Background: The trend toward temporizing external fixation of complex fractures has resulted in increased expenditures for these devices. Increasing pressure to reduce health-care expenditures has led to exploration of reuse of equipment intended for single use. Devices must be tested and recertified prior to redeployment in hospital stock. We report the rate of manufacturer recertification and institutional cost savings associated with a reuse program approved by the United States Food and Drug Administration. Methods: All Hoffmann-II external fixation components that had been removed at our institution during the study period were submitted to the manufacturer for visual inspection and mechanical testing. Pass rates for original components and previously recycled components were determined. With use of a conservative pass rate and the assumption of a maximum of three recertifications of each component, the total potential hospital savings on external fixation were calculated. Results: The first pass rate was 76%. The second pass rate (i.e., the rate for components that had already been recertified once and had been sent for a second recertification) was 83%, but that rate was derived from a limited sample. On the basis of a conservative pass-rate estimate of 75%, the predicted average number of uses of a recyclable component was 2.7. The recertified components were sold back to our hospital at 50% of the original price. Because carbon-fiber bars and half-pins are not recycled, 85% of the charges expended on a new external fixation component are spent on portions of the system that are recyclable. The potential total savings on reusable components was found to be 32%, with a total savings of 27% for the whole external fixation system. No recertified components failed in clinical use over the course of the study. Conclusions: With the expansion of cost-control efforts, the recycling of medical devices appears inevitable. Previous data have demonstrated the safety of reuse of external fixation devices, and this study confirms that finding. Our paper demonstrates the real cost savings associated with a manufacturer-based testing and recertification program. Issues of voluntary participation in reuse programs, component ownership, and the impact of savings on patient charges are yet to be worked out by individual institutions. Level of Evidence: Economic and decision analysis, Level II. See Instructions to Authors for a complete description of levels of evidence.
ASJC Scopus subject areas
- Orthopedics and Sports Medicine