ISO 17218:2014 specifies the requirements for the sterile acupuncture needles for single use (specialised for filiform needles). The standard relates to the manufacturing, packaging, and labelling of the needles.
New Zealand Register of Acupuncturists Inc President, Paddy McBride, says the standard is a ‘good step in the right direction’.
‘In the west, acupuncture is becoming more and more popular, and the numbers of people turning to it as a treatment are increasing dramatically. Concurrently, more needles are being manufactured in countries such as Japan, Korea, and Germany whereas until more recently the majority were manufactured in China.
‘It has become increasingly important to maintain quality control of needles, including the sharpness, strength, the use of non-corrosive metal, a use-by-date, standardisation of labelling, and sterility.’
Paddy referred to a study¹ that was, coincidentally, just published that reinforces the need for improved quality control of acupuncture needles. The Acupuncture Research Resource Centre at King’s College in London examined the surface conditions and various other physical properties of sterilised single-use stainless steel acupuncture needles from two of the popular brands widely used in many countries.
Scanning electron microscope (SEM) images were taken for 10 randomly chosen needles from each brand. Further SEM images were taken after each of these needles underwent a standard manipulation with an acupuncture needling practice gel. A comparison of forces and torques during the needling process was also carried out.
The study found:
‘The images revealed significant surface irregularities and inconsistencies at the needle tips, especially for needles from one of the two brands. Metallic lumps and small, loosely attached pieces of material were observed on the surfaces of some needles. Some of the lumps and pieces of material seen on the needle surfaces disappeared after the acupuncture manipulation. If these needles had been used on patients, the metallic lumps and small pieces of material could have been deposited in human tissues, which could have caused adverse events such as dermatitis. Malformed needle tips might also cause other adverse effects including bleeding, haematoma/bruising, or strong pain during needling. An off-centre needle tip could result in the needle altering its direction during insertion and consequently failing to reach the intended acupuncture point or damaging adjacent tissues’.
Paddy says with international standards being set for the manufacture of acupuncture needles, problems such as those referred to in the study are more likely to be minimised – ‘a good thing for all those who are choosing to have acupuncture treatment’.
Read the full study
¹Acupuncture in Medicine, King’s College London, Acupuncture Research Resource Centre, March 2014.