Balancing patient safety and sustainable healthcare for orthopaedic device utilization in resource-limited countries: insights from the REBOOT Study

Unofficial AI-generated summary based on the public title and abstract. Not an official translation.

🔬研究者:Provides empirical data on reuse prevalence and governance gaps, useful for studying circular healthcare in resource-limited settings.

🏢実務担当者:Offers cautionary insights for hospitals considering reprocessing: requires robust quality control and traceability.

🏛政策担当者:Highlights the need for clear guidelines and safety standards for medical device reuse, relevant for health ministries in LMICs.

Background Access to orthopaedic care in low- and middle-income countries is limited by device scarcity and high costs, despite the significantly greater burden of trauma. The reuse of reprocessed implants and equipment has emerged as a pragmatic solution, but safety assurance and governance remain inconsistent. We described current reuse practices in low- and middle-income countries, evaluated safety risks and mitigation strategies to balance equity and sustainability with patient protection, and highlighted opportunities to reduce healthcare costs. Methods We conducted a multinational, cross-sectional survey of orthopaedic clinicians in hospitals in low- or middle-income countries between June 2024 and February 2025. Primary outcomes were device-specific reuse prevalence and safety governance; secondary outcomes were reuse drivers and risks. Results A total of 113 respondents from 36 hospitals in seven low- and middle-income countries participated. The majority (84%) worked in university-based hospitals or postgraduate training centres, and most (78%) were orthopaedic and spine consultants or residents. External fixator components were most frequently reused (80%), with implantable pins or wires reused by 67%; 51% reported using reprocessed implantable devices at least weekly. Only 35% knew the exact source of reused implants; devices mostly originated from explants or de-sterilised but unimplanted stock. 55% used reprocessed implants without any quality testing or recertification, and 34% were unsure; just 8% reported formal re-evaluation. Ninety-eight per cent were unaware of any applicable guidelines. The reuse of reprocessed devices did not differ significantly by hospital affiliation, hospital resourcing, level of care, or respondent’s years of orthopaedic experience. Perceived benefits were affordability and access, while reported concerns included device failure, ethical/litigation issues, and patient disapproval—all amplified by variable reprocessing standards and poor traceability. Conclusions The use of reprocessed orthopaedic biomaterials is common in low- and middle-income countries. External fixator components are the most reprocessed implants, with cost and availability as the primary drivers. Unclear sourcing, weak quality assurance, and absent guidance create avoidable safety risks. Safer practice requires context-specific standards for sourcing/reprocessing, validated decontamination and sterilisation with full traceability, risk-stratified reuse, mandatory quality testing/recertification of reprocessed implants, informed consent that addresses reuse, and regular audit of practice compliance. Supplementary Information The online version contains supplementary material available at 10.1186/s13037-026-00475-1.

• semanticscholar https://doi.org/10.1186/s13037-026-00475-1first seen 2026-07-16 06:05:33