Interpretation of World Federation of... : Guidelines and Standards in Chinese Medicine (2025)

Introduction

In recent years, as evidence of the effectiveness of acupuncture therapy has gradually increased, acupuncture has been increasingly used in clinical practice around the world. At the same time, reports of the risks of acupuncture have also increased, raising questions about the safety of acupuncture¹. As an invasive procedure, acupuncture does carry certain risks, especially when practitioners are not adequately trained or do not perform the procedure according to specifications. It is therefore necessary to clarify the basic requirements for the safe use of acupuncture and to help acupuncture practitioners standardize acupuncture procedures to minimize risks. However, the risks involved in performing techniques with different needles vary, but there are also some commonalities. Therefore, before developing the safe use standards for various specific acupuncture needles, it is necessary to first develop the general requirements for the safe use of acupuncture, and lay a foundation for the establishment of subsequent relevant standards for various specific needles, so as to avoid repeating the common issues of the safe use of acupuncture in the standards for the safe use of specific needles². To reduce the acupuncture risk worldwide and meet the global basic needs for the safe use of acupuncture, the World Federation of Acupuncture-Moxibustion Societies (WFAS) authorized the Institute of Acupuncture and Moxibustion of the China Academy of Chinese Medical Sciences to preside and draft the standard “General Requirements for the Risk Control in the Safe Use of Acupuncture”³ (hereinafter referred to as “this standard”), which was released by WFAS in October 2023, published in December 2023, and officially uploaded to the WFAS website in September 2024.

As the first general international standard in the field of acupuncture safety standards, this standard specifies the basic requirements for the safe use of acupuncture, defines terms with common characteristics that are easily confused in the field of acupuncture safety, clarifies the scope and level of acupuncture risks, sorts out the sources of acupuncture risks, and formulates the control processes and control measures for acupuncture risks, and lays the foundation for the establishment of subsequent related standards for specific needles. To help the developers of standards related to the safe use of acupuncture needles to better understand and apply this standard, this paper interprets the development process and content of this standard, analyzes the terminology definition process of this standard, the current research status of acupuncture risk, and the sources of different types of acupuncture risk and corresponding control measures, and provides readers with professional references, so as to further promote the global promotion and application of this standard.

Scope

The purpose of this standard is to clarify the basic requirements for the safe use of acupuncture to minimize the risk of acupuncture, while avoiding the repetition of common issues of safe use of acupuncture in different specific standards and build a framework for the establishment of subsequent related specific standards.

Development process

This standard is developed in accordance with the technical procedures and rules established by the Standardization Working Committee of the WFAS. The development has gone through several key technical processes, including application, project establishment, drafting, review, approval, release, and publication. The development process is shown in Figure 1.

Team formation

To ensure the professionalism and international applicability of each part in the development process of this standard, the project team was formed with 14 members from 7 countries, including 6 drafting members and 8 expert committee members. The expert committee includes experts in acupuncture, methodological experts in international standardization, professional translators, and experts in policy and regulation.

International survey

To understand the opinions of future users of this standard, the drafting team conducted 2 rounds of international questionnaire surveys, including researchers of acupuncture standards in medical institutions, medical schools and research institutes, experts in the field of acupuncture standardization and overseas acupuncture experts. Based on this, the drafting team established the basic structure of this standard⁴.

Literature research

The drafting team conducted a systematic review and meta-analysis on the topic of acupuncture risks and registered in the International Prospective Register of Systematic Reviews (PROSPERO, registration number: CRD42022329627). Fourteen Chinese and English databases were extensively searched, covering the period from inception to October 2022. A total of 28,780 articles on the risks of acupuncture were retrieved, and after screening, a total of 784 articles in 8 languages ​​(Chinese, English, Japanese, Chinese, French, Danish, German, and Spanish) from 29 countries on 5 continents with were finally included, including 122 randomized controlled trials (RCTs), 54 clinical controlled trials (CCTs), 75 observational studies, and 531 case reports⁴. The results of quantitative and qualitative analysis that the incidence of adverse events of acupuncture is significantly lower than that of Western medicine and other nondrug therapies⁵. The results of the literature research provided strong support evidence for this standard.

Drafting the working draft

Based on the international survey and literature review, the drafting team adhered to the basic principles of practicality, operability, and international compatibility and completed the first working draft of this standard.

Consulting experts

Two rounds of expert consultation for the first working draft of this standard were held within the expert committee of this standard, and a total of 180 expert opinions were collected. The drafting team revised the working draft of this standard based on the expert feedback.

Interviewing experts

For controversial issues in the working draft, the drafting team conducted semistructured expert interviews with 32 experts from 8 countries. Based on the results of the expert interviews, the drafting team further revised and improved the working draft and finally completed the working draft of this standard for submission and review.

Review, approval, and release

The draft of this standard was reviewed by meeting review, letter review, and ballot within the WFAS Standardization Working Committee. After successfully passing the review, it was submitted to the WFAS Executive Committee for approval. It was officially released by WFAS in October 2023, the paper version was published by China Standards Press in December 2023, and the electronic version was uploaded to the website of WFAS in September 2024.

Content interpretation

The main content of this standard includes 7 parts: scope, normative references, terms and definitions, scope of acupuncture risk, degree of acupuncture risk, flowchart of acupuncture risk control, and primary causes of acupuncture risk and control measures.

Scope

The first part of the standard introduces the content and scope of application of this standard, that is, this standard specifies the risks involved in acupuncture application and the general requirements for its safe use, including the definitions, risk scope, risk degree, risk sources, control processes, and control measures of risks and other relevant questions of different acupuncture needles and their using procedures. This standard mainly regulates common issues in the safe application of acupuncture techniques but does not cover the technical specifications of acupuncture needles, nor does it cover content related to the training of acupuncture practitioners and the clinical treatment and efficacy of acupuncture. It is intended to solve common problems encountered in the acupuncture practice when using different types of acupuncture needles to avoid the occurrence of acupuncture risks.

Normative references

The second part of the standard introduces the normative references.

Terms and definitions

The third part of the standard introduces the terms and definitions related to the safe use of acupuncture, including 6 terms: acupuncture risks, adverse events of acupuncture, adverse reactions to acupuncture, acupuncture accidents, acupuncture negligence, and acupuncture contraindications. Terms and definitions are the basic elements of standards and play a vital role in the development of standards. Their accuracy and clarity have a direct impact on the understanding and implementation of standards. Clarifying terms and definitions helps all parties to be consistent in their use of the standards and ensures a common understanding of the content of the standards.

Acupuncture risk is defined as “the possibility of physical or psychological damages, injuries, or other adverse conditions associated with acupuncture.” Acupuncture risks are not necessarily caused by acupuncture treatment itself. The most common concepts related to acupuncture risks include adverse events of acupuncture, adverse reactions to acupuncture, acupuncture accidents, and acupuncture negligence. These 4 concepts need to be clearly distinguished, otherwise there will be confusion in evaluating the safety of acupuncture⁴.

Different health organizations have different definitions of adverse events, but the connotations of all definitions embody common characteristics of adverse events: (1) time rationality, (2) adverse medical events, and (3) not necessarily a causal relationship with the interventions¹. This standard defines “adverse events of acupuncture” as “all adverse medical events that occur during or after acupuncture treatments, such adverse medical events may not necessarily have a causal relationship with the acupuncture treatment itself.”

The “adverse reactions to acupuncture” are part of “adverse events of acupuncture,” in addition to meeting the characteristics of an adverse event, the following conditions must also be met: (1) it is caused by a standardized intervention, (2) it has a clear causal relationship with the intervention, and (3) it is an adverse attribute of the intervention itself¹. This standard defines “adverse reactions to acupuncture” as “the adverse medical events that occur during or after a normative acupuncture treatment are caused by the acupuncture treatment itself and are not related to the purpose of the treatment.” (NOTE: Normative acupuncture treatment includes normative diagnosis, needle manipulations, and using of acupuncture instruments and devices.)

The definition process of the 2 terms “acupuncture accidents” and “acupuncture negligence” in this standard referred to the interpretation of the connotations of the two terms “medical accident” and “medical negligence” in the “regulation on the handling of medical accidents” to make a distinction^6,7. This standard defines “acupuncture accidents” as “unpredictable and hard to prevent adverse medical events that occur during or after a normative acupuncture treatment. Such adverse medical events are caused by unpredictable and irresistible reasons, and are not related to the intended purpose of the acupuncture treatment itself,” and it defines the “acupuncture negligence” as “the adverse medical events that causing personal injuries to acupuncture receivers, and are caused by acupuncture practitioners’ negligent violations of health laws, administrative regulations, departmental rules, and/or diagnosis and treatment norms and routines in the process of acupuncture treatments.” In this standard, it defines the “acupuncture contraindications” as “conditions in which acupuncture is inappropriate.”

Scope of acupuncture risks

The fourth part of the standard introduces the scope and classification of acupuncture risks. The main sources of acupuncture risks include acupuncture providers, receivers, the environment, and needles⁸. The acupuncture needle acts as a medium to connect the other 3 factors. As an invasive procedure, the acupuncture provider punctures the receiver’s skin with the needle, penetrating the skin and subcutaneous tissue, or even deeper into the body tissue. When the needle is removed, it may be contaminated with the patient’s blood or tissue. Therefore, acupuncture can pose risks to the receiver, the provider, and the environment if not performed correctly⁵. On this basis, the risks of acupuncture can be divided into 3 categories: risks to acupuncture receivers, risks to acupuncture providers, and environmental risks.

Risks to acupuncture receivers refers to the possibility of different types of acupuncture adverse events occurring in acupuncture receivers, which can be further divided into the occurring possibility of adverse reactions of acupuncture, acupuncture accidents and acupuncture negligence. Common risks to acupuncture receivers include mainly the following categories.

• Adverse reactions to acupuncture: pain, allergy, stasis of blood, hematoma, fatigue, agitation, panic, hypoesthesia, etc.
• Adverse accidents: needle shock, bent needle, broken needle, stuck needle for nontherapeutic purposes, etc.
• Infections and disease transmission: local or systemic skin infection by acupuncture, transmission of infectious diseases such as hepatitis B, hepatitis C, AIDS, syphilis, etc.
• Nerve injuries: peripheral nerve injuries may occur due to the mechanical action of acupuncture devices, and sensory disturbance and varying degrees of dysfunction may be detected in the distribution area of the nerve. For example, the median nerve injury, ulnar nerve injury, radial nerve injury, brachial plexus nerve injury, sciatic nerve injury, tibial nerve injury, and peroneal nerve injury.
• Vascular trauma, vital organ damages, disability, or death: the mechanical action of the acupuncture device may destruct the anatomic integrity of human tissues or viscera, causing mechanical injuries, disability, or death, such as traumatic pneumothorax, subarachnoid hemorrhage, and injuries to brain tissue, spinal cord, blood vessels, and internal organs, especially brain and heart injuries are the most severe consequences, which can be fatal.

Risks to acupuncture providers refer to acupuncture providers who are exposed to multiple occupational hazards in practice, mainly needle stick injuries and infections. Pricking by various types of contaminated acupuncture needles can lead to blood-borne infections for the providers.

Environmental risks refer to the possibility of contamination to the environment caused by acupuncture devices and other medical wastes contaminated by blood or tissue of the receiver. The medical wastes belong to the category of special and highly contagious wastes with a long contamination incubation period to the environment.

The classification diagram of the above 3 categories of acupuncture risks is shown in Figure 2.

The degree of acupuncture risks

The fifth part of the standard introduces the degree of acupuncture risks, which can be divided into 3 levels according to the severity: high degree, moderate degree, and low degree. The classification of acupuncture risk degrees is shown in Table 1.

Flowchart of acupuncture risk control

The sixth part of the standard presents the process of acupuncture risk control in the form of a flowchart. According to the time sequence of acupuncture, it is divided into 3 steps: before acupuncture, acupuncture period, and after acupuncture. Each step is divided into a main process and a subprocess. The acupuncture risk control process is an important part of ensuring the safety of acupuncture treatment. Strict implementation of the acupuncture risk control process can effectively reduce the risk of acupuncture and improve the safety of acupuncture treatment. The acupuncture risk control process is shown in Figure 3.

Causes of acupuncture risks and control measures

The last part of the standard introduces the causes of acupuncture risks and their control measures are presented in detail. The causes of acupuncture risks are distinguished from 3 perspectives: risks caused by providers, risks caused by receivers, and environmental risks, and the corresponding control measures are proposed accordingly.

Risks caused by acupuncture providers and corresponding control measures

This standard specifies appropriate control measures for the risks caused by acupuncture providers (Table 2).

Risks caused by receivers and corresponding control measures

This standard specifies corresponding control measures for risks caused by receivers (Table 3).

Environmental risks and corresponding control measures

The acupuncture environmental risks include poor hygienic conditions and random disposal of health care waste. The environmental risks and their corresponding control measures are shown in Table 4.

Discussion

Definitions of terms in this standard

Terms and definitions are essential and normative elements of a standard. This standard clearly defines the 6 terms “acupuncture risks,” “adverse events of acupuncture,” “adverse reactions of acupuncture,” “acupuncture accidents,” “acupuncture negligence,” and “acupuncture contraindications.” During the expert consultation process, experts had disagreement with the definition of “adverse reactions of acupuncture.” Some experts believed that the definition of “adverse reactions of acupuncture” should not include the limitation of “normative acupuncture treatment.” The emergence of this disagreement just shows the necessity of clearly defining and distinguishing the terms “adverse reactions of acupuncture” and “acupuncture accidents.” Although acupuncture accidents and adverse reactions of acupuncture are both accidents that occur during or after acupuncture treatment, the occurrence of acupuncture accidents does not necessarily have a definite causal relationship with acupuncture itself. In addition to non-normative acupuncture treatment, other reasons may also cause acupuncture accidents. Furthermore, some acupuncture accidents can be predicted and avoided. Therefore, the concept of “acupuncture accidents” cannot represent the safety of acupuncture itself, and the safety of acupuncture should not be evaluated based on this concept. “Adverse reactions of acupuncture” are accidents that occur under the premise of normative acupuncture treatment. They are caused by acupuncture itself and are the adverse properties of acupuncture itself. They cannot be predicted or avoided in advance. Therefore, the concept of “adverse reactions of acupuncture” can better assess the safety of acupuncture itself¹.

Current status of acupuncture risk research

As an invasive treatment method, acupuncture undoubtedly carries certain risks. There are many detailed records and discussions of the safety and contraindications of acupuncture in the ancient Chinese medical literature. This has provided a basis for safe practice for generations of acupuncture practitioners and has effectively reduced the risks of acupuncture treatment. Current research on the risk of acupuncture is relatively scattered and lacks systematicity. Most current clinical studies and case reports describe the risks of only 1 or 2 acupuncture techniques, and their descriptions lack standardization, making it difficult to assess the risk of acupuncture in the broadest sense. The only relatively systematic and comprehensive systematic evaluation or survey research on acupuncture risks also has limitations in terms of time, region, and research content⁵. Therefore, the drafting team of this standard conducted a systematic review of the literature on the risks of acupuncture.

Risk analysis for acupuncture receivers

The drafting team of this standard reviewed and summarized the causes of acupuncture risks through a review of ancient Chinese medical literature and found that the causes of risk for acupuncture receivers mainly include 2 aspects: acupuncture providers and acupuncture receivers. From the perspective of acupuncture receivers, low awareness and low cooperation with acupuncture, weak mental and physical constitution, and poor physical condition before acupuncture can all lead to acupuncture risks. From the perspective of acupuncture providers, the failure to fully concentrate during acupuncture, to select appropriate needles, to avoid risky anatomical structures, to master the appropriate acupuncture depth, to follow the correct principles of tonification and sedation, and to master the appropriate acupuncture time, needle retention time, and needle removal techniques are all key factors leading to acupuncture risks⁵.

The drafting team’s systematic review and meta-analysis of the risk for acupuncture receivers shows that the risk incidence rate of the experimental group (intervention was acupuncture) was 6.51% (440/5627) in the 122 RCTs included, and the risk incidence rate of the control group (intervention was western medicine or other nondrug therapies) was 13.66% (771/4624). The incidence rate of the experimental group was significantly lower than that of the control group (P<0.001). Among the 54 CCTs included, the risk incidence rate of the experimental group (intervention was acupuncture) was 2.77% (89/3211), and the risk incidence rate of the control group (intervention was Western medicine or other nondrug therapies such as medium-frequency electrotherapy, traction, massage, etc.) was 15.33% (380/2476). The risk incidence rate of the experimental group was significantly lower than that of the control group (P<0.001). It can be seen that the risk to acupuncture receivers is much lower than that of western medicine and other nondrug therapies⁵.

In general, the risks to acupuncture receivers come from, on the one hand, the provider’s insufficient professional skills, lack of responsibility, excessive operation intensity, improper use of needles, ineffective disinfection and infection control measures, and lack of safety awareness; and on the other hand, the receivers’ excessive tension or anxiety, pathologic changes in organs, and low tolerance and cooperation. Normative acupuncture operations can reduce the risk to acupuncture receivers. Improving the professional skills and clinical ability of acupuncture providers is the primary measure to control acupuncture risks. At the same time, the cooperation of acupuncture receivers also plays a key role in risk control⁵. Therefore, only when the joint participation of acupuncture providers and receivers can the risks of acupuncture be minimized.

Analysis of risks to acupuncture providers

Non-normative acupuncture not only poses risks to the receivers but also risks to the providers themselves, such as acupuncture injuries (needle injuries caused by accidental puncture during acupuncture), blood-borne diseases (the risk of blood-borne diseases such as hepatitis B, hepatitis C, and AIDS), psychological stress (worries about personal safety, complaints, or legal liability), etc. In addition, the providers (medical staff) are very likely to experience intense anxiety, severe psychological distress, or even psychological disorders after occupational exposure to blood-borne diseases⁹. There is currently little research on the risks to acupuncture providers^10–21. Existing researches have shown that the incidence rate of needle injuries among practitioners (medical staff) in acupuncture medical institutions is 1.24%, and it mainly occurs during the needle removal procedure (58.73%)¹⁰. The risks to acupuncture providers are mainly caused by factors such as improper handling and non-normative disinfection by acupuncture providers⁵. In addition, long working hours, high levels of stress, poor awareness of occupational safety, inadequate protective equipment, and poor management and training systems can lead to occupational exposure to needles. Designing infection prevention and control training programs based on the characteristics of acupuncture work can improve the infection prevention and control knowledge and skills of acupuncture providers¹³. Health care institutions can strengthen occupational safety training for practitioners; standardize needle insertion and removal procedures and the proper use of personal protective equipment, and formulate standardized emergency reporting and response procedures. In addition, health care institutions should obtain the patient’s serological status in advance, strictly follow infection control measures such as “standard precautions” and “contact isolation,” conduct effective pre-job training, and pay attention to the risk of injury caused by special needles, which can prevent needle stick injuries and ensure occupational safety¹⁰.

Analysis of the environmental risks of acupuncture

Non-normative acupuncture practice poses risks not only to the receivers and providers, but also to the environment. At the same time, a poor treatment environment will also increase the risks to the acupuncture receivers and providers. The environmental risks of acupuncture are mainly reflected in the pollution of the environment caused by the improper disposal of needles and other medical waste that comes into contact with the receiver’s blood or tissue. This type of risk has a long incubation period.

Suggestions for future research directions in the field of acupuncture risks

Acupuncture risks include three categories: risks to acupuncture receivers, risks to acupuncture providers, and environmental risks. Existing research focuses mainly on the risks to acupuncture receivers, while research on the risks to acupuncture providers and environmental risks is seriously insufficient. Acupuncture providers, a large group of people, are exposed to many occupational risks in their daily work. From the perspective of protecting workers and reducing the spread of iatrogenic diseases, research on the risks to acupuncture providers should be given sufficient attention. In terms of environmental risks, the medical waste generated by acupuncture is highly contaminated. If it is not properly disposed of, it will inevitably cause serious environmental pollution. However, no research has been found in this area, so it is impossible to provide clear data on the scope and impact of the environmental risks of acupuncture. To comprehensively control the risks of acupuncture, it is necessary to have a more comprehensive collection of relevant data on the scope and extent of the risks of acupuncture. Therefore, in the future, there is an urgent need to conduct relevant research in the 2 areas of risks to acupuncture providers and environmental risks, accumulate original data, provide evidence-based evidence, better guide decision-making, and promote the safe use of acupuncture worldwide.

Recommendations for acupuncture providers for risk control

The main sources of acupuncture risk are acupuncture providers, receivers, the environment, and needles. Acupuncture providers play a leading role in the control of acupuncture risks. Acupuncture providers’ professional skills, sense of responsibility, operation intensity, needle selection, disinfection and infection control measures, and safety awareness can all play an important role in the occurrence of acupuncture risks. Therefore, it is of great importance to control acupuncture risks by the acupuncture providers. In practice, acupuncture providers should take the initiative to control risks from the following aspects: (1) Improve the awareness of the risks of acupuncture and the level of acupuncture techniques; (2) make good preparations before acupuncture: communicate effectively with the receiver, obtain detailed data about the receiver’s physical conditions, and explain to the receiver the possible reactions and precautions during acupuncture to eliminate their nervousness and anxiety. (3) Standardize the acupuncture process: concentrate during the treatment, select the correct body position according to the characteristics of the acupuncture points and the treatment needs, strictly follow sterile operation, select appropriate needles and acupuncture techniques, and observe the receiver’s reaction at all times. Once abnormalities are found, take corresponding measures in time. (4) Strengthen postacupuncture care: pay attention to protecting the needle hole after removing the needle, and carefully check the number of needles to avoid omissions. (5) Strengthen safety protection and infection control measures: increase self-protection awareness, avoid needle stick injuries, and wear gloves and other protective measures when treating receivers with open wounds, skin diseases, and infectious diseases. (6) Properly dispose of medical waste: in accordance with medical waste disposal regulations, properly dispose of used needles and other medical waste to prevent sharps injuries, the spread of diseases, and environmental pollution.

Summary

This standard has gone through a rigorous development process, defined the terms in the field of acupuncture risk, clarified the connotation of the terms related to acupuncture risk, specified the scope and level of acupuncture risk, the risk control process, the causes of risks and corresponding control measures, clarified the basic requirements for the safe use of acupuncture, and solved the common problems related to the risk of acupuncture that may be encountered in the practice of different types of acupuncture needles. The promotion and application of this standard will play a positive role in promoting the safe practice of acupuncture worldwide.

Acknowledgments

We are deeply grateful to all the experts of this standards committee, including Prof. Longxiang Huang and Prof. Weihong Liu from China, Prof. Binjiang Wu from Canada, Prof. Yongming Li from the U.S.A., Prof. Ramon Maria Calduch from Spain, Dr. Claudia Skopalik from Germany, Dr. Sergio Bangrazi from Italy, and Dr. Arne Kausland from Norway, for their invaluable guidance and critical feedback throughout the development of this standard. We also appreciate Mr. Chengyuan Li and Ms. Huihui Liu for their technical support in translating and polishing the English version of this standard

Statement of ethics

This study did not involve human or animal subjects, and no ethical approval was required. The study protocol adhered to the guidelines established by the journal.

Conflict of interest disclosure

The authors declare no competing interests.

Funding source

Independent project of the Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, titled “Research on the International Standard Transformation of Acupuncture” (Project No. zz20242220). The National Key Research and Development Program of China (Project No. 2019YFC1712202).

Data availability statement

Data availability statement: Data availability is not applicable to this article as no new data were created or analyzed in this study.

Author contributions

L.Z.: writing—original draft preparation. W.J.: conceptualization, methodology, project administration, and writing—reviewing and editing. C.S.: investigation, data curation, formal analysis, and writing—reviewing and editing. L.Y.: formal analysis. M.W.: visualization. H.J. and C.Z.: investigation and data curation. W.Z.: supervision.

References