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Civic group protests regulator’s inaction over insulin pumps FDA recalled
  • By Lee Hye-seon
  • Published 2019.10.07 16:10
  • Updated 2019.10.07 16:10
  • comments 0

A civic group supporting diabetic patients said it would hold a rally to protest the regulator’s neglect of Medtronic’s insulin pumps, which the U.S. has recently recalled.

The U.S. Food and Drug Administration ordered a recall of some Medtronic’s insulin pumps due to potential cybersecurity risks and listed the names of the products on its homepage in June.

The FDA asked patients to check to see if the model and software version of their insulin pump was affected. It recommended patients to read Medtronic’s letter to identify their pump’s software version. For those who live outside the U.S., the FDA ordered Medtronic to send a notification letter with instructions based on the country where they live.

The civic group criticized the food and drug safety ministry for not releasing any measure on Medtronic’s insulin pumps that the FDA recalled.

“Medtronic MiniMed Paradigm 712, which the FDA recalled due to cybersecurity risk, will benefit from health insurance coverage from next year,” the group said. “As patients question whether the reimbursable insulin pump is safe, the food and drug safety ministry should reveal what kind of measure it will take.”

The civic group also demanded the ministry identify all the local users of insulin pumps recalled in the U.S., replace the pumps with alternatives for patients, and send a notification letter to patients.

“The Ministries of Health and Welfare and Food and Drug Safety Ministry should thoroughly investigate this issue to protect the public health. We will watch over the government’s action, together with 4 million diabetic patients. If there is any problem, we will deal with it sternly,” it said.

The civic group for diabetic patients aims to advocate the rights of patients who receive insulin pump treatments among type-1 and type-2 diabetic patients.


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