At the just-concluded Science and Technology Week, the Shanghai Medical Device Testing Institute held an approach to the Food and Drug Testing Office. Professional and technical personnel explained in detail the stories that were previously unknown: how medical devices experienced before they went public. The test of "water simmering"? Is the pacemaker and vascular stent durable enough? What is the "airwave darkroom" like the studio?
Reasons for deep cutting steel plate fracture
After some fractures occur, the doctor will fix the fracture site and fix it with the plate to help the bone repair of the fracture. However, at present, about 3-5% of cases have steel plate fractures, and the cause of steel plate fracture needs to be carefully analyzed.
A patient who played the violin accidentally broke the humeral bone near the shoulder and went to the hospital for a plate implantation. I did not expect to go to the review after more than a year, but found that the steel plate was broken, and the bones did not grow well. It was necessary to carry out the second operation to re-integrate the steel plate. This time, the doctor used a thickened foreign brand steel plate for him. The result was reviewed after more than one year, and the steel plate was broken at the same position.
Because the fracture of the tibia in this part is not uncommon, the staff of the Municipal Medical Device Testing Institute has carried out research on this. Through various digital modeling, simulation and other methods, it is analyzed that the maximum stress exists in the fracture of the steel plate. The possibility of breaking is greatest. If the site is fixed with intramedullary nails, the stress on the intramedullary nail is less than the yield strength of the material. Therefore, this study is of great significance for clinical surgery.
The performance test of the vascular stent can not be sloppy. In the laboratory, there are many large and small instruments that simulate the use of vascular stents in the human body, such as the fatigue test of the cardiac stent, it is necessary to simulate 380 million pulsations (equivalent to the number of heart beats in the human body within 10 years). In addition, there is a coating peel test. Because the coating on the vascular stent in clinical use falls off after the stent is implanted, the size of the detached coating may cause embolization at the distal end of the artery, and small may cause changes in blood properties, and the size of the coating. The acceptable value of the international standard is currently not available. The Shanghai Center's research on this aspect will also provide a reference for future standards development.
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