Safety Guidelines for Japanese
Acupuncture and Moxibustion
Practice 2020 Ver.1.1

Supervising Editor: SAKAMOTO Ayumi
Edited by
Safety Committee, Clinical Information Department,

The Japan Society of Acupuncture and Moxibustion(JSAM) (Public Interest Incorporated Association)

■Supervising Editor
SAKAMOTO Ayumi
PhD, MD

Vice President, The Japan Society of Acupuncture andMoxibustion (JSAM) (Public Interest Incorporated Association)
President, Japan College Association of Oriental Medicine(Public Interest Incorporated Association)■Editors
Safety Committee, Clinical Information Department, The Japan Society of Acupuncture andMoxibustion (JSAM) (Public Interest Incorporated Association)
Chair

SUGAWARA Masaaki
PhD, LAc

Assistant Professor, Department of Acupuncture andMoxibustion, Faculty of Health Sciences, Tokyo Ariake
University of Medical and Health Sciences

Committee
Members

UEHARA Akihito
MS, LAcKIKUCHI Yuya
MS, LAc

Assistant Director, Oriental Medicine Clinical Institute,
Kuretake College of Medical Arts and Sciences
Assistant Professor, Department of Acupuncture,
Faculty of Health Care Sciences, Takarazuka Universityof Medical and Health Care
Professor, Department of Acupuncture and Moxibustion
Therapy, Faculty of Health Promotional Sciences,
Tokoha University
Associate Professor, Department of Sports Acupunctureand Moxibustion, Faculty of Nursing and Welfare,
Kyushu University of Nursing and Social Welfare
Assistant Professor, Department of Acupuncture andMoxibustion, Faculty of Health Care, Teikyo Heisei
University
Assistant Professor, School of Acupuncture andMoxibustion, Faculty of Acupuncture and Moxibustion,
Meiji University of Integrated Medicine
Head, Massage & Acupuncture Course, Osaka Minami
Prefectural Special Needs Education School for the
Visually Impaired
Visiting Lecturer, Morinomiya University of Medical
Sciences Acupuncture Information Center
Specially Appointed Researcher/Fellow, Department of
Bioinformatics Graduate School of Medicine, Chiba
University
Assistant Professor, Department of AcupunctureMoxibustion and Sports Trainer Science, Faculty of
Health Sciences, Kansai University of Health Sciences

SHINBARA Hisashi
PhD, LAc
TAGUCHI Taro
MS, LAcTSUNEMATSU Mikako
PhD, LAcFUKUDA Shimpei
PhD, LAc
FURUSE Nobutatsu
MS, LAc

MORITA Akira
PhD, LAc
YAMAZAKI Toshiya
MS, LAc
AdvisorYAMASHITA Hitoshi
PhD, LAc

Professor and Dean, Graduate School of Health
Sciences, Morinomiya University of Medical Sciences
Director, Clinical Information Department, The Japan
Society of Acupuncture and Moxibustion (JSAM)
LAc: Licensed Acupuncturist

On Publication of this Safety Guidelines
for Japanese Acupuncture and Moxibustion Practice 2020
Discussion around the safety of acupuncture and moxibustion in Japan began with the Guidelines ofInfection Control for the Acupuncture–Moxibustion Treatment (KOBAYASHI Hiroyoshi, Supervising
Editor) published in 1993 and has since been pursued principally by the Committee on Safety
Guidelines for Acupuncture and Moxibustion Treatment. Although the Committee was subsequently
somewhat inactive, the late Dr. OZAKI Akihiro led formation of the Acupuncture & Moxibustion
Safety Committee with members from, once again, the All Nippon Acupuncture & Moxibustion
Massage Association, the Japan Acupuncture & Moxibustion Association, the Japan Association of
Massage & Acupuncture Teachers, the Japan College Association of Oriental Medicine, as well as theJapan Society of Acupuncture and Moxibustion (JSAM). The committee pursued various discussions
which resulted in publication of the Guideline for the treatment by Acupuncture & Moxibustion in2007 (Ishiyaku Publishers, Inc.). Dr. Ozaki’s conception of the project was that by describing in detailthe human and the systemic factors involved in accidents, acupuncture and moxibustion practitioners
might acquire proper knowledge, which might consequently lead to greater approval by the wider
population of acupuncture and moxibustion. He therefore selected senior doctors with deep
knowledge of safety and infection control to be the members of the editorial committee, he was at thecenter of the writing work, and his editing of the Guideline was founded on the most up-to-date
information at the time.
More than ten years have already passed since publication of the Guideline for the treatment by
Acupuncture & Moxibustion and calls have come from all quarters regarding the need for its revision.
I therefore consider that publication of this new edition, Safety Guidelines for Japanese Acupunctureand Moxibustion Practice 2020, is quite timely. The Committee for Safe Acupuncture in the
Academic & Research Department of JSAM kindly led preparation of this Guideline, spending an
enormous amount of time on its preparation. I would like to take this opportunity to pay my respects
and to express my deep gratitude to the Committee for their unstinting efforts, to the benefit ofcontinued safety in acupuncture and moxibustion therapy.
This Guideline has been written in itemized format and comprehensively covers a wide variety ofevents so as to have as many stakeholders as possible read them. This format replicates the format
used in various medical guidelines. I also believe the reliability of this Guideline is unsurpassed at
this point, as its preparation involved thorough and minute examination of information on the safetyof acupuncture and moxibustion. On the other hand, a review of the enormous amount of
information is required to set out the scientific basis for the safety of acupuncture and moxibustion,
but I believe that will be the subject of future work. I look forward to the Committee for Safe
Acupuncture further working on this.
Last, I would like to close by expressing my sincere hope that this Guideline is put into practice by
the large majority of people involved in acupuncture and moxibustion and that it contributes tomaking acupuncture and moxibustion safe, reassuring, and pleasant.
January 2020
SAKAMOTO Ayumi
Vice President, The Japan Society of Acupuncture and Moxibustion (JSAM) (Public Interest
Incorporated Association)
President, The Japan College Association of Oriental Medicine (Public Interest Incorporated
Association)*In September 2020, the Committee for Safe Acupuncture in Academic & Research Department was transferred to the
Safety Committee in Clinical Information Department.

Foreword
It was in 1993 that the first guideline on the safety of acupuncture and moxibustion treatments was
published under the title Guidelines of Infection Control for the Acupuncture–Moxibustion Treatment,
which focused on measures against infection. The Committee on Safety Guidelines for Acupunctureand Moxibustion Treatment at the time edited the Guidelines under the supervision of the late Dr.
KOBAYASHI Hiroyoshi (former Professor, Department of Infection Control Science, Faculty of
Medicine, University of Tokyo). There was much rumor among the public at that time about the
spread of blood-borne infectious diseases including hepatitis B and C, and AIDS. Concern around
preventing infection heightened and in 1987 the Ministry of Health and Welfare issued toacupuncture and moxibustion practitioner organizations a directive titled Prevention of AIDS
Infection in Acupuncture and Moxibustion, which prompted preparation of the Guidelines.
The World Health Organization (WHO) subsequently released their Guidelines on Basic Training
and Safety in Acupuncture in 1999, and in response, the Guideline for the treatment by Acupuncture& Moxibustion were published in Japan in 2007. It was the Acupuncture & Moxibustion Safety
Committee, led by the late Dr. OZAKI Akihiro (Professor Emeritus, Meiji University of Oriental
Medicine [present day Meiji University of Integrative Medicine]) and Dr. SAKAMOTO Ayumi (Chair,
Kuretake Gakuen [Educational Corporation]), who edited the Guidelines. The predecessor of the
Acupuncture & Moxibustion Safety Committee was the aforementioned Committee on Safety
Guidelines for Acupuncture and Moxibustion Treatment, and was formed with committee members
from five organizations: the All Nippon Acupuncture & Moxibustion Massage Association (Public
Corporation), the Japan Acupuncture & Moxibustion Association (Public Corporation), the Japan
College Association of Oriental Medicine (Public Corporation), the Japan Association of Massage &Acupuncture Teachers, as well as the Japan Society of Acupuncture and Moxibustion (JSAM) (Public
Corporation).
The Acupuncture & Moxibustion Safety Committee also published the Risk Management Manual for
the Treatment by Acupuncture & Moxibustion in 2010, as a supplement to the Guideline for thetreatment by Acupuncture & Moxibustion. It provided readily comprehensible explanations using pastexamples of medical accidents involving acupuncture and moxibustion, including countermeasuresand legal interpretations.
Some 10 years after publication of the Guideline for the treatment by Acupuncture & Moxibustion
an update was due, yet no revision had been undertaken since the first edition. Then, the Liaison
Council on Acupuncture and Moxibustion Safety (previously the Acupuncture & Moxibustion Safety
Committee) was established as the next generation organization comprising the aforementioned fiveorganizations. With the agreement of all the organization heads, the Committee for Safe Acupuncturein the Academic & Research Department of JSAM (Public Interest Incorporated Association) took thelead and progressed preparation of the Guidelines, resulting in publication of the Safety Guidelines
for Japanese Acupuncture and Moxibustion Practice 2020 (“this Guideline”). For a manual, theaforementioned Guideline for the treatment by Acupuncture & Moxibustion contained a large
number of pages as it included a great deal of content, yet its name did not necessarily reflect thatfact. This Guideline has simplified the content into itemized form and is not a revised edition but acompletely new publication. In addition, as well as publishing this Guideline as a book, it was
decided that it would also be made publicly available for download at no charge on the website of
JSAM, so that anyone may read it.
Public comment on the draft of this Guideline was sought by making it available on the website of
JSAM. Comments were subsequently posted by a total of 39 contributors and the final version wascompleted after revisions based on those comments. I would like to sincerely thank all thecontributors who posted comments.
Last, I would like to pay my respects to all the members of the Acupuncture & Moxibustion Safety
Committee involved in editing the Guideline for the treatment by Acupuncture & Moxibustion, thepredecessor of this Guideline, and express my gratitude to all the people involved in the working
groups for their guidance in preparing this Guideline.

It is my sincere hope that the large majority of acupuncture and moxibustion practitioners practicein accordance with this Guideline, thereby bringing acupuncture and moxibustion in Japan to ahigher level of safety, and that acupuncture and moxibustion be held in high regard, both in Japanand overseas.
January 2020
SUGAWARA Masaaki – Chair
Committee for Safe Acupuncture, Academic & Research Department, The Japan Society of
Acupuncture and Moxibustion (JSAM) (Public Interest Incorporated Association)*In September 2020, the Committee for Safe Acupuncture in the Academic & Research Department was transferred to the
Safety Committee in the Clinical Information Department.

Features and Usage of this Guideline
This Guideline was prepared on the premise that acupuncture and moxibustion are performed as apart of medical treatment. It therefore comprehensively describes what acupuncture and moxibustion
practitioners should observe and practice from a medical safety viewpoint in their practice. The
content of this Guideline was reviewed on the basis of adverse event surveys in Japan and overseas.
There is at present, however, little literature that can establish scientific evidence on the safety ofacupuncture and moxibustion, and it is not possible to reach any conclusions that are based on an
adequate literature review. We considered it was therefore difficult to clearly specify evidence levels,
as in clinical practice guidelines for specific diseases, and instead defined the wordings for eachmatter as follows.
First, “must,” which carries a high level of compulsion, is the wording used for matters prescribed in
the Act on Practitioners of Massage, Finger Pressure, Acupuncture and Moxacauterization, etc.
(“Ahaki Act”) and other laws, matters that should be observed from a medical ethics viewpoint, as
well as matters with a clear scientific basis and that seek to ensure safety or patient rights. Second,“must not” carries a relatively high level of compulsion, although not obligation, and restricts mattersthat should be observed from a medical ethics viewpoint and matters that have a clear scientific basis
but are not mentioned in the Ahaki Act and are actions that are extremely dangerous or highly likely
to violate patient rights.
At the next level, “should” is used when strongly recommending actions to ensure safety or patient
rights in regard to matters that have a clear scientific basis and are common knowledge in medical
practice, while “should not” is used when strongly restricting actions that are highly dangerous or
may violate patient rights.
Then at the third level, “it is recommended,” or the wording “it is hoped” (“it is desirable”), is used
when there is a clear scientific basis in the medical field and putting those actions into practice
should increase safety, while the wording “it is not recommended” is used when restricting actions
that may decrease safety.
Last, at the lowest level, the wording “need to beware” (“it is necessary to exercise caution”) is used
in when caution is prompted by existing guidelines that suggest the possibility of an adverse event,even though there is currently little scientific evidence.
The editors hope that keeping these in mind when adopting the Guideline into practice is of benefit
to patients’ informed consent and to mutual understanding with other medical practitioners.
Moreover, this Guideline is not intended for use in trials or lawsuits in the event of a medical
accident, or the like.

Wordings in this Guideline Indicating Levels of Compulsion
Wording

Level ofcompulsion on
the practitioner

must

Obligationmust notRelatively strong

shouldStrongStrongly recommends actions to ensure
safety or patient rights

should notStrongStrongly restricts actions that are highly
dangerous or may violate patient rights

it is recommended (it ishoped, it is desirable)

Somewhat strong

Recommends actions that are expected toincrease safety

it is not recommended

Somewhat strong

Restricts actions that may decrease safety

need to beware(it is necessary to exercise
caution)Weak

Prompts caution because an adverse event
may occur, even though there is currently
little scientific basis.

Description
Imposes obligation to ensure safety or
patient rights
Strongly restricts actions that are extremely
dangerous or highly likely to violate patient
rightsContents
I. Definitions of Safety Terms and Classification
Definitions of Terms
Adverse Event Classification

1
3

II. General Requirements and Precautions for Safety
Observing Laws and Regulations
Risk Management
Treatment Record Keeping and Protection of Personal Information
Contraindicated Treatments
Contraindicated Cases
Cases in Which Caution Should be Exercised
Contraindicated Sites
Sites Where Caution Should be Exercised
Out-of-clinic Visits – Treatment Outside the Treatment Center, Outdoor Treatment,
Treatment at Sports Competitions and Disaster Sites –

5
6
8
9
10
11
12
13
15

III. Infection Control
Basics of Infection Control
Hygiene in Treatment CentersStandard Precautions – Hand Hygiene –Standard Precautions – Personal Protective Equipment –Standard Precautions – Respiratory Hygiene and Cough Etiquette –Standard Precautions – Bed and Surrounding Environment Hygiene –Standard Precautions – Waste Handling –Standard Precautions – Disposal of Excreta –Hygienic Needling – Disinfection of the Treatment Field –Hygienic Needling – Needling Technique –Equipment Cleaning, Disinfection, and Sterilization
Occupational Infection Control – Needlestick and Other Accidents –

16
17
18
20
21
22
23
24
25
26
27
28

IV. Preventing Adverse Events
Infection
Organ and Nerve Injury
Skin Disorders
Needle Breakage, Retained Needles, and Foreign Bodies
Adverse Effects (Adverse Reactions)
Forgotten Needles
Adverse Events Due to Moxibustion

29
30
32
33
34
36
37

V. Safety in Related Therapies
Low-frequency Electro-acupuncture Therapy
Kyutoshin Therapy (Moxa Needling Therapy)
Shiraku Acupuncture Therapy
Teishin Therapy and Shonishin Acupuncture (Japanese pediatric acupuncture)
Hinaishin Therapy and Empishin Therapy (Intradermal Needling Therapy)
Including Ear Acupuncture Therapy
Ryushin Therapy (Press-sphere Therapy) Including Ear Acupuncture Therapy

39
41
43
44
45
47

Appendix – Explanations of Terms

48

Acknowledgements

54

Note

54

I. Definitions of Safety Terms and Classification
Definitions of Terms
The following are definitions of safety terms.
1.

A medical accident is any personal injury that occurs at any point in the process of medicalcare at a place where medical care is undertaken, regardless of whether error or negligence bya medical practitioner is involved. This includes injuries that cause either physical or mental
harm, and also includes medical practitioners, not only patients. “Akushidento” [Japaneseterm] is synonymous with “medical accident.” [1]2.

A medical error is a type of medical accident and is an act by a medical practitioner in theperformance of medical care that causes harm to the patient in violation of the medical rules.
[1]

3.

An incident is an unforeseen event that causes the individuals concerned to experience a frightor surprise, “Hiyari-Hatto” [Japanese term], even if it does not cause personal or economic loss
to the patient. “Hiyari-Hatto” and “Nia-Misu” [Japanese term] refer to “Close call” and “nearmiss”, respectively. These are synonymous with “incident.” [1]4.

An adverse effect (adverse reaction) is an undesirable biological reaction in treatment that
occurs inevitably at a certain frequency. Adverse effects in acupuncture and moxibustion are
categorized into systemic adverse effects and local adverse effects, as follows. [2](1) Systemic adverse effects: Severe fatigue, severe malaise, excessive drowsiness, poor mood,etc.
(2) Local adverse effects: Pain during acupuncture, microhemorrhage, itching at acupuncture
site, pain at acupuncture site after treatment, etc.

5.

An adverse event is an undesirable medical event that occurs during or after treatment
regardless of causality. Sufferers include not only patients but also medical practitioners.
Although this term is similar to medical accident, a third party retroactively investigates andrecords this type of event. [3, 4]

6.

Risk management means actions or activities to prevent medical accidents or to promptly deal
with accidents that have occurred and to minimize harm. “Risuku kanri” [Japanese term] and“medical safety management” are synonymous with “risk management.” [1]7.

Informed consent means the practitioner fully explaining to the patient his/her condition, thetreatment policy, etc. in easy-to-understand terms, and the patient understanding andaccepting the treatment, then making a choice and giving consent. [1, 5]

Bibliography
[1]

[2]

Sagara Y, Iwanami H, Sadahiro W, et al. Current status and features of definitions of terms
related to health care accidents. Bulletin of Gunma Prefectural College of Health Sciences.
2008; 3: 83-100.
https://gair.media.gunma-u.ac.jp/dspace/bitstream/10087/6639/1/KJ00005071950.pdf
Yamashita H. Basic Course in Oriental Medicine – An Introduction to Current ClinicalAcupuncture and Moxibustion, 4. Adverse Events and Safety in Acupuncture andMoxibustion. Physiotherapy and Medical Rehabilitation. 2010; 40 (2): 9-14．
1

[3]

[4]
[5]

ICH GCP guidance. E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)
Guidance for Industry. 2018. p3.
https://www.fda.gov/media/93884/download (2.29.2020)
Ministerial Ordinance on Good Clinical Practice for Drugs.
https://www.pmda.go.jp/int-activities/int-harmony/ich/0076.html (2.29.2020)
World Medical Association (WMA). World Medical Association Declaration of Lisbon on the
Rights of the Patient. 2015. (The Declaration of Lisbon)
https://pdf-it.dev.acw.website/please-and-thank-you?url=https://www.wma.net/policiespost/wma-declaration-of-lisbon-on-the-rights-of-the-patient/&pdfName=wma-declaration-oflisbon-on-the-rights-of-the-patient (8.13.2019)2

Adverse Event Classification
1.

The severity of adverse events is classified into Grades 1 to 5, as follows. Grades 3 to 5 areconsidered “serious adverse events.” [1]Grade 1 (Mild): “Presents no subjective symptoms,” “Presents mild symptoms,” “Has only
clinical findings or laboratory results,” “Does not require treatment”
Grade 2 (Moderate): “Requires minimal treatment,” “Requires local or noninvasive
treatment,” “Instrumental activities of daily living appropriate for age are
restricted” *1
Grade 3 (Severe): “Has severe or medically critical symptoms, but they do not immediately
threaten life,” “Requires hospitalization or extension of hospitalization
period,” “Self care activities of daily living are restricted” *2
Grade 4 (Life-threatening): “Requires emergency treatment”
Grade 5 (Death): “Died”*1 “Instrumental activities of daily living” means preparation of meals, shopping for daily
necessities and clothes, using a phone, managing money, etc.
*2 “Self care activities of daily living” means the individual is not bed-ridden and can bathe,dress and undress, take meals, use the toilet, and take medicine.

2.

Adverse events involving acupuncture are classified as follows. [2](1) Infection(2) Organ Injury (including pneumothorax and vascular injuries)(3) Nerve Injury(4) Skin Disorders(5) Needle breakage, retained needles, foreign bodies (including embedded needles)(6) Other3.

Adverse events involving moxibustion are classified as follows. [2](1) Burn Injury(2) Canceration at moxibustion site(3) Other

4.

Adverse event causes are classified into four types based on causality. [3](1) Adverse effect (adverse reaction): Undesirable biological reaction that occurs
unintentionally(2) Error: Event caused through negligence, ignorance, intent, etc. on the part of thepractitioner or the treatment center(3) Inevitable accident: Natural disaster, etc.
(4) An event that has no causal relationship with the treatment or the practitioner’s actions

Bibliography[1] U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse
Events (CTCAE) v5.0. 2017.
https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quic
k_Reference_8.5x11.pdf#search=%27U.S.+Department+of+Health+and+Human+Services.
+Common+Terminology+Criteria+for+Adverse+Events%27 (2.29.2020)[2] Furuse N, Uehara A, Sugawara M, et al. Literature Review on Adverse Events (2012-2015)
Associated with Acupuncture and Moxibustion. Journal of the Japan Society of Acupunctureand Moxibustion. 2017; 67(1): 29-47.
https://www.jstage.jst.go.jp/article/jjsam/67/1/67_29/_pdf/-char/ja (8.13.2019)3

[3] Yamashita H. Basic Course in Oriental Medicine – An Introduction to Current ClinicalAcupuncture and Moxibustion, 4. Adverse Events and Safety in Acupuncture and Moxibustion.
Physiotherapy and Medical Rehabilitation. 2010; 40(2): 9-14.

4

II. General Requirements and Precautions for Safety
Observing Laws and Regulations
1.

Practitioners must observe the relevant laws and regulations, including the Act on Practitionersof Massage, Finger Pressure, Acupuncture and Moxacauterization, etc., and strive for safe
treatment. They must also promptly obey instructions from governmental authorities. [1]2.

Persons who establish a treatment center (business owners) must observe the Ordinance for
Enforcement of the Act on Practitioners of Massage, Finger Pressure, Acupuncture andMoxacauterization, etc., the Industrial Safety and Health Act, and other related laws andregulations and must take steps to manage safety and hygiene in the clinic and the health of
employees. [1-3]Bibliography[1] Act on Practitioners of Massage, Finger Pressure, Acupuncture and Moxacauterization, etc.
https://elaws.egov.go.jp/search/elawsSearch/elaws_search/lsg0500/detail?lawId=322AC0000000217(8.13.2019)[2] Ordinance for Enforcement of the Act on Practitioners of Massage, Finger Pressure,
Acupuncture and Moxacauterization, etc.
https://elaws.egov.go.jp/search/elawsSearch/elaws_search/lsg0500/detail?lawId=402M50000100019(8.13.2019)[3] Industrial Safety and Health Act
https://elaws.egov.go.jp/search/elawsSearch/elaws_search/lsg0500/detail?lawId=347AC0000000057(8.13.2019)5

Risk Management
Risk management aims to prevent medical accidents or to promptly deal with accidents that haveoccurred and minimize damage.
1.

Practitioners must understand the patient’s pathological condition through inquiry and testing
and must strive to make appropriate decisions on indication or non-indication. [1, 2]

2.

In the course of treatment, practitioners must provide to the patient, or the guardian if there isa guardian, full and appropriate explanations of the risks that may arise through treatment(adverse events), in addition to the benefits of treatment (therapeutic effects), and must strive
to obtain the patient’s understanding of and consent to the treatment (informed consent). [1,2]

3.

Practitioners must seek to reduce the risks with regard to treatment and must strive to prevent
adverse events and medical accidents. [2]4.

It is recommended that persons who establish a treatment center (business owners) or the
managers prepare in advance a response manual in the event of a medical accident, and also
make the staff at the treatment center aware of this manual. [2]5.

In the event that a patient suffers an adverse event, practitioners should tell the patient
him/herself, or the guardian, if there is a guardian, that an adverse event has occurred, andshould explain the cause of and treatment for the adverse event. [2]6.

In the event of a serious adverse event, practitioners should advise the patient to seek medical
attention. In addition, it is recommended that when the patient receives medical attention, thepractitioner concerned accompany the patient and explain to the physician the details of theincident/accident. [3]7.

In the event of an accident or incident, it is recommended that the practitioner concerned
strive to prevent recurrence by analyzing the causes of the accident or incident and compilingan accident/incident report, sharing that information with the staff of the treatment center, andinvestigating precautions. [3, 4]

8.

Practitioners should be prepared for any medical accident by subscribing to liability
insurance. [5]9.

It is hoped that practitioners have completed lifesaving training and are prepared for
emergencies either in the treatment center or when on out-of-clinic visits.

Bibliography[1] Article 1-4 (2), Medical Care Act.
https://elaws.egov.go.jp/search/elawsSearch/elaws_search/lsg0500/detail?lawId=323AC0000000205_201806
01_429AC0000000057&openerCode=1 (8.13.2019)[2] Japan Medical Association. Code of Medical Ethics. 3rd Edition. 2016. pp3-5, pp45-8.
http://dl.med.or.jp/dl-med/teireikaiken/20161012_2.pdf (8.13.2019)[3] Kohn LT, Corrigan JM, Donaldson MS. To Err is Human: building a safer health system. 1st
Edition. Tokyo. Nippon Hyoron Sha Co., Ltd. 2000. pp105-33.
[4] Japanese Association for Acute Medicine (General Incorporated Association). Japanese
Association for Acute Medicine Special Committee on Investigation of Causes of Death
6

Related to Medical Treatment (Translation Supervision), Nakajima K (Translation). World
Alliance for Patient Safety. WHO Draft Guidelines for Adverse Event Reporting and Learning
Systems – From Information to Action. 1st Edition. Tokyo. Herusu Shuppan, Co. Inc. 2011.
https://www.jeder-fehler-zaehlt.de/lit/further/Reporting_Guidelines.pdf (8.13.2019)[5] Fujiwara Y. Medical Errors in Acupuncture, Moxibustion and Massage – Reports from theClinic. 1st Edition. 2004.

7

Treatment Record Keeping and Protection of Personal Information
Treatment records (synonymous with medical records or clinical records) are not simply to record
the details of treatment and the course of symptoms but to show that appropriate treatment has been
performed and that accountability has been fulfilled. Practitioners therefore need to beware of the factthat these are public documents subject to request for disclosure in court trials, medical benefit
payments, etc., and also the fact that they contain personal information. [1]1.

In the course of entering details into treatment records, it is recommended that practitioners
first enter the details of treatment, and record the various important information obtained
before, during, and after treatment so that they are accurate and easy-to-understand. [1, 2]

2.

Practitioners and staff must take organizational, human, physical, and technical security
control measures, etc. to prevent leakage, loss, or impairment of personal information, and to
manage the security of other personal information. [3]3.

It is recommended that practitioners keep treatment records for five years from the date ofcompletion of the treatment. [1, 4]

4.

When handling personal information, practitioners must clearly present the purpose for usingthat information in advance to the patient him/herself, or the guardian if the patient is a minoror does not have the ability to make judgments, and it must not be used for any other purpose.
[3]

5.

When a request for disclosure of the individual’s personal information is received, it must be
disclosed without delay. It may be possible not to disclose all or part of that information,
however, if disclosure falls under Article 28-2 (i) to (iii) of the Act on the Protection of Personal
Information. [5]Bibliography[1] Article 24, Medical Practitioners’ Act.
https://elaws.egov.go.jp/search/elawsSearch/elaws_search/lsg0500/detail?lawId=323AC0000000201(8.13.2019)[2] Japan Society of Health Information Management. Guideline on Recording Health Information(Previously: Guideline on Medical Record Keeping, Revised Edition). 2017.
http://www.jhim.jp/data2017/recording-guide.pdf (8.13.2019)[3] Personal Information Protection Commission, Ministry of Health, Labour and Welfare.
Guidance for the Appropriate Handling of Personal Information by Medical and Nursing Carerelated Businesses. 2017.pp26-8.
https://www.mhlw.go.jp/file/06-Seisakujouhou-12600000Seisakutoukatsukan/0000194232.pdf (10.28.2019)[4] Important Notice on the Payment of Medical Expenses Pertaining to Treatment by Practitionersof Acupuncture, Moxacauterization, Massage and Finger Pressure. Healthcare Notice 0620
No. 1. 2018.
http://www.kouiki-hiroshima.jp/information/shikyuukijun-massage-h250424.pdf (10.28.2019)[5] Act on the Protection of Personal Information. Act No. 28 of 2018.
https://elaws.egov.go.jp/search/elawsSearch/elaws_search/lsg0500/detail?lawId=415AC0000000057(8.13.2019)8

Contraindicated Treatments
It is prohibited by law for practitioners of acupuncture and moxibustion to perform surgery orprescribe drugs. [1] Practitioners must not perform treatments that are at high risk of triggering
adverse events or that interfere with other medical treatments.
1.

Practitioners must not perform Embedded needling therapy, where a needle is intentionallyembedded inside the body, because needles that remain inside the body can injury nerves,organs, or blood vessels, or cause symptoms such as chronic pain, and may have a major
impact on surgical treatments and magnetic resonance imaging (MRI). [2, 3]

2.

Practitioners must not needle internal organs and nerves because it risks impairment offunction. [2, 3]

3.

Practitioners must not apply mercury to needles to facilitate needling (application of mercury
on insertion) because there is no adequate assurance of its safety. [4, 5]

Bibliography[1] Act on Practitioners of Massage, Finger Pressure, Acupuncture and Moxacauterization, etc.
Article 4https://elaws.egov.go.jp/search/elawsSearch/elaws_search/lsg0500/detail?lawId=322AC0000000217(8.13.2019)[2] Furuse N, Yamashita H, Masuyama S, et al. Case reports on adverse effects of acupuncture andmoxibustion : a review of papers published between 2007 and 2011. Journal of the Japan
Society of Acupuncture and Moxibustion. 2013; 63(2): 100-14.
https://www.jstage.jst.go.jp/article/jjsam/63/2/63_100/_pdf/-char/ja (8.13.2019)[3] Furuse N, Uehara A, Sugawara M, et al. Literature Review on Adverse Events (2012-2015)
Associated with Acupuncture and Moxibustion. Journal of the Japan Society of Acupunctureand Moxibustion. 2017; 67(1): 29-47.
https://www.jstage.jst.go.jp/article/jjsam/67/1/67_29/_pdf/-char/ja (8.13.2019)[4] Umeda T, Yamashita H, Egawa M, et al. Japanese Literature Survey on Risks and Safety of
Acupuncture and Moxibustion (8): Application of Mercury on Insertion and Puncturing theInternal Organs. Journal of the Japan Society of Acupuncture and Moxibustion. 2001; 51(2):
195-200.
https://www.jstage.jst.go.jp/article/jjsam1981/51/2/51_2_195/_pdf (8.13.2019)[5] Yamaguchi S. Mercury Poisoning. Journal of Japan Society for Safety Engineering. 1965; 4(3):179-86．
https://www.jstage.jst.go.jp/article/safety/4/3/4_179/_pdf (8.13.2019)9

Contraindicated Cases
Practitioners must not perform acupuncture and moxibustion treatment if doing so causes the loss ofopportunity for the patient to receive appropriate medical care and there is the risk of the patient
lapsing into a serious pathological condition.
1.

Practitioners must give the highest priority to first aid and treatment at a medical institution in
emergency cases such as cardiac arrest, respiratory arrest, impaired consciousness, heavy
bleeding, extensive burn injury, and poisoning. In addition, practitioners must not perform
acupuncture and moxibustion treatment as first aid. [1]2.

Practitioners should not perform treatment in cases where an abnormal vital sign(consciousness, body temperature, pulse, blood pressure, respiratory condition) is observed.
Practitioners should advise such patients to promptly seek treatment at a medical institution.
[2]

Bibliography[1] WHO. Guidelines on basic training and safety in acupuncture. 1999. p19.
https://apps.who.int/medicinedocs/pdf/whozip56e/whozip56e.pdf (12.31.2018)https://www.jstage.jst.go.jp/article/jjsam1981/50/3/50_3_505/_pdf/-char/ja (8.13.2019)[2] Fukui T (Ed.), Nara N (Ed.). Medical Diagnosis. 3rd Edition. Tokyo. Igaku-Shoin Ltd. 2016.
pp47-55.

10

Cases in Which Caution Should be Exercised
The effectiveness and safety of acupuncture and moxibustion treatment is unclear for certain
pathological conditions. In addition, there are many questions about the safety of treatment for
pregnant women. In the following cases, practitioners must perform treatment with extreme caution
after providing especially thorough explanation as well as obtaining consent.
1.

Practitioners should not perform treatment intended to heal malignant tumors because there iscurrently no scientific basis. This does not apply, however, to symptoms associated withmalignant tumors (e.g. pain) and adverse effects of drug therapy (e.g. nausea), but it isdesirable that practitioners perform such treatment under the guidance of a physician. [1, 2]

2.

In the treatment of pregnant women, practitioners should exercise extreme caution so that it
does not cause miscarriage or premature birth and should avoid strong stimulation at any site.
It is necessary to exercise caution particularly with treatment in the abdominal region. [3]3.

In the event that localized sensation of heat or swelling is severe, practitioners should avoid
localized treatment because the patient may be suffering trauma or some kind of infection. In
addition, if the patient’s course is unsatisfactory, practitioners should discontinue treatment
and advise the patient to undergo testing at a hospital. [4, 5]

4.

There have been reports of cases in which immuno-compromised patients (diabetic patients,
steroid users, etc.) have developed an infection after treatment. If a patient’s pathologicalcondition has not stabilized, practitioners should abide by the physician’s decision on thesuitability of treatment. [4, 5]

5.

Practitioners must be aware of the risk of bleeding when treating patients suffering
hemorrhagic disease, undergoing anticoagulant treatment, or using anticoagulants. [4, 5]

6.

Practitioners should give priority to identifying and treating the primary disease in patients
showing signs of fever. It is desirable for practitioners to refrain from treatment and advise
such patients to visit a hospital for a consultation. [3]Bibliography[1] Lu W, Rosentha DS. Acupuncture for cancer pain and related symptoms. Curr Pain Headache
Rep. 2013; 17(3): 321.
[2] Rithirangsriroj K, Manchana T, Akkayagorn L. Efficacy of acupuncture in prevention of delayed
chemotherapy induced nausea and vomiting in gynecologic cancer patients. Gynecol Oncol.
2015; 136(1): 82-6.
[3] WHO. Guidelines on basic training and safety in acupuncture. 1999. pp522-3.
https://apps.who.int/medicinedocs/pdf/whozip56e/whozip56e.pdf (12.31.2018)https://www.jstage.jst.go.jp/article/jjsam1981/50/3/50_3_505/_pdf/-char/ja (8.13.2019)[4] Furuse N, Yamashita H, Masuyama S, et al. Case reports on adverse effects of acupuncture andmoxibustion : a review of papers published between 2007 and 2011. Journal of the Japan
Society of Acupuncture and Moxibustion. 2013; 63(2): 100-14.
https://www.jstage.jst.go.jp/article/jjsam/63/2/63_100/_pdf/-char/ja (8.13.2019)[5] Furuse N, Uehara A, Sugawara M, et al. Literature Review on Adverse Events (2012-2015)
Associated with Acupuncture and Moxibustion. Journal of the Japan Society of Acupunctureand Moxibustion. 2017; 67(1): 29-47.
https://www.jstage.jst.go.jp/article/jjsam/67/1/67_29/_pdf/-char/ja (8.13.2019)11

Contraindicated Sites
Practitioners must not perform treatment at sites where it may injury organs or essential tissues orthere is an extremely high risk of doing so, or where it may worsen a condition.
1.

Practitioners must not needle the anterior or posterior fontanel of newborn babies, external
genital organs, nipples, umbilical region, eyeballs, suppurating parts, parts affected by acuteinflammation, large blood vessels, organs within the body cavity, central nervous system, andmalignant tumor sites. [1-3]2.

Practitioners must not perform direct moxibustion (scarring moxibustion) on the face, external
genital organs, nipples, umbilical region, suppurating parts, malignant tumors, parts affectedby acute inflammation, and parts affected by skin disease. [1-3]3.

Practitioners should exercise particular caution if performing treatment in the vicinity of theabove sites.

Bibliography[1] WHO. Guidelines on basic training and safety in acupuncture.1999. p20, pp24-6.
http://apps.who.int/iris/bitstream/handle/10665/66007/WHO_EDM_TRM_99.1.pdf;jsessionid=
C35DFDBD9200DB04757BEF7D90FD9D51?sequence=1 (12.31.2018)https://www.jstage.jst.go.jp/article/jjsam1981/50/3/50_3_505/_pdf/-char/ja (8.13.2019)[2] Kitamura S, Kumamoto K. Color Atlas of Regional Anatomy – For Acupuncture andMoxibustion Practitioners and Judo Therapists. 2nd Revised Edition. Tokyo. Nankodo Co., Ltd.
2012.
[3] Shiraishi N, Uehara A. Color Atlas of the Regional Anatomy of Clinical Acupoints.
Explanations with Five-panel Diagrams. 1st Edition. Tokyo. Bunkodo. 2010.

12

Sites Where Caution Should be Exercised
Practitioners must exercise particular caution in treatment at sites where there is a risk of injuringorgans or essential tissues, or there is the danger of marring appearance. In the course of treatment,
practitioners should have a thorough knowledge of anatomy and take patients’ physique into accountbefore deciding on the stimulation requirements (needling angle, needling depth, etc.).
[1-4]
1.

Face: Beware of injuring the eyeballs. Beware not to mar appearance with burn injury orinternal bleeding.

2.

Neck (anterior): Beware of injuring the common carotid artery, internal carotid artery, vagus
nerve, and trachea.

3.

Supraclavicular fossa: Beware of injuring the subclavian artery and lungs.

4.

Neck (posterior): Beware of injuring the medulla oblongata, spinal cord, greater occipital
nerve, and vertebral artery

5.

Upper limbs: Beware of injuring the median nerve, ulnar nerve, radial nerve, and radial artery6.

Thoracic region: Beware of injuring the intrathoracic organs such as the lungs and heart.
Beware of the presence of a sternal foramen.

7.

Spinal region: Beware of injuring the spinal cord and nerves

8.

Epigastric region: Beware of injuring the intra-abdominal organs such as the liver andstomach.

9.

Hypogastric region: Beware of injuring the pelvic viscera such as the large intestine andbladder.

10.

Lumbar region : Beware of injuring the intra-abdominal organs and retro-peritoneal organs(kidneys, ureter, etc.)

11.

Inguinal region: Beware of injuring the femoral artery and femoral nerve.

12. Lower limbs: Beware of injuring the sciatic nerve, peroneal nerve, tibial nerve, popliteal
artery, posterior tibial artery, and dorsal artery of the foot.
13.

Practitioners should avoid directly needling sites where artificial devices are implanted(artificial joints, artificial blood vessels, pacemakers, etc.). Practitioners should also pay close
attention when performing treatment in those areas. [5]Bibliography[1] Kitamura S, Kumamoto K. Color Atlas of Regional Anatomy – For Acupuncture andMoxibustion Practitioners and Judo Therapists. 2nd Revised Edition. Tokyo. Nankodo Co., Ltd.
2012.
[2] Shiraishi N, Uehara A. Color Atlas of the Regional Anatomy of Clinical Acupoints.
Explanations with Five-panel Diagrams. 1st Edition. Tokyo. Bunkodo. 2010.
[3] Furuse N, Yamashita H, Masuyama S, et al. Case reports on adverse effects of acupuncture andmoxibustion : a review of papers published between 2007 and 2011. Journal of the Japan
13

Society of Acupuncture and Moxibustion. 2013; 63(2): 100-14.
https://www.jstage.jst.go.jp/article/jjsam/63/2/63_100/_pdf/-char/ja (8.13.2019)[4] Furuse N, Uehara A, Sugawara M, et al. Literature Review on Adverse Events (2012-2015)
Associated with Acupuncture and Moxibustion. Journal of the Japan Society of Acupunctureand Moxibustion. 2017; 67(1): 29-47.
https://www.jstage.jst.go.jp/article/jjsam/67/1/67_29/_pdf/-char/ja (8.13.2019)[5] Murata M, Ono H, Ozu S, et al. TKA infection – Two cases of implant infection thought tohave been caused by acupuncture after knee replacement. Japanese Journal of Replacement
Arthroplasty. 2013; 43: 329-30.

14

Out-of-clinic Visits – Treatment Outside the Treatment Center, Outdoor
Treatment, Treatment at Sports Competitions and Disaster Sites –In the course of treatment outside the treatment center, that is, during out-of-clinic visits,
practitioners must exercise particular caution with hygiene and accident prevention since treatment
environments vary greatly depending on the location. Thorough preparation and safety measures are
therefore required.
1.

If practitioners perform treatment exclusively on out-of-clinic visits, they must notify theprefectural governor [in Japan]. [1]2.

Practitioners should not perform treatment in places where safety and hygiene are notensured. [2]3.

It is recommended that practitioners carry out standard precautions on out-of-clinic visits.
Practitioners must exercise particular caution with hygiene when performing treatment
outside the treatment center, especially treatment outdoors. [2]4.

It is necessary for practitioners to exercise greater caution than in the treatment center
because accidents that are difficult to predict may occur. [2]5.

Practitioners should be prepared for any medical accident by subscribing to liability
insurance. [3]6.

If practitioners perform treatment at a sports competition, disaster site, etc., they should obtain
permission from the organizer or the person in charge at the site in advance. When applying
for permission, it is recommended that practitioners check the surroundings where treatment
will be performed and also make advance arrangements with the relevant personnel, preparea treatment plan, and submit it. [2]7.

If practitioners perform treatment at a sports competition, disaster site, etc., it is desirable thatthey make appropriate judgements about contraindications and indications, and cooperatewith other medical personnel, such as rescue parties, etc., as necessary. [2]Bibliography[1] Act on Practitioners of Massage, Finger Pressure, Acupuncture and Moxacauterization, etc.
Article 9-3.
https://elaws.egov.go.jp/search/elawsSearch/elaws_search/lsg0500/detail?lawId=322AC0000000217(8.13.2019)[2] Fukubayashi T, (Supervising Ed.), Oriental Medicine in Sport Research Committee, Japan
College Association of Oriental Medicine (Public Interest Incorporated Association) (Ed.).
Oriental Medicine in Sport for Practitioners of Acupuncture, Moxibustion, and Massage.
Tokyo. Ido-No-Nippon-Sha, Inc. 2018. pp46-9.
[3] Fujiwara Y. Medical Errors in Acupuncture, Moxibustion and Massage – Reports from theClinic. 1st Edition. 2004.

15

III. Infection Control
Basics of Infection Control
Infection control in Japanese medical institutions is based on guidelines by the US Centers for
Disease Control and Prevention (CDC) and revolves around two kinds of precautions: standard
precautions and transmission-based precautions. It is recommended that acupuncture andmoxibustion practitioners also use infection control equivalent to these precautions in their practice.
For an infection to occur, (1) a source of infection (bacteria, virus, etc.), (2) a mode of transmission(droplet transmission, airborne transmission, contact transmission, etc.), and (3) a susceptible host(elderly individual, immuno-compromised patient, etc.) are required. These are called “the threeelements for infection to take place.” Connection of these three elements is thus called the “chain of
infection,” and the infection spreads by the chain extending. The important questions in infection
control are, therefore, how, and between which elements, to break the chain of infection. [1, 2]
The basics for breaking this chain of infection in medical settings are the standard precautions andtransmission-based precautions, which are described in detail in the CDC’s Guideline for Isolation
Precautions: Preventing Transmission of Infectious Agents in Health Care Settings. [1, 2]
The standard precautions are the most basic precautions in infection control and equate to theconcept of carrying out patient care from the approach that all body fluids except sweat (blood,secretions, excretions, damaged skin, mucous membranes) are substances possessing transmissibility.
[1, 2]
Transmission-based precautions are precautions used in addition to the standard precautions for
infection that demonstrate a specific mode of transmission and comprise three kinds of precautions:droplet transmission precautions, airborne transmission precautions, and contact transmission
precautions. [1, 2]

Bibliography[1] Siegel JD, Rhinehart E, Jackson M, Chiarello L; the Healthcare Infection Control Practices
Advisory Committee. 2007 Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Health Care Settings. Am J Infect Control. 2007; 35(10 Suppl 2): S15-20.
(CDC guideline)
https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines-H.pdf (8.13.2019)[2] Mitsuda T (Translator/Author). Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Health Care Settings 2007. Tokyo. Van Medical Co., Ltd. 2007. pp20-5.

16Hygiene in Treatment Centers
1.

Treatment center managers must strive to maintain hygiene in treatment centers. [1-3]2.

Surfaces in treatment center environments, such as treatment beds and trolleys, must always
be maintained in a clean state by regularly cleaning them with an appropriate disinfectant. It
is recommended, however, that if contamination by blood is visible, it is cleaned immediately
with an appropriate disinfectant. [3-5]3.

It is not recommended that surfaces in treatment center environments be disinfected byspraying disinfectant. [4, 5]

4.

It is recommended that curtains and blinds in treatment centers be cleaned if there is visible
dirt. [4, 5]

5.

It is recommended that the floors in treatment centers be made of materials that are easy toclean and that they be cleaned regularly. It is recommended, however, that if contaminationby blood is visible, it is cleaned immediately with an appropriate disinfectant. [4, 5]

Bibliography[1] Act on Practitioners of Massage, Finger Pressure, Acupuncture and Moxacauterization, etc.
Article 9-5 (2).
https://elaws.egov.go.jp/search/elawsSearch/elaws_search/lsg0500/detail?lawId=322AC0000000217(8.13.2019)[2] Ordinance for Enforcement of the Act on Practitioners of Massage, Finger Pressure,
Acupuncture and Moxacauterization, etc. Article 25-4.
https://elaws.egov.go.jp/search/elawsSearch/elaws_search/lsg0500/detail?lawId=402M50000100019(8.13.2019)[3] Ordinance for Enforcement of the Act on Practitioners of Massage, Finger Pressure,
Acupuncture and Moxacauterization, etc. Article 26.
https://elaws.egov.go.jp/search/elawsSearch/elaws_search/lsg0500/detail?lawId=402M50000100019(8.13.2019)[4] Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee(HICPAC). Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008. pp85-8.
(CDC guideline)
https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines-H.pdf (11.3.2019)[5] Mitsuda T (Translator/Author). Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Health Care Settings 2007. Tokyo. Van Medical Co., Ltd. 2007. pp132-4.

17

Standard Precautions – Hand Hygiene –1.

Practitioners must perform proper hand hygiene when performing treatment. [1]2.

It is recommended that practitioners remove any rings or other accessories from their fingers
when performing treatment. [2-5]3.

In order to perform proper hand hygiene, it is recommended that a place to wash hands (withwater supply) be provided in treatment rooms solely for practitioners to use, and that soap be
provided beside it. It is also recommended that a quick-drying alcohol-based hand rub beprovided on top of treatment trolleys. [2-5]4.

It is recommended that practitioners wash their hands with running water and soap after using
the toilet, when the practitioner’s hands are visibly soiled, and when they have come incontact, or may have come in contact, with microorganisms for which alcohol does notachieve adequate results. [2-5]5.

It is recommended that practitioners use single-use towels such as paper towels to dry theirhands after hand washing. [2-5]6.

It is recommended that practitioners disinfect their hands with a quick-drying alcohol-basedhand-rub if they are not visibly soiled. [2-5] It is recommended that practitioners wash theirhands with running water and soap if it is not possible to determine whether their hands are
soiled due to visual problems.

7.

It is recommended that the above hand hygiene be performed in the following situations.
(Reference: The Five Moments for Hand Hygiene recommended by WHO) [4, 5](1) Before touching a patient(2) Before aseptic procedures, such as needling(3) After body fluid exposure (including situations where there is the possibility of exposure)(4) After touching a patient, and(5) After touching patient surroundings (bed, sheets, bath towel, etc.)

8.

So as to prevent hand roughness, it is not recommended that practitioners frequent use of aquick-drying alcohol-based hand rub immediately after hand washing. [2, 3, 6, 7]

9.

It is recommended that practitioners strive to prevent hand roughness on a daily basis. [4, 5]

Bibliography[1] Act on Practitioners of Massage, Finger Pressure, Acupuncture and Moxacauterization, etc.
Article 6, Article 9-5.
https://elaws.egov.go.jp/search/elawsSearch/elaws_search/lsg0500/detail?lawId=322AC0000000217(8.13.2019)[2] WHO. WHO Guidelines on Hand Hygiene in Health Care: First Global Patient Safety Challenge
Clean Care Is Safer Care. 2009. p152-3.
https://apps.who.int/iris/bitstream/handle/10665/44102/9789241597906_eng.pdf (8.13.2019)[3] WHO. Ichikawa T (Translator). WHO Guidelines on Hand Hygiene in Health Care: a
Summary. 2009. pp12-6.
https://apps.who.int/iris/bitstream/handle/10665/70126/WHO_IER_PSP_2009.07_jpn.pdf(8.28.2019)18

[4] Boyce JM, Pittet D, and Healthcare Infection Control Practices Advisory Committee;
HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Guideline for Hand Hygiene in HealthCare Settings. Recommendations of the Healthcare Infection Control Practices Advisory
Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Society for Healthcare
Epidemiology of America/Association for Professionals in Infection Control/Infectious Diseases
Society of America. MMWR Recomm Rep. 2002; 51(RR-16): 29-30, 32-3. (CDC guideline)
https://www.cdc.gov/mmwr/PDF/rr/rr5116.pdf (8.13.2019)[5] Mitsuda T. (Translator). CDC Guideline on Hand Hygiene in Health Care Settings. Tokyo.
International Medical Publishers, Ltd. 2003. pp44-5, 48-52.
https://med.saraya.com/gakujutsu/guideline/pdf/h_hygiene_cdc.pdf (8.13.2019)[6] Siegel JD, Rhinehart E, Jackson M, Chiarello L; the Healthcare Infection Control Practices
Advisory Committee. 2007 Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Health Care Settings. Am J Infect Control. 2007; 35(10 Suppl 2): S77-78.
(CDC guideline)
https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines-H.pdf (8.13.2019)[7] Mitsuda T (Translator/Author). Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Health Care Settings 2007. Tokyo. Van Medical Co., Ltd. 2007. pp89-90.

19

Standard Precautions – Personal Protective Equipment –1.

It is desirable that practitioners use proper hand hygiene to prevent infection from exposure toblood or body fluids, as well as invasion by pathogens at needling sites, and in addition, thatpractitioners pay close attention to avoid touching the needle body while needling and whenremoving needles. [1, 2]
When practitioners cannot avoid touching the needle, however, for example when using thinneedles or long needles, it is recommended that they use personal protective equipment suchas medical gloves or fingerstalls. [3]2.

Practitioners should always use personal protective equipment such as medical gloves orfingerstalls, particularly if there is any wound on the practitioner’s hands. [3]3.

Practitioners must replace such personal protective equipment after each treatment. [1, 2, 4]

4.

In Shiraku acupuncture therapy, it is recommended that practitioners use aprons or gowns,
surgical masks, goggles, etc. as necessary. [1, 2]

Bibliography[1] Siegel JD, Rhinehart E, Jackson M, Chiarello L; the Healthcare Infection Control Practices
Advisory Committee. 2007 Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Health Care Settings. Am J Infect Control. 2007; 35(10 Suppl 2): S77-.
(CDC guideline)
https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines-H.pdf (8.13.2019)[2] Mitsuda T (Translator/Author). Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Health Care Settings 2007. Tokyo. Van Medical Co., Ltd. 2007. pp89-92.
[3] WHO. Guidelines on basic training and safety in acupuncture.1999. pp18-9.
http://apps.who.int/medicinedocs/pdf/whozip56e/whozip56e.pdf (8.13.2019)[4] Japan Infection Prevention and Control Conference for National and Public University
Hospitals (Editor). Guidelines for Infection Control in University Hospitals. 2018 Edition.
Tokyo. Jiho Inc. 2018. pp11-20.

20

Standard Precautions – Respiratory Hygiene and Cough Etiquette –Cough etiquette means the measures taken by a person with symptoms of respiratory infection(cough, sneezing, runny nose, etc.) to interrupt droplet transmission. Specific measures include
wearing a surgical mask, and immediately discarding tissues containing respiratory secretions in a
waste receptacle.
1.

It is recommended that practitioners avoid performing treatment if they have symptoms ofrespiratory infection, but if they cannot avoid performing treatment, they should wear asurgical mask. In addition, practitioners must perform hand hygiene if they come in contact
with respiratory secretions. [1-3]2.

It is recommended that practitioners have the patient wear a surgical mask if the patient has
symptoms of respiratory infection. [1-3]Bibliography[1] Siegel JD, Rhinehart E, Jackson M, Chiarello L; the Healthcare Infection Control Practices
Advisory Committee. 2007 Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Health Care Settings. Am J Infect Control. 2007;35(10 Suppl 2): S80-1.
(CDC guideline)
https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines-H.pdf (8.13.2019)[2] Mitsuda T (Translator/Author). Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Health Care Settings 2007. Tokyo. Van Medical Co., Ltd. 2007. p92.
[3] Japan Infection Prevention and Control Conference for National and Public University
Hospitals (Editor). Guidelines for Infection Control in University Hospitals. 2018 Edition.
Tokyo. Jiho Inc. 2018. pp11-20.

21

Standard Precautions – Bed and Surrounding Environment Hygiene –1.

When disinfecting surfaces in the proximity of treatment beds, it is recommended that they becleaned with an intermediate-level disinfectant (alcohol-based disinfectant, sodium
hypochlorite, etc.) or a low-level disinfectant. It is not recommended that surfaces in theproximity be disinfected by spraying disinfectant. [1, 2]

2.

Practitioners must use clean linen for treatment. If the linen is contaminated by blood or body
fluids, it is recommended that it be washed for 10 minutes with hot water at 80 degrees
Celsius, or that it be washed with appropriate use of a chlorine bleach (sodium hypochlorite).
[3]

3.

The area in the proximity of beds where treatment is performed must be cleaned so it is free ofcontaminants and dust. It is recommended that frequently touched surfaces such as
doorknobs and handrails be cleaned more frequently and with greater intensity than othersurfaces. [3, 4]

Bibliography[1] Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee(HICPAC). Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008. pp11-3,
87-8. (CDC guideline)
https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines-H.pdf (11.3.2019)[2] Mitsuda T. (Translator/Author). CDC Guideline for Disinfection and Sterilization in Healthcare
Facilities, 2008. Van Medical Co., Ltd. 2009. pp22-6,134.
[3] Japan Infection Prevention and Control Conference for National and Public University
Hospitals (Editor). Guidelines for Infection Control in University Hospitals. 2018 Edition.
Tokyo. Jiho Inc. 2018. pp11-20, 232-45.
[4] Siegel JD, Rhinehart E, Jackson M, Chiarello L; the Healthcare Infection Control Practices
Advisory Committee. 2007 Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Health Care Settings. Am J Infect Control. 2007;35(10 Suppl 2): S65-164.
(CDC guideline)
https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines-H.pdf (8.13.2019)[5] Mitsuda T (Translator/Author). Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Health Care Settings 2007. Tokyo. Van Medical Co., Ltd. 2007. p92.

22

Standard Precautions – Waste Handling –1.

When discarding absorbent cotton or guide tubes, etc. that may include needles or thepatient’s blood or body fluids, they must be handled as infectious waste. [1]2.

Infectious waste should be stored in containers designated for infectious waste that can besealed, are easy to store, and cannot be easily damaged. In particular, used needles should bediscarded in designated containers that are robust and puncture-resistant, to prevent
needlestick accidents. [1]3.

The containers used must display the biohazard mark so that the contents of the container canbe identified as infectious waste, they must be sealed at the time of collection and transport,
and a specialized waste disposal service must be used for processing, in accordance withlaws and regulations. [1]Bibliography[1] Environmental Regeneration and Material Cycles Bureau, Ministry of the Environment. Manualfor Infectious Waste Disposal under the Waste Management Act. 2018. pp1-10,16-8.
https://www.env.go.jp/recycle/kansen-manual1.pdf (8.13.2019)23

Standard Precautions – Disposal of Excreta –1.

When disposing of excreta such as vomit and excrement, it is recommended that disposable
gloves, surgical masks, and plastic aprons be worn, and that contaminated areas andsurroundings be disinfected by cleaning with sodium hypochlorite. When disposing of such
waste, it is recommended that the area be thoroughly ventilated by opening windows, etc. [1,2]2.

It is recommended that persons who have disposed of excreta thoroughly wash and disinfecttheir hands afterward. [1, 2]

Bibliography[1] Japan Infection Prevention and Control Conference for National and Public University
Hospitals (Editor). Guidelines for Infection Control in University Hospitals. 2018 Edition.
Tokyo. Jiho Inc. 2018. pp11-20.
[2] 2012 Ministry of Health, Labour and Welfare. Elderly Health Program Promotion Cost Grant(Elderly Health Promotion Program portion). Manual for Infection Control in Elderly Care
Facilities (March 2013). https://www.mhlw.go.jp/topics/kaigo/osirase/tp0628-1/dl/13031301.pdf (8.13.2019)24

Hygienic Needling – Disinfection of the Treatment Field –1.

Practitioners must disinfect the treatment field in the course of treatment. [1]2.

To disinfect the treatment field, it is recommended that ethanol for disinfection defined by theJapanese Pharmacopoeia (76.9 to 81.4%) or 70% isopropyl alcohol be used. [2] Lower
concentration alcohol-based disinfectants should not be used, as they may reduce theeffectiveness of disinfection. [3, 4]

3.

Low-level disinfectants (e.g., chlorhexidine gluconate, benzalkonium chloride) may be used if
alcohol-based disinfectants cannot be used due to allergies or other problems. [5, 6]

4.

When disinfecting the treatment field, it is recommended that the area be cleaned with acotton pad or other material moistened with disinfectant. In the following cases, it isrecommended that the antiseptic swab be replaced with a new swab before continuing toclean. [7, 8](1) If the antiseptic swab dries out during cleaning(2) If contamination is visible on the antiseptic swab(3) If the antiseptic swab comes into contact with damaged skin

Bibliography[1] Act on Practitioners of Massage, Finger Pressure, Acupuncture and Moxacauterization, etc.
Article 6.
https://elaws.egov.go.jp/search/elawsSearch/elaws_search/lsg0500/detail?lawId=322AC0000000217(8.13.2019)[2] Yoshida Pharmaceutical Company Limited, Literature Review Team (Authors), Okubo T(Supervisor), Kobayashi H. (Lead). Antiseptic and Disinfectant Text (Y‘s Text) Ⅴ Characteristics
of Antiseptics and Disinfectants. 2 Intermediate-level Antiseptics and Disinfectants. 5th Edition.
2016.
http://www.yoshida-pharm.com/2012/text05_02/ (8.13.2019)[3] Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee(HICPAC). Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008. pp39-58.
(CDC guideline)
https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines-H.pdf (11.3.2019)[4] Mitsuda T. (Translator/Author). CDC Guideline for Disinfection and Sterilization in Healthcare
Facilities, 2008. Van Medical Co., Ltd. 2009. pp63-92.
[5] Kobayashi H (Editor). New Enlarged and Expanded Edition. Guideline on Disinfection and
Sterilization. Tokyo. Herusu Shuppan, Co., Ltd. 2015. p131-44.
[6] Oie S. Disinfection and Sterilization Methods by Field (12) Organism Disinfection (1) WoundSites – Surgical Fields. The Journal of Infection Control and Prevention. 2015; 9 (Supple 2):
177-86.
[7] WHO. WHO best practices for injections and related procedures toolkit. 2010. p7.
http://apps.who.int/iris/bitstream/handle/10665/44298/9789241599252_eng.pdf;jsessionid=8F
D2DE176CC014C8AECFC43F8DAF7A25?sequence=1 (8.13.2019)[8] Council of Colleges of Acupuncture and Oriental Medicine (CCAOM). Clean Needle
Technique Manual -Best Practices for Acupuncture Needle Safety and Related Procedures-. 7thed. 2015. pp71-4.
https://www.acusova.com/resources/Documents/7thEditionManualEnglishPDFVersion.pdf#sear
ch=%27Clean+Needle+Technique+Manual+Best+Practices+for+Acupuncture+Needle+Safety+and+Related+Procedures%27 (2.29.2020)25

Hygienic Needling – Needling Technique –Needling must be performed hygienically in order to control infection. The following should beobserved when needling.
1.

Practitioners must perform hand hygiene before needling.

2.

It is recommended that practitioners wear medical gloves or fingerstalls.

3.

When performing more hygienic needling, it is recommended that practitioners practice theaseptic technique of inserting needles without touching the body, or Clean Needle Technique(CNT). It is also recommended that if practitioners hold the needle body, they use sterilized
gauze or a cotton pad to support the needle. [1]Bibliography[1] Council of Colleges of Acupuncture and Oriental Medicine (CCAOM). Clean Needle
Technique Manual -Best Practices for Acupuncture Needle Safety and Related Procedures-. 7thed. 2015. pp68-100.
https://www.acusova.com/resources/Documents/7thEditionManualEnglishPDFVersion.pdf#sear
ch=%27Clean+Needle+Technique+Manual+Best+Practices+for+Acupuncture+Needle+Safety+and+Related+Procedures%27 (2.29.2020)26

Equipment Cleaning, Disinfection, and Sterilization1.

It is recommended that in the course of treatment practitioners use sterile single-use needles
regardless of whether they penetrate the skin or not. It is particularly recommended that whenpractitioners use needles whose purpose is to penetrate the skin, such as filiform,
subcutaneous, or three-edged needles, they be sterile single-use needles. [1]2.

If using acupuncture needles that penetrate the skin and are intended for reuse, the needles
must be cleaned and sterilized using appropriate methods. [2]3.

If using needles whose purposes are not to penetrate the skin but are intended for reuse, suchas spoon needles, non-invasive dermal needles, practitioners must clean and disinfect theneedles using appropriate methods. [3, 4]

4.

It is recommended that any equipment that comes in direct contact with needles, such as
guide tubes and needle trays, be sterile and disposable. [1]5.

If guide tubes are to be reused, they must be cleaned and sterilized using appropriate
methods. In the case of needle trays, it is recommended that they be cleaned and disinfected.
[3, 4]

Bibliography[1] Prevention of AIDS Infection in Acupuncture and Moxibustion. Medical Professions Division
Directive No. 19.
https://www.mhlw.go.jp/web/t_doc?dataId=00ta4926&dataType=1&pageNo=1 (8.13.2019)[2] Act on Practitioners of Massage, Finger Pressure, Acupuncture and Moxacauterization, etc.
Article 6.
https://elaws.egov.go.jp/search/elawsSearch/elaws_search/lsg0500/detail?lawId=322AC0000000217(8.13.2019)[3] Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee(HICPAC). Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008. pp11-3.
(CDC guideline)
https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines-H.pdf (11.3.2019)[4] Mitsuda T. (Translator/Author). CDC Guideline for Disinfection and Sterilization in Healthcare
Facilities, 2008. Van Medical Co., Ltd. 2009. pp22-6.

27

Occupational Infection Control – Needlestick and Other Accidents–
1.

Practitioners must take steps to prevent treatment-related infection in order to protect thepatient and themselves from infection and to avoid becoming a carrier.

2.

It is recommended that practitioners use appropriate personal protective equipment, such as
medical gloves and fingerstalls to control infection from exposure to blood and body fluids,
and surgical masks to control droplet transmission. When removing needles, it is also
recommended that practitioners avoid direct contact with blood and body fluids by using
antiseptic swabs or sterile cotton pads. [1-3]3.

It is recommended that after removing used needles, practitioners immediately discard themin designated containers that are robust and puncture-resistant, to prevent needlestick
accidents. [3, 4]

4.

It is recommended that practitioners be vaccinated against hepatitis B because the hepatitis B
virus is the most contagious blood-borne pathogen. [5] In addition, it is recommended thatpractitioners take appropriate post-exposure measures in the event they are exposed to bloodor body fluids by needlestick accident involving an unvaccinated individual or a vaccine nonresponder. [3]5.

It is recommended that practitioners check in advance whether they have antibodies tomeasles, rubella, mumps, and chickenpox pathogens and check their antibody titers, and if
necessary, receive vaccinations against them because they are diseases with whichsusceptible individuals are likely to be infected. [5]Bibliography[1] Siegel JD, Rhinehart E, Jackson M, Chiarello L; the Healthcare Infection Control Practices
Advisory Committee. 2007 Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Health Care Settings. Am J Infect Control. 2007; 35(10 Suppl 2): S15-20.
(CDC guideline)
https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines-H.pdf (8.13.2019)[2] Mitsuda T (Translator/Author). Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Health Care Settings 2007. Tokyo. Van Medical Co., Ltd. 2007. pp20-5.
[3] Japan Infection Prevention and Control Conference for National and Public University
Hospitals (Editor). Guidelines for Infection Control in University Hospitals. 2018 Edition.
Tokyo. Jiho Inc. 2018. pp11-20[4] Environmental Regeneration and Material Cycles Bureau, Ministry of the Environment. Manualfor Infectious Waste Disposal Under the Waste Management Act. 2018. pp16-8.
https://www.env.go.jp/recycle/kansen-manual1.pdf (8.13.2019)[5] Committee for Revision of the Vaccine Guidelines, Japanese Society for Infection Prevention
and Control (Editor). Vaccine Guidelines for Healthcare Professionals. 2nd Edition. Japanese
Journal of Environmental Infections. 2014; 29 Supplement III: S1-S14.
http://www.kankyokansen.org/common/fckeditor/editor/filemanager/connectors/php/transfer.p
hp?file=/JSEI/uid000005_76616367756964652832292E706466 (8.13.2019)28

IV. Preventing Adverse Events
While acupuncture and moxibustion include numerous therapies such as filiform needle therapy,
low-frequency electro-acupuncture (electro-acupuncture) therapy, Kyutoshin therapy (Moxa needlingtherapy), Shiraku acupuncture therapy, Teishin therapy, Dermal needle therapy, Hinaishin &Empishin therapy (Intradermal needling therapy), direct moxibustion therapy, and indirectmoxibustion therapy, this section mainly describes safety measures in filiform needle acupunctureand direct moxibustion. Safety measures for the other therapies, from electro-acupuncture and others,
are described in the section on Safety in Related Therapies.

Infection
1.

Practitioners must observe the Standard Precautions and must strive to prevent infection in thecourse of treatment. [1]2.

There have been reports of cases of infection after treatment of immuno-compromised
patients (diabetic patients, long-term steroid users, etc.). If a patient’s pathological condition
has not stabilized, practitioners should abide by his/her physician’s decision on the suitabilityof treatment. [2, 3]

3.

There have been reports of suppurative arthritis after treatment. In order to prevent infection,practitioners should not perform intraarticular needling. [2, 4]

4.

In order to prevent infection, practitioners should avoid directly needling sites where artificial
devices are implanted (artificial joints, artificial blood vessels, pacemakers, etc.). Practitioners
should also pay close attention when performing treatment in those areas. [5]Bibliography[1] Garner JS. Guideline for isolation precautions in hospitals. Part I. Evolution of isolation
practices, Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1996;
24(1): 24-31.
[2] Furuse N, Yamashita H, Masuyama S, et al. Case reports on adverse effects of acupuncture andmoxibustion: a review of papers published between 2007 and 2011. Journal of the Japan
Society of Acupuncture and Moxibustion. 2013; 63(2): 100-14.
https://www.jstage.jst.go.jp/article/jjsam/63/2/63_100/_pdf (8.14.2019)[3] Furuse N, Uehara A, Sugawara M, et al. Literature Review on Adverse Events (2012-2015)
Associated with Acupuncture and Moxibustion. Journal of the Japan Society of Acupunctureand Moxibustion. 2017; 67(1): 29-47.
https://www.jstage.jst.go.jp/article/jjsam/67/1/67_29/_pdf/-char/ja (8.14.2019)[4] Tsutsui M, Kohyama A, Inoue K, et al. Methicillin-resistant Staphylococcus aureus (MRSA)
septic arthritis of the shoulder caused by acupuncture: a case report. Orthopedic Surgery.
2003; 54(4): 407-10.
[5] Murata M, Ono H, Ozu S, et al. TKA infection – Two cases of implant infection thought tohave been caused by acupuncture after knee replacement. Japanese Journal of Replacement
Arthroplasty. 2013; 43: 329-30.

29

Organ and Nerve Injury
Practitioners must fully understand local anatomy and safe depths and must avoid unnecessarily
deep needling and careless technique. Practitioners need to beware when needling because pressure
from the pressing hand supporting the needle, so-called pressing hand, reduces the safe depth. [1-8]1.

Practitioners must not put towels or blankets over the top of needles while they are retained
because the needles may penetrate into deeper regions. [5]2.

In order to prevent pneumothorax, practitioners must use caution when needling theshoulder/upper back region and thoracic region. [1-5]3.

In order to prevent heart injury (e.g. cardiac tamponade), practitioners must exercise caution
with deep needling in the precordia region and be aware of the presence of any sternal
foramen in the region of chest center acupuncture point (CV17). [1-3, 6]

4.

There have been reports of vascular injury (e.g. bleeding, hematoma, aneurysm) occurring in
the vertebral artery, subclavian artery, inferior abdominal wall artery, popliteal artery, etc.
after treatment. Practitioners should avoid careless technique and deep needling at sites
where large blood vessels are present because they may cause vascular injury. [1-3, 6, 7]

5.

Practitioners should avoid careless technique and deep needling and also ensure thoroughhygiene is used in treatment for patients with a bleeding tendency such as hemophilia,
because they are at higher risk of infection and bleeding (internal hemorrhage, hematoma)
than healthy patients. [1-3, 6]

6.

Practitioners should avoid careless technique and deep needling at sites where the nerves thatrun through the site are relatively large in anatomical terms. [1-3, 7]

7.

Careless technique and deep needling especially in the posterior region of the neck carries therisk of the needle penetrating a cervical intervertebral foramen, between a vertebral arch anda cervical vertebra, or between the occipital bone and a cervical vertebra, and injuring thecentral nervous system (brain and spinal cord), therefore practitioners must exercise caution.
[1-3, 7]Bibliography[1] Fujiwara Y. Medical Errors in Acupuncture, Moxibustion, and Massage – Reports from theClinic. 1st Edition. San-Oh Shoji. 2004.
[2] Furuse N, Yamashita H, Masuyama S, et al. Case reports on adverse effects of acupuncture andmoxibustion : a review of papers published between 2007 and 2011. Journal of the Japan
Society of Acupuncture and Moxibustion. 2013; 63(2): 100-14.
https://www.jstage.jst.go.jp/article/jjsam/63/2/63_100/_pdf/-char/ja (8.14.2019)[3] Furuse N, Uehara A, Sugawara M, et al. Literature Review on Adverse Events (2012-2015)
Associated with Acupuncture and Moxibustion. Journal of the Japan Society of Acupunctureand Moxibustion. 2017; 67(1): 29-47.
https://www.jstage.jst.go.jp/article/jjsam/67/1/67_29/_pdf/-char/ja (8.14.2019)[4] Furuse N, Yamashita H. Literature Review on Improvements in Acupuncture Safety –Pneumothorax. Ido-no-Nippon-Sha, Inc. 2014; 73(9): 118-25.
[5] Nakamoto K. Pneumothorax due to Acupuncture. Journal of the Japan Society of Acupunctureand Moxibustion. 1994; 44(3): 233-7.
https://www.jstage.jst.go.jp/article/jjsam1981/44/3/44_3_233/_pdf/-char/ja (8.14.2019)30

[6] Furuse N, Yamashita H. Literature Review on Improvements in Acupuncture Safety – Organ
Injuries and Abnormalities Other Than Pneumothorax. Ido-no-Nippon-Sha, Inc. 2015; 74(4):120-9.
[7] Furuse N, Yamashita H. Literature Review of Nerve Injury Cases Caused by Acupuncture. Idono-Nippon-Sha, Inc. 2013; 72(6): 138-46．
[8] Furuse N, Tanaka M, Takeuchi M, et al. – A Study of Educational Outcomes in Practical
Acupuncture Training – Needling Depth and Vertical Pressure as an Indicator. Journal of
Education and Research of Massage and Acupuncture. 2015; 37(1): 11-8.

31

Skin Disorders
There have been reports of cases in which skin disease (e.g., nodules, erythema, contact dermatitis)
has developed when acupuncture and constitutional factors (e.g., underlying diseases and metalallergies) have combined.
1.

In the course of treatment, it is desirable that practitioners ask patients beforehand whether
they have any history of skin disease or any allergies to alcohol or metal, for example. [1-3]2.

Practitioners should abide by his/her physician’s decision on the suitability of treatment if thepatient has a history of skin disease or allergy to metal, and there is any risk that treatment
may be a cause of skin disease or an aggravating factor. [1-3]3.

Practitioners should discontinue treatment and advise the patient to seek medical attention if askin lesion coinciding with a needling site is found either during or after treatment. [1-3]4.

Practitioners need to beware of needling at parts affected by skin lesion and to beware of
repeated needling over a long period at the same site, because they risk inducing an adverse
event. [4, 5]

Bibliography[1] Yamashita H, Miyamoto T, Umeda T, et al. Japanese Literature on the Risk and Safety of
Acupuncture and Moxibustion (9): Dermatological Adverse Events in Acupuncture Treatment.
Journal of the Japan Society of Acupuncture and Moxibustion. 2001; 51(2): 201-6.
https://www.jstage.jst.go.jp/article/jjsam1981/51/2/51_2_195/_pdf/-char/ja (8.14.2019)[2] Furuse N, Yamashita H, Masuyama S, et al. Case reports on adverse effects of acupuncture andmoxibustion : a review of papers published between 2007 and 2011. Journal of the Japan
Society of Acupuncture and Moxibustion. 2013; 63(2): 100-14.
https://www.jstage.jst.go.jp/article/jjsam/63/2/63_100/_pdf/-char/ja (8.14.2019)[3] Furuse N, Uehara A, Sugawara M, et al. Literature Review on Adverse Events (2012-2015)
Associated with Acupuncture and Moxibustion. Journal of the Japan Society of Acupunctureand Moxibustion. 2017; 67(1): 29-47.
https://www.jstage.jst.go.jp/article/jjsam/67/1/67_29/_pdf/-char/ja (8.14.2019)[4] Mune C, Saga K, Jimbow K. Two Cases of Giant Malignant Melanoma Presenting as Large
Masses. Rinsho Derma. 1998; 40(4): 673-5.
https://www.jstage.jst.go.jp/article/skincancer1986/15/2/15_2_142/_pdf (8.14.2019)[5] Nonogaki K, Yoshiike T, Takeshita Y. Squamous cell carcinoma of lower back skin after
acupuncture. Skin Cancer. 2016; 31(3): 285-9.

32

Needle Breakage, Retained needles, and Foreign Bodies
Needle breakage is unintentional breakage of the needle body and a retained needle is part of aneedle body that remains in the body due to needle breakage. “Foreign body” is the general term foranything present in the body that is not a normal cell and includes retained needles and calculus
around a retained needle as well as embedded needles by Embedded needling therapy.
1.

Practitioners must beware of retained needles because there are the risks that a needle
remaining in the body may cause chronic pain and that it will move within the body andinjure organs, nerves, or blood vessels. [1-4]2.

Practitioners must not practice Embedded needling therapy, where a needle is intentionallyembedded in the body. [1-6]3.

It is recommended that practitioners use single-use filiform needles so as to prevent needle
breakage. If using filiform needles intended for reuse, it is recommended that practitioners
check beforehand for any defects in the needle body, needle handle, and the join between
the two. [1-3]

4.

If it is difficult to remove a needle because it is completely buried, it is recommended thatpractitioners inform the patient and also advise him/her to seek medical advice about theappropriateness of removing the retained needle. [1-4]5.

Since retained needles may cause chronic pain, for example, it is hoped that in the ordinary
course of treatment practitioners ask patients, and especially the elderly, about any history ofEmbedded needling therapy. [1-3]Bibliography[1] Fujiwara Y. Medical Errors in Acupuncture, Moxibustion, and Massage – Reports from theClinic. 1st Edition. San-Oh Shoji. 2004.
[2] Furuse N, Yamashita H, Masuyama S, et al. Case reports on adverse effects of acupuncture andmoxibustion : a review of papers published between 2007 and 2011. Journal of the Japan
Society of Acupuncture and Moxibustion. 2013; 63(2): 100-14.
https://www.jstage.jst.go.jp/article/jjsam/63/2/63_100/_pdf/-char/ja (8.14.2019)[3] Furuse N, Uehara A, Sugawara M, et al. Literature Review on Adverse Events (2012-2015)
Associated with Acupuncture and Moxibustion. Journal of the Japan Society of Acupunctureand Moxibustion. 2017; 67(1): 29-47.
https://www.jstage.jst.go.jp/article/jjsam/67/1/67_29/_pdf/-char/ja (8.14.2019)[4] Kamimura K, Yamauchi N, Nohmi T, et al. An Experimental Study on Movement of Broken
Acupuncture Needles. Journal of the Japan Society of Acupuncture and Moxibustion. 1985;
35(3-4): 226-32.
https://www.jstage.jst.go.jp/article/jjsam1981/35/3-4/35_3-4_226/_pdf/-char/ja (8.14.2019)[5] Japan Acupuncture & Moxibustion Association. Requests Regarding Bloodletting, Acupunctureand Moxibustion, and Needle Breakage Treatment. Ido-no-Nippon-Sha. 1976; 35(9); 55-7.
[6] Nerve Injury Caused by Needle Burying. Special edition of Jurist. 1996; 140: 218-9.

33Adverse Effects (Adverse Reactions)
General1.

It is difficult to completely prevent adverse effects (e.g., microhemorrhage, poor mood, pain
accompanying needling, aggravation of symptoms, and difficulty removing needles [stuckneedles]) in treatment given that it involves inserting metal into, or bringing it in contact with,the body. Practitioners must therefore strive to give full and appropriate explanations to thepatient regarding any adverse effects that may accompany his/her treatment, so as to avoid
unnecessary problems. [1-5]2.

Practitioners should only perform treatment once the patient has fully understood andaccepted the risks of that treatment. When needling the face, it is hoped that practitioners
provide careful explanation because the patient’s appearance may be easily marred. [1-5]Specific Adverse Effects(1) Bleeding
1. Practitioners should refrain from careless technique and from using unnecessarily thick needles
and should also apply adequate pressure to the needling site after removing the needle toprevent bleeding.
2.

Practitioners should avoid direct contact with the needle body and the needling site by using
cotton wool to hold the needle body to prevent blood-borne infection from the patient to thepractitioner.

(2) Poor mood – Autonomic nervous system symptoms
1. Excessive stimulation carries the risk of inducing poor mood or autonomic nervous system
symptoms such as nausea, vomiting, dizziness, or cerebral anemia (fainting). It is desirable thatpractitioners check the patient’s sensitivity to stimulation and adjust it to an appropriate levelso as to avoid excessive stimulation.
2.

Practitioners need to beware that certain patients are particularly susceptible to cerebral
anemia (fainting), including patients receiving treatment for the first time, patients suffering
anxiety or severe tension such as nervousness or fear of needles, or who are in poor condition
due to lack of sleep, etc., and patients who are frail such as the elderly. For such patients, it isdesirable that practitioners start with weaker stimulation.

3.

Practitioners need to beware when needling a patient who is sitting up because he/she(especially an elderly patient) is susceptible to cerebral anemia (fainting). It is desirable thatpractitioners avoid treating patients sitting up, or take steps beforehand to prevent falls,
because it carries the risk of injury due to falling.

(3) Difficulty removing needles (stuck needles)
1. Practitioners should not insert needles any deeper than necessary because it carries the risk ofdifficulty removing the needle (stuck needle).
2.

Practitioners should instruct patients before treatment to refrain from moving during treatment(especially while needles are retained), except for specialized treatments such as movement
acupuncture therapy, to avoid difficulty removing needles (stuck needles).

3.

Practitioners should avoid removing needles forcefully because it carries the risk of needle
breakage and tissue injury. If there is any risk from a needle breakage, explain the situation to34

the patient and recommend that he/she seek medical attention at a hospital (consultation witha physician). It is hoped that when the patient receives medical attention, the practitioner
concerned accompany the patient and explain the situation to the physician the details of theincident/accident.

Bibliography[1] Furuse N, Shinbara H, Uehara A, et al. A Multicenter Prospective Survey of Adverse Events
Associated with Acupuncture and Moxibustion in Japan. Med Acupunct. 2017; 29(3): 155-62.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5512321/pdf/acu.2017.1230.pdf (8.13.2019)[2] Yamashita H. Introduction to Modern Clinical Acupuncture and Moxibustion. – 6. Adverse
Effects of Acupuncture and Moxibustion and Information Dissemination. Physiotherapy andMedical Rehabilitation. 2011; 41(2): 11-6.
[3] Article 1-4 (2), Medical Care Act.
https://www.mhlw.go.jp/web/t_doc?dataId=80090000&dataType=0&pageNo=1 (10.30.2019.)[4] Shinbara H, Togo T, Tsutani K. A Study of Acupuncture and Moxibustion Related Accidents
Using the Information Data Bank System. Program of the 64th Annual Congress of the Japan
Society of Acupuncture and Moxibustion. 2015; 248.
https://www.jstage.jst.go.jp/article/jjsam/65/S1/65_149/_pdf/-char/ja (8.14.2019)[5] Ozaki T. Safety and Risk Measures for the Key Facial Acupuncture Points. Ido-no-Nippon-Sha.
2006; Special Supplement. 11: 80-4.

35

Forgotten Needles
Forgetting to remove needles may cause organ injury, difficulty removing a needle (stuck needle),
needle breakage, needlestick accidents, etc.
1.

Practitioners should check the number of needles used before the patient changes position
and before the end of treatment as a precaution against forgotten needles. It is recommended
that the number of needles be checked by two or more practitioners double checking or by asingle practitioner cross checking. [1]Bibliography[1] Egawa M, Ishizaki N. Ideas for Safer Acupuncture Practice – II. Methods to Avoid Forgotten
Needles. Journal of the Japan Society of Acupuncture and Moxibustion. 2007; 57(1): 3-6.
https://www.jstage.jst.go.jp/article/jjsam/57/1/57_1_2/_pdf (8.14.2019)36

Adverse Events Due to Moxibustion
Adverse events due to moxibustion include burn injury, moxibustion scar suppuration, andcanceration at the moxibustion site.
1.

Practitioners must strive to practice moxibustion site hygiene. [1-3]2.

Practitioners should avoid moxibustion at sites where inflammation, infection, wound,circulatory impairment, etc. are present because treatment carries the risk of causing
suppuration, ulceration, or symptom aggravation. [1-3]3.

Practitioners need to beware of treating parts affected by disturbance of the senses (e.g. senseof pain and sense of heat) because it is difficult for such patients to give feedback about pain
and heat. Practitioners should ask the patient adequate questions about any history of disease(e.g., diabetes) that may cause sensory disturbance, and should also abide by his/her
physician’s decision on the suitability of treatment if his/her pathological condition has notstabilized. [1-3]4.

Practitioners should avoid excessive stimulation for immuno-compromised patients (diabetic
patients, long-term steroid users, etc.) because there is a higher risk of causing suppuration
and ulceration of moxibustion scars than in healthy individuals, and practitioners should also
abide by their physician’s decision on the suitability of treatment if his/her pathologicalcondition has not stabilized. [1-3]5.

Practitioners should stay by the patient’s side during moxibustion treatment, so that he / she isable to deal with any unforeseen situations. [1]6.

In the event of unintended slight burn injury (first degree), promptly cool the affected part
under running water. If the burn injury is moderate (second degree) or worse and carries therisk of infection, practitioners should advise the patient to see a specialist. [1-3]7.

Practitioners should pay close attention performing moxibustion with excessive stimulation
over a long period at the same site because it may induce an adverse event. [2-5]Bibliography[1] Council of Colleges of Acupuncture and Oriental Medicine (CCAOM). Clean Needle
Technique Manual -Best Practices for Acupuncture Needle Safety and Related Procedures-. 7thed. 2015. pp24-30.
https://www.acusova.com/resources/Documents/7thEditionManualEnglishPDFVersion.pdf#sear
ch=%27Clean+Needle+Technique+Manual+Best+Practices+for+Acupuncture+Needle+Safety+and+Related+Procedures%27 (2.29.2020)[2] Furuse N, Yamashita H, Masuyama S, et al. Case reports on adverse effects of acupuncture andmoxibustion : a review of papers published between 2007 and 2011. Journal of the Japan
Society of Acupuncture and Moxibustion. 2013; 63(2): 100-14.
https://www.jstage.jst.go.jp/article/jjsam/63/2/63_100/_pdf/-char/ja (8.14.2019)[3] Furuse N, Uehara A, Sugawara M, et al. Literature Review on Adverse Events (2012-2015)
Associated with Acupuncture and Moxibustion. Journal of the Japan Society of Acupunctureand Moxibustion. 2017; 67(1): 29-47.
https://www.jstage.jst.go.jp/article/jjsam/67/1/67_29/_pdf/-char/ja (2019. 8.14)[4] Komatsu T, Takahashi K. A Case of Squamous Cell Carcinoma in a Moxibustion Scar. Japanese
Journal of Dermatology. 2007; 117(5): 827.
37

[5] Kamei C, Kuramochi D, Kitahara M, et al. Squamous Cell Carcinoma from Moxibustion Scar A Case Report-. Journal of Japan Society of Plastic and Reconstructive Surgery. 2014; 34(6):461-6.

38

V. Safety in Related Therapies
The safety measures in therapies related to acupuncture and moxibustion (related therapies) assume
the measures to prevent adverse events for each specific therapy. In all related therapies, practitioners
should only commence therapy after fully explaining the expected effects and risks of the therapy tothe patient and obtaining his/her consent.

Low-frequency Electro-acupuncture Therapy
Low-frequency electro-acupuncture (EA) therapy is a therapy that introduces into the body lowfrequency electric stimulation via two acupuncture needles (filiform needles) inserted into the body.
In the course of electro-acupuncture, practitioners must check beforehand in writing or verballywhether there is anything that may contraindicate the therapy. Practitioners must also note theoutcomes of such checks in the medical record.
(1) Acupuncture needles
1. The needles used in electro-acupuncture must be needles that can withstand external forces
such as muscle contraction and corrosion due to electrolysis (electrolytic corrosion), which
can cause needle breakage.
2.

It is strongly recommended that practitioners use sterile stainless steel filiform needles for
single-use in order to prevent adverse events such as needle breakage. [1, 2]

3.

Practitioners should not use silver needles as they are susceptible to electrolytic corrosion.

4.

It is recommended that practitioners use needles of at least size 20 (0.20 mm needle body
diameter) in order to prevent needle breakage due to electrolytic corrosion etc. Needles with aneedle body length of at least 30 mm are recommended. [1](2) Electro-acupuncture stimulator
1. Practitioners must use a medical-grade certified electro-acupuncture stimulator as the device(energizing device) for electro-acupuncture. [1, 2]
2.

Practitioners should inspect energizing devices and electrical cords before using them. It is
desirable that they be regularly maintained and inspected.

3.

Practitioners should not use DC pulse current because it makes needles susceptible toelectrolytic corrosion. [2, 3]

4.

Practitioners should not use energizing devices in proximity to VHF therapy equipment or
microwave therapeutic devices because they affect the output of the energizing device. [1](3) Contraindicated Cases
1. Practitioners must not perform electro-acupuncture on patients who are using implanted
medical devices such as pacemakers or defibrillators because it carries the risk of causing
oversensing or another malfunction.
［4-6］
2.

Practitioners should not use electro-acupuncture in conjunction with wearable medical
devices (e.g. electro-cardiogram) because it carries the risk of malfunction.

39

3.

It is desirable that practitioners refrain from performing electro-acupuncture on patients withwhom it is not possible to adequately communicate since it is difficult to determine the rightlevel of stimulation.

(4) Additional Precaution
1. It is hoped that practitioners keep watch during electro-acupuncture because it carries the riskof muscle contraction altering the depth of needle insertion. [7]Bibliography[1] Electro-stimulator Assessment Working Group, The Japan Society of Acupuncture andMoxibustion (Public Interest Incorporated Association). Recommendations on Standards forElectro-stimulator Safety. Revised Edition. 2012.06.08.
https://ssl.jsam.jp/pdflib/YTzAqq.pdf (8.14.2019)[2] Zhang CS, Zhang GS, Xu S, et al. Examination of needle surface corrosion inelectroacupuncture. Acupunct Med. 2018; 36(6): 367-76.
[3] Kitade T, Minamikawa M, Morikawa K, et al. Influence of Differing Waveforms on ElectricalCorrosion. The Journal of The Japan Acupuncture & Moxibustion Society. 1976; 25(2): 34-8.
https://www.jstage.jst.go.jp/article/jjsam1955/25/2/25_2_34/_pdf/-char/ja[4] Graf D, Pruvot E. Inappropriate ICD shocks. Heart. 2007; 93(12): 1532.
[5] Lau EW, Birnie DH, Lemery R, et al. Acupuncture triggering inappropriate ICD shocks.
Europace. 2005; 7(1): 85-6.
[6] Fujiwara H, Taniguchi K, Takeuchi J, et al. The influence of low frequency acupuncture on ademand pacemaker. Chest. 1980; 78(1): 96-7.
[7] Cummings M. Safety aspects of electroacupuncture. Acupunct Med. 2011; 29(2): 83-5.
https://journals.sagepub.com/doi/pdf/10.1136/acupmed-2011-010035

40

Kyutoshin Therapy (Moxa Needling Therapy)
Kyutoshin therapy, also referred to as Moxa needling therapy, is a therapy that provides invasive
mechanical stimulation and non-invasive heat stimulation to the body by applying moxa on thehandle of the inserted acupuncture needle (filiform needle) and burning it. The types of moxa appliedon the needle handle include moxa balls, cut moxa wrapped in cylinders with Japanese paper, or
carbonized moxa made from charcoal. Practitioners need to beware of the risk of unintentional burninjury, such as falling off of the moxa balls.
(1) Acupuncture needles and Moxa
1. Practitioners must use filiform needles for Kyutoshin, with both metal and heat-resistanthandles and bodies.
2.

It is recommended that practitioners use sterile single-used filiform needles with metal
handles. [1]3.

It is recommended that practitioners use needles of at least size 20 (0.20 mm needle body
diameter) with a needle body length of at least 50 mm. [1]4.

Practitioners should ensure that the weight of the moxa ball, cut moxa, or carbonized moxa,
including the moxa needle cap, does not cause the needle body to sag. [1]5.

Practitioners should use moxa for moxa balls that is of sufficient quality that the ball does not
disintegrate during treatment. [1](2) Preventing Burn injury
1. Practitioners must beware of unintentional burn injury. In particular, practitioners must bewareof hot needles falling over, moxa falling, and excessive radiant heat from multiple moxa
needles or the needle body sagging. Practitioners must also take measures to prevent thesefrom happening, as necessary. [1]2.

Practitioners must give the patient instructions not to move during treatment, to prevent any
needle from falling over. [1]3.

Practitioners must keep watch over the patient while burning moxa. [2]4.

Practitioners should have the patient check the intensity of the heat felt and should also checkthe intensity of the heat with their own hands while burning moxa, because sensitivity to heatdiffers among individuals. [2]5.

Practitioners should not use Kyutoshin in combination with other thermotherapies, especiallyinfrared therapy, because the radiant heat is excessive. [2]6.

Practitioners need to beware when removing needles because the temperature of the needle
handle will be raised immediately after burning the moxa. [3]Bibliography[1] Yano T (Editor-in-Chief), Sakai T, Kitakoji H, Yasuno F (Editorial Committee). Illustrated Guide
To Acupuncture and Moxibustion Therapies – Everything You Need to Know for Good
Acupuncture and Moxibustion Clinical Practice I. 1st Edition. 2012. pp109-12.

41

[2] Council of Colleges of Acupuncture and Oriental Medicine (CCAOM). Clean Needle
Technique Manual -Best Practices for Acupuncture Needle Safety and Related Procedures-. 7thed. 2015. pp24-30.
https://www.acusova.com/resources/Documents/7thEditionManualEnglishPDFVersion.pdf#sear
ch=%27Clean+Needle+Technique+Manual+Best+Practices+for+Acupuncture+Needle+Safety+and+Related+Procedures%27 (2.29.2020)[3] Shinbara H, Nagaoka S. Study of Measures to Prevent Moxa Balls Falling During Moxa
Needling – Applying Starch Glue to the Needle Handle –. Journal of Japanese Society ofOriental Physiotherapy. 2015; 40(2): 41-7.

42Shiraku Acupuncture Therapy
Shiraku acupuncture therapy is a therapy that releases a small amount of blood by puncturing theskin using a three-edged needle or a filiform needle. [1]1.

It is recommended that practitioners ensure all acupuncture implements and personal
protective equipment that either will be contaminated or may be contaminated with blood besingle-use. [2]2.

If using implements that are intended for reuse (e.g. three-edged needles), practitioners must
use implements that have been cleaned, disinfected, and stored, or cleaned, sterilized, andstored, using appropriate methods. [3, 4]

3.

Practitioners must wear medical gloves as protection against exposure to blood. It is also
recommended that practitioners use a plastic apron or gown, surgical mask, goggles, andsimilar equipment, as necessary. [5]Bibliography[1] The Japan Association of Shiraku Acupuncture (Editor). New Edition. Shiraku Acupuncture
Manual – From the Basics to Clinical Practice. First Edition. Tokyo. Rikuzensha. 2013. p6．
[2] Directive from the Medical Professions Division, Health Policy Bureau, Ministry of Health andWelfare. Prevention of AIDS Infection in Acupuncture and Moxibustion. 3.20.1987. Medical
Professions Division Directive No. 19.
https://www.mhlw.go.jp/web/t_doc?dataId=00ta4926&dataType=1&pageNo=1 (8.14.2019)[3] Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee(HICPAC). Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008. pp11-3.
(CDC guideline)
https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines-H.pdf (11.3.2019)[4] Mitsuda T. (Translator/Author). CDC Guideline for Disinfection and Sterilization in Healthcare
Facilities, 2008. Van Medical Co., Ltd. 2009. pp22-6.
[5] Siegel JD, Rhinehart E, Jackson M, Chiarello L; the Healthcare Infection Control Practices
Advisory Committee. 2007 Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Health Care Settings. Am J Infect Control. 2007; 35(10 Suppl 2): S65-164.
(CDC guideline)
https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines-H.pdf (8.14.2019)43

Teishin Therapy and Shonishin Acupuncture (Japanese pediatric acupuncture)
Teishin therapy and Shonishin acupuncture (Japanese pediatric acupuncture) are therapies thatprovide non-invasive mechanical stimulation to the skin, the former using Teishin, and the latter
using non-invasive dermal needles.
1.

It is recommended that all needles that practitioners use in Teishin therapy and Shonishin
acupuncture be single-use. [1, 2]

2.

If using needles intended for reuse, practitioners must use needles that have been cleaned anddisinfected or sterilized using appropriate methods. [1, 2]

3.

In regard to the appropriate methods mentioned in 2), it is recommended that practitioners
clean and disinfect needles (cleaning only is allowable) if the needles come into contact withnormal skin, while practitioners must clean and sterilize needles if they come into contact
with damaged skin (e.g. skin affected by atopic dermatitis).

Bibliography[1] Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee(HICPAC). Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008. pp11-3.
(CDC guideline)
https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines-H.pdf (11.3.2019)[2] Mitsuda T. (Translator/Author). CDC Guideline for Disinfection and Sterilization in Healthcare
Facilities, 2008. Van Medical Co., Ltd. 2009. pp22-6.

44

Hinaishin Therapy and Empishin Therapy (Intradermal Needling Therapy)
Including Ear Acupuncture Therapy
Intradermal needle is the general term for Hinaishin and Empishin in both of which have shortneedle body. Intradermal needling therapy is performed using Hinaishin or Empishin for the purposeof providing invasive mechanical stimulation continuously to the skin and to the subcutaneous tissue.
1.

It is recommended that practitioners use sterile single-use intradermal needles. Practitioners
must not reuse intradermal needles. Once they have been applied, practitioners must also notreapply intradermal needles. Practitioners must instruct patients not to reapply them. [1]2.

Practitioners should not perform treatment at sites where there is any skin abnormality, e.g.
inflammation sites, injury sites, infection sites, and open wounds. [1]3.

Practitioners must instruct patients in the appropriate and safe methods of peeling off anddiscarding needles, to prevent needlestick accidents. Practitioners should peel off and discard
intradermal needles if these are difficult for the patient to do. [1, 2]

4.

There have been reports of minor cases of itching, pain, discomfort, etc. as adverse events due
to intradermal needles. When performing treatment, practitioners should explain theseadverse events to the patient and the ways to deal with them, and obtain their consent before
proceeding. [1, 3]

5.

Practitioners should avoid applying intradermal needles for long periods because it carries therisk of causing breakage and embedding in the skin due to breakage. [4]6.

Practitioners should advise the patient to promptly seek medical help if an intradermal needle
or part thereof is completely embedded within the skin and cannot be removed. It is desirable
that practitioners accompany the patient whenever possible and assist procedures by
explaining the details of the treatment to the physician, for example.

7.

Practitioners need to beware that the risk of an intradermal needle adverse event increases
with the time the needle is applied. Practitioners should instruct the patient to promptly
remove an intradermal needle if he/she experiences pain or discomfort at the site. [3]8.

Intradermal needles are susceptible to peeling off when they become wet with a large volume
of water, such as when bathing, showering, swimming, or sweating. It is recommended that
intradermal needles be removed beforehand, to prevent any accident due to them peeling off.

9.

It is hoped that steps be taken to prevent intradermal needles from peeling off after they havebeen applied, such as covering them with adhesive tape, to prevent them from peeling off due
to exercise and to prevent any consequent accident.

Bibliography[1] Council of Colleges of Acupuncture and Oriental Medicine (CCAOM). Clean Needle
Technique Manual -Best Practices for Acupuncture Needle Safety and Related Procedures-. 7thed. 2015. pp59-62.
https://www.acusova.com/resources/Documents/7thEditionManualEnglishPDFVersion.pdf#sear
ch=%27Clean+Needle+Technique+Manual+Best+Practices+for+Acupuncture+Needle+Safety+and+Related+Procedures%27 (2.29.2020)45

[2] Kikuchi T, Yamaguchi S, Omata H, et al. Accidental Insertion Involving a Nurse Mistakenly
Inserting a Hospitalized Patient’s Subcutaneous Needle. Program of the 64th Annual Congressof the Japan Society of Acupuncture and Moxibustion. 2015; 249.
https://www.jstage.jst.go.jp/article/jjsam/65/S1/65_149/_pdf/-char/ja (8.14.2019)[3] Furuya E, Kaneko Y, Uehara A, et al. Evaluation of the Safety of Retaining Press-Tacks in
Volunteer Subjects. Journal of the Japan Society of Acupuncture and Moxibustion. 2011; 61(3):310.
https://www.jstage.jst.go.jp/article/jjsam/61/3/61_3_247/_pdf/-char/ja (8.14.2019)[4] Takata K, Ebiko K, Kimura Y, et al. Necessity of Precautions Against Expired and Broken Press
Tack Needle. Kampo Medicine. 2016; 67(2): 191-4.
https://www.jstage.jst.go.jp/article/kampomed/67/2/67_191/_pdf/-char/ja (8.14.2019)46

Ryushin Therapy (Press-sphere Therapy) Including Ear Acupuncture Therapy
Ryushin therapy, also referred to as Press-sphere therapy, is a therapy that provides continuous,
non-invasive, mechanical stimulation to the skin by applying spheres onto the acupoints or othertarget points on the body surface. Spheres are applied not for puncturing the skin but for pressing
those points. The types of press-spheres include herbal substances, seeds, stainless steel, and granule
coated by gold or silver.
1.

In the course of treatment, practitioners need to beware of the patient’s history because theretained spheres and adhesive tape may cause allergic reaction. [1]2.

Practitioners must fix spheres with adhesive tape to prevent the spheres from falling off.

3.

There have been reports of adverse events where spheres have made their way into the innerear via a perforation in the eardrum. In Ear acupuncture, practitioners should check whether
the patient has a perforated eardrum and refrain from applying spheres if the patient has aperforation. [2-4]Bibliography[1] Council of Colleges of Acupuncture and Oriental Medicine (CCAOM). Clean Needle
Technique Manual -Best Practices for Acupuncture Needle Safety and Related Procedures-. 7thed. 2015. p63.
https://www.acusova.com/resources/Documents/7thEditionManualEnglishPDFVersion.pdf#sear
ch=%27Clean+Needle+Technique+Manual+Best+Practices+for+Acupuncture+Needle+Safety+and+Related+Procedures%27 (2.29.2020)[2] Yamauchi D, Hori T, Kiyakawa H. A Case of a Ball for Ear Pressure Point Diet AcupressureEntering the Middle Ear. Otol Jpn. 2012; 22(4): 491.
[3] Igarashi K, Matsumoto Y, et al. Ear Pressure Point Gold Pellets Entering the Eustachian Tube.
Otol Jpn. 2013; 23(4): 540.
[4] Oji T, Okamoto H, et al. A Case of an Adverse Event Due to Ear Acupuncture Therapy. Kampo
Medicine. 2015; 66 (Supplement): 336.

47

Appendix – Explanation of Terms
Accident report
A written report on the details of a medical accident. These reports help to identify accident trends
and conditions, and they identify the issues and the points that require systematic prevention
measures to prevent accidents from recurring.
Airborne transmission
Infection by germs that spread by floating in the air for long periods of time on droplet nuclei of 5
microns or less. It may be prevented by using filtration masks and air-conditioning, such as rooms
with negative pressure.
Alcohol-based disinfectant
Alcohol is the main component of such disinfectants, of which there are two types: ethyl alcohol(ethanol) and isopropyl alcohol (isopropanol).
Benzalkonium chloride
A cationic surfactant (invert soap) and a low-level disinfectant mainly used for disinfection ofenvironmental surfaces (beds, floors, etc.). It is sometimes added to quick-drying alcohol-based handrub.
Biohazard marks
Marks affixed to containers holding infectious waste so as to be able to identify them as such. If thecontents are liquid or sludge (e.g., blood), the mark is red, if solid (e.g., blood-stained gauze) the markis orange, and if sharp (e.g., syringe needles, acupuncture needles) the mark is yellow.
Cardiac tamponade
A condition in which a large amount of fluid (pericardial fluid or blood) or gas accumulates in the
pericardium (pericardial sac) around the heart, preventing the heart from fully expanding. This can becaused by needling to the heart.
Chlorhexidine gluconate
A low-level disinfectant for use on the body and causes little skin irritation and has almost no odor.
Not only does it demonstrate sterilizing properties when used, but it also remains on the skin anddemonstrates a lasting antimicrobial effect. It is sometimes added to quick-drying alcohol-based hand
rubs.
48

Cleaning
The physical removal of organic matter from the body or equipment.
Contact transmission
Infection caused by microorganisms that spread through direct contact via the patient or indirectcontact via the surrounding objects and environmental surfaces. It can be prevented by isolation in an
individual room, using gloves, and hand disinfection using a disinfectant.
Dangerous needling depth (dangerous depth)
A needling depth that exceeds the safe depth and that carries the risk of injuring organs or major
blood vessels or nerves.
Dermal needles
A general term for needles intended for stimulating body surface. They are divided into non-invasive
needles and invasive needles.
Disinfection
Reducing the number of germs. It does not kill germs completely and the extent of effectiveness
depends on the disinfectant.
Droplet transmission
Infection by germs that spread on droplet nuclei larger than 5 microns. It may be prevented bymaintaining distance from the patient, by having the patient wear a mask, and so on.
Electro-acupuncture stimulators
Therapeutic devices specifically for electro-acupuncture therapy. They are classified as Class II(controlled medical devices) medical devices.
EmpishinA type of subcutaneous needle of which the shape is like a pushpin. This type of needle is inserted
perpendicularly to acupoints to stimulate subcutaneous tissue. Empishin are also called as
intradermal thumbtack type needles.
Ethanol for disinfection49

A medium-level disinfectant widely used on the body and environmental surfaces. It is effective foralmost all microorganisms, except spores. In the Japanese Pharmacopoeia, ethanol for disinfection isdefined as 76.9 to 81.4 vol% ethanol.
Ethanol for disinfection defined by the Japanese Pharmacopoeia
See Ethanol for disinfection.
Filiform needle
A type of needle for insertion. It consists of a needle body (the part that is inserted) and a needle
handle (the part for manipulating the needle). Usually acupuncture needles refers to filiform needles.
Fingerstalls
These are used to prevent transmission to both the patient and the practitioner. They are made oflatex rubber and are available sterilized or unsterilized.
First aid
Treatment performed by trained paramedics at the scene of the injury/illness incident, or while beingtransported to a hospital, prior to comprehensive or decisive treatment at a medical facility, etc.
Foreign body
The general term for anything present in the body that is not a “normal cell.” Specifically, thisincludes retained needles and calculus around a retained needle. Embedded needles that
intentionally embedded inside the body are also foreign bodies.
Hemophilia
A disease caused by an inherent deficiency of blood coagulation factor, resulting in a tendency to
bleed. Needling may cause bleeding into deep tissues (internal bleeding, hematoma).
Hinaishin
Type of intradermal needles. The needles are inserted sideways into the skin for stimulation to thesubcutaneous tissue. Hinaishin also called as intradermal granule type needles.
Incident report
A written report on the details of an incident. These reports help to identify incident trends andconditions, and they identify the issues and the points that require systematic prevention measures toprevent accidents from recurring. An incident is an unforeseen event that causes the individuals
50concerned to experience a fright or surprise, even if it does not cause personal or economic loss tothe patient.
Infectious waste
Waste from medical institutions, etc. that contains infectious (or potentially infectious) pathogens thatcan be transmitted to humans.
Intermediate-level disinfection (disinfectants)
These kill all germs except spores, although some demonstrate sporicidal performance. They include
sodium hypochlorite, povidone iodine, alcohols, etc.
Intradermal needles
The general term for an Hinaishin and Empishin in both of which have short needle body. Theirneedles are inserted sideways into the skin for stimulation to the subcutaneous tissue.
Isopropyl alcohol (isopropanol)
A medium-level disinfectant widely used on the human body and environmental surfaces. It iseffective against virtually all microorganisms, except spores. It is a more powerful degreaser thanethyl alcohol and has a distinct odor.
Low-frequency electro-acupuncture (electro-acupuncture)
An acupuncture therapy that provides low-frequency electrical stimulation to the body via filiform
needles inserted into the body.
Low-level disinfection (disinfectants)
Disinfection that is effective against most bacteria, certain types of viruses, and fungi, but ineffective
against Mycobacterium tuberculosis and spores. Disinfectants include chlorhexidine gluconate,
quaternary ammonium compounds (benzalkonium chloride and benzethonium chloride), andamphoteric surfactants.
Embedded needling therapy
These terms refer to the therapy whereby a needle is intentionally embedded inside the body.

51

Medical gloves
Single-use gloves used to prevent infections in both patients and health care providers, including
gloves made of latex rubber, nitrile rubber, and plastic. These include unsterilized gloves for medical
examination and sterile gloves used during surgery and aseptic operations.
Nerve injury
Neurological symptoms originating in injury to the nerve itself or damage to nervous tissue (such as
hemorrhage and hematoma) caused by needling.
Organ injury
Injury to internal organs or blood vessels caused by needling or a retained needle.
Oversensing
Misrecognition by cardiac pacemakers of muscle potential or noise as heartbeat.
Personal protective equipment
The items used if there is a possibility of contamination of clothing by blood or body fluids, including
gowns or aprons, masks, goggles, gloves and so on. These are all single-use items and are replaced
after every use.
Quick-drying alcohol-based hand rub
A disinfectant based on alcohol used to make germs inactive and/or to temporarily control their
proliferation on the hands.
Retained needles
Needles that remain in the body due to needle breakage. Retained needles include needles thatremain inside the body by Embedded needling therapy.
Safe needling depth (safe depth)
The needling depth that does not carry the risk of injuring organs, major blood vessels, or nerves.
Shonishin acupuncture therapy (Japanese pediatric acupuncture)
Acupuncture treatment applied to babies and children. Treatment is mainly performed with noninvasive dermal needles.

52

Single-use filiform needles
Filiform needles intended for single-use. The type of needle is classified as a Class II medical device(controlled medical device) and the requirements is stipulated by Japan Industrial Standard (JIST9301: 2016: Acupuncture needle for single use).
Sodium hypochlorite
A medium-level disinfectant that demonstrates immediate sterilizing properties against mostmicroorganisms, including spores. Its use in medical devices is limited to plastic products because it
corrodes metals. It is also used to bleach clothing and linen.
Stuck needles (Difficulty removing needles)
A circumstance in which an inserted needle cannot be removed.
Sterilization
Sterilizing by killing all germs, including spores.
Teishin
The stick-shaped needles with round tips intended for pressing acupoints or rubbing meridians. Typesof needles that do not penetrate the skin.
Three-edged needle
A type of needle for insertion of which the tip is like a triangular awl and is used in Shiraku
acupuncture therapy.
Vaccine non-responder
A person who has been vaccinated but does not have the antibody titers needed for prevention. In
hepatitis B vaccination, it refers to individuals who have not become positive for antibodies even after
two series of vaccinations (three vaccinations per series).
Note: When translating acupuncture and moxibustion terms this time, please note that some of them
are not officially recognized translations.

53

Acknowledgment
This Guideline was written with assistance for “Scientific research and investigation for standard
development in ISO/TC249 and foundation research in the field of Kampo and acupuncture asimportant wings of integrative medicine,” research relating to laying the foundations for international
standardization of integrative medicine – Research Project for Improving Quality in Healthcare andCollecting Scientific Evidence on Integrative Medicine in 2019 by the Department of ClinicalResearch and Trials (Division of Clinical Research and Trials) at the Japan Agency for Medical
Research and Development (AMED). (Task Management Number: 19lk0310066h0001, Lead
Research Institute: Chiba University, Principal Researcher: NAMIKI Takao)

NoteThis book was originally published in Japanese under the title of: “Shinkyu Anzen Taisaku Gaidorain
2020 Nenban”
Editor: Committee for Safe Acupuncture, JSAM c 2020 1st ed.
ISHIYAKU PUBLISHERS, INC.
7–10, Honkomagome 1 chome, Bunkyo–ku,
Tokyo 113–8612, Japan

54

Safety Guidelines for Japanese Acupuncture andMoxibustion Practice 2020
Published: March 1, 2020
Revised (Ver.1.1): June 4, 2021
Supervising Editor: SAKAMOTO Ayumi
Edited and Published by: Safety Committee, Clinical Information Department,
The Japan Society of Acupuncture and Moxibustion (JSAM) (Public Interest
Incorporated Association)© Copyright 2020 JSAM. All Rights Reserved.

55