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 misuse. 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 (for example, when a product is contaminated at the point of manufacture prior to distribution).

Featured Resource:

• CORHA’s Potential Medical Product-Related Infection/Outbreak: Assessment Questions presents information and questions for use by health departments, healthcare facilities, and other parties involved in investigating possible medical product involvement in a cluster of infections or outbreak

Additional Resources:

Resources related to medical product outbreaks:

• CDC’s Outbreak Investigations in Healthcare Settings website, which contains examples of healthcare outbreaks that were caused by distributed medical products including contaminated stem cell products, saline flush, and heater-cooler devices
• CORHA’s Injection Safety and Drug Diversion topic pages
• The FDA MedWatch form is located here: MedWatch Online Voluntary Reporting Form (fda.gov). Maintain a low threshold for reporting observed or suspected adverse events for human medical products.