SINGAPORE: Cordlife has been given the green light to resume cord blood banking services in a "controlled manner".
It will not be allowed to collect test, process and/or store more than 30 units of new cord blood per month, from Sep 15, 2024, to Jan 13, 2025.
These restrictions are to safeguard the interest of its customers, the Ministry of Health (MOH) said on Thursday (Aug 29).
MOH’s notice, which was issued to Cordlife on Thursday, is pending the company’s written representations.
On Dec 15, 2023, the health ministry directed Cordlife to stop the collection, testing, processing and storage of any new cord blood for a period of six months, after it was revealed that seven of the company's storage tanks were exposed to temperatures above acceptable limits.
The suspension was extended by an additional three months on Jun 15 this year for Cordlife to complete the validation of its new cord blood processing method.
Follow-up audits conducted by MOH on Cordlife in August have shown that Cordlife has met the essential requirements to resume its provision of cord blood banking services, said the ministry.
“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.
“Nevertheless, MOH has asked that Cordlife 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,” it added.
MOH said it will continue to closely monitor Cordlife’s operational stability, staff capabilities and continued compliance with its regulatory requirements, including prior to its next licence renewal on Jan 13, 2025.
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It will not be allowed to collect test, process and/or store more than 30 units of new cord blood per month, from Sep 15, 2024, to Jan 13, 2025.
These restrictions are to safeguard the interest of its customers, the Ministry of Health (MOH) said on Thursday (Aug 29).
MOH’s notice, which was issued to Cordlife on Thursday, is pending the company’s written representations.
On Dec 15, 2023, the health ministry directed Cordlife to stop the collection, testing, processing and storage of any new cord blood for a period of six months, after it was revealed that seven of the company's storage tanks were exposed to temperatures above acceptable limits.
The suspension was extended by an additional three months on Jun 15 this year for Cordlife to complete the validation of its new cord blood processing method.
Follow-up audits conducted by MOH on Cordlife in August have shown that Cordlife has met the essential requirements to resume its provision of cord blood banking services, said the ministry.
“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.
“Nevertheless, MOH has asked that Cordlife 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,” it added.
MOH said it will continue to closely monitor Cordlife’s operational stability, staff capabilities and continued compliance with its regulatory requirements, including prior to its next licence renewal on Jan 13, 2025.
Continue reading...