Analysis: Classifying Ventilation Modes and Improving Operator Training with ISO 19223:2019.

Abstract

The Centers for Disease Control and Prevention has reported that more than 300,000 patients are ventilated in the United States each year. Human factors and communication issues have been cited as the two most common causes of ventilator-related sentinel events, according to reports of patient mortality or severe harm received by The Joint Commission during 2004–15. Over a decade ago, it was determined that the scope of the International Electrotechnical Commission (IEC) standard IEC 60601-1:2005 had to be extended to consider equipment usability in its third edition. The Joint Working Group (JWG) of the International Organization for Standardization (ISO) and IEC subcommittees responsible for critical care ventilators (ISO/TC 121/SC 3 and IEC TC/SC 62D/JWG 1) concurred that there was a wide recognition that a key factor adversely affecting lung ventilator usability was the lack of a standardized vocabulary relating to the modes of operation for these devices. At that time, ISO 4135:2001 was the only international standard that included terms related to devices of that type; however, its scope was restricted to defining terms that were used in standards related to the performance of such equipment and therefore did not cover usage factors. The terms in general clinical use had origins in the early days of mechanical ventilation, when the emphasis was on saving the lives of patients who were unable to breathe on their own, with little attention given to patients' respiratory activity.