Responsible Off-Label Device Use in Surgical Innovation: A Review and LABEL Framework

BackgroundOff-label and Instructions-for-Use (IFU)-silent medical-device use is common in surgery. Such use is not inherently unsafe, unethical, or unlawful. However, it raises important questions about evidence, consent, professional judgement, documentation, adverse-event reporting, and institutional governance.MethodsA review and critical synthesis of literature on off-label medical-device use, IFU-discordant use, physician-directed device use, and selected device examples relevant to general surgery was performed. Regulatory guidance from global agencies, professional statements, prior reviews, selected legal and governance literature, and device-specific surgical literature was reviewed.StatisticsNo meta-analysis was performed because the included literature was heterogeneous in device type, anatomical context, regulatory status, study design, and outcomes. Findings were synthesized descriptively.ResultsThe literature fell into three groups: regulatory and professional guidance; previous reviews and specialty statements; and device-specific surgical literature. A practical taxonomy for off-label, IFU-silent use, modified use, reuse/reprocessing, expired-device use, and repurposing is summarised. We integrated off-label and IFU-silent device use with ethics, professionalism, consent, patient safety, adverse-event reporting, and governance. We propose the LABEL framework: Label, Alternatives, Basis, Explain, and Log/Learn.ConclusionResponsible off-label device use requires transparency and accountability. Sound judgement, evidence, patient-specific reasoning, consent, documentation, and audit remain professional obligations, and the LABEL framework provides a practical guide.