Anti-COVID-19 Vaccination in the Italian General Population: Proactive Clinical Risk Analysis Using Failure Mode, Effects, and Criticality Analysis Technique
2024

Analyzing Risks in COVID-19 Vaccination in Italy

Sample size: 157792 publication Evidence: moderate

Author Information

Author(s): Balestracci Beatrice, Candido Giuseppe, Federici Lorenzo, Parretti Chiara, Tartaglia Riccardo, Lachman Peter, Bianco Alessandra, La Regina Micaela, Gómez-Cantarino Sagrario, Geisler Anja Edith

Primary Institution: Department of Engineering Sciences, Guglielmo Marconi University

Hypothesis

What are the patient safety threats related to the anti-COVID-19 large-scale vaccination process?

Conclusion

The study emphasizes the importance of ensuring patient safety and effective clinical risk management in mass vaccination campaigns.

Supporting Evidence

  • 157,792 doses of the COVID-19 vaccine were administered during the study.
  • The FMECA analysis identified critical steps in the vaccination process that could lead to serious harm.
  • High-risk phases included managing severe allergic reactions and ensuring vaccination teams were well-trained.
  • Twenty interventions were implemented to improve the vaccination process and mitigate risks.

Takeaway

This study looked at how to keep people safe during COVID-19 vaccinations by finding and fixing problems before they happen.

Methodology

The study used the Failure Mode, Effects, and Criticality Analysis (FMECA) technique to identify risks in the vaccination process.

Potential Biases

The results are influenced by the experience of the professionals conducting the analysis.

Limitations

The study's findings may vary based on the professionals involved, and it did not incorporate patient input during the analysis.

Participant Demographics

The study involved a multidisciplinary team from various healthcare backgrounds.

Digital Object Identifier (DOI)

10.3390/healthcare12242541

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