While acupuncture detractors often like to point out that acupuncture does involve some risks, the truth is that the profession and materials are highly regulated in Europe and North America. For example, the vast majority of acupuncture needles are one-time-use, avoiding the problems of improper sterilization. Medical equipment, moreover, is subject to a variety of norms and standards across Canada, all of which must be met in order for acupuncture needles to make it to the market, and to continue being sold. These norms and standards require regular reports to be made to approve the products’ continued sale. It can be difficult to parse out the different rules applying to these standards, however, since they tend to be written in cryptic legal language, and they tend to be so long that it’s easy to get lost while reading them.
It is very important for medical devices such as acupuncture needles and TDP Lamps to follow all the guidelines in order to meet the safety requirements. Apart from that, only professionals are allowed to have access to certain kinds of medical devices such as acupuncture needles.
International Standards and Guidelines
These norms were formulated as guidelines that would facilitate consistent international regulation regarding medical devices. Countries and regions are free to adopt these standards, or to modify them in any way they see fit. For a more in-depth explanation regarding international medical device standards, this article makes a great starting point. Canada, the United States and the European Union all adopt international legislation to
different degrees, and sometimes substitute their own; however, despite this lack of concordance, the policies tend to be consistent enough that an acupuncture needle approved for Canadian customers can more often than not be approved in the US and in the EU, once requirements such as proper paperwork and inspections are fulfilled.
These standards include risk management measures, their effect on the body, and quality control, which usually involves sterilization.
For example, some acupuncture needles are coated by silicone. This kind of silicone is different from silicone used in constructions or decorations. Therefore, silicone coated acupuncture needles such as brand Acu-Relaxo and ShinLin Spring are safe for insertion into human body.
Even for non-coated acupuncture needles, the stainless steel has its standards. Therefore, not all stainless steel can be used for non-coated acupuncture needles. Normally, stainless steel imported from German has high standards