FMEA may Effectively Identify and Mitigate Risks in ZAP-X Radiosurgery System Implementation, reveals Study

To address the risk associated with the ZAP-X Radiosurgery System using the FMEA approach, researchers Dr. Libin K. Babu, Quality Department, Indraprastha Apollo Hospitals, New Delhi, Delhi, India and the team conducted a study where they mapped all processes and sub-processes associated with the ZAP-X Radiosurgery System implementation. The team identified failure modes through discussions on potential issues, prioritized risks using Risk Priority Numbers (RPN) based on severity, likelihood, and detectability, and proposed controls to improve safety and reliability.

The key findings of the study are:

1)Overall findings:

  i)A total of 78 failure modes were identified across 6 processes and 33 sub-processes

  ii)RPNs ranged from 48 (highest) to 1 (lowest)

2)Process: Equipment –

 i)FMEA identified the highest RPN (48) in the operational handover sub-process due to inadequate staff training.

ii)The lowest RPNs (2) were seen in installation and calibration, where risks like instability were mitigated by trained teams and tested protocols.

3) Process: Infection Control- Had an average RPN of 8 across two sub-processes, indicating moderate risks, both effectively managed by existing controls:

i) Proper protocols not followed for infected patients.

ii) Risk of hospital-associated infections

4) Process: Fire Safety - It includes five sub-processes. The highest RPN (36) was linked to fire suppression system failure due to the lack of a system suited for ZAP-X equipment. The lowest RPN (6) involved fire hazards from patients wearing oxygen masks caused by untrained staff and missing protocols, which was mitigated by stopping oxygen supply and staff training.

5) Process: Security

i) RPNs (4, 8): Risks included unauthorized access, cyber threats, and system misuse.

ii) Mitigated by safety interlocks, limited access, encryption, and warning notifications.

6) Process: Radiation Safety

i) Highest RPN (32): Machine non-compliance with regulatory standards.

ii) Lowest RPN (1): Radiation exposure to attendants mitigated by restricted access and self-shielding machine design.

7) Process: Patient Treatment-

i) Average RPN (6): Moderate risks identified, such as excess dose delivery and incorrect alignment.

ii) Control Measures:

• Emergency stop (E-Stop) for beam deviations.

• Real-time patient monitoring and dose verification.

• High voltage enabled only with safety controls.

• Regular maintenance checks ensure optimal performance.