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Re-use of explanted osteosynthesis devices: a reliable and inexpensive reprocessing protocol
Valentina Danesi1, Luca Cristofolini, Susanna Stea
1Medical Technology Lab, Rizzoli Orthopaedic Institute, Bologna, Italy. vdanesi@tecno.ior.it
Injury
|March 8, 2011
Summary
A new reprocessing protocol for explanted osteosynthesis devices in low- and middle-income countries (LMIC) was developed. This method ensures safe reuse of surgical implants, addressing device scarcity and improving patient care.
Area of Science:
- Orthopaedic Surgery
- Biomaterials Science
- Public Health
Background:
- Orthopaedic surgery relies on osteosynthesis devices for fracture treatment.
- Cost and availability of these devices limit their use in low- and middle-income countries (LMIC).
- Surgeons in LMIC often re-use single-use devices, posing safety risks.
Purpose of the Study:
- To report a reprocessing protocol for explanted osteosynthesis devices.
- To address the need for accessible orthopaedic implants in LMIC.
- To mitigate risks associated with re-used surgical devices.
Main Methods:
- Identified explanted devices using a dedicated register.
- Obtained ethical approval and informed patient consent.
- Applied rigorous decontamination and visual inspection protocols using simple, available equipment.
Main Results:
- Reprocessed 2050 osteosynthesis devices (plates, screws, staples).
- Achieved a 66% acceptance rate for reprocessed devices.
- Protocol implementation estimated at 25 minutes per unit with costs of €10-€15.
Conclusions:
- The protocol efficiently screens a large volume of devices.
- Reprocessed devices can yield satisfactory results with careful implementation.
- This protocol reduces risks of inadequate sterilization and structural failure in LMIC settings.
