Abstract

Background

Re-use of medical devices labeled and marketed for single use only is a current practice around the world.

Objectives

To estimate the average difference per surgery in device-related costs (DRCs) when performed with single-use devices under a single-use policy (SUP) instead of a re-use policy (RP) from the perspective of the private health sector of Argentina.

Methods

An analytical model was developed in Microsoft Excel and populated with data from a literature review, a Delphi-like panel, and local cost estimations. Four single-use devices were selected for analysis: plastic trocars, endocutters, linear cutters, and harmonic scalpels. DRCs were expressed in 2012 US dollars and divided into four cost categories: devices, adverse events, device failure, and surgical time extension. Outputs were expressed as DRCs per surgery under a SUP, under a RP, the difference between them expressed in US dollars (Diff_$), and the difference between them expressed as a percentage of surgery costs (Diff_%S). Deterministic and probabilistic sensitivity analyses were performed to analyze the impact of uncertainty on results.

Results

Expected DRCs per surgery were as follows: for trocars: SUP, US $424.6; RP, US $244.2; Diff_$, US $−180.4; and Diff_%S, −3.8%; for endocutters: SUP, US $1667.4; RP, US $1102.3; Diff_$, US $−565.1; and Diff_%S, −11.1%; for linear cutters: SUP, US $1228.1; RP, US $1045.9; Diff_$, US $−182.2; and Diff_%S, −3.4%; and for harmonic scalpels: SUP, US $1040.9; RP, US $292.4; Diff_$, US $−748.5; and Diff_%S, −14.8%. Sensitivity analyses showed results to be robust.

Conclusions

RP was shown to be less costly in all devices and scenarios considered. Nevertheless, the real frequency of adverse events and their cost implications are still uncertain. More research is needed to assess the effectiveness and safety of these off-label policies.