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Interest of the preliminary risk analysis method in a central sterile supply department
  1. Juliette Niel-Lainé1,
  2. Nicolas Martelli1,
  3. Brigitte Bonan1,
  4. Damien Talon2,
  5. Alain Desroches3,
  6. Patrice Prognon1,
  7. Florence Vincent1
  1. 1Department of Pharmacy, Georges Pompidou European Hospital, Paris, France
  2. 2Department of Pharmacy, Bichat Hospital, Paris, France
  3. 3Ecole Centrale Paris, Pôle de Santé et de Biotechnologie, Grande Voie des Vignes, Chatenay Malabry, France
  1. Correspondence to Dr Juliette Niel-Lainé, Department of Pharmacy, Georges Pompidou European Hospital, 20, rue Leblanc, 75015, Paris, France; lainejuliette{at}


Objectives In order to improve its quality-assurance programme based on ISO 9001, the Central Sterile Supply Department of a public university hospital has performed a prospective risk analysis using the Preliminary Risk Analysis method (PRA). The objectives were the achievement of a global risk mapping related to the whole process of sterilising medical devices, and second, the implementation of corrective measures to reduce identified risks.

Methods A multidisciplinary team, formed in January 2008, validated results at each step of the study. During the analysis, 416 hazardous situations were identified, among which 81 were quoted first in priority and led to the description of 141 risk scenarios. The PRA team assessed 42 scenarios with risk ranking assessed as ‘acceptable under control’ or ‘unacceptable.’ They adopted 23 follow-up actions measures and 13 safety parameters.

Results and discussion The PRA constitutes an appropriate tool for assessing quality-improvement policy and safety in healthcare facilities that can be easily integrated into standard quality-management systems.

  • Sterilisation
  • central supply
  • medical device
  • risk management
  • quality assurance
  • continuous quality improvement
  • healthcare quality improvement
  • process mapping
  • risk management
  • safety culture

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  • Competing interests None.

  • Provenance and peer review Not commissioned; externally peer reviewed.