Product information FAQ

Nickel is a common cause of allergic reactions. Such reactions can result in reddening of the skin and the formation of blisters accompanied by severe itching (such as contact dermatitis).

Almost all acupuncture needles are made of nickel-chromium steel wire. A minimum percentage of nickel is necessary to ensure the corrosion resistance and especially the pliability of the steel wire.

Steel wire: chemical composition

An acupuncture needle made of steel wire typically has the following chemical composition (in % by weight):

• Chromium (Cr): 16.0 to 18.0
• Nickel (Ni): 6.0 to 9.0
• Manganese (Mn): max. 2.0
• Silicon (Si): max. 1.5
• Carbon (C): max. 0.12
• Molybdenum (Mo): ≤ 0.8
• Phosphorus (P): ≤ 0.045
• Sulphur (S): ≤ 0.030

The relevant material standards require that the elements not listed in the table are "not intentionally added" and that the manufacturer of the steel "takes appropriate measures to avoid the addition of such elements [...]." It therefore cannot be ruled out that acupuncture needles contain traces of other elements.

All manufacturers known to us use only a select few, similar steel grades that do not deviate considerably from the above-mentioned composition. They may differ in terms of their pliability, surface finish and other processing. What they have in common, however, is that they generally contain nickel. According to a relatively new ISO standard on sterile acupuncture needles for single use (ISO 17218:2014-02, "Sterile acupuncture needles for single use"), two types of needle are the most "popular". Both types are made of nickel-chromium steel wire.

When the additional coating completely encompasses the steel wire, it may prevent nickel and other substances from diffusing out of the steel wire. The shaft of the acupuncture needle would at least be practically sealed. The requirement for this is, however, the complete and seamless coverage by the gold, silver or coating, and this depends on the respective manufacturer's mastery of the manufacturing process. This is particularly true because a bonding layer made of nickel is not often used for the plating of steel (but see below for Apex Gold).

The little feedback that we have received over the last years could speak for the good or at least better tolerability of these acupuncture needles. But perhaps they only reflect their limited application. Due to the overall lack of experience, our view is that a clear statement on the suitability of gold-plated, silver-plated or coated acupuncture needles is admittedly very difficult.

Given permanent needles such as ASP (auricular semi-permanent) or Apex needles are short and thick in comparison with "normal" acupuncture needles, other types of steel can be used by their manufacturers. The employed chromium-molybdenum steel is classified as nickel-free according to the relevant technical regulations (DIN 17440 and US-ASTM F899). Even when this steel is generally/frequently used for the manufacture of medical products, it constitutes a standard for industrial production, which means that no absolute freedom from nickel is guaranteed. Because steelwork is not "production in a clean room", the steel may contain "traces" of nickel and/or other allergy-causing materials!

The risk appears to be lower with Apex Gold from Asiamed due to the plating. The process of plating occurs without an additional bonding layer formed of nickel (see also Tab 1.2). While material analyses* of the different steel permanent needles have already detected small amounts of nickel, the results for Apex Gold have thus far been "nickel-free".

*Determination of the chemical composition with the aid of energy-dispersive electron beam microanalysis in a scanning electron microscope (EDX method) and energy-dispersive X-ray fluorescence (ED-XRF method) by the Test Center for Coating and Material Properties of MFPA Weimar at the Institute for Material Science at Ilmenau University of Technology in 2001 and 2009.

It is nevertheless a fact that: the treatment of allergy-prone patients must therefore always only be carried out with the appropriate caution.

"Normal" acupuncture needles are almost always made of a nickel-chromium steel (see also Tab 1). The use of other materials is rare. We are currently not aware of any such product. The situation with permanent needles is, however, different. Due to good or better biocompatibility, permanent needles from Sedatelec, for example, have been made of titanium in recent years.

Conclusions

If the steel needle is long and thin, then it almost certainly contains nickel. In case of doubt, the option of non-invasive acupressure or optical stimulation of acupuncture points using a laser device (so-called "laser acupuncture") remains.

The traces of oxidation on copper handles make acupuncture needles or their copper handles look dirty. This appears to be particularly unacceptable to patients in the case of acupuncture needles, which are a sterile medical product.

The tarnished copper handles are, however, only superficially a "blemish".

The blemishes, like the "verdigris" of copper roofs, are nothing more than the natural corrosion of the copper. On the one hand, untreated copper will constantly corrode and develop blemishes. If one wants "unblemished" shiny copper handles, the handles must be chemically treated (passivation). The gloss of the copper handles is therefore achieved through the use of chemicals. On the other hand, copper (even tarnished!) possesses a bactericidal action and is already toxic in low concentrations to many microorganisms.

Nevertheless, tarnished copper handles are accepted as grounds for complaint and are forwarded to the relevant manufacturer by us. In essence, they are merely a question of aesthetics.

While we work in "millimetres", specifications in "Japanese or Korean gauge" (dimension or thickness) are used in the USA and parts of Great Britain. The diameters of acupuncture needles can also be given in "Chinese gauge".

To simplify this, the labelling of acupuncture needle diameters is done using colour coding. This is based on the colour coding of cannulas, which is standardised in EN ISO 6009 and EN ISO 9626. In the case of plastic handles, the colour coding is reflected by the colour of the handle. This colour coding is also widely used for labelling the packaging of needles with metal handles. With a few deviations, most manufacturers and brands use this coding.

Acupuncture needles: diameters

Diameter (in mm)	Colour code	Korean or Japanese gauge	Chinese gauge
0.12	dark green	02	44
0.14	light green	01	42
0.16	red	1	40
0.18	ivory	2	38
0.20	light blue	3	36
0.22	pink	4	34
0.25	purple	5	32
0.30	brown or yellow	8	30
0.35	black	10	28
0.40	blue	12	26 / 24

Note: The comparison of different units of measurement is not standardised and can thus only serve as a guideline. Slightly deviating specifications are not unusual especially in the case of Chinese gauge.

You can display all acupuncture needles with a diameter of 0.30 mm, for example. To do this, use the following filter: Acupuncture needle: Diameter (mm/gauge) 0.30 mm

Acupuncture needles with a guide tube

Longer acupuncture needles require greater dexterity in their application. In old traditions in Japanese texts, guide tubes are spoken of as tools for easier handling of acupuncture needles. The use of guide tubes in acupuncture is based on a long tradition. Initially, thin bamboo shoots were used that were constantly adapted and evolved into guide tubes made of metal up to the current plastic tubes. To mount the guide tube on the acupuncture needle, small (mostly colourful) plastic wedges or adhesives are customary.

To use an acupuncture needle, remove the acupuncture needle with the accompanying guide tube from the individual blister pack. Then place the end of the guide tube with the needle tip on the skin and release the needle handle from the guide tube. You now see the needle handle that protrudes from the guide tube. Gently tap on the handle with a finger until this has disappeared into the guide tube. Subsequently remove the guide tube and insert the acupuncture needle further into the skin as needed.

Special types of guide tube

Place N'Press

In the case of acupuncture needles with a Place N'Press guide tube, the needle is mounted into the guide tube purely mechanically. The otherwise usual small plastic wedges or adhesive dots are thereby made redundant. This patented solution allows for a single-handed application and treatment without prior troublesome releasing of the acupuncture needle from the guide tube.

A short description in English with a graphical representation of the handling can be found here.

Only the s|needle J-Type Place N'Press needles are equipped with this special guide tube.

Safe-T Sleeve™

The usual tubes only drive acupuncture needles a few millimetres into the skin. After removal of the guide tube, the acupuncture needle can bend strongly during insertion and complicate application. For example, this occurs:

• in the case of thick, dense or fibrous tissues or even when deeper tissue should be reached
• when especially thin and long acupuncture needles are used

In these cases, the acupuncturist can get by with a sterile swab, for example, which they use to push the acupuncture needle in deeper.

Safe-T Sleeve™ is a simple but innovative application system to ensure the sterility of an acupuncture needle without tools such as swabs even in difficult treatment situations. This device is formed of a "normal" guide tube over which an additional soft tube is fitted; the Safe-T Sleeve™.

The Safe-T Sleeve™ is available in diameters between 0.18 and 0.35, sizes from 40 to 100 mm, and in coated or uncoated variants.

• TeWa CJ-Type Safe-T Sleeve
• TeWa CJ-Type Safe-T Sleeve (s) - uncoated

A short instruction manual (English) can be found here.

The Safe-T Sleeve™ was developed by John Stan ("Doctor of Traditional Chinese Medicine"), an acupuncturist and distributor of acupuncture supplies (founder of Eastern Currents in Canada), as an efficient way of ensuring compliance with the so-called "Clean Needle Technique", which is a requirement in North America (see the National Certification Commission for Acupuncture and Oriental Medicine, NCCAOM).

You can also find various informational tutorials and tips on the use of the Safe-T Sleeve™ on YouTube acupuncture needles from John Stan.

The purpose of using an anti-friction coating is to ensure the lowest possible puncturing resistance of the acupuncture needle and thereby an acupuncture treatment that is as comfortable as possible for the patient.

A silicone coating is generally used to coat acupuncture needles. The technique and means originally come from the manufacture of cannulas and catheters, where the use of this type of coating has been employed for years to improve sliding properties or reduce puncture resistance.

Given acupuncture needles have also been subject to the strict regulations for medical products at least since 1998, the manufacturers of acupuncture needles are obligated to submit evidence of the biocompatibility of the materials used, and thus also any coating used. Compliance with and monitoring of these requirements by so-called "appointed bodies" is confirmed or explained by the CE marking on the packaging.

It is clear that acupuncture needles with plastic handles are not suitable for use in combination with moxa. However, can one use coated acupuncture needles, in combination with moxa, for example?

We are only aware of one study in Korea in which the effects of moxa or heat therapy on coated and gold-plated acupuncture needles were investigated:

Sabina Lim, Seunghun Lee, Seung-Ho Yi, Yang-Sun Son, Sung-min Choi and Young-Kon Kim: The Biological Safety of Stainless Steel Needles Used in Warm-needling. Advance Access Publication 20 December 2008 (eCAM 2010;7(2)259–264. doi:10.1093/ecam/nen066)

The study can be found here or on the PubMed Central (PMC) page of the NCBI.

The investigation found that even coated acupuncture needles are biologically safe for use in the context of heat therapy. The measured temperatures had no negative effect on the coating.

However, the coating was only exposed indirectly to warmth or heat, which means that the heat was directed over the handle of the steel needle. A coated steel needle should never be exposed to a direct flame!

The strong temperature fluctuations between acupuncture needles made of "SS304" steel wire (note: commonly used steel wire for acupuncture needles, see also Tab 1) and the gold-plated acupuncture needles noted in the study should be due to the relatively poor heat-conducting property of steel:

• Steel: approx. 15 λ
• Gold: 314 λ
• Copper: 401 λ
• Silver: 429 λ

Further information on thermal conductivity can be found on Wikipedia.