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20 May

Final report says UK infected blood scandal “should have been avoided”

Credit: Leon Neal via Getty Images

The final report from the seven-year inquiry into the UK infected blood scandal concluded that patients were knowingly exposed to risks and the medical catastrophe could largely have been avoided.  

The British medical scandal resulted in nearly 30,000 people being infected with hepatitis C and HIV, as a result of receiving contaminated blood or contaminated clotting factor products between 1970 and 1991.  

The final report indicated that the UK government covered up the scandal “to save face and to save expense.” 

In the 1970s, the availability of a new treatment for haemophilia, known as factor VIII/IX, necessitated the use of blood plasma, which was in short supply. This led to the UK opting for imports from the US. Much of the imported blood was bought from high-risk donors, including prisoners and drug users. One vial could contain clotting proteins from tens of thousands of people, meaning it would take only one person carrying the virus to contaminate the entire batch.

22 May

Roche’s Tina-quant Lp(a) test receives FDA breakthrough device designation

Roche has received the US Food and Drug Administration’s (FDA) breakthrough device designation for its Tina-quant lipoprotein Lp(a) RxDx assay, a diagnostic tool for cardiovascular disease risk. This designation is a significant step towards the approval of the test, which measures lipoprotein(a) levels, a potential risk factor for cardiovascular diseases. 

The FDA’s breakthrough device designation for the Tina-quant Lp(a) RxDx assay specifically targets its use in selecting patients with a history of atherosclerotic disease and elevated Lp(a) for Lp(a) lowering drug treatment. 

The test involves a routine blood draw and measures the number of Lp(a) molecules per litre of blood. On receiving approval, the test will be made available on selected cobas-branded platforms. 

Roche’s portfolio of cardiovascular disease tests will be expanded with this assay, aiding healthcare professionals in making informed treatment decisions. 

16 May

NICE recommends targeted radiation therapy for liver tumours

New guidance from the National Institute for Health and Care Excellence (NICE) recommends that patients with neuroendocrine tumours (NETs) in the liver could benefit from a therapy that targets the tumours with radiation. 

Selective Internal Radiation Therapy (SIRT), a procedure which limits radiation exposure to surrounding tissue, involves injecting radioactive spheres into the artery that takes blood to the liver.

The microspheres deliver targeted radiation that kills the cancer cells. 

From reviewing evidence on the safety and efficacy of SIRT, which looked at treatments including Boston Scientific’s TheraSphere Y90 Microspheres, NICE found that the procedure may result in fewer side effects, faster recovery times, and better quality of life for patients compared with surgery or chemotherapy. 

22 May

UK MHRA proposes international medical device recognition framework

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced a proposed framework for the global recognition of medical devices. In a statement of policy intent, the agency detailed the UK Government’s intent to acknowledge regulatory approvals from specific countries. This policy aims to facilitate access to quality-assured medical devices and streamline the assessment process. 

It focuses on certain device types and classes, with prior approvals from Australia, Canada, the EU, and the US being considered for recognition. This initiative is designed to reduce the duplication of assessments by comparable regulators, allowing resources to be allocated to evaluate more innovative products. 

In addition to the countries already listed, the MHRA is in talks with the Pharmaceuticals and Medical Devices Agency (PMDA) to include Japan among recognised regulatory bodies. 

15 May

FDA issues recall notice for Philips after another respiratory device fails

The FDA has issued a recall notice for the Philips Trilogy EVO, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal ventilator devices due to a power malfunction that would cause its Trilogy EVO Continuous Ventilators to fail. 

Philips is urging users to update the software on their devices after it was found that a “battery depleted” or “loss of power” alarm would appear while sufficient power is still available, resulting in a sudden loss of ventilation. 

The only devices of the Trilogy EVO series not affected by the failure are ventilators with the software version installed. Complaints to the FDA found that the software algorithm that calculates remaining battery life can malfunction and cause the ventilator to either issue a “loss of power” alarm that stops assisted breathing support therapy while operating on battery power alone or a “battery depleted” alarm while continuing therapy if plugged into a permanent power source.