Ministry of Health extends Cordlife ban by up to 3 months

SINGAPORE: The Ministry of Health (MOH) has extended the suspension of Cordlife for up to another three months, the company announced on Tuesday (May 28).

The ailing company’s original six-month suspension was due to end on June 15, but authorities have decided that more time is needed to ensure Cordlife can meet the 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 customers. A further 17,000 customers may have been affected, it was announced in November.

The Ministry of Health had instructed Cordlife to stop collecting, testing, processing and/or storing new cord blood and human tissue samples and to stop offering new types of tests to patients from December 15, 2023.

In April and May, the ministry conducted further inspections to assess Cordlife’s progress in addressing the problems.

It said the company still needs to complete the validation of its AXP II cord blood processing system and the development of appropriate operating procedures and practices for the AXP II system.

In addition, the training and competency assessment of staff in using the system has not yet been completed.

“Additional time will be needed to evaluate the validation data, approve the validation result, review and approve the standard operating procedures, and conduct training and competency assessments for staff. The Ministry of Health has estimated that meeting all requirements will take approximately three months from June 15.”

“The Ministry of Health has also stated that compliance with the above requirements is crucial for the company to properly resume cord blood banking operations.”

Cordlife was informed on Monday of the extension of the suspension for “up to a further three months”.

The suspension could end earlier if the Director General of the Ministry of Health gives his approval, subject to the company’s submissions to the ministry.

Cordlife stated that the company does not intend to submit such written statements to the Ministry of Health and will inform the Ministry.

“The company will continue to work to accelerate efficacy testing, among other corrective efforts, and will keep the Ministry of Health updated on its progress in meeting all requirements and obtaining approval to resume operations as soon as possible,” Cordlife said.