Health Ministry extends Cordlife’s suspension for up to 3 months

Health Ministry extends Cordlife's suspension for up to 3 months

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 first six-month suspension of the troubled business was scheduled to end on June 15, but specialists now believe more time is required to allow Cordlife to fulfill its obligations to continue its cord blood banking operations.

Seven of Cordlife’s storage tanks were exposed to temperatures above appropriate boundaries, &nbsp, damaging cord blood products &nbsp, belonging to at least 2, 150 customers. Another 17, 000 customers were perhaps affected, it was announced in November. &nbsp,

MOH had ordered Cordlife to prevent the series, testing, processing and/or store of any new rope body and human cells, or provide any new types of tests to individuals, from Dec 15, 2023.

In April and May, Cordlife conducted additional inspections by the government to assess the company’s progress in fixing the problems.

It claimed that the company has not yet completed the development of its important operating methods and techniques for the AXP II System, and the verification of its AXP II System for cable body running.

Additionally, it has not finished conducting the staff’s skills assessments and education for using the system.

The MOH has determined that the implementation of all requirements may take around three months from Jun 15.” More period will also be needed to assess the validation data, review the outcome of the validation, review and review the standard operating procedures, staff training and competency assessments, and the MOH has determined that the completion of all requirements may take around three months from Jun 15.

The MOH further stated that the company’s proper resumption of its cord blood banking service operations depends on the successful completion of the foregoing requirements.

On Monday, Cordlife was informed of the extension of its suspension that would allow it to serve 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 stated it will inform the ministry and does not intend to submit these written representations to MOH.

The company will continue to work to expedite potency testing, in addition to other rectification efforts, and will keep the MOH informed of its progress in meeting all requirements and obtaining approval to resume operations as soon as possible, Cordlife said.