Related Experiment Video
Updated: Aug 24, 2026

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
Importance of cleaning for reprocessing endoscopes and thermolabile sterile medical devices: French use and
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.
Abstract:
In France, endoscope maintenance regulations present some particularities in terms of the definitions and texts referring to the disinfection and sterilization of medical devices, with respect to the prion risk. The main measures specified are a double cleaning prior to disinfection, with some stipulations concerning the procedure itself, such as time limits, duration and rinsing. The use of aldehydes in cleaning products is prohibited and it is recommended that peracetic acid, or any chlorinated product, be used at the disinfection phase. For machines, the recycling of detergents or disinfectants is prohibited, and traceability procedures are mandatory. The French Agency for Safety of Health Products (AFSSAPS) is committed to providing standards that prevent any undesirable consequences for the patient, the operator or the equipment. All these measures will be described in a 'user's guide' intended for medical care units, to be released by the National Technical Committee on Nosocomial Infections (CTIN).
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.
Related Concept Videos
Cleaning, Sterilization, and Disinfection
Cleaning
The cleaning process usually involves using water with detergents or enzymatic cleaner and removing foreign material from objects and surfaces, including organic material such as body fluids or inorganic material like soil. Cleaning is performed before high-level disinfection and sterilization because foreign materials on the cover of the devices interfere with process...
Methods of Sterilization II: Chemical Methods
Using chemical sterilization rather than heat to clean out equipment is recommended. It eradicates and removes all bacteria,...
Standard Precaution
Hand hygiene is the most crucial means to prevent the transmission of disease. Employers are legally required to provide their workers with personal protective equipment (PPE) to minimize exposure or contact with...
Methods of Sterilization I: Physical Methods
Steam sterilization uses non-toxic, low-cost moist heat in the form of saturated steam under pressure, which is fast, microbicidal, and sporicidal, and quickly warms and penetrates fabrics. Autoclaves, or steam sterilizers, expose each item to direct steam contact for a predetermined time at the necessary...
Good Manufacturing Practices
Physical Methods for Controlling Microbial Growth: Radiation and Filtration
