BACKGROUND: 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. STUDY DESIGN: 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. RESULTS: 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. CONCLUSIONS: 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.
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机译：背景：可重复使用的不锈钢套管针传统上用于插入释放左炔诺孕酮的避孕植入物，但由于灭菌要求，它们难以维护。此外，在许多情况下并不总是可以使用消毒设备，并且清洁不充分可能导致HIV传播。研究设计：将一种新型的用于两杆植入物的一次性套管针[即，Sin-implant（II）和Jadelle]与传统的可重复使用的两杆式套管针进行了比较。肯尼亚的临床医生根据使用方便，故障和不良事件评估了套管针。结果：新的一次性套管针完成了80次插入，而传统的可重复使用套管针完成了80次插入。没有发现性能差异。一次性套管针易于使用，没有故障，也没有引起不良的患者事件。这些临床数据，再加上产品技术文件的审查以及挪威认证机构（Det Norske Veritas）对生产设施的检查，最终获得了CE标记，CE标记是在该医疗设备中分发该产品的强制性合格标记。欧盟成员国。结论：一次性套管针消除了消毒的需要。这将有助于在资源有限的环境中提供避孕植入物，并可能降低艾滋病毒传播的风险。结合近期植入物价格的下降，这些新的发展应该会在世界许多地方增加使用这种重要避孕技术的机会。
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