Pilot 1

UC1

Cybersecurity in Hospital Equipment for COVID-19 ICU patients

Pilot 1 of the CYLCOMED project simulates the integration of cybersecurity tools into hospital equipment within an Intensive Care Unit (ICU) setting. The pilot leverages digital twins (entirely synthetic data environments) to evaluate a legacy infusion controller and its interaction with added clinical functionalities, thereby avoiding the use of real patient data.

Given the complexity and time demands associated with medical device certification, the project adopted a workaround strategy: integrating CYLCOMED’s cybersecurity features into an external Linux-based board. This board connects to legacy devices, namely, a Vision Air multiparameter monitor and an infusion pump tree, using a serial communication channel. This design maintains critical ICU features such as closed-loop control of Neuromuscular Transmission (NMT), while addressing cybersecurity vulnerabilities.

In addition to managing secure device operations, the external board also transmits vital patient data to a web server that emulates a Hospital Information System (HIS) over Ethernet, complying with regulatory security protocols. The integration aims to ensure data confidentiality, integrity, and availability, while preserving medical device safety and performance.

The clinical focus of the pilot responds to the needs of ICU patients—particularly those suffering from Acute Respiratory Distress Syndrome (ARDS), such as during the COVID-19 pandemic. In such cases, neuromuscular blocking agents (NMBAs) play a vital role in improving patient outcomes during mechanical ventilation. However, precise NMT monitoring is essential, as the ideal drug dosage varies significantly across individuals based on factors like age, muscle mass, or pre-existing conditions. Traditional methods require continuous monitoring by nurses, making automation both a clinical and operational priority.

To address this, the pilot incorporates a novel NMT monitoring technique called NMTCuff, developed by RGB Medical, into the Vision Air monitor. This CE-certified equipment now includes a new “infusion controller” module, with embedded CYLCOMED cybersecurity functionalities.

CYLCOMED Solution: The evaluation confirmed that integrating CYLCOMED’s software cybersecurity components into the external board does not compromise the clinical performance of the infusion controller. This result validates the approach of retrofitting legacy medical devices with modern cybersecurity tools, achieving improved system security while maintaining patient safety and operational efficiency in critical care environments.