Puncture needles belong to several classes of medical devices
Jun 10, 2022
Objective To measure the tips of several Tuohy epidural needles (EN) and explore their clinical significance. Methods Fifty-one 18GEN from six different manufacturers were processed by computer and measured on the printed images (1) the distance PA between the EN axis L and the intersection point A on the back of the bevel to the tip P. (2) The vertical distance from P to L, PB. (3) The included Angle β between PC and PA of the longest diameter line of the needle bevel. The difficulty of 25G nib-type waist hemp needle (SN) penetrating through the EN diagonal opening was observed in vitro, and the Angle α between SN penetrating part and EN was measured. Results (1)PA, PB, β and α were significantly different among EN (P0.05 or P0.01). (2)SN is difficult to wear various EN (P0.01). (3) PA, PB, β and α were significantly different among different difficulty levels (P0.01). Conclusion The shape of EN tip produced by different manufacturers is different
Puncture needles generally belong to Class 2 medical instruments, but biopsy needles, lumbar puncture needles, disposable sterile puncture needles, etc., all belong to Class 3 medical instruments.
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