SINGAPORE: The Ministry of Health (MOH) has extended Cordlife’s suspension for up to another three months, the company announced on Tuesday (May 28).
The beleaguered company’s initial six-month suspension was due to end on Jun 15, but authorities have determined that more time is needed to ensure Cordlife can meet requirements to resume its cord blood banking operations.
Seven of Cordlife's storage tanks were exposed to temperatures above acceptable limits, damaging cord blood units belonging to at least 2,150 clients. Another 17,000 clients were possibly affected, it was announced in November.
MOH had ordered Cordlife to stop the collection, testing, processing and/or storage of any new cord blood and human tissues, or provide any new types of tests to patients, from Dec 15, 2023.
Further inspections were conducted by the ministry in April and May to evaluate Cordlife’s progress in rectifying the issues.
It said the company has yet to complete the validation of its AXP II System for cord blood processing, the development of its relevant operating procedures and practices for the AXP II System.
It has also not completed the training and competency assessment of its staff in using the system.
“Additional time will also be needed, to assess the validation data, approve the outcome of the validation, review and approve the standard operating procedures, and conduct staff training and competency assessments, and the MOH has assessed that the completion of all requirements will take around three months from Jun 15.
“The MOH has further stated that the fulfilment of the foregoing requirements is vital to the company's proper resumption of its cord blood banking service operations.”
Cordlife was informed on Monday about the extension in its suspension for “up to an additional three months”.
The suspension may end sooner if approval is granted by MOH’s director-general of health, pending the company’s representations to the ministry.
Cordlife said it does not intend to submit such written representations to MOH and will inform the ministry.
“The company will continue to make efforts to expedite potency testing, on top of other rectification efforts, and will update the MOH on its progress to fulfil all requirements and receive approval to resume operations as soon as possible,” said Cordlife.
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The beleaguered company’s initial six-month suspension was due to end on Jun 15, but authorities have determined that more time is needed to ensure Cordlife can meet requirements to resume its cord blood banking operations.
Seven of Cordlife's storage tanks were exposed to temperatures above acceptable limits, damaging cord blood units belonging to at least 2,150 clients. Another 17,000 clients were possibly affected, it was announced in November.
MOH had ordered Cordlife to stop the collection, testing, processing and/or storage of any new cord blood and human tissues, or provide any new types of tests to patients, from Dec 15, 2023.
Further inspections were conducted by the ministry in April and May to evaluate Cordlife’s progress in rectifying the issues.
It said the company has yet to complete the validation of its AXP II System for cord blood processing, the development of its relevant operating procedures and practices for the AXP II System.
It has also not completed the training and competency assessment of its staff in using the system.
“Additional time will also be needed, to assess the validation data, approve the outcome of the validation, review and approve the standard operating procedures, and conduct staff training and competency assessments, and the MOH has assessed that the completion of all requirements will take around three months from Jun 15.
“The MOH has further stated that the fulfilment of the foregoing requirements is vital to the company's proper resumption of its cord blood banking service operations.”
Cordlife was informed on Monday about the extension in its suspension for “up to an additional three months”.
The suspension may end sooner if approval is granted by MOH’s director-general of health, pending the company’s representations to the ministry.
Cordlife said it does not intend to submit such written representations to MOH and will inform the ministry.
“The company will continue to make efforts to expedite potency testing, on top of other rectification efforts, and will update the MOH on its progress to fulfil all requirements and receive approval to resume operations as soon as possible,” said Cordlife.
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