Cordlife allowed to resume limited cord blood banking services

SINGAPORE – Private cord blood bank Cordlife has been given the green light by the authorities to resume cord blood banking services on a limited basis, more than eight months after the company was

directed to stop its services because of lapses found at its storage facility

.

Cordlife can collect, test, process or store only 30 units of new cord blood per month from Sept 15, 2024, to Jan 13, 2025, the Ministry of Health (MOH) said in a press statement on Aug 29.

“MOH will continue to closely monitor Cordlife’s operational stability, staff capabilities and continued compliance with our regulatory requirements, including prior to its next licence renewal on Jan 13, 2025,” a spokesman for the ministry added.

Follow-up audits by MOH showed that Cordlife has met the essential requirements to resume its provision of cord blood banking services.

“For example, Cordlife has validated its new cord blood processing method, implemented a new temperature monitoring system with acceptable temperature monitoring practices, and streamlined its incident tracking and escalation workflow,” said the MOH spokesman.

Processes at the company have been in the spotlight since it was revealed on Nov 30, 2023, that cryopreserved cord blood units in seven of its 22 storage tanks were exposed to suboptimal storage temperatures.

Cord blood units have to be stored at temperatures no higher than minus 150 deg C.

About 7,500 cord blood units in two tanks and in a dry shipper – a container used to transport cord blood units at extremely low temperatures – have been considered non-viable and unlikely to be suitable for stem cell transplants.

On Dec 15, 2023, the company was issued a six-month suspension and had to cease collecting, testing, processing and/or storing any new cord blood and human tissues. The suspension was extended by an additional three months on June 15 for Cordlife to complete the validation of its new cord blood processing method.

While Cordlife has been allowed to resume its services, MOH said it asked the company to adopt a “carefully calibrated approach to gradually ramp up the provision of its services to ensure the welfare of its customers”.

“This is also considering that Cordlife has undergone significant changes in its governance, manpower and processes,” said the MOH spokesman.

Responding to The Straits Times, Cordlife said that as part of its preparations to receive new clients from Sept 15, it will be prioritising the retraining of obstetricians in Singapore, as it is the obstetricians who collect cord blood after a birth.

“This initiative is essential to ensure that healthcare professionals are fully updated with our latest cord blood collection standard operating procedures,” said a Cordlife spokesman, adding that training will be ongoing.

“Our goal is to earn back public trust and attract new clients by proving our renewed dedication to excellence,” said the spokesman.

Towards this goal, a comprehensive set of safety measures developed with MOH – guided by the Foundation for the Accreditation of Cellular Therapy and the Association for the Advancement of Blood and Biotherapies – has been implemented.