Importance of cleaning for reprocessing endoscopes and thermolabile sterile medical devices: French use and

J C Darbord1

  • 1Lab. Bacteriology-Virology, Central Pharmacy For Hospitals, Paris 5 University, Assistance Publique des Hôpitaux de Paris, 7 rue du Fer à Moulin, F-75005 Paris, France.

Insights

French regulations mandate specific endoscope reprocessing steps, including double cleaning and avoiding aldehydes. Peracetic acid or chlorinated products are recommended for disinfection, with mandatory traceability and no recycling of cleaning agents to mitigate prion risk.

Area of Science:

  • Infection Control
  • Medical Device Reprocessing
  • Prion Safety

Background:

  • Endoscope maintenance regulations in France have unique requirements.
  • These regulations address the specific risks associated with prion transmission.
  • Existing guidelines require careful adherence to prevent healthcare-associated infections.

Purpose of the Study:

  • To outline the specific French regulations for endoscope disinfection and sterilization.
  • To highlight particularities concerning prion risk mitigation.
  • To inform healthcare units about mandatory procedures and recommendations.

Main Methods:

  • Review of French regulations regarding medical device reprocessing.
  • Identification of key procedural stipulations for cleaning and disinfection.
  • Emphasis on prohibited substances and recommended disinfectants.
  • Inclusion of machine-specific requirements like non-recycling and traceability.

Main Results:

  • Mandatory double cleaning before disinfection with specific procedural constraints.
  • Prohibition of aldehydes in cleaning products; recommendation of peracetic acid or chlorinated products for disinfection.
  • Prohibition of detergent/disinfectant recycling in reprocessing machines.
  • Mandatory traceability procedures for endoscope reprocessing.

Conclusions:

  • French regulations impose stringent, specific protocols for endoscope reprocessing to manage prion risk.
  • Adherence to these guidelines, including material restrictions and traceability, is crucial for patient and operator safety.
  • A forthcoming 'user's guide' will consolidate these measures for medical care units.

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