Hospital Inspections Annual Report 2024

In 2024, Swissmedic inspected the reprocessing, maintenance and vigilance – in other words monitoring and reporting of serious incidents – of medical devices in 23 Swiss hospitals. The report shows that many hospitals still have considerable challenges to overcome to ensure compliance with legal requirements. Particular attention is paid in the report to root cause analysis and the resulting recommendations.

In the course of its hospital inspections, Swissmedic examined the quality and safety of medical devices in reprocessing units (RUMEDs) and Endoscopy departments. It also inspected maintenance procedures and vigilance systems. Hospitals were chosen on the basis of a representative procedure that took account of regional and institutional differences.

The results reveal recurring weaknesses in all areas of the inspections.

• Deficiencies were often found in the infrastructure, staffing resources and process workflows of RUMEDs and Endoscopy departments. The lack of further training for specialist staff and and inadequate physical separation between clean zones and dirty zones are particularly critical issues.
• Turning to maintenance, the life cycle processes for medical devices (such as inventory control and preventive maintenance) were found to be inadequately documented and established.
• Cybersecurity risks were unresolved in more than 40 percent of cases.
• Hospitals rarely have complete vigilance strategies. Training and process quality are insufficient in many cases.

Swissmedic did not identify any direct risk to patients. However, in critical cases, immediate action was demanded to guarantee the safety and functionality of medical devices.

Root cause analysis and action areas

The detailed analysis provided in the report highlights structural issues: Time and cost pressure, lack of investment and a shortage of qualified staff are hampering quality development. In particular, RUMEDs' hierarchical subordination to surgical units is proving counterproductive. Swissmedic recommends increasing RUMEDs' organisational autonomy and improving their quality assurance by means of periodic reporting.

A further important potential solution is to encourage vocational training as medical device technologists. Investment in modern infrastructure and training is also indispensable. The findings from the inspections provide a basis for further improvements that will increase safety and efficiency in Swiss healthcare institutions.

Flexible endoscopes are used for diagnosis and treatment in body orifices and hollow organs. They become unstable if reprocessed at elevated temperatures and can be destroyed. For this reason, they cannot be sterilised with steam. Errors during reprocessing, as a result of inadequate disinfection or unqualified staff, for example, harbour the risk of infection. Deficiencies in quality management and infrastructure make sustainable quality development difficult. Regular training and standardised processes are crucial in guaranteeing patient safety.