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

Abstract

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. Unapproved device modifications can be associated with increased risk of dosing errors, monitoring errors, tubing misconnections and serious or potentially fatal adverse events; furthermore, health care providers who implement unapproved device modifications may assume legal and financial liability should harm come to patients as a consequence of the modification. Using the inhaled nitric oxide delivery system as an example, the objective of this paper is to raise awareness of the potential dangers associated with unapproved modification and interfacing of therapeutic gas delivery systems and ventilators in the neonatal intensive care unit setting. The paper also highlights the rationale and necessity for rigorous validation processes that ensure that interfaced medical devices perform as intended in the clinical setting.

Keywords: equipment failure; medical device legislation; patient safety.

Figure 1

Schematic diagram of the iNO delivery system. The schematic of the iNO delivery device (INOmax DS_IR^® Plus) is contained within the gray border. Nitric oxide from iNO cylinder (upper right of the diagram) enters the back of the iNO delivery device and passes through a filter and various safety valves within the iNO delivery device before entering an injector module located between the ventilator and the humidifier. Based on the ventilator flow and the set iNO dose, the injector module mixes the appropriate gas mixture flowing into the humidifier and the inspiratory limb of the ventilator circuit. The sample tee located in the inspiratory limb allows gas samples to be monitored by the iNO delivery device for NO, NO₂, and O₂ levels being inspired by the patient. Reproduced with permission from INOmax DS_IR^® Plus Operation Manual, Mallinckrodt Manufacturing, Madison, WI, USA; 2014.