China Releases New Regulations That Aim To Strengthen Supervision, Management Of Blood Collection Centers

Main Category: Blood / Hematology
Article Date: 05 Mar 2008 - 7:00 PDT

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China's Ministry of Health on Friday released new regulations that aim to strengthen the supervision and management of blood collection centers in the country, China Daily reports. According to the health ministry, the regulations -- which went into effect on Saturday and are applicable to the country's 145 collection centers -- will play an important role in preventing the spread of bloodborne diseases, including HIV and hepatitis (Juan, China Daily, 3/1).

Blood selling practices during the 1990s in China's central Henan province contributed to the spread of HIV, which, according to some advocates, affected about one million people. The situation in Henan led officials to pledge reform, and the health ministry has said that it maintains stringent supervision of blood collection centers in the country. According to the ministry of health, it closed about 150 illegal collection and supply agencies nationwide in 2004, the last year for which official figures are available. The health ministry in July 2007 also ordered all blood collection centers in the country to install video cameras to ensure that medical staff members are following regulations. Despite the health ministry's efforts, the country's State Food and Drug Administration in June 2007 discovered fake plasma being used in at least 18 hospitals in northeastern China.

SFDA last year announced a new policy under which all blood products in the country will be screened for HIV and other bloodborne diseases and approved before entering the market (Kaiser Daily HIV/AIDS Report, 9/14/07).

Under the new regulations, areas where prevalence of diseases such as HIV is high are prohibited from establishing blood collection centers. In addition, provincial-level health officials are required to approve blood collection centers before they are established, and areas that hope to establish centers should have the capacity to collect at least 30 tons of plasma annually. Also under the regulations, areas where voluntary blood donations do not match the local demand for two years will be prohibited from opening a new center.

The regulations also establish corporate responsibility and liability guidelines for manufacturers of plasma-based products to establish and operate collection centers. The guidelines were commissioned by the health ministry in 2006. Other requirements under the new regulations include having qualified technical staff, quality sanitation and proper blood-testing equipment. In addition, all blood donors will have to pass a health test before they can donate blood. Donors also are not permitted to give blood within two weeks of their last donation under the regulations. Those appointed to manage the centers will be held fully responsible for the safety and quality of the blood collected, China Daily reports (China Daily, 3/1).

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