Reprocessing capabilities of newly approved devices for use in surgery

Abstract

Introduction

Single-use medical devices used in surgery can create environmental waste and increased costs. Reprocessed medical devices may reduce cost and environmental impact. This study investigated the reprocessing capabilities of newly FDA-approved devices in surgery.

Methods

Devices were identified using the publicly-available FDA Releasable 510(k) Database from 2018 to 2023 using the instrument product codes for laparoscope, general, and plastic surgery (GCJ); and electrosurgical (GEI) devices. GCJ and GEI devices were categorized based on usage, and the number of devices (total, single, and reprocessed) were extracted. Costs were obtained from public websites.

Results

There were 658,510(k) applications for surgical devices, representing 3.8 % (658/16723) of total applications. Reprocessing capabilities existed for 29 % of GCJ devices and 14 % of GEI devices. Among GCJ devices, 5 (56 %) laparoscopy and 16 (38 %) camera devices had reprocessing capabilities. For GEI devices, 7 (50 %) laparoscopic and 5 (50 %) cable devices had reprocessing capabilities. Only one (6 %) tissue ablation device had reprocessing capabilities. The average cost of GCJ and GEI single-use devices ($11314; $8554, respectively) was less than reprocessed counterparts ($17206; $16134, respectively).

Conclusion

Reprocessing capabilities for newly approved surgical devices are variable and overall limited. To enhance adoption of reprocessing in surgical practice, future efforts will likely be needed to expand the reprocessing potential of new surgical devices.