CMDE release: answers to common problems of 2 medical devices

Q.How to select the worst-case samples for the mechanical properties of interbody fusion cage?

A.The effects of bone graft size, lateral hole size, inclination, length, width and height of fusion cages with different models and specifications on the mechanical properties of the products should be considered. At the same time, the models and specifications of samples in the worst case may be different due to different mechanical property indexes (such as compression, compression shear, torsion, etc.), Combined with the test methods and loading methods of dynamic and static mechanical properties of cervical and thoracolumbar interbody fusion cage, the selection of samples in the worst case of cervical and thoracolumbar interbody fusion cage is comprehensively considered.

Q.What should be paid attention to when using the reverse type red blood cell reagent and microcolumn gel card?

We should consider the compatibility of products in the clinical trials of the registration of reverse typing products and microcolumn gel cards. At the same time, we should pay attention to the test in vitro diagnostic reagents and contrast methods. We should use corresponding reverse typing red cell reagents and microcolumn gel cards to carry out clinical trials. In general, the use of microcolumn gel cards is not specified in the general typing of RBC instructions. However, in the microcolumn gel card instructions, the reverse set red blood cells should be clearly defined.

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