Medical Subject Headings (MeSH): Product Surveillance, Postmarketing

Product surveillance, also known as postmarketing surveillance, is the ongoing monitoring and assessment of the safety and effectiveness of medical products, such as drugs and medical devices, after they have been approved and made available to the public. The purpose of product surveillance is to identify any potential safety concerns or adverse events associated with the product, and to take appropriate actions to protect patients and the public.

Product surveillance is typically conducted by the regulatory agencies responsible for the approval and oversight of medical products, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). These agencies rely on a variety of sources to gather information about the safety and effectiveness of medical products, including reports from healthcare professionals, manufacturers, and patients.

Some of the key activities involved in product surveillance include:

Monitoring for adverse events: This includes tracking and analyzing reports of serious side effects or other problems associated with the product.

Evaluating the benefits and risks of the product: This includes assessing the effectiveness of the product in treating the condition it is intended for, as well as its potential risks and side effects.

Communicating with healthcare professionals and the public: This includes providing information about the product’s safety and effectiveness, as well as any recommendations for its use.

Taking action to protect the public: This can include issuing warnings or recalls, or revising the product’s labeling or instructions for use.

Product surveillance is an important aspect of healthcare that helps to ensure the safety and effectiveness of medical products and protect patients and the public from potential risks.