Ask HRC: Hospital Obligations to Report Adverse Events Involving Tissue Products
December 1, 2009 | Healthcare Risk, Quality, & Safety Guidance
A member hospital asked if the facility is obligated to report adverse events involving tissue to the U.S. Food and Drug Administration (FDA) under the medical device reporting requirements of the Safe Medical Devices Act. Many types of tissue—including ligaments, tendons, cartilage, and dura mater—are regulated by FDA’s Center for Biologics Evaluation and Research. The center requires that establishments or suppliers involved in the distribution of human cells, tissues, and cellular and tissue-based products report to FDA adverse reactions involving their products if the reaction is fatal, life-threatening, results in permanent impairment of a body function or permanent damage to a body structure, or necessitates medical or survival intervention. The hospital that provided the suspect tissue to the patient does not have reporting obligations to FDA. Nevertheless, if the hospital is accredited by the Joint Commission, it must comply with requirements to investigate adverse events related to tissue and to report the adverse events to the tissue supplier. These requirements are outlined in the chapter on transplant safety in Joint Commission’s Comprehensive Accreditation Manual for Hospitals.
Some tissue-like products are regulated as medical devices. These include human collagen products, femoral veins intended as arteriovenous shunts, and preserved umbilical cord vein grafts. If the product is regulated as a medical device, healthcare facilities must comply with obligations to report serious device-related incidents—deaths, serious injuries, and...