Are there weaknesses in the monitoring and reporting of safety and efficacy of medical devices in pediatric use?
While there are some success stories related to monitoring and reporting of medical device use in pediatrics, these appear to be limited. In part, the successes seem to be a byproduct of the design of specific device trials (e.g., ASD closure device that included mandatory reporting of successes and failures) rather than a validation of the overall reporting system. There is very limited awareness by physicians of existing monitoring and reporting systems (e.g., FDA’s Manufacturer and User Facility Device Experience (MAUDE) database and Medwatch). Of the physicians who are familiar with the reporting mechanisms, few feel it is either their responsibility or within their skill set to monitor and report device usage. In other instances such as pediatric cardiology, postmarket monitoring and reporting of the safety and effectiveness of medical devices is limited to retrospective chart review-type analyses. These publications tend to come from institutions that perform a large number of pr
