New agents from Bayer, GE Healthcare and Guerbet to ease local shortage of medical imaging

MedTech News: The Therapeutic Goods Administration (TGA) has authorised the supply of overseas-registered iodinated contrast media diagnostic agents, used in computerised tomography (CT) scans, to ease the shortage created by the COVID-19 lockdown in Shanghai, China.

The lockdown stopped production at a GE Healthcare facility. The company has since returned the facility to 100% production capacity but the impact of the disruption to the supply of the dye used to visualise blood flow and monitor tumours is still being felt. GE, the largest player in the Australian market, expects to resume normal supply in the country in mid-July.

To ease the shortage impacting patient care and surgical procedures, the TGA is allowing the Australian affiliates of Guerbet, Bayer and GE to supply multiple overseas-registered products. The section 19A approvals cover a range of volumes of GE’s Omnipaque, Guerbet’s Xenetix and Optiray and Bayer’s Ultravist. TGA has approved the supply of the overseas products until 28 February 2023.

In hospital settings, the Australasian College for Emergency Medicine has encouraged shared decision making and consultation with emergency department leadership to facilitate patient flow in consideration of the current shortage.

The TGA continues to recommend the “urgent conservation of stock until the shortage is resolved as current supply is very limited.”