Research Article| Volume 42, ISSUE 10, P1101-1106, October 2011

Re-use of explanted osteosynthesis devices: A reliable and inexpensive reprocessing protocol



      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.


      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.


      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.


      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.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Injury
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Arora A.
        • Agarwal A.
        • Gikas P.
        • et al.
        Musculoskeletal training for orthopaedists and nonorthopaedists: experiences in India.
        Clin Orthop. 2008; 466: 2350-2359
        • Bach O.
        • Hope M.J.
        • Chaheka C.V.
        • et al.
        Disability can be avoided after open fractures in Africa: results from Malawi.
        Injury Int J Care Injured. 2004; 35: 846-851
        • Beck D.J.
        • Seligson D.
        External fixator parts should not be reused.
        J Orthop Trauma. 2006; 20: 39-42
        • Beveridge M.
        • Howard A.
        The burden of orthopaedic disease in developing countries.
        J Bone Joint Surg. 2004; 86A: 1819-1822
        • Breme J.
        • Biehl V.
        • Black J.
        • Hastins G.
        Metallic biomaterials.
        Handbook of biomaterial properties. Chapman & Hall, London, England1998 (p. 135–213)
        • Dirschl D.R.
        • Smith I.J.
        Reuse of external skeletal fixator components: effects on costs and complications.
        J Trauma. 1998; 44: 855-858
        • Faldini A.
        Pediatric, orthopaedics in developing countries.
        in: XII National Congress of the Italian Society of Pediatric Orthopaedic Surgery (SITOP), September 29–October 12005
        • Horwitz D.S.
        • Schabel K.L.S.
        • Higgins T.F.
        The economic impact of reprocessing external fixation components.
        J Bone Joint Surg. 2007; 89A: 2132-2136
        • Jacob P.
        • Polisena J.
        • Hailey D.
        • et al.
        Economic analysis of reprocessing single-use medical devices: a systematic literature review.
        Infect Control Hosp Epidemiol. 2008; 29: 297-301
        • Linde C.L.
        • Bocray A.
        • Jonsson H.
        • et al.
        Re-used pacemakers—as safe as new? A restrospective case-control study.
        Eur Heart J. 1998; 19: 154-157
        • Magetsari R.
        • van der Houwen E.B.
        • Bakker M.T.J.
        • et al.
        Biomechanical and surface physio-chemical analysis of used osteosynthesis plates and screws: potential for reuse in developing countries?.
        J Biomed Mater Res (Appl Biomater). 2006; 79B: 236-244
        • Matsuura M.
        • Lounici S.
        • Inoue N.
        • et al.
        Assessment of external fixator reusability using load- and cycle-dependent tests.
        Clin Orthop. 2003; 406: 275-281
        • Mock C.
        • Lormand J.D.
        • Goosen J.
        • et al.
        Guidelines for essential trauma care.
        World Health Organization, Geneva, Switzerland2004
        • Mock C.
        The global burden of musculoskeletal injuries: challenges and solutions.
        Clin Orthop. 2008; 466: 2306-2316
        • Naddumba E.K.
        Musculoskeletal trauma services in Uganda.
        Clin Orthop. 2008; 466: 2317-2322
        • Oluwadiya K.
        • Olasinde A.A.
        • Odu O.O.
        • et al.
        Management of motorcycle limb trauma in a teaching hospital in south-western Nigeria.
        Niger J Med. 2008; 17: 53-56
        • Padhi N.R.
        • Padhi P.
        Use of external fixators for open tibial injuries in the rural third world: Panacea of the poor?.
        Injury Int J Care Injured. 2007; 38: 150-159
        • Rüedi T.P.
        • Buckley R.E.
        • Moran C.G.
        AO principles of fracture management.
        AO Publishing, Dübendorf, Switzerland2007
        • Sikka R.S.
        • Fischer D.A.
        • Swiontkowski M.F.
        Reprocessing single-use devices: an orthopaedic perspective.
        J Bone Joint Surg. 2005; 87A: 450-457
        • Sung J.K.
        • Levin R.
        • Siegel J.
        • et al.
        Reuse of external fixation components: a randomized trial.
        J Orthop Trauma. 2008; 22: 126-131
        • Teoh S.H.
        Fatigue of biomaterials: a review.
        Int J Fatigue. 2000; 22: 825-837
        • Vishwanath J.
        • Jain P.
        • Dhal A.
        Olecranon traction using a recycled plate: a new technique for supracondylar humeral fractures.
        Injury Int J Care Injured. 1999; 30: 713-715
        • Wilcox C.M.
        Methodology of reprocessing one-time use accessories.
        Gastrointest Endosc Clin N Am. 2000; 10: 379-384
        • Wosar M.A.
        • Marcellin-Little D.J.
        • Roe S.C.
        Influence of bolt tightening torque, wire size, and component reuse on wire fixation in circular external fixation.
        Vet Surg. 2002; 31: 571-576
        • Zirkle L.G.
        Injuries in developing countries: how can we help?.
        Clin Orthop. 2008; 466: 2443-2450