AMDD Vol.23
NEWSLETTER

November 2016

English translation of the Japanese newsletter

CONTENTS- Current Situation and Issues of Radiation Exposure, and New Technologies in the Fieldof Cardiology- Medical Devices as a Growth Strategy- Patient’s Voice: Issues and the Future of Treatment for Pediatric Cancer- Voice from the Local Government: Aiming for a Hub Cluster in Asia - Arrival of basefor open innovation in “Fujinokuni” (home of Mt. Fuji) Shizuoka Prefecture- AMDD Holds the Extraordinary General Meeting- AMDD Participates in “Kasumigaseki Kid’s Day,” a Summer Vacation Event- Value of Medical Technology <Cancer> Companion Diagnosis- AMDD Holds the 26th Media Lecture — The Influence of Radiation on the Medical
Frontline and the Latest Technology for Reducing Radiation Exposure- Radiation Exposure, Risks, and Cutting-edge Technologies in Orthopedic Surgery- Measurements of Medical Exposure and Protection for Intravascular Treatment

Current Situation and Issues of Radiation Exposure, and New
Technologies in the Field of Cardiology“The Influence of Radiation on the Medical Frontline and the Latest Technology
for Reducing Radiation Exposure” was the second part of a media lecture titled“Safety of Medical Practitioners,” held by the American Medical Devices andDiagnostics Manufacturers’ Association (AMDD) in July. Summaries of the lecturesthat were delivered by Dr. Toshiaki Nitatori, Dr. Takashi Miyamoto, and Dr. Takashi
Moritake are featured below.
The Current Situation of Medical Exposure
Looking at the history of surgical medical care, the discovery of X-rays by Wilhelm Röntgenin 1895 brought a new form of medical care using radiation. Currently, radiation is used invarious examinations and treatments, and what draws attention to radiation exposure ofhealthcare professionals is interventional radiology (IR, or abbreviated to IVR in Japan). This
literally refers to “image-guided diagnosis and treatment.” It allows medical professionals toprovide treatment with minimally invasive techniques, while they look at images, for example,
in cardiac catheterization. It can reduce risks because only tiny incisions need to be madeinto the body. On the other hand, IVR is accompanied by the issue of radiation.
When cardiac catheterization is performed, patients are exposed to a radiation dose of a little
over 1 gray. Although the effect of radiation on patients may be small because they receive
such surgery only once or twice in their lives, healthcare professionals are repeatedly exposed.

1There is an occupational dose limit for radiation exposure and the limited dose of radiation
for the entire body is 50 mSv/year or 5 mSv/3 months for women. Medical institutions arelegally required to install a radiation exposure dosimeter on site and report the measurements
to an administrator every month. However, people’s awareness of radiation exposure is still
low and it is hard to say whether such requirements are strictly observed.
However, the radiation exposure among healthcare professionals is more serious than
anticipated. The prevalence of lens opacity is 52% for cardiologists and 45% for nurses. The
risk related to malignant brain tumors is also high. Specifically, an investigation into
cardiologists with brain tumors revealed that many are unilateral and that the tumors are
more concentrated on the left side. In other words, it is considered that tumors appear morecommonly on the left because cardiologists operate the catheter with their right hand during
surgery and are often exposed to radiation on the left side. These are relatively shocking
figures.
Protection from Radiation Exposure
Finally, healthcare professionals have started to think about how to protect themselves fromradiation exposure. Various kinds of devices are being developed for protection and a robot
navigation method is one of them. It is a magnetic navigation system that the user operates
with the use of a strong magnetic field without directly touching an electrode catheter.
However, while this can prevent operators from being exposed to radiation, it cannot prevent
patients from such exposure. Because it creates a large magnetic field, there are concerns
about its effect on the surroundings. As a result, the robot navigation system is not so popular.
The hottest device now is a 3D mapping method. This is a catheter navigation system which
creates CT- and MRI-produced 3D images of the heart on a computer screen, adds electricalinformation to the images, and displays an electrode catheter on the images after obtaining
maps of the cardiac form and arrhythmia.
With this technology, CT scanning is performed every 3 seconds. This is technology which
utilizes a technique used by Israel’s Air Force. It achieves accurate navigation by building up
3D visual information on 2D images which are recorded beforehand. Since it can correct thepatient’s body movements and heart rate, it can shorten the procedure time and reduce thelevel of radiation exposure.
Medical devices are constantly evolving and healthcare professionals’ awareness of radiationis also changing. Because IVR is applied not only to heart surgery but also to surgery of thebrain, kidney, liver, and other organs, the importance of protecting people from radiation
exposure continues to grow.

Dr. Toshiaki Nitatori
Chief Professor
Kyorin University, Department of Radiology

Graduated from the School of Medicine, Iwate Medical University in 1978. Studied at the University ofCalifornia in San Francisco (USA) in 1989. Worked as an Instructor and Assistant Professor at the2

Department of Radiology, School of Medicine, Kyorin University before assuming his current post in
2001.

Medical Devices as a Growth Strategy
The Significance of Health and Longevity, and Healthcare and Medical Strategy
While Japan is the world’s top country in terms of life expectancy, what is noteworthy is its
healthy life expectancy. Healthy life expectancy refers to the period where someone’s daily
life is not restricted by things such as nursing care. The difference between the average life
expectancy and the healthy life expectancy is 9 years for men and 12 years for women in
Japan.
The Strategic Market Creation Plan, one of the measures of the Japan Revitalization Strategy
promoted by the Abe Administration, aims to create new markets driven by issues. Of those,“Extending the nation’s healthy life expectancy” has become a main pillar of the plan.
With the rapid pace of an aging population, social security expenses will spiral if things
continue as they are. In order to control the growing expenses, closing the gap between the
average life expectancy and healthy life expectancy will be a big point. To do this, the Prime
Minister has assumed the post of Director and set up the Headquarters for Healthcare andMedical Strategy Promotion, laid out the promotion framework, and is currently working on
this issue.
Efforts for the Research and Development of Medical Devices
The healthcare and medical strategy has four pillars: research and development of thehealthcare field, creation of new industries, global expansion of healthcare, and promotionof ICT for healthcare. The plan to promote research and development in the healthcare fieldsets ten basic policies, including the establishment of circulation between basic research andclinical settings, creation of a system that puts the accomplishments of basic research into
practical use, the expected functions of the Japan Agency for Medical Research andDevelopment (AMED), and nine collaborative projects. These nine projects include thedevelopment of medical devices.
The size of the medical device market in Japan had been hovering at approximately 2 trillion
yen for some time, but it grew to 2.8 trillion yen in 2014, the largest size on record. Looking
at its breakdown, devices for treatments such as catheters account for 53% and devices fordiagnosis, such as endoscopes and CTs, account for 25%. Since total medical expenses inJapan as a whole are approximately 40 trillion yen, the proportion of medical devices
accounts for about 7%.
The Japan Revitalization Strategy 2016, which was approved by the Cabinet in June this year,
includes a plan to promote the development of medical devices, and a basic plan based on
the Act on Promotion of Medical Devices was also formulated. According to this plan, fiveareas in technology development of medical devices have been selected to focus on: surgery
support robots/systems, artificial tissues/organs, minimally invasive treatment, imaging(image diagnosis), and home medical devices. These areas require technological developmentin the medical device industry.
3

Development Based on Needs in Medical Settings
A major feature of this effort is to promote development based on needs in medical settings.
The staff of AMED will directly visit 11 core clinical facilities across the country to interview
doctors and other healthcare professionals to determine their needs. Based on these needs,
AMED is also attempting to publicly solicit new research and development.
Furthermore, the Medical Device InCubation Platform (MEDIC), which was launched in2014, has started offering consultations. Although AMED is the headquarters of MEDIC,
one-stop contacts have been set up at 71 regional support bodies across the country toprovide consultations about medical devices. Recently, we have been witnessing a spate of
consultations from different industries such as electrical and electronic manufacturers, andorganizations related to automotive parts, optics and chemistry. The so-called practice of“escort consultation,” which means giving advice until the release of a medical device, isgrowing.
However, there is a possibility that we may be left behind amid global competition unless weput the developed medical devices into practical use as quickly as possible. Thus, back-up
measures for early commercialization of medical devices are being taken.
The first measure is the transfer of the Pharmaceutical Affairs Law to the Pharmaceuticaland Medical Device Act which is based on the characteristics of medical devices. The second
measure is the effort being made in nationally strategic special zones. The improvement ofvarious systems is being promoted to shorten the period of clinical trials and speed up theprocess from development to approval and release onto the market. The strategic special
zones are currently located in the Kansai area, Sendai, and Tokyo. The third measure is toimprove and strengthen the system of the Pharmaceuticals and Medical Devices Agency(PMDA) and expand the preparatory consultation system. It promotes the earlycommercialization of medical devices by giving instructions and advice to medical device
manufacturers from the initial stage of development. Finally, though this will be a futureissue, the establishment of an early approval system for innovative medical devices is being
reviewed.
Creation of a New Industry in the Healthcare Field
We will promote the creation of a new industry in the next-generation healthcare service,
which is different from the public healthcare service. In order to expand the healthcare
service not covered by public health insurance, the relaxation of regulations will be needed.
For example, there is a service business related to a simplified test on self-collected blood.
However, there are always concerns that such blood collection may correspond to a medical
practice. We would like to promote a private service by asking such business vendors to use
the system to eliminate regulatory gray zones. We are aiming to take advantage of the vitalityof the private sector more in the future.
Promotion of ICT and Global Expansion
Although the digitalization and standardization of information on medical service fee bills
are making progress, the reality is that there is little progress with regards to the content ofdoctor’s interviews, results of tests/examinations, etc. In order to use such information in amore integrated manner, we are reviewing a way to set up a new information-collecting body.
We plan to establish a mechanism that can efficiently collect an enormous amount of
information.

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The overseas expansion of Japanese-style healthcare has already begun. Under the Asian
Human Well-Being Initiative, we will provide support and cooperation to rapidly growing
Asian countries and regions primarily in the nursing care field. We presented the “G7 IseShima Vision for Global Health” during this year’s G7 Ise-Shima Summit to push forwardwith global health. The world is paying attention to the further development of this visionin the future.

Mr. Hiroto Izumi
Special Advisor to the Prime Minister

Graduated from the Department of Urban Engineering, the University of Tokyo in 1976. Mr. Izumi
started his career in 1976 at the Ministry of Construction, and has served in various posts, such as
Director-General at the Housing Bureau in 2007, Director-General at the Regional Revitalization Bureau
in the Cabinet Secretariat in 2009, and Special Advisor to the Cabinet in 2012. He has been in his present
position since 2013, and has been a professor of the National Graduate Institute for Policy Studies since2006. Mr. Izumi has a doctorate degree in engineering.

Patient’s Voice
Issues and the Future of Treatment for Pediatric Cancer

Public Interest Incorporated Foundation
Children’s Cancer Association of JapanThe Children’s Cancer Association of Japan is an association for children with pediatriccancer and their families which was established in 1968. Currently, we are engaged in a wide
range of activities including consultation, helping to cover medical expenses, informationprovision, and PR activities in cooperation with volunteers and medical personnel. We work
mainly at the Headquarters in Tokyo, the Osaka Office, and 21 other branches across thecountry.
Pediatric cancer is a collective term for over several hundred different types of pediatricmalignancy, including leukemia and brain tumors which appear more commonly in earlychildhood. The number of children diagnosed with pediatric cancer is said to be about 2,500
to 3,000 per year in the entire field of pediatric cancer, and most of them are orphan diseasesof unknown causes. The treatment period for pediatric cancer is long and the burden of
medical and treatment expenses are significant despite such expenses being subsidized,
including the medical subsidy for infants and children, and grant-in-aid program for chronic
diseases in childhood. On top of that, both patients and their families are subjected to a great
deal of mental and economic stress during treatment, including the double life of families,5collaboration with schools and kindergartens during treatment, and taking care of thepatients’ brothers and sisters.
Depending on the type of disease, it is said that about 70% to 80% of the children can now
complete treatment. However, as a result of an improvement in the cure rate, the increase ineconomic and psychosocial burdens after completing treatment itself has become a new issue.
This is due to the aftereffects of treatment, late complications, and prolonged treatment ofunresectable remaining tumors, in addition to the post-treatment issues of returning toschool/work, marriage, and future childbearing, etc. On the other hand, pediatric cancer still
ranks first in terms of the number of children who die from disease, and the lives of about
500 small children are lost every year.
The early diagnosis of pediatric cancer is considered difficult because the proliferation ofcancer cells is fast and because pediatric cancer often occurs in deeper parts of the body.
Also, it is reported that early diagnosis does not become a factor which affects the prognosisof pediatric cancer in many cases. However, it is said that the outcome of pediatric cancer
has improved since it is now possible to accurately evaluate the cancer site and progression
as a result of improved diagnostic techniques such as image diagnosis. Thus, reliablediagnosis is required.
There are a wide range of cancer types to differentiate between and, in pediatric cancer
which appears more commonly in early childhood, reliable diagnosis is becoming possible
not only with imaging and pathological tests, but also with diagnosis by advanced medical
technologies such as chromosomal/genetic testing and immunological tests. It is expectedthat such advanced medical care will lead to subsequent personalized medicine.
In treatment, too, a less invasive treatment is required, such as particle therapy which wasrecently introduced to the public health insurance system. It can prevent aftereffects causedby the effect of concentrated treatment during childhood and onset of diseases and/or
disorders (late complications) which newly occur over time. At the same time, I sincerely
hope that medical care for aftereffects and late complications, such as regenerative medicine
with devices that can supplement functional disorders as a result of quadruple amputations
or artificial joints, and visual and visual field disorders or iPS cells, will achieve significant
development. I also hope that patients with pediatric cancer can receive advanced medicine
that places less burden on them.

Voice from the Local Government
Aiming for a Hub Cluster in Asia - Arrival of base for open innovation in“Fujinokuni” (home of Mt. Fuji) Shizuoka Prefecture

Mr. Hideki Mizuguchi
Manager
Research and Development Management Division
Commerce and Industry Bureau
Economy and Industry Department
Shizuoka Prefectural Government
6

Shizuoka Prefecture has the country’s largest gross production value of drugs, medical
devices, and cosmetics and research institutes, and the production plants of many companies
are concentrated there. Especially in the east area of the prefecture around Mt. Fuji,
companies such as Terumo which have a top-class share of medical devices in Japan, andBeckman Coulter, which manufactures laboratory test equipment, are located. In order totake advantage of the buildup of such leading companies in Japan for further regional
revitalization, Shizuoka Prefecture has started a Pharma Valley Project, utilizing theopportunity of the opening of the Shizuoka Cancer Center in 2002. This project aims to
support the prefecture to have the world’s longest healthy life expectancy, using the two
measures of “overcoming diseases and promoting health” and “industrial development” as
the main drivers.
One of the characteristics of this project is that we have formed an industrial cluster — aso-called “Medical Castle Town”— by establishing a network among government, industry,
academia, and financial institutions. It centers on the Shizuoka Cancer Center which is thecountry’s top-class advanced cancer specialized hospital equipped with a proton therapy
system and with abundant experience in robot surgery.
More than 500 organizations, including the National Institute of Genetics, a core base ofgenetics in Japan, and medical device/drug makers, local companies, universities, research
institutes, and financial institutions, are participating in and collaborating with this project.
More than 70 products have been produced from this project to date.
On September 1, 2016, the Pharma Valley Center (official name: Shizuoka Prefectural
Medical and Health Industry Research and Development Center), a new base facility of thisproject, fully opened. This Center is a strategic facility that promotes the entry of local
companies into the medical care field. It is also involved in the development of products andvarious functions for research and development, corporate support, development of humanresources, and interaction/collaboration necessary for open innovation, packaged in an
integrated manner. Terumo has moved into the Center to develop and manufacture ME
products such as an artificial heart-lung machine, while Tokai Buhin Kogyo, a local company,
has also moved in to develop and manufacture implants. Also, 8 companies including
Olympus Terumo Biomaterials, Sunstar, and local companies, intellectual property offices,and consultants have moved into 23 laboratory offices.
The Shizuoka Industrial Foundation Pharma Valley Center, a public interest incorporated
foundation, is a core support body of the project and designated manager of the facility. It
fully backs up the tenant companies and local companies. With a collaboration going beyond
boundaries among diverse companies, expectations for the birth of many innovative
products that can compete globally are growing.
With the opening of this Center, the Pharma Valley Project has moved to a new stage. Bytaking full advantage of the functions of this Center, we will send messages about medical
devices, drugs, and other products Made in Mt. Fuji to the world. We will create an attractive
region so that pharmaceutical, medical device, and cosmetic makers and researchers insideand outside of the country will have an interest in this region in order to grow a hub cluster
in Asia suitable as the “Capital of Beauty and Health.”7Foreground: Pharma Valley Center
Background: Shizuoka Cancer Center (photos provided by Nagaizumi Town Office)

AMDD Holds the Extraordinary General Meeting
The American Medical Devices and Diagnostics Manufacturers’ Association (AMDD) held
the AMDD Extraordinary General Meeting on September 15. Chairman Kosuke Kato
(Managing Director of Edwards Lifesciences Corporation) expressed his appreciation tovarious people concerned and shared his expectations for future activities in the opening
greetings. He then looked back at different events such as the revision of the reimbursementof medical fees in April and the public–private dialogue which occurred about 9 months
after AMDD became a general incorporated foundation in January this year.
Mr. Hiroto Izumi, Special Advisor to the Prime Minister, was invited to give the special
lecture and delivered a speech on the sustainable healthcare and medical strategy that theJapanese governments aims for under the leadership of Prime Minister Abe. He also talked
about the role of medical devices in the strategy under the title of “Medical Devices as a
Growth Strategy.”

Kosuke Kato, Chairman of AMDD

AMDD Participates in “Kasumigaseki Kid’s Day,” a Summer Vacation
Event
The American Medical Devices and Diagnostics Manufacturers’ Association (AMDD) took
part in a program called “Kasumigaseki Kid’s Day”, which was held from July 27 to 28.
Various medical devices were exhibited in a booth by the Ministry of Health, Labour andWelfare, entitled “Touching Cutting-Edge Medical Devices That Save Human Lives.” This8

year, our booth was allocated next to a booth about related home medical care, which became
the most popular area in the venue.
Children on their summer vacation accompanied
by adults enjoyed operating different medical
devices and touching a heart model. Although thishas become an annual event, many member
companies of AMDD took part in the event andeagerly explained their medical devices to children
with whom they do not usually have theopportunity to communicate with.

The Value of Medical Technology ＜Cancer＞
Companion Diagnosis
The progress of molecular biology has enhanced our understanding of diseases to themolecular level, and the development of molecular target drugs is now making progress,
primarily in the area of cancer treatment. Molecular target treatment controls the growth andprogression of cancer by targeting molecules (genes, proteins) involved in the growth,
infiltration, and metastasis of cancer cells. Therefore, it is essential to test cancer patients forthe onset of such molecules. A companion diagnosis conducts that test.
For example, the excessive onset of HER2 proteins on tumor cells is observed at a rate of
one in six patients with gastric cancer and at a rate of one in five patients with breast cancer.
Since molecular target treatment using a monoclonal antibody drug can be given to suchpatients, a test using a companion diagnostic drug is performed. With the use of companion
diagnosis, we can select the patient group for whom a high effect can be expected andoptimize the treatment to avoid serious side effects
If we could select the patient group that is expected to be most responsive to the treatmentin this way, it would also enable us to shorten the development period of new drugs. This
would be done by conducting clinical studies in a smaller number of patients and providing
the most appropriate drug to the most appropriate patient group more safely.
As its name suggests, companion diagnosis
is used from the initial stage of drug
discovery, and unified development with atherapeutic drug is said to be advisable.
Compared to drugs already available on themarket, these drugs, including diagnostic
drugs developed in a retrofitted manner, arecalled companion diagnostic drugs.
(Text by Michi Arakawa, Roche Diagnostics
K.K.)

9

AMDD Holds the 26th Media Lecture— The Influence of Radiation on the Medical Frontline and the Latest Technology for
Reducing Radiation Exposure
The American Medical Devices and Diagnostics Manufacturers’ Association (AMDD) heldthe 26th Media Lecture on July 21st in Tokyo. Under the title “The Influence of Radiationon the Medical Frontline and the Latest Technology for Reducing Radiation Exposure,” thesecond lecture in the “Safety of Medical Practitioners” series, three doctors presented
lectures on the occupational exposure of healthcare professionals who handle radiation.
First, Dr. Toshiaki Nitatori, Chief Professor of the Department of Radiology, Kyorin
University, delivered a lecture on cutting-edge technology to protect against radiation
exposure along with the history of and an introduction of radiation.
Next, Dr. Takashi Miyamoto, Senior Assistant Professor of the Trauma Center of Nagasaki
University Hospital Emergency Medical Center, delivered a lecture on the reality ofirradiation at the Department of Orthopedic Surgery and the need for doctors to recognize
themselves that they are exposed to radiation.
Finally, Dr. Takashi Moritake, Associate Professor of the Department of Radiological Health
Science, University of Occupational and Environmental Health, described how doctors needto understand and manage their radiation dose, and how the education of young doctors isessential.
At the back of the venue, medical devices which are actually used in medical settings were
exhibited. Many reporters who participated in the media lecture commented that they“learned a lot about the radiation exposure of healthcare professionals, a topic seldom
touched upon” and that they were “very satisfied” with the event.
(Please see the article on page 1 and inserted articles for summaries of the lectures by thethree doctors)

Dr. Toshiaki Nitatori

Dr. Takashi Miyamoto

Dr. Takashi Moritake10

Radiation Exposure, Risks, and Cutting-edge Technologies in
Orthopedic Surgery
About Radiation Exposure
Radiation exists in our own backyard and, in fact, we are constantly exposed to radiation in
our daily lives. For example, I got on an airplane from Nagasaki for this lecture. During theflight, I was exposed to radiation from space (cosmic radiation). When the altitude gets higher,
the air becomes thinner and the exposure to radiation coming from space increases. Whenyou fly from Japan to New York, for example, it is said that you are exposed to a radiationdose of 0.19 mSv. You are also exposed to radiation from food.
The annual radiation dose is 2.3 mSv as a global average, 1.1 mSv in Japan, and about 0.8
mSv in Kanagawa Prefecture. There are areas with a high radiation dose such as Ramsar in
India at 30 mSv and Guarapari in Brazil at 35 mSv. The radiation dose varies depending on
location.
When a pregnant woman gets injured and undergoes an X-ray in an examination, people
often make a noise, saying that she was “exposed to radiation.” The radiation dose for one
chest X-ray is 0.2 mSv. If you are concerned about such a small dose, you should beconcerned about getting on an airplane for your overseas trip. You should undergo thenecessary examination by considering its advantages.
Since we cannot actually see radiation, many people tend to be blindly scared of it. But, it isimportant that we should be “correctly scared of ” radiation with accurate knowledge.
Risks of Medical Exposure
The most frequent radiation exposure in Japan is medical exposure which accounts for 60%
of all types of exposure. In particular, we, orthopedic surgeons, have an inseparable
relationship with exposure. The reason is, while we primarily treat bones in the field of
orthopedic surgery, X-ray photography is indispensable for a diagnosis.
The number of hospitals in Japan is 3.7 times the number of hospitals in the United States,
and therefore there are more examinations/tests for patients. I sometimes enter a CT roomwith patients. Even with a protector attached to my body, there is always the risk of radiation
exposure.
However, we are more susceptible to exposure when we perform surgery with IVR(interventional radiology) than during examinations. We used to perform surgery by broadly
cutting the skin or muscle and directly looking at the bone. But now, a minimally invasive
surgery which is performed by making a small incision and inserting an instrument throughthe hole along with radiographic guidance of images has become the mainstream. While sucha technique is minimally invasive, since it uses radiation, the risk of exposure is increasing
for both patients and doctors.
The upper limit of exposure for healthcare professionals is 50 mSv/year. If we are exposed
to radiation of 0.2 mSv per surgery, it means that we can perform surgery only for about 250
patients a year. However, we actually perform surgery for 700 to 800 patients per year atNagasaki University.

11With IVR, we take advantage of C-arm (surgical X-ray equipment). This equipment acts as
our eyes but has 10% to 20% scattered radiation. Scattered radiation refers to secondary
radiation which is produced when it hits an absorber. It flies in every direction, such as into
the eyes, thyroid gland, and chest. The radiation dose is small compared to the direct radiationthat patients are exposed to. But since healthcare professionals are repeatedly exposed toscattered radiation, the risk increases.
In the case of orthopedic surgery, the exposure rate is higher for assistants than for operators
because of the position they are in and it is said that assistants are exposed to five times more
the amount of radiation than operators.
Countermeasures are necessary for the use of C-arm. Because we are exposed to scatteredradiation squarely if we irradiate patients from directly above, it is ideal to irradiate frombelow. If we irradiate from below, radiation is scattered under the feet.
The NCRP (National Council on Radiation Protection and Measurements) sets three
concepts for patients: “Block,” “Keep a distance,” and “Shorten time.” These concepts canbe applied to healthcare professionals, too.
For blocking, though we wear a protector or goggles, our hands are most susceptible toexposure. While protective gloves are available, since they are heavy, we cannot wear themfor a long time. Therefore, it is important to shorten surgery time as much as possible.
Cutting-Edge Equipment and Training Trends
With people’s increasing awareness of exposure, a system that does not irradiate has been
introduced. It is a surgical navigation called a distal targeting system. It navigates the locationand direction of a drill to insert a locking screw from the side after inserting a femoral
interlocking nail. It allows us to operate while looking at a monitor and, like a shooting game,it emits a sound when the target is locked on and a hole is opened up when the drill is applied
to it. Young doctors of the gaming generation are good at operating it compared to elderly
doctors.
Across the country, the time of irradiation was shortened at hospitals which introduced thisdistal targeting system and the awareness about exposure among the doctors grewsignificantly. This had a profound effect and was a groundbreaking event. Unfortunately,
however, statistically no significant difference was found at our university. As one of thecauses, it is considered that the surgical time at our university was short from the beginning.
Aiming to shorten the irradiation time, the Orthopaedic Trauma Association in the UnitedStates is also taking the initiative. It has developed a surgical simulator and is promoting thestandardization of surgical procedures so that only those who passed a test related to thissimulator can perform surgery for patients. There is a report showing that those who weretrained with the simulator could shorten the surgical time by 75% by becoming more awareof the irradiation time.
The key words to reducing the risk of exposure are blocking, distance, and time but the mostsignificant key word is the doctor’s high level of awareness.

12Dr. Takashi Miyamoto
Senior Assistant Professor
Nagasaki University Hospital Trauma Center

Graduated from Kagoshima University School of Medicine in 1996 and joined the Department ofOrthopedic Surgery of Nagasaki University in the same year. Studied abroad at University Tennessee
Cambell Clinic in 2006 and Massachusetts General Hospital in 2008. Dr. Miyamoto has been in his current
position since 2015.

Measurements of Medical Exposure and Protection for Intravascular
Treatment
The Radiation Exposure of Patients and Doctors
Speaking of “radiation exposure,” we can see that it differs between patients and healthcare
professionals. Let’s list differences and similarities of exposure between the two. Moreaccurately, patients call it “medical exposure” and healthcare professionals “occupational
exposure.” The measuring method, protection, etc. also differ.
However, the largest difference between the two may be the purpose of radiation control.
While patients cannot get tested or treated unless they are exposed to radiation, healthcare
professionals do not need to be exposed to even 1 mSv of radiation. Healthcare
professionals must not be exposed to unnecessary radiation. Although there are suchcontradictory purposes, we must confront the issue of radiation exposure.
Then, what is the principle of protection from medical exposure? The International
Commission on Radiological Protection (ICRP) specifies it as follows. It says that all radiation
exposure must be justified from the standpoint of their effects on patients. The biggest goal
is to reasonably reduce the stochastic effects. In other words, it means we must reduce thestochastic effects on the carcinogenic rate, etc. but we cannot completely eliminate radiation
exposure. Nevertheless, we must avoid deterministic effects, such as skin disorders, as muchas possible. However, cancer treatment with radiotherapy is excluded because it is justified.
Understanding Exposure DoseThe ICRP states that doctors are ultimately responsible for exposure, though this is a bit ofa home truth for doctors. In order for doctors to fulfill this principle, information is necessary.
At first, we must have a scale to properly judge the radiation dose. It is a diagnostic reference
level (DRL). The DRL has been introduced to study a standard radiation dose used in IVR(interventional radiology). The radiation dose needed for patients differs depending on their
symptoms and we cannot set a limit across the board. Therefore, we often estimate the mostappropriate radiation dose (75 percentile value) based on the two values of integral dose andarea dose from an IVR standard point. If the mean value (median value) of radiation dose13

at your hospital is below the DRL, there is no problem. But you must take appropriate
measures if it is above the DRL.
The DRL is effective because it reduces the stochastic effects. Unfortunately, however, it is
not effective at all for deterministic effects such as skin peel off or hair loss. In order to avoid
the deterministic effects, we must not exceed the threshold dose. It is essential that you know
the threshold dose that causes a skin disorder and whether the radiation dose exceeds it ornot.
In June 2015, the J-RIME (Japan Network for Research and Information on Medical
Exposures) posted the DRL on its website. According to its website, it states that thefluoroscopy radiation dose rate at the IVR standard point is “20 mGy/min,” and I felt that
there was something slightly wrong with that. The patient’s exposure during IVR isconsidered to be the product of both clinical and radiological elements. Clinical elements
refer to doctors’ techniques, characteristics of diseases, etc., while radiological elements refer
to mechanical things. However, since only the exposure dose rate is shown here,
unfortunately, it does not directly lead to reducing patients’ exposure. I suppose that moreclinical elements should be incorporated into the DRL. Meanwhile, work to revise the DRL
by adding clinical elements has already begun.
Risk Management of IVR Exposure That Should be Conducted by Doctors
First, doctors must obtain the patients’ informed consent about the risk of exposure.
Doctors must provide patients with accurate knowledge to help them understand and accept
the risk of exposure.
Next is the management of a radiation dose. Doctors must weigh the risks of exposure
against the benefit of a disease getting better if the radiation dose increases. This behaviorof thinking about the balance between the risks and benefits itself is a form of managementof exposure risks. If you increase the radiation dose, the image quality gets better. If you
decrease the radiation dose, the image quality deteriorates. You must always predict the risks
by understanding the threshold dose, etc. and consider whether the benefits outweigh or do
not justify the risks. This is the behavior of justifying the exposure. Also, optimizing radiation
protection means achieving the ideal levels of risks and amount of image data. Justificationof exposure and optimization of radiation protection — doctors must perform both but
there is a reality here which has not been recognized before.
Education on Radiation at Schools of Medicine
Despite the various efforts we have made, doctors’ awareness about radiation exposure islow. It seems to me that there are also problems with medical education. There are no morethan 10 universities that have professors who specialize in radiology and some medical
schools do not even have basic courses in radiology.
With the publication of the revised version of “Education on Radiation Rays” in the corecurriculum in 2010, universities began to step up their education on radiation. However,doctors’ awareness about radiation exposure is still low and I think that we need to makefurther efforts to enlighten them and enhance their understanding.

14Dr. Takashi Moritake
Associate Professor
Department of Radiological Health Science
University of Occupational and Environmental Health, Japan,
Graduated from the University of Tsukuba School of Medicine in 1993. Worked as a hospital staff
member (Department of Neurosurgery) at the University of Tsukuba Hospital in 1998. Joined the
University of Tsukuba Graduate School of Medicine, Division of Medicine in 2000 and completed thedoctoral program in 2004. Worked as a Special Researcher at the Japan Society for the Promotion of
Science in 2004, a researcher of the Genome Diagnosis Research Group of the National Institute ofRadiological Sciences in 2006, and as an Instructor at the University of Tsukuba Hospital Proton Beam
Therapy Center in 2009. Dr. Moritake has been in his current position since 2013.

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