澳大利亚治疗用品管理局（TGA）负责监督140万台医疗设备的安全性，但该机构正面临人力资源的严重危机[1]。2024年，该部门的监测团队编制仅达预算的50%，现有成员不足30人[1]。面对医院强制报告制度启动后预期不良事件增加十倍的形势，TGA曾申请增加150名员工以应对工作量，但遭到政府拒绝[1]。
陈旧的系统和严重的人员不足使监管效能大幅下降[1]。TGA的信息技术基础设施每周宕机一次，处理单份不良事件报告需耗时至少85分钟，且缺乏自动警示功能[1]。这种低效直接反映在调查覆盖率上——在2019年至2023年间，37540份不良事件报告中仅有4.2%得到调查[1]。若处理额外报告所需资源获得批准，年度成本可能高达1580万澳元[1]。
Australia's Therapeutic Goods Administration (TGA) oversees the safety of 1.4 million medical devices but operates with severe resource constraints that undermine its regulatory capacity [1]. The monitoring team is staffed at only 50 percent of its budgeted level, with just 30 personnel currently employed, despite anticipated tenfold increases in adverse event reports following the implementation of mandatory hospital reporting requirements [1]. The government has declined to approve the agency's request for funding to hire an additional 150 staff members, with the estimated annual cost of processing these additional reports potentially reaching AUD $15.8 million [1].
The TGA's capacity to investigate reported safety incidents remains inadequate. Between 2019 and 2023, only 4.2 percent of 37,540 adverse event reports underwent investigation [1]. The agency's aging IT infrastructure compounds these challenges, with systems experiencing weekly outages and requiring at least 85 minutes to process each individual report, while lacking automated alert functionality [1]. These systemic deficiencies create a significant gap between incoming demand and the TGA's ability to respond as hospitals are expected to dramatically increase their submission of incident reports to the regulator.