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Medical Products

Resources to establish an approach to assess medical product-related healthcare outbreak & response

Tools to help investigate possible medical product involvement
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CORHA logo
Relevant dates
Last updated: February 01, 2023
Published: December 26, 2024

About Medical Products

Medical products, such as devices, drugs, and biologics, play crucial roles in medical diagnosis and treatment. They also present risks. Patient infections can occur when a medical product is contaminated during manufacturing, compounding, storage, preparation, use, or disposal. Outbreaks can occur when groups of patients are exposed to contaminated medical products either in a single facility (as a result of mishandling by healthcare personnel) or across multiple facilities or jurisdictions (for example, when a product is contaminated at the point of manufacture prior to distribution).

Differentiating between intrinsic contamination (occurring before arrival at the point of use facility) and extrinsic contamination (occurring after arrival at point of use facility) is a critical step to determine the scope of an outbreak and appropriate intervention. This typically requires collaboration between healthcare facility, public health, laboratory, and regulatory partners. For more information refer to the CORHA Principles & Practices.

Resources, Guides, Reports, & Toolkits

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Featured New Updated

Medical Product Investigations

This supplement to the CORHA Principles and Practices provides an overview of medical product-related outbreak detection, investigation, and control.

Featured New Updated

Potential Medical Product-Related Infection/Outbreak: Assessment Questions

 By FDA

This webpage provides a portal for health professionals, consumers and patients to voluntarily report observed or suspected adverse events for human medical products to FDA. Voluntary reporting can help FDA identify unknown risk for approved medical products.

New Updated

Outbreak and Patient Notifications

 By CDC

Part of CDC's Healthcare-Associated Infections (HAIs) website, this resource contains examples of healthcare outbreaks that were caused by distributed medical products including artificial tears, contaminated stem cell products, saline flush, and heater-cooler devices.

New Updated

Medical Devices

 By FDA

This page provides FDA updates, reports, and safety communications related to medical devices.

Principles & Practices

Comprehensive information to build, standardize or improve practices related to HAI/AR outbreak detection, reporting, investigation, or control.

Medical Products Outbreak Reports & News