Abnormal use refers to the act or omission of an act by the operator or user that deviates from the intended use or prescribed procedures established by the device’s manufacturer. This type of use poses an inherent risk to the proper functioning of the medical device, potentially compromising its safety and effectiveness.
Medical devices are designed and manufactured with specific intended uses, indications, and instructions for use. These are carefully established by the manufacturer based on extensive testing, clinical trials, and risk assessments to ensure the device’s safe and effective performance in the intended patient population and medical conditions.
Abnormal use occurs when the medical device is operated or applied in a manner that exceeds or deviates from the manufacturer’s specified guidelines. This may include using the device for unapproved indications, applying it to an inappropriate patient population, or disregarding the recommended procedures and precautions outlined in the device’s instructions for use.
Confounding by Indication
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