Division of Neonatal and Developmental Medicine, Stanford University Medical Center, United States.
The University of Queensland, Australia.
Semin Perinatol. 2019 Dec;43(8):151176. doi: 10.1053/j.semperi.2019.08.005. Epub 2019 Aug 10.
Currently, the majority of medical devices are designed for adults; some are then miniaturized for use in neonates. This process neglects population-specific testing that would ensure that the medical devices used for neonates are actually safe and effective for that group. Incorporating human-centered design principles and utilizing methods to evaluate devices that include simulation and clinical testing can improve the safety of devices used in caring for neonates. However, significant regulatory, financial, social and ethical barriers to development remain. In order to overcome these barriers and create a pipeline of safe and effective neonatal medical devices, specific incentives are required.
目前，大多数医疗器械都是为成年人设计的；有些则被缩小尺寸，用于新生儿。这一过程忽略了针对特定人群的测试，而这些测试本可以确保用于新生儿的医疗器械对该群体确实是安全有效的。纳入以人为本的设计原则，并利用包括模拟和临床测试在内的方法来评估设备，可以提高用于护理新生儿的设备的安全性。但是，在开发过程中仍然存在重大的监管、财务、社会和伦理障碍。为了克服这些障碍，开发出安全有效的新生儿医疗器械，需要有具体的激励措施。
