Risk analysis: Applicator for RTI’s Thin-Film Polymer Device

Focus Areas: HIV
Content Type: Reports
Authors: PATH, RTI International
Published: September 2016

This preliminary risk analysis was written by PATH in collaboration with RTI International to identify potential risks associated with use of the TFPD system with focus on the applicator. Because the TFPD system is still in early development, the scope of the first iteration is limited to hazards associated with packaging, use, and disposal; risks associated only with the implant and a description and evaluation of mitigation efforts (risk control) will be added in later revisions. Risks associated with different design configurations (for example, reusable vs. single-use trocar applicators) is differentiated in the hazard statement. This risk analysis assumes that health care workers (HCWs) have been appropriately trained and that the device has been manufactured without preexisting defects. Applicators addressed in this hazard analysis are limited to trocar-based designs.


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