The Safety Alert Broadcast System aims to communicate safety and quality information to South Australian health services to ensure that statewide, national and international experiences and information are actively shared across the system.
Each alert specifies action to be taken by health services, the timeframe in which such action must occur, and specific responsibility for the actions.
The Safety Alert Broadcast System (SABS) includes three tiers of notifications to provide SA health services with early warnings of issues, namely:
Safety Alert: Requiring immediate attention and action.
Safety Notice: Requiring risk assessment at the local level to determine appropriate action.
Safety Information: Ensuring that lessons learnt from statewide, national and international sources are shared actively across the South Australian health system.
The established process for Therapeutic Goods Administration (TGA) medical device recalls/product corrections is for the manufacturer/sponsor to dispatch letters to the relevant service providers within two working days of the recall date. If affected, the health service will have received a letter from the manufacturer/sponsor advising of the recall.
If a device failure is experienced, a health professional or biomedical engineer should report the incident to the Therapeutic Goods Administration Incident Reporting and Investigation Scheme (IRIS). Refer to the Reporting problems section of the TGA web page.
Medical devices include a wide range of products, such as medical gloves, bandages, syringes, blood pressure monitors, and X-ray equipment. They generally have a physical or mechanical effect on the body, or are used to measure (or monitor) the body and its functions.
If the report is being made by an SA Health staff member it should also be reported into the Safety Learning System (SLS) using the classification Medical Device / equipment. There is an SLS Topic Guide available.
SA TGA Liaison Officer Telephone: (08) 8226 6035 Email: SABS@sa.gov.au
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