9-Year-Old Scoliosis Child Farewell to Repeated Surgery! "Hong Kong and Macao Medicine and Equipment Communication" First Device Put into Clinical Practice _ Xiaolei
Original Title: 9-Year-Old Scoliosis Child Farewell to Repeated Surgery! "Hong Kong and Macao Medicine and Equipment Communication" First Device Put into Clinical Practice With the help of the "Hong Kong and Macao Medicine and Equipment Link" project, Xiaolei (pseudonym), a 9-year-old patient with severe early-onset scoliosis, became the first beneficiary of the project to introduce the device "magnetic controllable extension titanium rod". With the help of "magnetic controllable extension titanium rod", Xiaolei did not have to undergo a total of 10 large wound operations with full spinal exposure every six months, thus avoiding great pain. On May 3, Professor Zhang Wenzhi, Department of Spine Surgery, Shenzhen Hospital,titanium sheet grade 5, University of Hong Kong, led the operation. With the support of the hospital's operating room, anesthesia, ultrasound,Titanium 6Al4V wire, radiation and other multidisciplinary teams, Xiaolei successfully performed titanium rod implantation and recovered well after the operation. This is the first application of "magnetic controllable extension titanium rod", an epoch-making device for early-onset scoliosis in the mainland. Professor Zhang Wenzhi said that compared with traditional growth rods, this device will bring revolutionary progress in the treatment of such diseases. Photo: Professor Zhang Wenzhi, Department of Spine Surgery, Shenzhen Hospital, titanium bar gr7 ,titanium bar grade 5, University of Hong Kong Zhang Wenzhi: The traditional growth rod needs an open operation every six months to one year to open the wound and then extend the growth rod. So now the advantage of the "magnetic controllable extension titanium rod" is that there is a very small magnetic motor in the growth rod. We can push this motor through external magnetic instruments, and it will automatically extend, which has the advantage of avoiding open surgery later. Expand the full text According to Xiaolei's mother, at the beginning of this year, when they visited Peking Union Medical College Hospital, they learned that Shenzhen Hospital of Hong Kong University had become the first pilot hospital of "Hong Kong and Macao Medicine and Equipment Link", and that "Magnetic Controllable Extension Titanium Rod" as the first approved device would soon be put into clinical use. Under the recommendation and docking of the attending professor in Beijing, Xiaolei and his parents embarked on a trip to Shenzhen in April this year, and had an operation on May 3. The operation was very successful. Subsequently, Xiaolei only needs regular follow-up visits every 2-3 months, stretching in vitro through specific instruments, adjusting the length of the titanium rod and the angle of the spine until it is basically cured. On April 29, the patient, Ms. Yang (not her real name), was injected with the first dose of "anti-D immunoglobulin injection", becoming the first patient to benefit from the "Hong Kong-Macao Pharmaceutical Equipment Communication" project. On May 3, Xiaolei, a child, also underwent a successful operation, becoming the beneficiary of the first imported instrument "magnetic controllable extension titanium rod". Photo: Lu Chongmao, Dean of Shenzhen Hospital, University of Hong Kong Lu Chongmao: "The listing of medical devices must be approved by the state. Different products have different time. Generally speaking, many medical devices in the mainland are three to five years later than those in Hong Kong,ti6al4v, and some are even longer. So through the policy of" Hong Kong and Macao Medical Devices Link ", we can speed up the medical use of more advanced medical devices in Shenzhen and even the whole Greater Bay Area, and also provide data to the state to speed up the approval of listing." END Source | Happy 1062 Reporter | Mai Jie Editor | Qiu Xiang returns to Sohu to see more Responsible Editor:. yunchtitanium.com
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This is the footer for your site.Introduction to the US FDA Guideline "Key Points for Non-clinical Evaluation of Medical Devices Containing Nickel-Titanium Alloy" _ Characteristics
Original Title: Brief Introduction to the US FDA Guidelines on Key Points for Non-clinical Evaluation of Medical Devices Containing Nitinol Brief Introduction of FDA's Guideline on Nonclinical Evaluation of Medical Devices Containing Nitinol In October 2020, FDA of the United States issued the Guidelines for Non-clinical Evaluation of Medical Devices Containing Nitinol, which elaborated the key points of technical review of medical devices containing Nitinol. The contents of the Guidelines are briefly introduced as follows. I. Basic Concepts Nitinol is a near-equiatomic alloy of nickel and titanium, which has the properties of superelasticity and shape memory, and is widely used in cardiovascular devices such as heart stents, valves, guidewires, and other fields of medical devices. Compared with traditional metals such as stainless steel, titanium or cobalt-chromium alloys, nickel-titanium alloys have complex properties and are susceptible to many factors such as alloy composition, thermal processing, surface treatment, corrosion of biological tissues and so on. When evaluating its safety and effectiveness, it is necessary to focus on thermodynamic properties, process sensitivity and so on. II. Key points of technical evaluation (I) Basic information 1. Material composition If the material of the nickel-titanium alloy used in the device conforms to a recognized standard, it shall be specified in the application (e.g., ASTM F2063). If the material does not conform to a recognized standard,titanium plate gr7, the composition of the material shall be defined and its properties shall be described. 2. Manufacturing process The production process flow diagram shall be provided, especially the thermal process, surface treatment steps, final cleaning steps, etc. 3. Superelastic/shape memory properties At operating temperatures, superelasticity or shape memory can be achieved by adjusting the composition and heat treatment of the nitinol alloy. Due to the large difference in properties between the two, the applicant should specify in the application which properties (superelasticity or shape memory) of the nickel-titanium alloy are used. 4. Deformation temperature The change of temperature will affect the mechanical property of nickel-titanium alloy. It is recommended to specify the phase transformation temperature of the finished product in the data. Refer to ASTM F2004 and ASTM F2082. (II) Mechanical test 1. Key points of experiment It is recommended to explain the control mode adopted for mechanical testing; for deformable implantable devices,3d titanium wire, it is recommended to consider clinical deformation and temperature drift before mechanical testing; mechanical testing should be carried out at actual clinical temperature; if fatigue testing is carried out, it is recommended to use clinically relevant solvents (such as PBS); If the shape memory properties of the device are utilized, it is recommended that shape memory testing be performed at clinical temperatures and service cycles, and that functional properties and device integrity be evaluated. 2. Stress calculation/strain analysis If a computational analysis is performed, an appropriate metal model should be used to correctly reflect the thermodynamic properties of the nitinol alloy. A material model may be selected by reference to ASTM F2516. The applicant shall verify the calculation model. If the device is subjected to a cyclic load test, the fatigue safety factor shall also be calculated. Expand the full text (III) Corrosion resistance test 1. Pitting Corrosion of nitinol alloys can result in the release of nickel ions and affect the integrity of the device. The corrosion resistance depends on the manufacturing process and surface treatment. Pitting corrosion testing is recommended in accordance with ASTM F2129. 2. Release of nickel ion If Nitinol devices do not meet the accepted criteria for corrosion resistance, or do not use a proven surface treatment process, a nickel ion release test should be considered. Refer to ASTM F3306 for test methods. 3. Galvanic corrosion If Nitinol devices are expected to be in contact with dissimilar metals, consideration should be given to performing a galvanic corrosion test, as recommended in ASTM F3044. (IV) Biocompatibility It is recommended to refer to ISO 10993 -1 for biocompatibility evaluation. If a nickel ion release test is performed, refer to ISO 10993 -17. (V) Label information It is recommended that the label clearly indicate that the device contains nitinol, suggesting that it may cause allergic reactions in patients, nickel titanium wire ,Titanium welding pipe, especially in long-term or permanent implanted devices. III. References: [1] FDA. Technical Considerations for Non-Clinical Assessment of MedicalDevices Containing Nitinol - Guidance for Industry and Food and Drug Administration Staff. October 15, 2020 Labels: Medical Device FDA Registration, US Medical Device GMP Certification Release date: 2021-07-06 20:07 Views: 27 In October 2020, FDA of the United States issued the Guidelines for Non-clinical Evaluation of Medical Devices Containing Nitinol, which elaborated the key points of technical review of medical devices containing Nitinol. The contents of the Guidelines are briefly introduced as follows. Brief Introduction of FDA's Guideline on Nonclinical Evaluation of Medical Devices Containing Nitinol In October 2020, FDA of the United States issued the Guidelines for Non-clinical Evaluation of Medical Devices Containing Nitinol, which elaborated the key points of technical review of medical devices containing Nitinol. The contents of the Guidelines are briefly introduced as follows. I. Basic Concepts Nitinol is a near-equiatomic alloy of nickel and titanium, which has the properties of superelasticity and shape memory, and is widely used in cardiovascular devices such as heart stents, valves, guidewires, and other fields of medical devices. Compared with traditional metals such as stainless steel, titanium or cobalt-chromium alloys, nickel-titanium alloys have complex properties and are susceptible to many factors such as alloy composition, thermal processing, surface treatment, corrosion of biological tissues and so on. When evaluating its safety and effectiveness, it is necessary to focus on thermodynamic properties, process sensitivity and so on. II. Key Points of Technical Evaluation (I) Basic information 1. Material composition If the material of the nickel-titanium alloy used in the device conforms to a recognized standard, it shall be specified in the application (e.g., ASTM F2063). If the material does not conform to a recognized standard, the composition of the material shall be defined and its properties shall be described. 2. Manufacturing process The production process flow diagram shall be provided, especially the thermal process, surface treatment steps, final cleaning steps, etc. 3. Superelastic/shape memory properties At operating temperatures, superelasticity or shape memory can be achieved by adjusting the composition and heat treatment of the nitinol alloy. Due to the large difference between the two properties, the applicant should specify in the application which property (superelasticity or shape memory) of the nickel-titanium alloy is used. 4. Deformation temperature The change of temperature will affect the mechanical property of nickel-titanium alloy. It is recommended to specify the phase transformation temperature of the finished product in the data. Refer to ASTM F2004 and ASTM F2082. (II) Mechanical test 1. Key points of experiment It is recommended to explain the control mode adopted for mechanical testing; for deformable implantable devices, it is recommended to consider clinical deformation and temperature drift before mechanical testing; mechanical testing should be carried out at actual clinical temperature; if fatigue testing is carried out, it is recommended to use clinically relevant solvents (such as PBS); If the shape memory properties of the device are utilized, it is recommended that shape memory testing be performed at clinical temperatures and service cycles, and that functional properties and device integrity be evaluated. 2. Stress calculation/strain analysis If a computational analysis is performed, an appropriate metal model should be used to correctly reflect the thermodynamic properties of the nitinol alloy. A material model may be selected by reference to ASTM F2516. The applicant shall verify the calculation model. If the device is subjected to a cyclic load test, the fatigue safety factor shall also be calculated. (III) Corrosion resistance test 1. Pitting Corrosion of nitinol alloys can lead to the release of nickel ions and affect the integrity of the device. The corrosion resistance depends on the manufacturing process and surface treatment. Pitting corrosion testing is recommended in accordance with ASTM F2129. 2. Release of nickel ion If Nitinol devices do not meet the accepted criteria for corrosion resistance or do not use a proven surface treatment process, a nickel ion release test should be considered. Refer to ASTM F3306 for the test method. 3. Galvanic corrosion If Nitinol devices are expected to be in contact with dissimilar metals, consideration should be given to performing a galvanic corrosion test, as recommended in ASTM F3044. (IV) Biocompatibility It is recommended to refer to ISO 10993 -1 for biocompatibility evaluation. If a nickel ion release test is performed, refer to ISO 10993 -17. (V) Label information It is recommended that the label clearly indicate that the device contains nitinol, suggesting that it may cause allergic reactions in patients,titanium bar gr5, especially in long-term or permanent implanted devices. III. References: [1] FDA. Technical Considerations for Non-Clinical Assessment of MedicalDevices Containing Nitinol - Guidance for Industry and Food and Drug Administration Staff. October 15, 2020 Tags: Medical Device FDA Registration, US Medical Device GMP Certification Return to Sohu to see more Responsible Editor:. yunchtitanium.com
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