Vigilance Obligations for Reprocessed Medical Devices in Switzerland – Swissmedic Requirements

Legal Basis and Scope

Under the Medical Devices Ordinance (MedDO), any serious incident or potential serious public health threat involving a reprocessed medical device triggers mandatory vigilance reporting to Swissmedic. This applies to:

• Reprocessed reusable devices (e.g., surgical instruments, endoscopes).
• Exceptionally authorised reprocessed single-use devices (SUDs).
• Any adverse event where reprocessing (cleaning, disinfection, sterilisation, or maintenance) is suspected as a contributing factor.

The goal is to identify reprocessing-related risks, enable rapid corrective actions, and prevent recurrence while ensuring traceability across the reprocessing chain. Vigilance MEP - Swissmedic

Reportable Events

Reportable incidents include but are not limited to:

• Infections or adverse reactions potentially linked to inadequate reprocessing.
• Device malfunction, breakage, or performance deterioration post-reprocessing.
• Cross-contamination or residual contamination events.
• Trends showing increased frequency/severity of events associated with reprocessed devices.
• Any event meeting the definition of serious incident under MedDO vigilance provisions.

Even if no harm occurred, events with potential for serious harm (near-misses) must be evaluated and reported if reprocessing is implicated.

Reporting Responsibilities and Timelines

• Healthcare institutions/operators – Report immediately upon awareness (within 2 days for death/life-threatening, 10 days otherwise) if they identify or suspect a reprocessing-related issue.
• Reprocessors (in-house or third-party) – Report serious incidents discovered during or after reprocessing; forward user reports to the manufacturer and Swissmedic if required.
• Manufacturers – Receive reports from operators/reprocessors, investigate reprocessing as a possible root cause, and fulfil their own vigilance obligations (including trend analysis and FSCAs if applicable).

All reports are submitted via the Swissmedic e-Business portal, including details on the device, reprocessing cycle (where known), event description, patient outcome, and suspected reprocessing link.

Specific Vigilance Considerations for Reprocessed Devices

• Document the reprocessing history (cycle number, parameters, operator) in incident reports to facilitate root cause analysis.
• Investigate whether non-compliance with validated procedures, inadequate validation, or equipment failure contributed.
• Manufacturers must assess if reprocessing instructions need updates or if certain devices should no longer be considered reusable.
• Swissmedic may request additional data from all parties in the chain (operator, reprocessor, manufacturer) during assessment.

Coordination and Follow-up

• Operators and reprocessors must cooperate fully with Swissmedic and manufacturer investigations.
• If a Field Safety Corrective Action (FSCA) is initiated due to reprocessing issues, all affected parties must implement promptly and report status.
• Periodic summary reporting on reprocessing-related vigilance may be required in high-risk cases.

Non-reporting or delayed reporting can result in administrative measures or sanctions.

Practical Guidance

Swissmedic provides specific checklists for reporting reprocessing-related incidents, examples of common scenarios (e.g., endoscope-related infections), guidance on documenting reprocessing details in reports, and FAQs. Early reporting and complete information on reprocessing steps are emphasised to accelerate risk assessment.

This vigilance framework for reprocessed devices strengthens post-market safety monitoring in Switzerland by addressing risks specific to reprocessing practices, ensuring accountability across the supply and use chain. Full obligations, reporting templates, and resources are available on the Swissmedic vigilance for reprocessed devices page. Vigilance MEP - Swissmedic