A regulatory framework will be developed to govern medical devices, such as orthokeratology contact lenses.
Secretary for Food & Health Dr Ko Wing-man told legislators today there is no specific law regulating the manufacture, import, sale or use of medical devices in Hong Kong, nor are orthokeratology contact lenses included in the list of medical devices covered under the Department of Health’s voluntary Medical Device Administrative Control System.
“To protect public health while ensuring the community’s continued access to the benefits of new technologies, the administration will develop and establish a regulatory framework for governing medical devices.
“Having regard to the recommendations of the Global Harmonisation Task Force and the World Health Organisation, the administration will adopt a risk-based approach in determining the appropriate level of control for medical devices according to their risks.”
Hospital Authority figures show that between 2011 and 2013, in-patient admissions due to keratitis, sclera and other cornea disorders were 578, 605 and 648, however, there is no breakdown of the number of patients seeking treatment due to microbial keratitis.
Dr Ko reminded the public to follow the instructions of ophthalmologists and registered optometrists in wearing and caring for orthokeratology contact lenses, adding that inappropriate cleaning or usage can lead to corneal infections or ulcers.
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