, is an independent charitable organization, established for the public good and to promote the science of radiation protection. It provides recommendations and guidance on all aspects of protection against ionizing radiation, setting policy and general direction.

- The WHO World Health Organization (WHO) has established a program to set standards, promote and monitor their application in practice, to protect patients, workers and the public against potential health risks in a radiation emergency, existing or planned radiation.

- The CSN (Consejo de Seguridad Nuclear) in Spain, the only competent entity in that country in charge of nuclear safety and radiation protection.

- In the USA, the FDA has the Center for Devices and Radiological Health (CDRH), which is the FDA body that oversees radiation-emitting devices, providing industry with efficient, consistent regulatory pathways, ensuring consumer confidence, but above all ensuring that patient and providers have continuous, safe and effective access to radiation-emitting devices.

- CDSCO The Central Drugs Standard Control Organization in India.

- In Argentina: The National Atomic Energy Commission CNEA.

Diagnostic imaging: History and evolution.

Since its beginnings, the development of diagnostic imaging has been in constant evolution with the introduction of new techniques and emerging medical needs.

In the 1950s, ultrasound introduced by the Austrian physician Karl Theodore Dussik in 1942 for use in medicine. Real-time ultrasound in the 1970s.
The EMI scanner created by Sir Godfrey Hounsfield, Electronic Engineer of England (later CT) first installed in a hospital in 1971.
Poul Lauterbur, a chemist from Ohio USA, succeeded in generating the first MRI image, in 2D and 3D using gradients in 1973.
Peter Mansfield, a physicist from England, discovered how fast images can be obtained by developing a Magnetic Resonance Imaging protocol called Echoplanar Imaging, which allows images to be collected much faster than before.
Julio Palmaz Interventional Radiologist from Argentina created the expandable balloon in 1985.
Willi Kalender Physician and Physicist, developed and introduced helical CT, developed quantitative diagnostic procedures for the evaluation of osteoporosis, pulmonary and cardiac diseases.
Juan Carlos Parodi, Cardiovascular Surgeon from Argentina, developed the Aortic Endovascular Prosthesis in 1991.

General considerations.

With a flourishing and introduction of diverse imaging techniques in recent decades, some of the older X-ray techniques have been displaced.

Undoubtedly today, 128 years after the discovery of that first image, advancement has been significant. With a great number of techniques now available for the detection of diseases in their earliest stages, some potentially fatal outcomes are now avoidable. They improve the quality of life, and may even be used for the detection and treatment of fetal pathologies.

For complex procedures, it is commonly identified as better practice to use a combination of several techniques. In recent years, for example, percutaneous punctures guided by ultrasound or computed tomography have considerably reduced the need for exploratory surgery, and exploratory endoscopy has also reduced the need for barium ingestion. It is also used not only to diagnose but also to treat, as for example in laparoscopic surgeries.

Technology applied to everything has facilitated in this case the storage of images, the writing of reports and the access to both with a single link, receiving and visualizing them by cell phone or any device with internet access, or finding the history of studies of a person in a web portal.

This has radically changed the speed of diagnosis and treatment. A medical professional can now obtain the results of the studies immediately, reducing the mortality rate in a high percentage of cases, improving the quality of life of patients, and also reducing costs with all actors.

What is radiation, how is it measured and why?

The spontaneous disintegration of atoms in the form of electromagnetic energy (gamma or x-rays) or particles (alpha particles and beta-neutrons) releases energy that we call radiation.

The half-life of a radioactive element is the time it takes to decrease its activity by disintegration to half its initial value, and varies in time range from a fraction of a second to millions of years. For example, iodine-131 has a half-life of 8 days, while carbon-14 has a half-life of 5,730 years. Frequently used in archaeology, paleontology, geology, hydrology, geophysics, oceanography, biomedical and other sciences for radiocarbon dating, and to disprove or test theories.

Equivalent dose: Health effects depend on the absorbed dose, the type of radiation and the sensitivity of each tissue or organ: this is described as the "Radiation Weighting Factor". The equivalent dose can be calculated as follows:

EQUIVALENT DOSE(Sv)= (the absorbed dose in Gy) X (this weighting factor).

This calculation results in Sievert Sv, which is the way to measure radiation in its potential to cause damage expressed as milli sievert or micro sievert. Also in combination with a unit of time, to know how many Micro or milli Sievert a health worker is exposed to daily, yearly, etc.

Effective Dose: is a calculated, but not measured quantity unlike the Equivalent Dose. It is an estimate of the uniform Equivalent Dose throughout the body that would produce the same level of risk of adverse effects resulting from non-uniform partial body irradiation. Also measured in Sievert Sv. The potential to produce cancer and other unwanted effects is directly related to the dose received.

In medicine, the different amounts of doses are precisely regulated and specified for each of the devices used in medical diagnostic studies such as radiography, computed tomography, dental CT, fluoroscopy, mammography and others. In order to preserve the health of patients and workers in medicine, as well as in any industry that uses ionizing radiation. For more details regarding FDA regulations please consult the links below.

Conclusion

Diagnostic imaging, with its rich history and evolution, is one of many tools now available to the clinician. These devices are now faster and more accurate, with an extremely wide range of coverage. This category of device has become a fundamental and indispensable tool within the clinician’s toolbox, supporting clinicians in the advancement of modern medicine and the diagnosis and treatment of pathologies.

About the Author:

Maria Soledad Gomez has 10+ years of industry experience working in a variety of roles within regulated industry, healthcare and medicine, including food/beverage, hospitals and veterinary medicine. Maria Sole writes technical articles on a wide variety of topics in the medical field.

About the Editor:

Brian Hoy has 20+ years of industry experience in medical devices and business formation, covering the complete life cycle with global scope. Brian consults for industry and gives general advisory and off-hours support. (English translation by Brian Hoy)

#diagnosticimaging

#medicaldevicediagnosticimaging

#Howthemedicaldeviceindustryischangingourworld

#medicaldeviceindustryimpactonglobalbusiness

#medicaldevicecompliance

#medicaldevicesandglobalexpansion

Publication ID: PUB0006EN