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.

Rationale for Use of an FDA-Cleared Delivery System for Administration of Inhaled Nitric Oxide in Patients Undergoing Magnetic Resonance Imaging.

Inhaled nitric oxide (iNO) is a pulmonary vasodilator approved for use to improve lung function in neonates >34 weeks' gestational age with hypoxic respiratory failure and pulmonary hypertension. Infants with severe respiratory disease frequently require magnetic resonance imaging (MRI) scans for evaluation of treatment and diagnosis of concurrent disease processes. Until 2015, incompatibility between the standard iNO delivery system components and the magnetic field within the MRI setting required iNO treatment to be interrupted for MRI, which could increase risk of deoxygenation and rebound pulmonary hypertension.