Assessment of a disposable trocar for insertion of contraceptive implants☆
Received 22 July 2009; received in revised form 13 August 2009; accepted 19 August 2009. published online 05 October 2009.
Abstract
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.
☆ Support for this research was provided by the Bill & Melinda Gates Foundation. The views expressed in this publication do not necessarily reflect those of Family Health International, Marie Stopes International or the funding agency.
ABSTRACT