#32026D1126EU extends Malta’s emergency use of Wofasteril SC super for hospital PPE disinfection
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This decision lets Malta continue allowing Wofasteril SC super to be placed on the market and used in the High Degree Isolation Unit at Mater Dei Hospital. The product is used to disinfect healthcare workers’ personal protective equipment before they remove it after treating patients with suspected or confirmed highly infectious diseases. The practical effect is narrow but important: it supports infection-control procedures in a specialist hospital unit where staff safety depends on reliable PPE decontamination. The decision mainly affects Malta’s health authority, Mater Dei Hospital, healthcare workers in the isolation unit, and the supplier of the product.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Extends Malta’s emergency permission for Wofasteril SC super in a specific hospital isolation unit
- Allows continued use of the product for disinfecting healthcare workers’ PPE before removal
- Supports infection-control measures for care involving highly infectious diseases
Obligations
What this law requires
Malta’s competent authority may extend the derogation only for the making available on the market and use of Wofasteril® SC super in the High Degree Isolation Unit at Mater Dei Hospital in Msida.
Any supply or use under the Maltese derogation must remain limited to Wofasteril® SC super for PPE disinfection in the High Degree Isolation Unit at Mater Dei Hospital; the decision does not authorise general market use elsewhere.
Healthcare PPE in the High Degree Isolation Unit should be disinfected with the authorised product before healthcare professionals remove it after leaving rooms of patients suspected or confirmed to have highly infectious diseases.