Abstract
Introduction
Orthopaedic surgical treatments emphasizing immobilization using open reduction and
internal fixation with osteosynthesis devices are widely accepted for their efficacy
in treating complex fractures and reducing permanent musculoskeletal deformity. However,
such treatments are profoundly underutilized in low- and middle-income countries (LMIC),
partially due to inadequate availability of the costly osteosynthesis devices. Orthopaedic
surgeons in some LMIC regularly re-use osteosynthesis devices in an effort to meet
treatment demands, even though such devices typically are regulated for single-use
only. The purpose of this study is to report a reprocessing protocol applied to explanted
osteosynthesis devices obtained at a leading trauma care hospital.
Methods
Explanted osteosynthesis devices were identified through a Register of Explanted Orthopaedic
Prostheses. Guidelines to handle ethical issues were approved by the local Ethical
Committee and informed patient consent was obtained at the time of explant surgery.
Primary acceptance criteria were established and applied to osteosynthesis devices
explanted between 2005 and 2008. A rigorous protocol for conducting decontamination
and visual inspection based on specific screening criteria was implemented using simple
equipment that is readily available in LMIC.
Results
A total of 2050 osteosynthesis devices, including a large variety of plates, screws
and staples, were reprocessed using the decontamination and inspection protocols.
The acceptance rate was 66%. Estimated labour time and implementation time of the
protocol to reprocess a typical osteosynthesis unit (1 plate and 5 screws) was 25 min, with an estimated fixed cost (in Italy) of €10 per unit for implementing the
protocol, plus an additional €5 for final sterilization at the end-user hospital site.
Discussion
This study was motivated by the treatment demands encountered by orthopaedic surgeons
providing medical treatment in several different LMIC and their need for access to
basic osteosynthesis devices. The rigorous decontamination protocol and generalized
inspection criteria proved useful for efficiently screening a large volume of devices.
Given that re-used osteosynthesis devices can yield satisfactory results, this study
addresses potential complications of re-used devices and valid concerns that relate
to patient safety. Implementing this defined reprocessing protocol into existing re-use
practises in LMIC helps to limit the risks of inadequate sterilization and structural
failure without adding additional risks to patients receiving re-used devices.
Keywords
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Article info
Publication history
Accepted:
February 8,
2011
Identification
Copyright
© 2011 Elsevier Ltd. Published by Elsevier Inc. All rights reserved.
