Dec, 2019 Vol.32

AMDD Held an Extraordinary General Meeting and 10th Anniversary Event
On September 12, 2019, the American Medical Devices and Diagnostics Manufacturers’ Association (AMDD) held an extraordinary general
meeting at the Imperial Hotel, Tokyo, Japan. To open the meeting, Chairman Kosuke Kato (President and Representative Director of Edwards
Lifesciences Ltd.) gave a report on AMDD’s activities in 2019. The Advocacy Committee then reported on activities over the past 10 years
since the group was founded and spoke about future advocacy activities. The general meeting closed with congratulatory speeches fromseveral people who have collaborated with the Japanese medical device industry, including Ms. Arlene
Maeda (Senior Commercial Attache, Commercial Department, the U.S. Embassy in Japan) and Mr. Phil
Agress (Senior Vice President of the Global Strategy and Analysis Department and General Manager of the
Asian Division, Advanced Medical Technology Association (AdvaMed)).
At the AMDD 10th-anniversary event, held at the same time as the general meeting, Dr. Makoto
Suematsu (President of the Japan Agency for Medical Research and Development (AMED)) gave a special
lecture about AMED’s activities for resolving issues in healthcare (for the lecture overview, see page 2).
After the general meeting, AMDD hosted a reception with participants from government agencies and industry
groups who have helped promote the medical device industry during the 10 years since AMDD’s founding. Several
attendees gave congratulatory speeches, including Mr. Masayoshi Shintani (Parliamentary Vice Minister of Health,Labour, and Welfare and Member of the House of Representatives), Mr. Yasuhiro Fujiwara (Chief Executive of thePharmaceuticals and Medical Devices Agency (PMDA)), Mr. Steve Knode (Acting Minister-Counselor for Commercial Affairs, the U.S. Embassy in Japan), Mr. Kenichi Matsumoto (Chairman, Japan Federation of Medical Devices
Mr. Shintani
Dr. Imamura
Associations (JFMDA)), and Dr. Satoshi Imamura (Vice President, Japan Medical Association (JMA)).

Value of Medical Technology〈Diagnosing and Treating Heart Conditions〉

Connected AEDs Provide a New Approachfor Outside-of-Hospital Cardiac Arrests
According to FY2018 statistics by the Fire and Disaster Management Agency, the number ofcardiogenic cardiac arrest cases witnessed outside of hospital facilities rose to 25,538 per year
and is anticipated to increase annually. Out of these cases, the number in which AEDs wereused by rescuers who happened to be there also increased. Cardiac arrest occurs suddenly
without warning and causes convulsions (disordered electrical activity occurs). The heart thenloses its function as a pump which sends blood throughout the body, and leads to death withina short time. It is said that early defibrillation using AEDs is the only method that can restore theheart to its normal rhythm.
For sudden cardiac arrest cases, prevention, early awareness, calling the Japanese 119
emergency number, the use of cardiopulmonary resuscitation and AEDs (basic life-support
device), transferring the patient to an ambulance crew (advanced life support), restarting theheart, and then proceeding to intensive care without delay all lead to improving the survival rate
and rehabilitation rate (chain of survival)*.
In the past, information about life-saving measures was limited to points such as theamount and number of times to administer cardiopulmonary resuscitation (CPR) or electricalshocks. However, if a connected AED is used, detailed data such as the initial EKG andanalysis waveforms recorded in the AED can be provided to medical specialists in real time,using a wireless LAN to connect to a dedicated cloud system, before the ambulance crew
arrives and before the patient is taken to the hospital. Using a connected AED that connects
medical devices to the internet can help prepare the ambulance crew for specific actions thatthey can take and can help prepare
Connected AEDs and Information Linkage
medical practitioners for the early
Cloud system
introduction of percutaneous coronary
intervention (PCI) and percutaneous
cardiopulmonary support (PCPS) after
the patient is taken to the hospital. As
such, connected AEDs have strong
potential to make quicker and more
Facilities,
Ambulance crew
Hospitaleffective contributions to the chain of
convenience
Sharing information of
After-the-fact
stores,etc.
survival.
treatment taken by rescuers verification*Ministry of Health, Labour, and Welfare: Guidelines
for Life-Saving Resuscitation (For Citizens) (2015)(Responsibility for wording: Yusuke Fujimoto, Stryker Japan KK)

Online remote monitoring(location and standby status)*Achievement of high-quality, efficient operation

Remote monitoringof AEDs

Information sharing between
healthcare providers

AMDD’s10th Anniversary Activities■ Dream Medical Devices and IVD Idea Contest
Elementary school children nationwide submitted about
150 applications to the “You Can Be an Inventor! Dream
Machines and Tests to Check and Treat Patients Idea
Contest” (held as an event related to the 2019 Japan-US
Medtech and Healthtech Innovation Forum Kobe). Out ofthese applications, ten children were chosen to make final
presentations at the judging and award ceremony on
November 9 at the Konan University Port Island Campus
in Hyogo Prefecture. Even though they were nervous, thechildren confidently presented
their ideas in front of thejudges and the audience. Morethan 500 people visited thevenue and enjoyed thehands-on medical device
booths and poster exhibits ofall the contest entries.
■ 10th Anniversary Booklet
AMDD issued a 10th
anniversary booklet called“AMDD: 10-Year History and Beyond” thatsummarized the history of AMDD over the
past 10 years since its founding in 2009
and AMDD’s thoughts for the future. Thispublication presented information such as
proposals for maintaining and revising thevarious laws and regulations towards
resolving device lag. AMDD has had a major impact inovercoming device lag from when the organization was an
ACCJ Medical Device and IVD Subcommittee to its work
today. Included are also articles about the experiences ofexpert advisors of the Central Social Insurance Medical
Council, trends in the insurance reimbursement system,and the future of Japan healthcare.
*To obtain the anniversary booklet, please contact theemail address below.
AMDD PR Office: amdd@cosmopr.co.jp

AMDDVol.32

NEWSLETTERC O N T E N T S
Awareness of Issues with Single-Use Medical
Devices (SUDs) at Clinical Facilities and01
the Role of Remanufactured SUDs
AMDD 10th Anniversary Special Lecture
2019: How to Solve Medical Problems
through Linkage and Sharing of Data 02
Patient’s Voice
Achieving a Society Where People with
Epilepsy Can Live with Peace of Mind 03
Supporting patients with a clinical teamPhysical Therapists
03
AMDD Held an Extraordinary General
Meeting and 10th Anniversary Event 04
AMDD’s 10th Anniversary Activities

04

Value of Medical Technology
Connected AEDs Provide a New Approach04
for Outside-of-Hospital Cardiac Arrests

Awareness of Issues with Single-Use Medical Devices (SUDs)
at Clinical Facilities and the Role of Remanufactured SUDs
Background for Single-Use Medical Devices

There are three types of medical devices: single-use medical devices,
reusable medical devices, and remanufactured single-use medical
devices. As a medical professional, I would like to more widely share
the role of single-use medical devices (SUD) and raise awareness ofthe challenges they must still overcome.
In 2014, the Ministry of Health, Labour, and Welfare (MHLW)
issued a notice about the handling single-use medical devices andprohibited their reuse. The notice stated that SUDs must not be reused
because hospitals cannot guarantee their safety. In the past, some
hospitals washed, sterilized, and then reused reusable medical devices
and some SUDs. The notice clarified that such devices cannot bereused without a special, logical reason. The “special reason” mustmeet various conditions, such as passing inspections by the Infection
Control Committee and the Medical Device Safety Control
Committee, and gain approval by the Medical Safety Control
Committee. It could be interpreted that if the special reason meets theabove criteria, devices can be reused. However, meeting these criteria
was a high hurdle for individual hospitals, so the notice essentiallyprohibited reuse.

Introduction of Remanufactured SUDs

In July 2017, the MHLW created a new system for remanufacturing
SUDs. The new system allowed for the reuse of SUDs if
manufacturers collected their associated medical devices andprocessed them through dismantling, washing, and sterilization. It
became possible to reuse reprocessed SUDs as remanufactured
single-use medical devices (R-SUDs).
R-SUDs were authorized and registered as different products thanoriginal SUDs, and the remanufacturers and sellers bore all
responsibility for safety and collection, etc. In this system, if theremanufacturing process was approved, safety was recognized.
Used medical devices were put into individually sealed containers
and were taken to remanufacturers and sellers. However, the rules
stated that there must be a person in the remanufacturing process withspecialized knowledge about sterilization, such as professional with
first class sterilization technician (Certified Sterilization Specialist:

CSS) issued by the Japanese Society of Medical Instrumentation. The
remanufactured parts were assigned new serial numbers to create
traceability and track the number of times an item wasremanufactured, and underwent stringent checks before being resold.
Hospitals are unable to conduct these measures, so businesses mustenter this market gap.

Significance of R-SUDs

What is the significance of creating a new R-SUD system? The
system would result in a decrease in cost for the government andhospital management. But doctors and other medical practitioners
still feel uncertain about the safety of these items, and may feel there
are no advantages. For patients who are adequately covered underhealth insurance, there is little impact due to the decrease inhealthcare costs and do not feel a direct benefit. On the other hand,for remanufacturers this is a new business opportunity.
One characteristic of the R-SUD system is that the advantages
and disadvantages are not straightforward as they can differ based ona stakeholder’s perspective.
In hospitals, if medical practitioners do not understand the
R-SUD business and information is not thoroughly disseminated,things will not go smoothly. So, it will be necessary to have a key
person take initiative for the R-SUD business. It takes time to collectused SUDs, so a structure must be introduced for collecting thedevices. There are also other challenges with methods for dismantlingand washing the devices, and there will be delays with introducing
these into the market, so everyone will need to work together.

Dr. Masaki Takashina , M.D., Ph.D.
Graduated from the Osaka University
Faculty of Medicine in 1985. Professor,
Director of the Sterile Supply, Director of
the Supply Center, Director of the
Department of Clinical Engineering, and
Deputy Director of the Department ofSurgery at Osaka University Hospital.

All opinions in the newsletter are the views of the authorsand do not represent the views of AMDD or its activities.

Contact: Public Relations, American Medical Devices and Diagnostics Manufacturers’ Association (AMDD)
C/O Cosmo Public Relations Corporation, 1-8-10 Azabudai, Minato-ku, Tokyo, Japan 〒106-0041
Tel: +81(0)3-5561-2915
Website: https://www.amdd.jp/en/

04 AMDD NEWSLETTER Vol.32

AMDD NEWSLETTER Vol.32 01

Patient’s Voice

AMDD 10th Anniversary Special Lecture 2019:

How to Solve Medical Problems throughLinkage and Sharing of Data
Necessity for Data Sharing

Against the backdrop of an unprecedented super-aging
society, the Japan Agency for Medical Research andDevelopment (AMED) believes their mission for data
linkage and sharing is critical.
According to research data on annual population change,in the 1860s, around the time of the Meiji Restoration in
Japan, average lifespan was 50 years old. At that time, Japan
was a relatively young country with one in five people 50 orolder, while the other four were under 50.
However, beginning in the 1970s, the composition of the
population shifted dramatically. The percentage of the
population that are 50 or older is now projected to increase
until the 2040s. Beyond then, the population ratio will again
shift and Japan will settle into a 21st century model in which
two out of three people are 50 or older.
We have about 20 to 25 years left until the 2040s. For
the development of new drugs and medical devices, that isprobably only one to two cycles. We will have to speed up
our efforts to adapt to this approaching era, or we won’t beable to catch up.
Sharing real-world data about patients will be essential,
but there will be difficulties. Change will not come from alaw or system, but it will be up to each individual. With
doctors and clinical laboratory technicians in facilities,
universities, academia and the industrial world, eachmarching to their own drummer, it will not be easy to geteveryone in step together.

Two Solutions from AMED

AMED has taken the challenge to address these problems
with two solutions.
The first is to accumulate imaging data using Japan
Excellence of Diagnostic Imaging (JEDI). AMED willcollect and integrate data and use AI to make diagnoses andsupport treatment.
In order to use AI, it will be necessary to collect a large
amount of high-quality data. Since FY2016, six academic
societies have been using the Science Information NETwork(SINET5) to accumulate pathological images withannotations.
The Japanese Society of Pathology used the AI engine at
the National Institute of Informatics (NII) for pathologicaldiagnoses to create a system that outputs highly probablediagnoses, and a pathologist makes the final judgment. This
began in Fukushima Prefecture, and the system is getting
results.
The second thing is the Initiative on Rare andUndiagnosed Diseases (IRUD). AMED aims to research andcollate the genes of patients nationwide who have rarediseases or undiagnosed diseases, search these results from a
database, set a diagnosis, and clarify the patient’s condition
for treatment.
There are currently about 7,000 rare diseases, and 3,000
to 3,500 of these are related to genetic abnormalities.
However, at the global level, rare diseases are more

02 AMDD NEWSLETTER Vol.32

prevalent. For example, for extremely rare developmental
impairments with only four reported cases in Japan, there
are about 30 cases worldwide.
Many patients with this type of undiagnosed disease are
inevitably forced into a never-ending journey of notreceiving a diagnosis at their local hospital, not receiving adiagnosis at a regional core hospital, undergoing an
inconclusive examination at a university hospital, referral toa national center, and visiting several hospitals only to end
up back at the first hospital. If disease information could becollated in a single database, it would be possible to reach adiagnosis immediately. In Europe, there is a rare disease
database called Orphanet. But in the future, it will beessential to build a global data sharing system. Linking
databases will become more and more important.
How global databases are linked and shared is very
important. The feasibility of that is based on building mutual
trust, so at first, this will probably start with building
trusting relationships.
In Japan, extensive data on healthcare costs andfundamental data on nursing care exists, but if it becomes
possible to link them, this will provide important clues into
the balance between healthcare and nursing care and theneeds of the very elderly for healthcare and for nursing care.
In order to do that, it is necessary to make reforms to
informed consent that allow the secondary use of acquireddata.
We only have 20 years left until the super-aging society
will be upon us, so a sense of urgency is needed.

Ms. Satomi Umemoto

President,
Japan Epilepsy Association (Nami no Kai)

The Association of Parents with Epileptic Children and the
Association for the Protection of Epileptic Patients were launched
in 1973, which was the start of the movement to improve life for
epilepsy patients in Japan. In 1976, the Japan Epilepsy Association(JEA) was established when both of these groups integrated.
Currently, the JEA is made up of about 5,000 members, mainly
patients with epilepsy and their families, but also support staff
such as medical specialists and professionals. As the Japanesebranch of the International Bureau for Epilepsy (IBE), the JEA
works on many types of topics regarding epilepsy, such asencouraging public awareness, providing support for
consultations, conducting research studies, and promoting policies.
Epilepsy is a cranial nerve condition, and it is estimated that
there are about a million people in Japan with this disorder. When
weak electricity flows into the brain, it “shorts out” the system forsome reason and epileptic seizures occur, which are associatedwith various symptoms. Epilepsy is the general term for a disorderin which these epileptic seizures occur repeatedly.
Diagnoses and treatments for epilepsy have developed rapidly,
and it is possible to control about 80% of all the seizure symptoms.
The main treatment method is drugs, which are supplemented withsurgical procedures and dietary changes. Testing and identification
are important for quick and effective treatment. With epilepsy,

Graduated from Keio University School of Medicine in 1983.
Bioengineer Step IV at Institute for Biomedical Engineering,
University of California, San Diego. Professor at Department ofBiochemistry and Integrative Medical Biology, School of Medicine,
Keio University in 2001. Leader, Global Center of Excellence forLife Sciences, Human Metabolomic
Systems Biology, Ministry of Education,
Culture, Sports, Science, andTechnology. Research Director of the
Suematsu Gas Biology Project, Japan
Science and Technology Agency,
Strategic Basic Research Programs(Exploratory Research for Advanced
Technologies, or ERATO) in 2009. The
Founding President of AMED since2015. Main research interest: metabolic
biochemistry.

Japan Epilepsy Association(Nami no Kai)
https://www.jea-net.jp/

Physical Therapists
clinical teamPresident, Japan Agency for Medical Research and Development(AMED)

EEG and imaging diagnoses (MRI, SPECT, PET, MEG) are
important. These tests are used to identify the type of epilepsy andthe type of epileptic seizure, and treatment starts based on theinternational classifications for epilepsy and epileptic seizures. In
recent years, devices that predict epileptic seizures have been
researched and developed, and efforts are being made to help
maintain an environment in which epilepsy patients can havepeace of mind in their social lives.
In Japan, the government and prefectures have implemented
the Program for Maintaining a Regional Structure Linking
Diagnosis and Treatment for Epilepsy nationwide. It is now
possible to use new anti-epileptic drugs as a result of efforts bymany pharmaceutical companies. In addition, we believe that there
are strong prospects to further develop devices for testing,identification, and treatment, and that these devices will
significantly contribute to achieving a society where people withepilepsy can live with peace of mind.

No. 3

Supporting patients with aDr. Makoto Suematsu, M.D., Ph.D.

Achieving a Society Where
People with Epilepsy Can
Live with Peace of Mind

Mr. Hideyuki Saito

Vice President,
Japanese Physical Therapy Association (JPTA)

In the Physical Therapists and Occupational Therapists Act(established June 29, 1965), physical therapy is defined as“Having people with physical disabilities engage in therapeutic gymnastics or other exercise, and adding electricalstimulation, massages, heating, or other physical means,mainly in order to restore their basic abilities to move.”
Physical therapy is promoted in today’s regional comprehensive care system by medical insurance, nursing careinsurance, and regional care conferences. It is recognized
as an occupation that concentrates on supporting
self-reliance and has strong potential for preventative
nursing care, measures against dementia, and linking
healthcare and nursing care. More specifically, it can besaid that physical therapy in Japan is coming closer tointernational standards and the concept of “promotion,
prevention, treatment/intervention, habilitation, and rehabilitation” established by the World Confederation for Physical
Therapy.
From the perspective of team healthcare and medical
devices that support healthcare, in facilities that require
medical care in the acute, recovery, and chronic stages, an
era is approaching when doctors, nurses, and physicaltherapists will be core members in team healthcare. In

particular, for patients with serious conditions, we caneasily imagine that providing physical therapy, which
supports self-reliance and increases patients’ physical andmental reserve capacity and residual functions, in combination with sophisticated medical devices, which support theirlives and health, will protect the dignity of their lives andreduce the burden on doctors and nurses. High-quality
medical facilities have teams of healthcare professions that
follow an established delegation of authority. It is importantto spread this structure throughout Japan.
Finally, regarding the increasing level of sophistication in
medical devices that we are already seeing, we cannot
avoid developing technical innovations such as robotics,
ICT, and artificial intelligence. In closing, I will say that weshould work towards creating a paradigm shift from“person-to-person” interactions to “person-to-person-tomedical device” interactions.

Japanese Physical Therapy
Association (JPTA)
http://www.japanpt.or.jp

AMDD NEWSLETTER Vol.32 03

Patient’s Voice

AMDD 10th Anniversary Special Lecture 2019:

How to Solve Medical Problems throughLinkage and Sharing of Data
Necessity for Data Sharing

Against the backdrop of an unprecedented super-aging
society, the Japan Agency for Medical Research andDevelopment (AMED) believes their mission for data
linkage and sharing is critical.
According to research data on annual population change,in the 1860s, around the time of the Meiji Restoration in
Japan, average lifespan was 50 years old. At that time, Japan
was a relatively young country with one in five people 50 orolder, while the other four were under 50.
However, beginning in the 1970s, the composition of the
population shifted dramatically. The percentage of the
population that are 50 or older is now projected to increase
until the 2040s. Beyond then, the population ratio will again
shift and Japan will settle into a 21st century model in which
two out of three people are 50 or older.
We have about 20 to 25 years left until the 2040s. For
the development of new drugs and medical devices, that isprobably only one to two cycles. We will have to speed up
our efforts to adapt to this approaching era, or we won’t beable to catch up.
Sharing real-world data about patients will be essential,
but there will be difficulties. Change will not come from alaw or system, but it will be up to each individual. With
doctors and clinical laboratory technicians in facilities,
universities, academia and the industrial world, eachmarching to their own drummer, it will not be easy to geteveryone in step together.

Two Solutions from AMED

AMED has taken the challenge to address these problems
with two solutions.
The first is to accumulate imaging data using Japan
Excellence of Diagnostic Imaging (JEDI). AMED willcollect and integrate data and use AI to make diagnoses andsupport treatment.
In order to use AI, it will be necessary to collect a large
amount of high-quality data. Since FY2016, six academic
societies have been using the Science Information NETwork(SINET5) to accumulate pathological images withannotations.
The Japanese Society of Pathology used the AI engine at
the National Institute of Informatics (NII) for pathologicaldiagnoses to create a system that outputs highly probablediagnoses, and a pathologist makes the final judgment. This
began in Fukushima Prefecture, and the system is getting
results.
The second thing is the Initiative on Rare andUndiagnosed Diseases (IRUD). AMED aims to research andcollate the genes of patients nationwide who have rarediseases or undiagnosed diseases, search these results from a
database, set a diagnosis, and clarify the patient’s condition
for treatment.
There are currently about 7,000 rare diseases, and 3,000
to 3,500 of these are related to genetic abnormalities.
However, at the global level, rare diseases are more

02 AMDD NEWSLETTER Vol.32

prevalent. For example, for extremely rare developmental
impairments with only four reported cases in Japan, there
are about 30 cases worldwide.
Many patients with this type of undiagnosed disease are
inevitably forced into a never-ending journey of notreceiving a diagnosis at their local hospital, not receiving adiagnosis at a regional core hospital, undergoing an
inconclusive examination at a university hospital, referral toa national center, and visiting several hospitals only to end
up back at the first hospital. If disease information could becollated in a single database, it would be possible to reach adiagnosis immediately. In Europe, there is a rare disease
database called Orphanet. But in the future, it will beessential to build a global data sharing system. Linking
databases will become more and more important.
How global databases are linked and shared is very
important. The feasibility of that is based on building mutual
trust, so at first, this will probably start with building
trusting relationships.
In Japan, extensive data on healthcare costs andfundamental data on nursing care exists, but if it becomes
possible to link them, this will provide important clues into
the balance between healthcare and nursing care and theneeds of the very elderly for healthcare and for nursing care.
In order to do that, it is necessary to make reforms to
informed consent that allow the secondary use of acquireddata.
We only have 20 years left until the super-aging society
will be upon us, so a sense of urgency is needed.

Ms. Satomi Umemoto

President,
Japan Epilepsy Association (Nami no Kai)

The Association of Parents with Epileptic Children and the
Association for the Protection of Epileptic Patients were launched
in 1973, which was the start of the movement to improve life for
epilepsy patients in Japan. In 1976, the Japan Epilepsy Association(JEA) was established when both of these groups integrated.
Currently, the JEA is made up of about 5,000 members, mainly
patients with epilepsy and their families, but also support staff
such as medical specialists and professionals. As the Japanesebranch of the International Bureau for Epilepsy (IBE), the JEA
works on many types of topics regarding epilepsy, such asencouraging public awareness, providing support for
consultations, conducting research studies, and promoting policies.
Epilepsy is a cranial nerve condition, and it is estimated that
there are about a million people in Japan with this disorder. When
weak electricity flows into the brain, it “shorts out” the system forsome reason and epileptic seizures occur, which are associatedwith various symptoms. Epilepsy is the general term for a disorderin which these epileptic seizures occur repeatedly.
Diagnoses and treatments for epilepsy have developed rapidly,
and it is possible to control about 80% of all the seizure symptoms.
The main treatment method is drugs, which are supplemented withsurgical procedures and dietary changes. Testing and identification
are important for quick and effective treatment. With epilepsy,

Graduated from Keio University School of Medicine in 1983.
Bioengineer Step IV at Institute for Biomedical Engineering,
University of California, San Diego. Professor at Department ofBiochemistry and Integrative Medical Biology, School of Medicine,
Keio University in 2001. Leader, Global Center of Excellence forLife Sciences, Human Metabolomic
Systems Biology, Ministry of Education,
Culture, Sports, Science, andTechnology. Research Director of the
Suematsu Gas Biology Project, Japan
Science and Technology Agency,
Strategic Basic Research Programs(Exploratory Research for Advanced
Technologies, or ERATO) in 2009. The
Founding President of AMED since2015. Main research interest: metabolic
biochemistry.

Japan Epilepsy Association(Nami no Kai)
https://www.jea-net.jp/

Physical Therapists
clinical teamPresident, Japan Agency for Medical Research and Development(AMED)

EEG and imaging diagnoses (MRI, SPECT, PET, MEG) are
important. These tests are used to identify the type of epilepsy andthe type of epileptic seizure, and treatment starts based on theinternational classifications for epilepsy and epileptic seizures. In
recent years, devices that predict epileptic seizures have been
researched and developed, and efforts are being made to help
maintain an environment in which epilepsy patients can havepeace of mind in their social lives.
In Japan, the government and prefectures have implemented
the Program for Maintaining a Regional Structure Linking
Diagnosis and Treatment for Epilepsy nationwide. It is now
possible to use new anti-epileptic drugs as a result of efforts bymany pharmaceutical companies. In addition, we believe that there
are strong prospects to further develop devices for testing,identification, and treatment, and that these devices will
significantly contribute to achieving a society where people withepilepsy can live with peace of mind.

No. 3

Supporting patients with aDr. Makoto Suematsu, M.D., Ph.D.

Achieving a Society Where
People with Epilepsy Can
Live with Peace of Mind

Mr. Hideyuki Saito

Vice President,
Japanese Physical Therapy Association (JPTA)

In the Physical Therapists and Occupational Therapists Act(established June 29, 1965), physical therapy is defined as“Having people with physical disabilities engage in therapeutic gymnastics or other exercise, and adding electricalstimulation, massages, heating, or other physical means,mainly in order to restore their basic abilities to move.”
Physical therapy is promoted in today’s regional comprehensive care system by medical insurance, nursing careinsurance, and regional care conferences. It is recognized
as an occupation that concentrates on supporting
self-reliance and has strong potential for preventative
nursing care, measures against dementia, and linking
healthcare and nursing care. More specifically, it can besaid that physical therapy in Japan is coming closer tointernational standards and the concept of “promotion,
prevention, treatment/intervention, habilitation, and rehabilitation” established by the World Confederation for Physical
Therapy.
From the perspective of team healthcare and medical
devices that support healthcare, in facilities that require
medical care in the acute, recovery, and chronic stages, an
era is approaching when doctors, nurses, and physicaltherapists will be core members in team healthcare. In

particular, for patients with serious conditions, we caneasily imagine that providing physical therapy, which
supports self-reliance and increases patients’ physical andmental reserve capacity and residual functions, in combination with sophisticated medical devices, which support theirlives and health, will protect the dignity of their lives andreduce the burden on doctors and nurses. High-quality
medical facilities have teams of healthcare professions that
follow an established delegation of authority. It is importantto spread this structure throughout Japan.
Finally, regarding the increasing level of sophistication in
medical devices that we are already seeing, we cannot
avoid developing technical innovations such as robotics,
ICT, and artificial intelligence. In closing, I will say that weshould work towards creating a paradigm shift from“person-to-person” interactions to “person-to-person-tomedical device” interactions.

Japanese Physical Therapy
Association (JPTA)
http://www.japanpt.or.jp

AMDD NEWSLETTER Vol.32 03

Dec, 2019 Vol.32

AMDD Held an Extraordinary General Meeting and 10th Anniversary Event
On September 12, 2019, the American Medical Devices and Diagnostics Manufacturers’ Association (AMDD) held an extraordinary general
meeting at the Imperial Hotel, Tokyo, Japan. To open the meeting, Chairman Kosuke Kato (President and Representative Director of Edwards
Lifesciences Ltd.) gave a report on AMDD’s activities in 2019. The Advocacy Committee then reported on activities over the past 10 years
since the group was founded and spoke about future advocacy activities. The general meeting closed with congratulatory speeches fromseveral people who have collaborated with the Japanese medical device industry, including Ms. Arlene
Maeda (Senior Commercial Attache, Commercial Department, the U.S. Embassy in Japan) and Mr. Phil
Agress (Senior Vice President of the Global Strategy and Analysis Department and General Manager of the
Asian Division, Advanced Medical Technology Association (AdvaMed)).
At the AMDD 10th-anniversary event, held at the same time as the general meeting, Dr. Makoto
Suematsu (President of the Japan Agency for Medical Research and Development (AMED)) gave a special
lecture about AMED’s activities for resolving issues in healthcare (for the lecture overview, see page 2).
After the general meeting, AMDD hosted a reception with participants from government agencies and industry
groups who have helped promote the medical device industry during the 10 years since AMDD’s founding. Several
attendees gave congratulatory speeches, including Mr. Masayoshi Shintani (Parliamentary Vice Minister of Health,Labour, and Welfare and Member of the House of Representatives), Mr. Yasuhiro Fujiwara (Chief Executive of thePharmaceuticals and Medical Devices Agency (PMDA)), Mr. Steve Knode (Acting Minister-Counselor for Commercial Affairs, the U.S. Embassy in Japan), Mr. Kenichi Matsumoto (Chairman, Japan Federation of Medical Devices
Mr. Shintani
Dr. Imamura
Associations (JFMDA)), and Dr. Satoshi Imamura (Vice President, Japan Medical Association (JMA)).

Value of Medical Technology〈Diagnosing and Treating Heart Conditions〉

Connected AEDs Provide a New Approachfor Outside-of-Hospital Cardiac Arrests
According to FY2018 statistics by the Fire and Disaster Management Agency, the number ofcardiogenic cardiac arrest cases witnessed outside of hospital facilities rose to 25,538 per year
and is anticipated to increase annually. Out of these cases, the number in which AEDs wereused by rescuers who happened to be there also increased. Cardiac arrest occurs suddenly
without warning and causes convulsions (disordered electrical activity occurs). The heart thenloses its function as a pump which sends blood throughout the body, and leads to death withina short time. It is said that early defibrillation using AEDs is the only method that can restore theheart to its normal rhythm.
For sudden cardiac arrest cases, prevention, early awareness, calling the Japanese 119
emergency number, the use of cardiopulmonary resuscitation and AEDs (basic life-support
device), transferring the patient to an ambulance crew (advanced life support), restarting theheart, and then proceeding to intensive care without delay all lead to improving the survival rate
and rehabilitation rate (chain of survival)*.
In the past, information about life-saving measures was limited to points such as theamount and number of times to administer cardiopulmonary resuscitation (CPR) or electricalshocks. However, if a connected AED is used, detailed data such as the initial EKG andanalysis waveforms recorded in the AED can be provided to medical specialists in real time,using a wireless LAN to connect to a dedicated cloud system, before the ambulance crew
arrives and before the patient is taken to the hospital. Using a connected AED that connects
medical devices to the internet can help prepare the ambulance crew for specific actions thatthey can take and can help prepare
Connected AEDs and Information Linkage
medical practitioners for the early
Cloud system
introduction of percutaneous coronary
intervention (PCI) and percutaneous
cardiopulmonary support (PCPS) after
the patient is taken to the hospital. As
such, connected AEDs have strong
potential to make quicker and more
Facilities,
Ambulance crew
Hospitaleffective contributions to the chain of
convenience
Sharing information of
After-the-fact
stores,etc.
survival.
treatment taken by rescuers verification*Ministry of Health, Labour, and Welfare: Guidelines
for Life-Saving Resuscitation (For Citizens) (2015)(Responsibility for wording: Yusuke Fujimoto, Stryker Japan KK)

Online remote monitoring(location and standby status)*Achievement of high-quality, efficient operation

Remote monitoringof AEDs

Information sharing between
healthcare providers

AMDD’s10th Anniversary Activities■ Dream Medical Devices and IVD Idea Contest
Elementary school children nationwide submitted about
150 applications to the “You Can Be an Inventor! Dream
Machines and Tests to Check and Treat Patients Idea
Contest” (held as an event related to the 2019 Japan-US
Medtech and Healthtech Innovation Forum Kobe). Out ofthese applications, ten children were chosen to make final
presentations at the judging and award ceremony on
November 9 at the Konan University Port Island Campus
in Hyogo Prefecture. Even though they were nervous, thechildren confidently presented
their ideas in front of thejudges and the audience. Morethan 500 people visited thevenue and enjoyed thehands-on medical device
booths and poster exhibits ofall the contest entries.
■ 10th Anniversary Booklet
AMDD issued a 10th
anniversary booklet called“AMDD: 10-Year History and Beyond” thatsummarized the history of AMDD over the
past 10 years since its founding in 2009
and AMDD’s thoughts for the future. Thispublication presented information such as
proposals for maintaining and revising thevarious laws and regulations towards
resolving device lag. AMDD has had a major impact inovercoming device lag from when the organization was an
ACCJ Medical Device and IVD Subcommittee to its work
today. Included are also articles about the experiences ofexpert advisors of the Central Social Insurance Medical
Council, trends in the insurance reimbursement system,and the future of Japan healthcare.
*To obtain the anniversary booklet, please contact theemail address below.
AMDD PR Office: amdd@cosmopr.co.jp

AMDDVol.32

NEWSLETTERC O N T E N T S
Awareness of Issues with Single-Use Medical
Devices (SUDs) at Clinical Facilities and01
the Role of Remanufactured SUDs
AMDD 10th Anniversary Special Lecture
2019: How to Solve Medical Problems
through Linkage and Sharing of Data 02
Patient’s Voice
Achieving a Society Where People with
Epilepsy Can Live with Peace of Mind 03
Supporting patients with a clinical teamPhysical Therapists
03
AMDD Held an Extraordinary General
Meeting and 10th Anniversary Event 04
AMDD’s 10th Anniversary Activities

04

Value of Medical Technology
Connected AEDs Provide a New Approach04
for Outside-of-Hospital Cardiac Arrests

Awareness of Issues with Single-Use Medical Devices (SUDs)
at Clinical Facilities and the Role of Remanufactured SUDs
Background for Single-Use Medical Devices

There are three types of medical devices: single-use medical devices,
reusable medical devices, and remanufactured single-use medical
devices. As a medical professional, I would like to more widely share
the role of single-use medical devices (SUD) and raise awareness ofthe challenges they must still overcome.
In 2014, the Ministry of Health, Labour, and Welfare (MHLW)
issued a notice about the handling single-use medical devices andprohibited their reuse. The notice stated that SUDs must not be reused
because hospitals cannot guarantee their safety. In the past, some
hospitals washed, sterilized, and then reused reusable medical devices
and some SUDs. The notice clarified that such devices cannot bereused without a special, logical reason. The “special reason” mustmeet various conditions, such as passing inspections by the Infection
Control Committee and the Medical Device Safety Control
Committee, and gain approval by the Medical Safety Control
Committee. It could be interpreted that if the special reason meets theabove criteria, devices can be reused. However, meeting these criteria
was a high hurdle for individual hospitals, so the notice essentiallyprohibited reuse.

Introduction of Remanufactured SUDs

In July 2017, the MHLW created a new system for remanufacturing
SUDs. The new system allowed for the reuse of SUDs if
manufacturers collected their associated medical devices andprocessed them through dismantling, washing, and sterilization. It
became possible to reuse reprocessed SUDs as remanufactured
single-use medical devices (R-SUDs).
R-SUDs were authorized and registered as different products thanoriginal SUDs, and the remanufacturers and sellers bore all
responsibility for safety and collection, etc. In this system, if theremanufacturing process was approved, safety was recognized.
Used medical devices were put into individually sealed containers
and were taken to remanufacturers and sellers. However, the rules
stated that there must be a person in the remanufacturing process withspecialized knowledge about sterilization, such as professional with
first class sterilization technician (Certified Sterilization Specialist:

CSS) issued by the Japanese Society of Medical Instrumentation. The
remanufactured parts were assigned new serial numbers to create
traceability and track the number of times an item wasremanufactured, and underwent stringent checks before being resold.
Hospitals are unable to conduct these measures, so businesses mustenter this market gap.

Significance of R-SUDs

What is the significance of creating a new R-SUD system? The
system would result in a decrease in cost for the government andhospital management. But doctors and other medical practitioners
still feel uncertain about the safety of these items, and may feel there
are no advantages. For patients who are adequately covered underhealth insurance, there is little impact due to the decrease inhealthcare costs and do not feel a direct benefit. On the other hand,for remanufacturers this is a new business opportunity.
One characteristic of the R-SUD system is that the advantages
and disadvantages are not straightforward as they can differ based ona stakeholder’s perspective.
In hospitals, if medical practitioners do not understand the
R-SUD business and information is not thoroughly disseminated,things will not go smoothly. So, it will be necessary to have a key
person take initiative for the R-SUD business. It takes time to collectused SUDs, so a structure must be introduced for collecting thedevices. There are also other challenges with methods for dismantlingand washing the devices, and there will be delays with introducing
these into the market, so everyone will need to work together.

Dr. Masaki Takashina , M.D., Ph.D.
Graduated from the Osaka University
Faculty of Medicine in 1985. Professor,
Director of the Sterile Supply, Director of
the Supply Center, Director of the
Department of Clinical Engineering, and
Deputy Director of the Department ofSurgery at Osaka University Hospital.

All opinions in the newsletter are the views of the authorsand do not represent the views of AMDD or its activities.

Contact: Public Relations, American Medical Devices and Diagnostics Manufacturers’ Association (AMDD)
C/O Cosmo Public Relations Corporation, 1-8-10 Azabudai, Minato-ku, Tokyo, Japan 〒106-0041
Tel: +81(0)3-5561-2915
Website: https://www.amdd.jp/en/

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