Compatibility and Safety Implications Associated with Interfacing Medical Devices in Neonatal Respiratory Care: A Case Example Using the Inhaled Nitric Oxide Delivery System.

Over the past decade, international organizations have instituted strict regulations for the safe use of connected medical devices. The International Organization for Standardization and the Medical Device Single Audit Program instituted certifications to ensure that connected devices are compatible and operate within their proper clinical parameters. These efforts came about, in part, as a consequence of clinicians' decisions to use nonstandard, modified, or improvised devices for purposes outside the original manufacturers' approved parameters.