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Reliability and Safety Testing of a Ventilator Remote Control System Against Communication Failures and Network

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Remote ventilator control systems were tested for safety and usability under network disruptions. The NKV-550 ventilator showed robustness, but the NK-DocBox system requires specific network quality of service (QoS) to remain safe.

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Area of Science:

  • Biomedical Engineering
  • Medical Device Interoperability
  • Critical Care Technology

Background:

  • The COVID-19 pandemic highlighted the need for remote ventilator control to protect healthcare workers and improve patient care.
  • Remote control can extend specialized clinical expertise to diverse settings like tele-critical care and military medicine.
  • Communication failures and network disruptions pose risks to the safety and effectiveness of remote ventilator control systems.

Purpose of the Study:

  • To assess the robustness, usability, and safety of a remote ventilator control system (NK-DocBox) under simulated communication failures and network disruptions.
  • To establish consensus safety requirements and test methods for remote ventilator control technologies.
  • To evaluate the performance of the NKV-550 critical care ventilator with remote control capabilities.

Main Methods:

  • Developed two test methods to evaluate the NK-DocBox system controlling an NKV-550 ventilator.
  • Tested ventilator robustness using high-frequency and erroneous remote-control commands via an OpenICE-based application.
  • Utilized a network emulator to simulate various network Quality of Service (QoS) degradations (bandwidth, delay, jitter, packet loss, bit errors).

Main Results:

  • The NKV-550 ventilator correctly handled high-frequency commands and ignored invalid parameter adjustments.
  • Network QoS degradation, except for packet reordering, interfered with the NK-DocBox system's remote-control functions.
  • The system became unsafe with network delay >500ms, jitter >100ms, data drop rate >1%, bandwidth <12 Mbps, or bit error rate >1e-6.

Conclusions:

  • The test methods confirmed the NKV-550 ventilator's robustness and quantified the impact of network disruptions on the NK-DocBox system.
  • Minimum network QoS requirements for safe operation of the NK-DocBox system were identified.
  • The developed test methods are generalizable for evaluating other remote medical device control systems against communication failures.