Re-Use of Explanted Osteosynthesis Devices: Cleaning and Inspection Protocol for Assessing Device Integrity

Osteosnythesis devices, including screws, fracture plates and staples, are generally considered single-use devices. However, healthcare systems in many developing countries do not adequately cover their cost, despite their accepted efficacy for treating complex fractures and reducing the disabling affects of permanent musculoskeletal deformity. Consequently, orthopaedic surgeons in such countries regularly re-use osteosynthesis devices. While the economic, safety and ethical perspectives of re-using osteosynthesis devices are debatable,2 such concerns are superseded by a lack of availability and existing re-use practices in developing nations. Given that re-used osteosynthesis devices can yield satisfactory results, protocols that address potential complications of re-used devices, such as infection and device breakage, are valid scientific concerns. A prior biomechanical study1 showed a reduction in the cycles to failure for explanted plates available for re-use. However, the explanted plates were not screened for surface damage or deformity (bending) prior to testing. Given the reduction in the mechanical properties that occurs when biomaterials are subjected to scratches or corrosion,3 establishing suitable accept/reject criteria for screening explanted osteosynthesis devices could improve the mechanical integrity of devices available for re-use. The purpose of this study was to establish such criteria and develop a simple cleaning and inspection protocol for screening osteosynthesis devices.