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Contraception. 2010 Feb;81(2):140-2. doi: 10.1016/j.contraception.2009.08.006. Epub 2009 Sep 30.
Reusable stainless steel trocars have traditionally been used to insert levonorgestrel-releasing contraceptive implants, yet they are cumbersome to maintain because of sterilization requirements. In addition, sterilization equipment is not always available in many settings and inadequate cleaning could lead to HIV transmission.
A new disposable trocar for two-rod implants [i.e., Sino-implant (II) and Jadelle] was compared to a traditional reusable two-rod trocar. Clinicians in Kenya assessed the trocars in terms of ease of use, malfunctions and adverse events.
Eighty insertions were done with the new disposable trocar and 80 insertions were done with the traditional reusable trocar; no differences in performance were found. The disposable trocar was easy to use, did not malfunction and did not cause adverse patient events. These clinical data, combined with the review of the product technical file and an inspection of the manufacturing facility by a Norwegian certification body (Det Norske Veritas), resulted in obtaining the CE Mark, a mandatory conformity mark for the distribution of this medical device in European Union member states.
Disposable trocars eliminate the need for sterilization; this will facilitate provision of contraceptive implants in resource-constrained settings and may decrease the risk of HIV transmission. Combined with recent reduction in prices of implants, these new developments should increase access to this important contraceptive technology in many parts of the world.
传统上，可重复使用的不锈钢套管针被用于插入左炔诺孕酮释放型避孕植入物，但由于需要消毒，它们的维护比较繁琐。此外，许多地方可能没有消毒设备，清洁不充分可能会导致 HIV 传播。
一种新的一次性双棒植入物套管针（即 Sino-implant[即乙孕铜避孕植入剂]和 Jadelle）与传统的可重复使用的双棒套管针进行了比较。肯尼亚的临床医生从易用性、故障和不良事件等方面对套管针进行了评估。
使用新的一次性套管针进行了 80 次插入，使用传统的可重复使用套管针进行了 80 次插入，性能没有差异。一次性套管针易于使用，没有发生故障，也没有导致不良的患者事件。这些临床数据，加上对产品技术文件的审查和挪威认证机构（Det Norske Veritas）对制造工厂的检查，使该医疗器械获得了 CE 标志，这是在欧盟成员国分销这种医疗器械的强制性合格标志。
一次性套管针消除了消毒的需要；这将便于在资源有限的环境中提供避孕植入物，并可能降低 HIV 传播的风险。再加上最近植入物价格的降低，这些新的发展应该会增加世界许多地区获得这种重要避孕技术的机会。
