Related Experiment Video
Updated: Aug 16, 2025
Mechanical Ventilation Boot Camp Curriculum
Published on: March 12, 2018
A novel method for conformity assessment testing of mechanical ventilators for post-market surveillance purposes
Almir Badnjevic1,2,3,4, Amar Deumic1,2, Ammar Trakic1
1Verlab Research Institute for Biomedical Engineering, Medical Devices and Artificial Intelligence, Sarajevo, Bosnia and Herzegovina.
Background:
Mechanical ventilators are medical devices used in intensive care units when patients are in need of mechanical aid to facilitate the process of breathing. As the function of breathing is the exchange of gases, the mechanical ventilator takes over that function while the patient is incapable to spontaneous breathing. As these devices are used to maintain the life of patents, their performance must be ensured and there cannot be significant deviations in the volumes and pressure of gases they introduce to the patient. The new Medical Device Regulation (MDR) defines medical device post-market surveillance (PMS) as performed by independent, third-party, notified bodies more strategically in hope to improve traceability of device performance. However, there is still an apparent gap in terms of standardised conformity assessment testing methods.
Objective:
This paper proposes a novel method for conformity assessment testing of mechanical ventilators for post-market surveillance purposes.
Method:
The method was developed on the basis of metrology characteristics of mechanical ventilators and evaluation of their vital safety and performance parameters. In addition to the evaluation of essential safety and visual integrity of mechanical ventilators, their performance in terms of volume of oxygen delivered to the patient as well as the flow and pressure of the delivered gas is evaluated.
Results:
The developed method was validated between 2018 and 2021 in healthcare institutions of all levels. The results obtained during validation suggest that conformity assessment testing of mechanical ventilators as a method used during PMS contributes to significant improvement in devices' accuracy and reliability.
Conclusion:
A standardized approach in conformity assessment testing of mechanical ventilators during PMS, besides increasing reliability of the devices, is the first step in digital transformation of management of these devices in healthcare institutions opening possibility for use of artificial intelligence.
Related Concept Videos
01:23Mechanical Ventilation III: Noninvasive Ventilation
Noninvasive Positive-Pressure Ventilation...
01:23Mechanical Ventilation II: Invasive Ventilation
Negative-Pressure Ventilators
Negative-pressure ventilators create a vacuum around the chest or body to draw air into the lungs, simulating breathing. This method does not require an...
01:29Mechanical Ventilation I: Indication and Settings
01:20Assessment of Ventilation I: Respiratory Rate
A Ventilation assessment is critical for monitoring a patient's health status. Respiration, one of the most accessible vital signs, provides insights into the function of numerous body systems and can indicate serious health issues, such as brainstem injuries from head trauma.
Critical Guidelines for Assessing Ventilation:
01:29Assessment of Ventilation II: Respiratory Depth and Rhythm
Respiratory depth measures the volume of air inhaled or exhaled during a breath. It can vary from shallow to deep and typically remains consistent when a person is at rest or asleep. Occasionally, individuals will automatically inhale deeply, known as sighing, which inflates the lungs with more air than normal breathing.
To assess respiratory depth, observe the degree of chest excursion or movement:
01:14Ventilatory Modes
There are three ventilatory modes: full support, partial support, and spontaneous. These are described below.
Full Support Modes
Full support modes include controlled mechanical ventilation, continuous mandatory...