Home / Health / Medical Watchdog Staffed at 50% as Device Risks Rise
Medical Watchdog Staffed at 50% as Device Risks Rise
2 Aug
Summary
- Watchdog's medical device monitoring team is half-staffed.
- Government rejected funding increase despite rising reports.
- Understaffing hinders ability to track device safety trends.
The agency overseeing Australia's medical devices is critically understaffed, operating with only half the budgeted personnel. This situation occurs as the Therapeutic Goods Administration (TGA) anticipates a significant increase in adverse event reports following the implementation of mandatory hospital reporting in March of this year. Despite these challenges, the federal government refused to approve additional funding for the TGA.
Internal documents from 2024 and 2025 reveal that the TGA's adverse event monitoring team was severely under-resourced, missing half its staff. The situation is exacerbated by outdated IT systems that hinder data analysis and trend identification. This deficiency in resources and technology compromises the agency's ability to effectively screen and investigate tens of thousands of alerts received annually.
These revelations coincide with ongoing investigations highlighting loopholes in Australia's medical device approval system. The TGA's post-market surveillance, designed to catch flawed devices, is demonstrably strained. Reports indicate that only a small fraction of adverse event notifications are investigated, and missing data further limits the reliability of safety assessments.
In response to inquiries, the TGA confirmed a budget request for increased funding was rejected but stated its monitoring team now comprises 30 staff members. An agency representative acknowledged issues with legacy IT systems, stating a transformation is underway, supported by temporary software solutions and departmental funding. The level of investigation is deemed appropriate for the current risk landscape.
