Switzerland 2025 Update on Good Practices for Endoscope Reprocessing

On 12th September 2025, Swissmedic published an update to the Swiss Good Practices for the Reprocessing of Flexible, Thermolabile Endoscopes (GPAE), available in German and French. This guidance is the central reference for reprocessing in hospitals and outpatient facilities, aligning hygiene and safety standards with Articles 71–73 of the Swiss Medical Devices Ordinance (MedDO). The update follows findings from the Hospital Inspections Annual Report 2024, where many facilities failed to meet reprocessing requirements, posing risks to patient safety.

Key Updates in the 2025 GPAE Guidance

Legal Clarifications under MedDO

• Swissmedic specifies reprocessing duties under Art. 71–73 MedDO.

• Healthcare institutions must meet legal hygiene and safety obligations.

Alignment with Technology and Science

• Reflects the state of the art in reprocessing thermolabile endoscopes.

• Ensures Swiss requirements are harmonized with international standards while explicitly addressing national legal obligations.

Reference to Hospital Inspections Annual Report 2024

• Swissmedic identified gaps in compliance, particularly around hygiene and documentation.

• The GPAE update aims to close these gaps and reduce patient risk.

Why This Update Matters

• Provides a legal and scientific framework for endoscope reprocessing.

• Strengthens patient safety through stricter hygiene standards.

• Supports healthcare providers in aligning practices with enforceable requirements.

Compliance Actions for Healthcare Providers

1. Review reprocessing procedures against updated GPAE guidance.

2. Ensure staff are trained on Articles 71–73 MedDO obligations.

3. Audit existing processes to identify non-compliance highlighted in Hospital Inspections 2024.

4. Update documentation and quality management systems accordingly.

Internal links:

• Learn more about Swissmedic Switzerland Medical Device Registration

External links:

• Swissmedic – Reprocessing Guidance (GPAE)

• Swissmedic – Hospital Inspections Annual Report 2024

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