UK suspension lifted for organ transplant fluids three years after contamination reports

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TWO MEDICAL transplant devices have returned to UK clinics following more than three years of suspension prompted by reports of contamination in fluids used to preserve organs. 

The Medicines and Healthcare products Regulatory Agency (MHRA) lifted the suspension earlier this month after confirming manufacturer Carnamedica and UK distributor Bridge to Life had completed “corrective action” to prevent microbial contamination that had “posed a risk of significant patient harm”. 

Contamination in “Belzer”-branded cold storage solution (CSS) and machine perfusion solution (MPS) – fluids used to preserve kidneys, livers and pancreases prepared for transplantation – was identified in early 2023 when five strains of bacteria, black mould and particulates were found in bags containing the fluids. No infections were reported as a result of the defects, but the MHRA said contamination could have led to sepsis, necrosis, regional ischaemia or transplant failure. 

Bridge to Life suspended sales of all CSS and MPS products in April 2023, having already suspended sales of specific batches after initial reports of leaks and discoloration in January.

‘Proud to be back’

The MHRA said that Carnamedica and Bridge to Life had completed the appropriate “corrective action” to prevent the defects from returning. This includes pressure testing every single bag before aseptic filling and 100% quality checks of each product before distribution.

The defects were caused by a number of third-party suppliers in Carnamedica’s supply chain. It is understood that verifying that each organisation involved in the supply chain had made improvements to their own processes delayed the devices’ return to clinics. 

However, the regulator warned that healthcare staff should be “particularly alert” if transplant patients become infected with an “unusual organism” or develop an “unusual antibiotic resistance pattern” after receiving organs preserved in Belzer solutions. 

Carnamedica CEO Paweł Szczudło told TCE: “We are proud to be back, supporting British patients in receiving a new lease on life through transplantation, and we remain open to cooperation on new projects that can transform human lives.”

Szczudło added that the Belzer manufacturing technology “relies strictly on an aseptic filling process finished by sterilising filtration. This completely eliminates the degradation of sugars and amino acids, as well as cross-reactions between components typically induced by the heat of autoclaving.”

Bridge to Life was approached for comment.