Understanding Clinical Investigation and preparation of Technical file for Continuous Positive Airway Pressure (CPAP) Medical Device
Abstract
Continuous Positive Airway Pressure (CPAP) devices are essential medical tools for managing Obstructive Sleep Apnoea (OSA) it is a disorder marked by frequent blockages of the upper airway while a person is asleep. This review delves into the clinical investigation, design considerations, regulatory standards, and technical documentation involved in CPAP development. CPAP devices deliver continuous airflow through a mask to prevent airway collapse, thereby restoring normal respiration during sleep. Due to their moderate risk classification across various regulatory bodies (e.g., FDA Class II, CDSCO Class B/C, EMA Class IIa/IIb), manufacturers must adhere to stringent global standards, including ISO 13485 (Quality Management System), ISO 14971 (Risk Management), ISO 10993 (Biocompatibility), and IEC 60601 (Electrical Safety), and IEC 62366 (Application of Usability Engineering) This review elaborates on the structure and importance of the Device History File (DHF) and the Technical File, which document all phases from design inputs and outputs to risk analysis, usability, validation, and post-market surveillance. Detailed insights are provided into biocompatibility assessments, environmental testing, and clinical evaluations comparing CPAP with Mandibular Advancement Splints (MAS). The study highlights CPAP’s superiority in reducing the Apnoea-Hypopnea Index (AHI) and improving physical health scores, although MAS demonstrated better adherence and comfort. A critical case study of Philips’ 2021 recall further emphasizes the importance of material biocompatibility and robust risk management. This review ultimately serves as a comprehensive resource for developers aiming to ensure regulatory compliance and patient safety in CPAP manufacturing.
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