Acupuncture Disposable Needles
- History, manufacture and clinical usage
Published on Journal of Acupuncture in Medicine March 2002
by Professor Man Fong Mei （梅万方教授）
The needle is the most important tool for an acupuncturist. If we look back at history, the earliest acupuncture needle was made in bone called the ‘Bian’ about 5000 years ago. Since then they were made with gold, silver and more recently, stainless steel.
European Jesuits wrote a number of books on Chinese medicine and even the publication in France, Soulie de Morant’s work on acupuncture did not popularise this Eastern art of healing until Nixon’s visit to China in 1972. James Reston published a special report on acupuncture anaesthesia following his own experience in a Chinese hospital during the Nixon visit. Subsequently global interest in this ‘magic’ needle exploded, along with this professional demand for the needle increased rapidly in the West. Acupuncture needles were traditionally hand-crafted to perfection, demand meant a mass production method had to be devised. In February 1972 AcuMedic first imported silver and gold handled, stainless steel filiform needles in both coil and spiral format. These needles were reused many times using the sterilising process of either an autoclav or glassbead.
However sterilisation standards were not strictly observed causing many cases of cross infection reported in the press. The Hepatitis B outbreak caused by acupuncture treatment prompted AcuMedic to invest in the design of the worlds first ‘disposable acupuncture needle’ in 1978. The initial production batches were rather expensive as single-use sterile packaging was rather prohibitive in set-up cost. An idea then came about to package the needles in plastic tubes, therefore, reducing the cost by using the gamma-ray sterilisation method. Hence the arrival of a lower cost needle that increased the popularity of the disposable ‘concept’ which was alien to many practitioners. The AcuMedic original type was responsible for the initial change in usage in the West. Demands were coming from European countries and North America, manufacturers in Japan and Korea then followed suit in reducing the cost further by designing plastic handled needles suitable for mass production. Chinese manufacturers took up the third wave of the challenge in reducing the cost of disposable needles by combining automation with low labour costs.
Competitive marketing of needles has unfortunately created many ‘side-effects’. Low quality materials are used and many essential safety and quality assured processes of manufacturing are omitted, for the sake of competitive pricing. There could be many inherent dangers for both patient and acupuncturist. Like other single use medical instruments, disposable acupuncture needles are now subject to prescribed standards set by different authorities such as the European MDA and the U.S. FDA.
Manufacturing Specifications and process
Manufacturing specification differs according to countries. Australian TGA (Therapeutic Goods Administration), for instance, recommends a sterilisation dose of 25 kgy of ethylene oxide gas. Whereas, some countries accept lower specifications. As sterilisation is an important safety factor a responsible manufacturer must insist that the disinfection level reaches SAL=10 according to EN46002 and EN550 standards. The EU harmonised standards applied to the acupuncture needles are: EN46002, EN550, EN1441, and EN556 together with the international standards IS09002 in conformance with the European Council Directive Annex V of 93/42/EEC. Different standards are required for the U.S. FDA registration.
The first step in the process of manufacture is to choose the stainless steel wire. Surgical grade steel oCr19Ni9 ore is selected for AcuMedic needles.Then the wires are cut to length and according to different diameters, ready for sharpening, polishing and winding of the handles. The finished products are classified and put on the production conveyer belt to the test room for tactile testing and quality examination. This is a crucial procedure that some manufacturers skim to cut costs for competition. Needles that have passed this procedure are to be cleansed and the pointing being re-examined according to different manufacturers technical facilities, (An electronic microscope linked with a computer system is used for the AcuMedic range).
All of these works are carried out including packaging in an isolated environment with room cleanliness levels reaching 100, 000 ≥ 0.5ìm ≤ 3500/L.
Before packaging the plastic slice PVC and the dialytic paper are tested with heat-pressure and for resistance to pressure in accordance to the demanding standard of sterility packaging. The final product is sterilised in an E.O. chamber capable of meeting the bacteria indicator test of ATCC9372 specification.
The products are stored in a quarantine area for distribution,
Distribution Quality System (ISO 9002)
Besides proper labelling and storage, all needles in the chain of sales and distribution must be accountable. Should clinical accidents happen, or if there are faulty needles, they must be traceable back through the distribution channel and manufacturing process in order to identify the batch and investigate what has gone wrong. Traceability is of the utmost importance considering the numerical factor of billions of needles being produced and the complicated supply chain. A company's management system is therefore a determining factor for your choice of brand for the assurance of safety and traceability.
Acupuncture needles are generally available in thickness diameter of 0.20mm to 035mm. For ear acupuncture 7mm (length) x 0.20mm (diameter) needles are used to prevent puncture of the car cartilage. These are used in conjunction with the semi-permanent press needles, pressure balls and the ear seeds. For facial and finger acupuncture, both 7mm and 15mm needles are used.
The most popular sizes for body acupuncture are 30mm and 40mm needles available in 0.20mm (36 gauge), 0.25mm (34 gauge), 0.28mm (32 gauge) and 0.30mm (30 gauge) diameter. For deeper muscle treatment, a thicker needle is available to cope with muscle tension and the possibility of spasm. Needles can be violently bent or broken by muscle movement. This is the reason why quality and strict manufacturing criteria are necessary to prevent breakage during treatment. The diameter recommended is 0.35mm to 0.40mm and the length generally ranges from 50mm to 75mm specially for the treatment of sciatica- For back Shu points, BL13, BL14, BL15, BL17, BL18 and BL19 to BL22, a 15mm x 0.25mm needle should be used at an angle of 45 degree. Sensitive points such as LR3 and SI19 require a thinner needle such as 15mm x 0.20mm is normally used, whereas needles no longer than 15mm should be used on GB21 point, to prevent the possibility of pneumothorax.
Those who use electro-acupuncture, a metal coil handle needle should be used to facilitate electrical conductivity and to avoid the slipping of the crocodile clip. A plastic handled needle should not be used in this case. Similar reasons apply to moxibustion, either direct or via the moxa caps, in the selection of the right needle. Certain Japanese needles have been manufactured with silicone coating for easy insertion. Such coating is found to be hazardous to health. Japanese needles have a thin pointing and Chinese needles tend to adopt a pine sharp point for needle sensation (De Qi). Whether the practitioner inserts the needle manually or via the guide tube, the choice of needles should be based on clinical efficacy and safety.
In conclusion, acupuncture needles have been made with different pointing, lengths and thickness. Choose your needle carefully according to different anatomical and clinical usage, insist on quality and safely as the first priority.
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