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SFDA Uncovers Medical Equipment Malpractice
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Production licenses of 328 medical equipment firms have been revoked due to "malpractice," said Yan Jiangying, spokeswoman for the State Food and Drug Administration (SFDA) in Beijing Tuesday.

The SFDA began its nationwide survey of medical equipment quality in July last year. The administration also revoked the registration licenses of 65 items of medical equipment because they failed quality tests and cancelled registrations of another 147, Yan said.

None of the companies or items were named and Yan did not explain what types of "malpractice" had occurred.

Starting September 18, the SFDA will launch special inspections to verify the authenticity of applications for domestic and imported medical appliances, with a complete verification of medical devices, including cardiac pacemakers, artificial heart valves, and blood transfusion equipment, said Yan.

Potentially hazardous drugs will also be withdrawn from the market at the first sign of a problem, according to a draft action plan, to be posted on the administration's website for public feedback. The system would require drug makers to pull problematic products off the shelves even before results of lab examinations are out, said Yan Jiangying.

Under the current practice, only when laboratory examination results are released and major problems identified, can authorities seal, seize, or destroy hazardous products.

The recall system will shorten the period in which potentially dangerous drugs are withdrawn, and lower the risks patients are exposed to, Yan told China Daily. "It takes time to figure out the problem when adverse effects of drugs are detected among users. The new recall system can prevent damage from spreading."

At yesterday's press briefing, Yan also said the country is facing a shortage of human albumin, or plasma protein, but said blood products were safe.

"We found no serious violation of laws or regulations (during recent inspections) and most manufacturers have strictly abided by the good manufacturing practices," she said.

She said the government will not ease a ban on imported blood products out of safety concerns and called for more blood donations. "I hope more of our people give blood, as this is the only way to solve the problem at its root," Yan said.

China imposed the ban in the mid-1980s after HIV infection was detected in imported blood products.

To safeguard product safety, all plasma-based products and vaccines will undergo mandatory tests starting from next January before they hit the market, Yan said.

In addition, a 90-day quarantine period will be applied to raw plasma used in blood products to ensure there are no virus infections such as HIV.

(Xinhua News Agency, China Daily September 12, 2007)

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