Aware of its increasing importance in the global medical device market and looking to push the market for devices used in traditional Chinese medicine (TCM), China is driving the development of new international standards.
The first standard for a TCM device published through the International Standards Organization (ISO) is for sterile single-use acupuncture needles. The ISO 17218:2014 standard was published on Feb. 3.
Acupuncture therapy is used in 182 countries all over the world. By some estimates, there are more than 4 billion acupuncture needles in use around the world and the number is growing by 5% to 10% every year.
The Chinese government has been pushing the development of TCM and has even put forward a series of five-year plans for TCM. The current plan, the twelfth, aims to increase the number of TCM hospitals in China to 2,297 and the total industry output to ¥550 billion ($88 billion) by 2015. China's TCM exports in 2013 reached an estimated $3 billion and are expected to reach $3.5 billion in 2014, according to Liu Zhanglin, vice president of the China Chamber of Commerce for Import and Export of Medicine and Health Product (CCCMHPIE).
The acupuncture needle standard was only a first tentative step. China is now leading the development of a new ISO standard for devices used to measure blood pressure.
The creation of the ISO/AWI 19614 for pulse graph force transducers was officially approved at the fourth annual meeting of the ISO/TC 249, the standardization committee for TCM of the ISO. Pulse pressure transducers are widely used on electropulsographs that are a common diagnostic tool used in TCM.
Established in 2009, the ISO/TC 249 has 23 participating countries including Australia, Canada, Germany, India, Japan, South Korea, Singapore, Thailand, Vietnam and the U.S. and 14 observer countries like the U.K., New Zealand and Hong Kong. The Standardization Administration of China acts as the secretariat.
"Nowadays there are a couple of projects under development in the field of TCM medical devices such as the quality and safety of electro-acupuncture stimulators, herbal decoction apparatus and moxibustion devices," said Shirley Xu, the project manager at the secretariat.
The project to develop the standards for the pulse pressure transducers is the latest, said Xu, and it could take three to four years to develop and publish an international standard.
For China, this new project is particularly important and might help it take on a greater role as a standard setter.
"This is the first time that the establishment of an international standard is led by a Chinese standardization institute," said Zhang Diedong, vice director of the Active Implantable Medical Device Department at the Shanghai Testing & Inspection Institute for Medical Devices (CMTC), the inspection lab that is undertaking the project. Zhang is also secretary of a sub-committee that looks at standards for electronic devices under the National Medical Device Standardization Committee.
"[The] pulse transducer is a core component for medical devices that need to collect pulse waves," said Zheng. "An international standard, without a doubt, would push the development of relevant devices. By leading the work to establish this standard, China would be more familiar with the operations and rules of international standards and make more contributions to international standardization."
This is the first standard under development for pulse pressure transducers. Other pulse transducers, which often track blood volumes, do not qualify for certification under this standard.
"But this standard is not just applicable to TCM only. As long as the working principle is the same and the body signals to be collected are the same, the standard shall apply to any pulse pressure transducer," said Zheng.
"ISO international standards ensure that products and services are safe, reliable and of good quality. For business, they are strategic tools that reduce costs by minimizing waste and errors and increasing productivity. They help companies to access new markets, level the playing field for developing countries and facilitate free and fair global trade."
Standards are increasingly needed as the market for TCM and TCM-related products grows. The ISO/TC 249 committee is now working on 20 standards.
"Though there are already some domestic industrial standards . . . most of them are new," Zheng told Medical Device Daily.