Exploration of shelf-life issues in medical devices, highlighting concerns about safety and effectiveness.
Introduction Medical devices are integral to the United States (US) healthcare sector, supporting the prevention, diagnosis, monitoring, and treatment of various medical conditions. Ranging from simple bandages to advanced diagnostic tools, these devices are key to delivering quality patient care. Among the critical parameters ensuring their safety and effectiveness is shelf-life, which defines the duration during which a device remains stable and functional as claimed on its label.
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Thakor et al. (2025) studied this question.
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