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

Area of Science:

• Medical Device Regulation and Governance
• Surgical Practice and Ethics

Background:

• Off-label and Instructions-for-Use (IFU)-silent medical device use is prevalent in surgical settings.
• While not inherently unsafe, such practices raise critical issues regarding evidence, consent, professional judgment, and reporting.

Purpose of the Study:

• To review and synthesize literature concerning off-label and IFU-discordant medical device use in surgery.
• To propose a practical framework for responsible medical device utilization in clinical practice.

Main Methods:

• A comprehensive literature review and critical synthesis of regulatory guidance, professional statements, and surgical literature.
• Descriptive synthesis of findings due to heterogeneity in study designs and outcomes.

Main Results:

• Categorization of literature into regulatory guidance, reviews, and device-specific studies.
• Development of a taxonomy for various forms of non-standard device use (off-label, modified, reuse, etc.).
• Integration of ethical, professional, and governance aspects into device use, proposing the LABEL framework (Label, Alternatives, Basis, Explain, Log/Learn).

Conclusions:

• Responsible off-label medical device use necessitates transparency, accountability, and sound professional judgment.
• The LABEL framework offers a practical guide for clinicians to ensure evidence-based, patient-centered, and well-documented device utilization.