Acupuncture Safety in Taiwan

Abstract

Background:

The safety of acupuncture treatments is crucial for patients. Although acupuncture is generally considered a relatively safe therapeutic modality, acupuncture-related adverse events cannot be entirely avoided. The development and implementation of effective preventive strategies are essential for enhancing clinical safety.

Objective:

This article focuses on the acupuncture safety strategies implemented within Taiwan’s medical system, aiming to address the multifaceted and complex nature of acupuncture-related adverse events and to propose practical approaches for risk reduction.

Methods:

This article emphasizes the application of preventive strategies tailored to known risk factors. A structured, phased educational model has been adopted to reinforce both theoretical knowledge and clinical proficiency. In addition, improvements in the use of acupuncture instruments and the standardization of procedural workflows have strengthened adherence to safety protocols. The integration of modern technologies with traditional medical knowledge has further advanced innovation in clinical safety.

Conclusion:

Taiwan’s comprehensive approach to promoting acupuncture safety offers valuable insights and a practical reference for enhancing acupuncture safety in global settings.

INTRODUCTION

Acupuncture has a long-standing history in Eastern regions and serves as a fundamental component of traditional medicine. Following U.S. President Nixon’s visit to China in 1972, acupuncture gained worldwide popularity, quickly becoming one of the most sought-after complementary and alternative medicine methods.¹ The safety of acupuncture treatments is crucial for patients. According to statistics from Taiwan’s National Health Insurance Research Database, the incidence rates of several acupuncture-related adverse events (AEs) of concern are as follows: mild bleeding (0.08%), severe bleeding (0.004%), cellulitis (0.064%), nerve injury (0.05%), and pneumothorax (0.87 cases per million acupuncture treatments).^2–5 In addition, several chronic diseases, age, and the use of anticoagulants increase the risk of acupuncture-related AEs. Systematic reviews of related literature indicate that acupuncture rarely causes serious adverse events (SAEs) and mostly results in minor adverse events (AEs), which generally require no medical intervention.^6,7 Common minor AEs related to acupuncture may include local pain at the needle insertion site or minimal bleeding (1–2 drops of blood) after needle removal, which can also occur in other medical procedures involving needle insertion. Those are considered as AEs in some clinical trials and are not considered as AEs in other clinical trials.

However, despite being regarded as one of the safest medical practices, the occurrence of SAEs in acupuncture cannot be eliminated. Bäumler et al., in a comprehensive review of acupuncture-related publications (including cohort studies, randomized controlled trials, surveys, and monitoring), estimated that 21 cases of SAEs per 12,500 acupuncture treatments. SAEs can be associated with mortality or irreversible organ damage. Among these, pneumothorax, severe cardiovascular or vagal reactions, and falls or injuries are the most common SAEs, occurring at a rate of approximately 1 to 3 cases per million treatments. Pneumothorax, one of the major acupuncture-related SAEs, is preventable by avoiding deep needling in the torso and following recommended needling depth. Falls or injuries can also be prevented by anticipating the potential of falls and adjusting the treatment room environment.

Chan et al. categorized acupuncture-related AEs into four major types: organ or tissue injury (e.g., complications from needle breakage or retained needles), infections, local reactions (e.g., contact dermatitis or localized allergic reactions), and other effects such as dizziness or fainting.⁸ Additional data analyses have identified various factors contributing to AEs, including practitioner-related issues (e.g., excessive needle depth, improper point selection, or incorrect needling techniques), patient factors (e.g., excessive nervousness), equipment-related problems (e.g., contaminated needles), and procedural errors (e.g., inadequate skin disinfection leading to infection).^9,10 Severe incidents, such as needle breakage, may stem from excessive or repetitive manipulation.

Nonetheless, the literature widely agrees that most acupuncture-related AEs are preventable. According to statistics from the department of Acupuncture, China Medical University Hospital (a medical center in Taiwan), there were five acupuncture-related safety incidents, or SAEs, in 2020 and one in 2023 (pneumothorax). After implementing the following strategies, no further incidents have occurred to date. Preventive strategies should address the identified risk factors and include measures such as enhancing clinical training and continuing education for practitioners, ensuring the safe use of equipment, and optimizing procedural protocols to reduce the incidence of AEs effectively. For high-risk patients—such as infants, pregnant women, the elderly, cancer patients, individuals with coagulation disorders, and those with drainage tubes or endotracheal tubes—greater caution and enhanced evaluation during clinical procedures are essential to ensure safety. Table 1 outlines key considerations for high-risk patients.^11–15

Table 1.

Acupuncture Adverse Effects and Precautions for High-Risk Patients

Patient	Adverse event	Author (year)/study type
Pregnant women	Mild adverse events included bleeding or hematoma, pain, fatigue, and drowsiness. Serious adverse events, such as pneumothorax, infection, and nerve impairment, were reported and deemed likely related to acupuncture. Maternal hypertension and/or pre-eclampsia, congenital anomalies in infants, stillbirth, and neonatal death were mentioned in some clinical trials but were evaluated as unlikely to be associated with acupuncture treatment. For pregnant women, it is essential to avoid certain acupoints that are contraindicated during pregnancy, including SP6, LI4, BL60, BL67, GB21, LU7, CV3–CV7, and BL27–34. Avoid applying strong needle stimulation and take into account the different stages of pregnancy when developing a treatment plan.	Park et al. (2014)/ systematic review11
Children	Mild adverse events included crying, pain, bruising, transient bleeding at the puncture site, numbness at the puncture site, exacerbation of preexisting symptoms or conditions, and vasovagal reactions such as dizziness or nausea/vomiting. Serious adverse events in pediatric cases included thumb deformity (12 cases), infection, cardiac rupture, pneumothorax, nerve impairment, subarachnoid hemorrhage, intestinal obstruction, and hemoptysis. For children, needle insertion depth differs from that used in adults; therefore, minimal needle depth should be employed.	Adams et al. (2011)/ Systematic Review12
Cancer patients	Mild adverse events include bleeding or hematoma and syncope. Serious adverse events are primarily pneumothorax. It is not recommended to perform acupuncture on high-risk areas of the body in patients with cancerous lesions, enlarged lymph nodes, irradiated sites, implanted medical devices (e.g., prostheses, intravenous catheters, or ostomy bags), anatomical deformities (e.g., spinal instability), or bleeding tendencies. Acupuncture techniques should be modified for cancer-related conditions, such as anticoagulant therapy, deep vein thrombosis, cachexia, immunosuppression, infection, or open wounds, as well as during systemic anti-cancer treatments. Acupuncture is contraindicated when the neutrophil count is below 0.5 × 109/L (500/mm³) or the platelet count is below 20 × 109/L (20,000/mm³).	de Valois et al. (2024)/ peer-reviewed expert opinion13
Patients on anticoagulant therapy	Mild adverse events include minor bleeding; however, the incidence among patients receiving antiplatelet therapy was not significantly different compared to the control group.	Kwon et al. (2018)/Retrospective Study14
	Mild adverse events include asymptomatic bruising and minor bleeding. Only one case of severe bleeding was reported, involving tendon and organ damage caused by acupuncture.	Michael McCulloch et al. (2015)/ systematic review15

PHYSICIAN FACTORS: STRENGTHENING CLINICAL EDUCATION

Acupuncture is widely practiced in Taiwan, and traditional Chinese medicine (TCM) has been incorporated into the formal higher education system. To enhance and ensure the safety of acupuncture practices, a phased educational framework has been developed for learners at different stages, including current students, interns, and licensed physicians. Table 2 outlines the phased educational objectives.

Table 2.

Phased Safety Education Programs for Acupuncturists in Taiwan

	Basics courses	Clinic courses	Assessment
Current Students	➢Traditional Chinese Medicine courses (e.g., acupuncture & moxibustion theory, disease treatments) ➢Western Medicine courses (e.g., Anatomy)	➢Clinical skills (Acupuncture procedures, Virtual Reality Acupuncture System and the Anatomage Table) ➢Project-Based Learning courses	Examinations
Internship	➢Healthcare quality ➢Infection control ➢Emergency response training	➢Clinical skills (Acupuncture techniques, patient management, and emergency response handling）	Objective Structured Clinical Examination
Licensed Physicians	➢Continuing medical education （Special lectures on various diseases）	➢Acupuncture techniques ➢Health care quality, ethics, and legal considerations	License renewal

Current Students

Current students, typically enrolled in undergraduate or post-bachelor programs, are provided with a systematic learning pathway. The curriculum includes foundational courses and practical skills training, guiding students in mastering the theoretical and operational standards of acupuncture within the contexts of acupuncture theory, anatomy, and kinesiology. In recent years, technological advancements have been integrated into the curriculum with the introduction of innovative tools such as the virtual reality (VR) Acupuncture System and the Anatomage Table EDU 7.0. The VR Acupuncture System uses audiovisual technology in a simulated environment, enabling students to interact with high-precision human anatomical models. The Anatomage Table software builds on prior research on acupuncture point depths, offering three-dimensional simulations of anatomical structures and acupuncture points.^16–18

Acupuncture is a skill-intensive practice. The use of three-dimensional simulation tools significantly enhances students’ mastery of acupuncture techniques by combining comprehensive anatomical knowledge. These tools allow students to clearly understand the trajectory of the needle tip as it penetrates from superficial to deeper layers of body tissues. This approach reduces the risk of injury to vital organs during future clinical procedures while improving the practicality and safety of acupuncture training.

Interns

Internship training is primarily conducted in the TCM departments of hospitals. The program includes hands-on and online courses focused on acupuncture procedures, medical quality assurance, infection control, and emergency response training, with an emphasis on safety. Interns are regularly evaluated through Objective Structured Clinical Examinations. These evaluations involve assessors, standardized patients, and the interns themselves. Interns simulate real-world clinical scenarios, demonstrating their proficiency in acupuncture procedures, including aseptic techniques, and managing complications such as needling-induced fainting or other adverse reactions.

Licensed Physicians

For licensed physicians, the validity of acupuncture licenses in Taiwan is regulated by law, requiring periodic completion of continuing medical education (CME) hours. CME programs emphasize safety assessments and clinical application standards, encouraging practitioners to conduct more thorough evaluations during treatment. This ongoing education ensures the quality and professionalism of TCM clinical services while also reinforcing the safety of acupuncture practices.

Preventive strategies must be implemented before AEs occur. The phased educational objectives in acupuncture training emphasize robust foundational knowledge and precise operational skills. This approach not only reduces the likelihood of adverse events but also promotes a safer and more effective integration of acupuncture practices into clinical settings.

EQUIPMENT-RELATED ISSUES: ENSURING SAFE USE OF INSTRUMENTS

The National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM) first introduced the Clean Needle Technique Guidelines in 1984, which has since been updated to its seventh edition. This guideline serves as a critical standard for regulating the safety of acupuncture, moxibustion, and cupping practices.¹⁸ It explicitly mandates that practitioners adhere strictly to aseptic techniques, effective disinfection procedures, and infection control measures during operations to minimize the risk of adverse events.

Our institution has established clinical acupuncture practice guidelines, emphasizing the use of sterile, single-use disposable needles. The use of needles is strictly limited to those within their valid shelf life, and the “one acupoint, one needle” principle is strictly enforced to prevent the reuse of needles. All needles must remain sealed prior to use. These measures aim to comprehensively enhance the safety and professionalism of clinical procedures.

PATIENT AND OTHER FACTORS: OPTIMIZING PROCEDURES AND ENHANCING RISK ASSESSMENTS

The risk of infection during acupuncture procedures, including percutaneous infections caused by reused needles or the transmission of severe diseases, represents a significant challenge in medical infection control. These issues are often attributed to noncompliance with procedural standards, such as needles falling due to patient movement or improper handling and disposal of needles posttreatment. To address these challenges, Taiwan’s TCM hospitals have optimized acupuncture workflows by implementing “Operational Guidelines for Medical Institutions” and further refining procedural standards. Table 3 illustrates the acupuncture processes used in Taiwanese institutions.

Table 3.

Guidelines for Clinical Practice of Acupuncture in Traditional Chinese Medicine

Timeline	Procedure
Pre-Acupuncture Treatment	Patient identification First-time acupuncture treatment Current conditions (check for the following): History of fainting during acupuncture Fasting Vomiting Sleep deprivation Overexertion Anger or emotional instability Fever History of abnormal bleeding Presence of a pacemaker Metal allergy Previous injuries with poor healing Keloids or hypertrophic scars Current use of anticoagulants or antiplatelet medications History of hypertension, diabetes, heart disease, or epilepsy Pregnancy Age ≥65 years or ≤5 years
During Acupuncture Treatment	Environment confirmation Aseptic technique Needle selection Acupuncture execution (physician determines the necessity of acupuncture points while avoiding hazardous areas.)
After Acupuncture Treatment	Triple-check mechanism for needle removal Record patient reactions posttreatment

Before acupuncture, a comprehensive assessment of the patient and the operating environment is required to mitigate risks associated with agitation due to unstable medical conditions or emotional distress. The risks for falls (from the patient’s bed) before and after treatment should also be evaluated. The area around the treatment bed must remain tidy, with blankets and outer garments removed to ensure aseptic practices. Standardized towels should be used to cover exposed areas, secured with clips, and appropriately marked to maintain clear visibility of acupuncture sites.

During acupuncture procedures, needles with high-contrast colors are employed to improve visibility and reduce operational errors. For instance, silver needles are used for areas with brown hair, and gold needles for areas with black hair. In addition, short-handled needles are equipped with plastic markers to enhance visibility and safety during use. These measures significantly reduce the likelihood of procedural errors and improve operational safety.

After acupuncture treatment, to prevent adverse events such as needle breakage or accidental needlestick injury (caused by an unsterilized needle left from a previous patient), a “Triple Check Mechanism” is implemented. This involves the physician, nursing staff, and the patient or caregiver jointly verifying the number of needles used and their corresponding placement on the body. Records of needle use and their locations are maintained on paper to ensure accurate documentation.

Since 2021, our institution has adopted artificial intelligence (AI) technology to further optimize acupuncture workflows. A “Smart Optical Needle Counting and Disposal Box” has been developed, integrating a visual recognition system to identify needle shapes and assist in tracking the number of needles used and retrieved. This innovation has revolutionized needle management by enabling precise and intelligent tracking. It exemplifies the integration of technology and healthcare to enhance patient safety, setting a benchmark for technological innovation in medical practice.

CONCLUSION

The safety of acupuncture has garnered increasing attention. Strategies such as implementing comprehensive clinical education, optimizing acupuncture procedural workflows, and incorporating technology-driven innovations have provided robust support for reducing adverse events. These measures have significantly enhanced the overall safety of acupuncture treatments.

AUTHORS’ CONTRIBUTIONS

Y.-F.L.: Conceptualization, methodology, investigation, project administration, writing—original draft, writing—review and editing, visualization. E.B.-A.: Writing—review and editing. Y.-C.L.: Conceptualization, methodology, resources, writing—review and editing, supervision, project administration.

AUTHOR DISCLOSURE STATEMENT

No competing financial interests exist.

FUNDING INFORMATION

This research is funded by China Medical University hospital, with the project number CMUH-EDU11402、DMR-113-128.