The Health Bureau, the Department of Health and the Hospital Authority have jointly stressed that innovative medical products must be scientifically proven, with clinical trials showing that they are safe and effective, before they can be translated to clinical applications.
They were responding to media inquires about the donation to local healthcare institutions of histotripsy devices, which use high-intensity ultrasound waves. The University of Hong Kong’s LKS Faculty of Medicine, the Chinese University’s Faculty of Medicine and the Hong Kong Sanatorium & Hospital are using the devices in clinical trials for the treatment of liver cancer.
The authorities said they are paying close attention to the results of the studies, and expect that the data will provide a scientific basis for their wider application in the future.
The donated devices have not been listed under the voluntary Medical Device Administrative Control System, but the Department of Health said it is processing a recent application for the listing of a histotripsy device.
With regard to trials of medical devices in the public healthcare system, the Hospital Authority said considerations include safety, evidence of the devices’ therapeutic effectiveness, the cost-effectiveness of their use, and comprehensive comparisons with existing treatments.
It added that the adoption of new devices will not and should not be influenced by whether a treatment method is provided or sponsored by individual pharmaceutical or device manufacturers. It also iterated that use in the public healthcare system of medical devices that are still undergoing clinical trials should be handled in a very careful and prudent manner.
The authorities also stressed that clinical trials should be distinguished from clinical services, stating that no clinical service will be provided where trials of a treatment are ongoing.
They advised that patients should consult medical professionals and not be influenced by advertisements or publicity.
