China adopts new rules on customized medical devices
By Liu Yang, Zhao Jing
To save a 25-year-old patient with a giant tumor on his thoracic vertebrae, a group of orthopedic specialists removed three of his vertebrae.
The three vertebrae had been severely eroded by the tumor, and without surgeons implanting customized, 3D-printed, titanium alloy artificial thoracic vertebrae, the patient could have faced paraplegia.
The 3D-printed artificial vertebrae required technicians to convert bone and joint imaging of data based on the individual patient's CT data, and then build a digital model. The machine can finish the 3D printing in 72 hours.
The operation was also the first customized implantable surgery in China after the country issued its first-ever regulation on the administration and supervision of customized medical devices.
The rule was proposed to the National People's Congress in 2014 by Dr. Liu Zhongjun, who is the Director of the Institute of Spine Surgery at Peking University Third Hospital.
During an interview, he showed CGTN a customized cervical vertebra 3D printing device. Liu said that the new regulation not only provides critical legal safeguards for patients and doctors, but also clarifies the safety of medical devices.
Why is the customized 3D printing medical device so important for patients?
In the past 40 years, taking orthopedics as an example, the improvement of the surgical treatment level of spine, joints and trauma has been directly related to the application of various metal implants or similar equipment.
In most cases, standardized medical devices can meet the needs of operations. Still, in some cases including particular anatomical sites or lesions causing significant bone defects, standardized medical devices struggle to meet the needs of the operation, resulting in poor therapeutic effects or the forced abandonment of the process.
Therefore, custom-made medical devices have given many patients new hope.
In the past 10 years, with the emergence of 3D printing technology for metal materials, the design and manufacturing technology of individual customized medical devices has made a breakthrough.
The application of 3D-printed titanium alloys has dramatically promoted scientific and technological innovation in the field of orthopedics and made breakthroughs in the treatment of many complicated diseases.