News

Nov. 07, 2011

Sysmex Reference Counter was Employed as National Standard for Blood Cell Count in China

- Contribution of Quality Improvement and Standardization -

Sysmex Corporation (HQ: Kobe, Japan; President: Hisashi Ietsugu) today announced its employment of Sysmex Reference Counter by BIMT^*1(Beijing Institute of Medical Device Testing) as the national standard for research on standardization for blood cell counting in China.
BIMT is subordinate to the Beijing Municipal Drug Administration. At the same time, it functions as Beijing Medical Device Quality Supervision and Inspection Center of State Food and Drug Administration (SFDA). It is the first time that China's license organization has officially employed the Reference Counter developed by Sysmex. As the Reference Counter will be used as the standard of blood cell counting data in China, it will surely contribute the quality improvement and standardization for blood cell count testing in China.

In China, along with rapid economic growth, infrastructure in the medical field is developing not only in urban areas, but also inland. A huge variety of manufacturers are in the process of going into the IVD market in China. Under such circumstances, the number of licensing applications for medical devices and IVD reagents has been increasing drastically - the importance of SFDA, which is fully responsible for registering and licensing the medical devices and reagents, has been well-recognized recently.

Sysmex has been collaborating with NCCL (National Center for Clinical Laboratory) for many years on standardization and quality improvement on blood testing in China, by supporting the establishment of traceability system for blood cell counting and an External Quality Assessment Scheme (EQAS).

As such achievements on the standardization and network construction for EQAS were recognized by SFDA, it was decided that the Sysmex Reference Counter would be installed at BIMT and employed as the national standard for blood cell count in China. Hereafter, this reference counter will be used for the licensing test process for all hematology analyzers in China. Through this application, research on standardization in SFDA-affiliated inspection organizations and inspection activity in China can be promoted.

Currently, besides China, Sysmex has been supporting Thailand, Philippines and Mongolia on the establishment of EQAS nationwide networks. Sysmex will continuously contribute the quality improvement of healthcare testing in the medical developing countries, through scientific support activities.

< Reference >

*1.BIMT (Beijing Institute of Medical Device Testing)

BIMT is subordinate to Beijing Municipal Drug Administration. At the same time, it functions as Beijing Medical Device Quality Supervision and Inspection Center of SFDA. Under the accreditation, BIMT’s business scope mainly covers random inspection of medical device supervision, registration type testing, certification testing, import and export commodity inspection, new model of measuring instruments testing, innovative products evaluation test, entrustment testing and arbitration testing, etc.

Also, as the technical focal point of International Organization for Standardization TC212, IEC TC 62C., it is responsible for establishing national standards and industry standards, revising plans and programs, standards drafting, validation, approval and other standard management work.

*2.Reference Counter

Specially designed and developed semi-automated blood cell counter to assign the values for RBC and WBC, based on the ICSH-recommended specifications.

*3.SFDA (State Food and Drug Administration)

SFDA was founded on the basis of the State Drug Administration. SFDA is directly under the State Council of the People's Republic of China, which is in charge of comprehensive supervision on the safety management of food, health food and cosmetics and is the competent authority of drug regulation in mainland China.

*4.NCCL (National Center for Clinical Laboratory)

Belongs to Health and Welfare Ministry and has responsibility for managing the national EQAS and establishing the quality management system for clinical laboratories in China.

*5.EQAS (External Quality Assessment Scheme)

One type of quality control process – evaluates the quality of routine testing in the clinical laboratories by comparing the results of unknown samples delivered among many participating laboratories statistically.

*6.ICSH (International Council for Standardization in Haematology)

International committee consisting of experts in hematology field and having responsibility for promoting international standardization by preparing reference methods and guidelines for hematology testing.

Information contained in the news release is current as of the date of the announcement,
but may be subject to change without prior notice.

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