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UK MHRA Rectal Catheter Alert: Infant Safety and Post-Market Lessons
This episode examines the UK MHRA's Device Safety Information alert (DSI/2026/008), issued on August 18, 2026, which advises against the use of rectal catheters (gas/colic relievers) in infants. We explore why the MHRA took this precautionary action based on a lack of safety and efficacy data, rather than direct adverse event reports. The discussion focuses on the critical post-market surveillance lessons for manufacturers of direct-to-consumer medical devices, particularly those intended for vulnerable populations like children. Key Questions: - What is the UK MHRA's DSI/2026/008 and why was…
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