Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States: Joint Recommendations From Pediatric Innovator Roundtables.

OBJECTIVE: The purpose of this report is to provide insight from pediatric stakeholders with a shared desire to facilitate a revision of the current United States regulatory pathways for the development of pediatric healthcare devices. METHODS: On August 5, 2020, a group of innovators, engineers, professors and clinicians met to discuss challenges and opportunities for the development of new medical devices for pediatric health and the importance of creating a regulatory environment that encourages and accelerates the research and development of such devices. On January 6, 2021, this group joined regulatory experts at a follow-up meeting. RESULTS: One of the primary issues identified was the need to present decision-makers with opportunities that change the return-on-investment balance between adult and pediatric devices to promote investment in pediatric devices. DISCUSSION/CONCLUSION: Several proposed strategies were discussed, and these strategies can be divided into two broad categories: 1. Removal of real and perceived barriers to pediatric device innovation; 2. Increasing incentives for pediatric device innovation.

Perceptions of a strategy to prevent and relieve care provider distress in the neonatal intensive care unit.

BACKGROUND: A Midwestern neonatal intensive care unit (NICU) employs a multidisciplinary conference, the Comprehensive Care Round (CCR), to facilitate communication and consensus building and thereby prevent or address moral distress within the health care team. METHODS: A cross-sectional survey, 3 years after implementation of CCR, to evaluate health care providers' (HCP) perceptions of comfort with expressing distress, support from team members in care situations that evoke moral distress, barriers to communication, and attainment of CCR objectives. RESULTS: Of 370 HCP, 116 (31%) participated in the survey (42% nurses, 37% allied health, and 21% medical); 51% had previously attended CCR. CCR attendance was higher among HCP aged >35 years, those who cared for CCR patients, and nonnurses. Neonatologist were more likely than others (44% versus 4%, p <0.01) to report that referred cases were not overdue for discussion and that families appreciated the attention their child received from CCR. Of note, HCP who were comfortable with expressing distress also felt supported by team members (R = 0.5, p <0.001). CONCLUSION: CCR, developed to prevent or address moral distress, occurs later than most NICU HCP consider appropriate and appears to better serve HCP who are already comfortable with discussing moral distress. Helping HCP become comfortable with crucial conversations should support meaningful participation and contribution to multidisciplinary conferences.

The comprehensive care rounds: facilitating multidisciplinary communication among caregivers of complex patients in the neonatal intensive care unit.

Care of the very sick infant can be complicated by extraneous factors that challenge the cohesiveness of the health care team. Chaos results from low levels of professional agreement and certainty about outcomes and manifests in stress and miscommunication among care providers. This milieu is fertile ground for errors of commission and omission. Effective communication and collaboration are recognized as essential for reducing medical errors in such stressful environments. This article describes a multidisciplinary conference, the Comprehensive Care Rounds, at a neonatal intensive care unit of a Magnet-recognized midwestern pediatric hospital. The Comprehensive Care Round provides a forum for open communication among team members and builds on the hospital's efforts at systems approach to developing a culture of safety and quality.