Runtime Verification of Pacemaker Functionality Using Hierarchical Fuzzy Colored Petri-nets.

Area of Science:

• Biomedical Engineering
• Software Engineering
• Control Systems

Background:

• Implanted medical devices, such as pacemakers, are crucial but prone to software errors causing malfunctions and patient harm.
• Effective software verification is essential to mitigate risks associated with pacemaker device failures.
• Previous research utilized Fuzzy Petri-nets (FPN) and Colored Petri-nets (CPN) for medical device verification.

Purpose of the Study:

• To develop and present a novel method for verifying pacemaker software to decrease failure risks.
• To enhance the monitoring of pacemaker software's runtime behavior and status.
• To improve the efficiency of software verification processes for critical medical devices.

Main Methods:

• A hierarchical Fuzzy Colored Petri-net (FCPN) model was developed, incorporating fuzzy rules derived from pacemaker function limitations.
• The FCPN model was used to supervise the runtime function and status of the pacemaker software.
• The proposed method builds upon prior experience with FPN for insulin pumps and CPN for pacemakers.

Main Results:

• The hierarchical FCPN approach reduced verification complexity compared to previous FPN and CPN methods.
• Verification runtime decreased by 90.61% with the hierarchical Petri-net (PN) structure.
• The HFCPN enhanced the performance of the inference engine required for runtime verification.

Conclusions:

• The hierarchical Fuzzy Colored Petri-net (FCPN) offers a more efficient and less complex method for pacemaker software verification.
• This advanced verification technique contributes to reducing the risk of critical failures in implanted medical devices.
• The study demonstrates a significant improvement in verification runtime, enhancing the safety and reliability of pacemaker technology.