China's drug watchdog has vowed to strengthen inspections for
licenses of imported drugs and medical devices, after allegations
involving the death of a teenager who received an artificial heart
The State Food and Drug Administration (SFDA) would launch a
six-month campaign of special inspections of licenses for imported
medical devices, said SFDA spokeswoman Yan Jiangying.
The SFDA would verify the authenticity of the applications for
domestic and imported medical appliances, with a complete
verification of cardiac pacemakers, valves, brackets and artificial
joints by November.
A court in Shanghai on July 25 began hearing legal proceedings
in which a couple are suing Shanghai East Hospital for allegedly
attaching an unregistered imported device to their son's heart.
Zhou Yiqing, 13, received a ventricular assist device (VAD) in
April 2004, but he died a year later after further heart surgery at
the same hospital.
A VAD is a mechanical pump that helps the heart pump blood
through the body. Zhou's parents claim the hospital used a
VAD that had not been registered by the SFDA. However, the
hospital says on its website that the German-made device was
imported in 1998 when SFDA had no registration regulation on
imported medical appliance.
According to Nanfang Daily, the parents had acquired a
written certificate from SFDA, stating the German-made device has
They claimed the operation was actually a medical experiment.
The case has been adjourned to allow more evidence to be
(Xinhua News Agency August 10, 2007)