关键词：医疗设备；随插即用；标准
摘 要：This BAA is providing core program support to develop key capabilities of the Medical Device Plug-and-Play (MD PnP) Interoperability Program to lead medical device interoperability to support clinical solutions for improving patient safety and healthcare efficiency. Under MD PnP program leadership during the past year, a multi-institutional/industry working group submitted to FDA a Pre-IDE regulatory submission of a safe integrated medical device system; an updated version of the MD FIRE procurement language was signed by the VA and posted on our public website; the Clinical Landscape & Needs subgroup of the newly formed and FDA-sponsored Medical Device Interoperability Coordinating Council collected and shared clinical scenarios; we contributed materially to UL s proposed standard for certifiable safety of medical device interfaces; we collaborated with the VA, NIST, NSF, ONC, and others, including work with AAMI on standards and smart alarms initiatives.