Production licenses of 328 medical equipment firms have been
revoked due to "malpractice," said Yan Jiangying, spokeswoman for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Potentially hazardous drugs will also be withdrawn from the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dangerous drugs are withdrawn, and lower the risks patients are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)