The Healthy Weight Collaborative: quality improvement methods promoting healthy weight.

Promoting healthy weight requires innovative approaches and a concerted response across all sectors of society. This commentary features the framework guiding the Healthy Weight Collaborative, a two-phased quality improvement (QI) learning collaborative and key activity of the Collaborate for Healthy Weight initiative. Multi-sector teams from primary care, public health, and community-based organizations use QI to identify, test, and implement program and policy changes in their communities related to promoting healthy weight. We describe the Collaborative's overall design based on the Action Model to Achieve Healthy People 2020 Goals and our approach of applying QI methods to advance implementation of sustainable ways to promote healthy weight and healthy equity. We provide specifics on measurement and change strategies as well as examples of Plan-Do-Study-Act cycles from teams participating in Phase 1 of the Collaborative. These teams will serve as leaders for sustainable, positive change in their communities.

High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.

Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.