Evaluation of the Implementation of CDC’s Health Alert Related to the FDA LeadCare Recall From the State Health Department Perspective

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. The Centers for Disease Control and Prevention (CDC) announced a health alert with retesting recommendations because those with a blood lead level of concern may have been missed and not connected to the appropriate follow-up services. A qualitative evaluation of 9 state childhood lead poisoning prevention programs’ experiences is presented in this report. Interviewees reported using a variety of media and notification methods to inform key stakeholders about the recall and recommendations. Challenges experienced by programs in responding to retesting recommendations include incomplete and out-of-date lists of LeadCare users; missing or inaccurate information in their surveillance database; not having large laboratories and hospitals consider contacting persons for retesting to be within their purview; and having limited staff members to conduct emergency response activities. Two of the 9 states report subsequent challenges with their retesting rates. The retesting recommendations were generally viewed positively. The interviewees’ comments provide insight into steps CDC might take to better serve state and local lead programs. Programs’ experiences have led to a better understanding of the roles of their program when emergency events occur, their relationship with stakeholders as related to the blood lead testing and reporting process, and areas of improvement in surveillance databases. Public health agencies at all levels have important roles to play in preventing lead exposures and providing needed services when exposures occur. Programs may achieve long-term benefits by improving surveillance systems and having a better understanding of laboratory practices. CDC will continue to provide timely information and recommendations to state and local public health agencies to inform both routine and emergency response activities.