Response to the U.S. FDA LeadCare Testing Systems Recall and CDC Health Alert

摘要

On May 17, 2017, the Food and Drug Administration (FDA) issued a safety recall for the Magellan Diagnostics’ LeadCare Testing Systems due to the potential for inaccurately low blood lead test results when used with venous blood samples, which has implications for the follow-up care of persons exposed to lead. Concurrent with the recall, the Centers for Disease Control and Prevention (CDC) issued a health alert regarding the use of LeadCare Testing Systems. CDC provided recommendations for specific high-risk populations so that persons potentially impacted by falsely low test results could be retested and receive appropriate follow-up care. Childhood lead poisoning prevention programs in state and local public health agencies collect blood lead test results for children and had a lead role in identifying children for retesting. CDC’s Lead Poisoning Prevention Program sought to understand how the recall and recommendations impacted state and local public health agencies. Case studies are presented that highlight the experiences of four state childhood lead poisoning prevention programs in responding to the recall and recommendations. Collectively, the case studies point to several lessons learned, including the importance of: (1) having a well-functioning surveillance system in place prior to a serious incident; (2) having a clear understanding of the roles partners play in the continuum of care for children potentially exposed to lead; (3) ensuring effective communications with all staff, both internal and external, to public health agencies that have a role in responding to a serious incident. The ability to respond to public health emergencies or other serious incidents takes the combined effort of federal, state, and local public health agencies as well as others in the healthcare delivery system. CDC will continue to support state and local lead poisoning prevention programs so they have the information and tools they need to address and prevent the health effects of lead exposures in communities.