[{"innerBlocks":[],"name":"core\/freeform","postId":761,"blockType":{"name":"core\/freeform","keywords":[],"attributes":{"content":{"type":"string","source":"raw"},"lock":{"type":"object"}},"providesContext":[],"usesContext":[],"selectors":[],"supports":{"className":false,"customClassName":false,"reusable":false},"styles":[],"variations":[],"apiVersion":3,"title":"Classic","description":"Use the classic WordPress editor.","category":"text"},"originalContent":"The Food and Drug Administration on Thursday warned patients and providers to be aware that certain Medtronic MiniMed insulin pumps are being recalled because of potential cybersecurity risks.

According to the regulatory agency, the recalled pumps include Medtronic\u2019s MiniMed 508 insulin pump and MiniMed Paradigm series insulin pumps, which wirelessly connect to patients\u2019 blood glucose meters and continuous glucose monitoring systems.

\u201cThe FDA has become aware that an unauthorized person (someone other than a patient, patient caregiver or healthcare provider) could potentially connect wirelessly to a nearby MiniMed insulin pump with cybersecurity vulnerabilities,\u201d states the agency\u2019s safety communication<\/a>. \u201cThis person could change the pump\u2019s settings to either over-deliver insulin to a patient, leading to low blood sugar (hypoglycemia), or stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis.\u201d

As a result, the FDA is recommending that patients with diabetes using MiniMed insulin pump models switch to devices that are better equipped to protect against these potential risks.

Also See<\/b>: FDA issues warning about use of diabetes management devices<\/a>

\u201cThe FDA urges manufacturers everywhere to remain vigilant about their medical products\u2014to monitor and assess cybersecurity vulnerability risk, and to be proactive about disclosing vulnerabilities and mitigations to address them,\u201d said Suzanne Schwartz, MD, deputy director of the Office of Strategic Partnerships and Technology Innovation and acting division director for All Hazards Response, Science and Strategic Partnerships in the FDA\u2019s Center for Devices and Radiological Health.

\u201cAny medical device connected to a communications network, like Wi-Fi, or public or home Internet, may have cybersecurity vulnerabilities that could be exploited by unauthorized users,\u201d added Schwartz.

While the FDA says it is not aware of any confirmed reports of patient harm related to these potential cybersecurity risks, the agency notes that Medtronic is \u201cunable to adequately update\u201d the insulin pumps with any software or patch to address the vulnerabilities.

\u201cMedtronic is providing alternative insulin pumps to patients with enhanced built-in cybersecurity capabilities,\u201d according to the FDA\u2019s announcement. \u201cIn the U.S., Medtronic has identified 4,000 patients who are potentially using insulin pumps that are vulnerable to this issue. In addition, Medtronic is working with distributor partners to identify additional patients potentially using these pumps.\u201d","saveContent":"The Food and Drug Administration on Thursday warned patients and providers to be aware that certain Medtronic MiniMed insulin pumps are being recalled because of potential cybersecurity risks.

According to the regulatory agency, the recalled pumps include Medtronic\u2019s MiniMed 508 insulin pump and MiniMed Paradigm series insulin pumps, which wirelessly connect to patients\u2019 blood glucose meters and continuous glucose monitoring systems.

\u201cThe FDA has become aware that an unauthorized person (someone other than a patient, patient caregiver or healthcare provider) could potentially connect wirelessly to a nearby MiniMed insulin pump with cybersecurity vulnerabilities,\u201d states the agency\u2019s safety communication<\/a>. \u201cThis person could change the pump\u2019s settings to either over-deliver insulin to a patient, leading to low blood sugar (hypoglycemia), or stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis.\u201d

As a result, the FDA is recommending that patients with diabetes using MiniMed insulin pump models switch to devices that are better equipped to protect against these potential risks.

Also See<\/b>: FDA issues warning about use of diabetes management devices<\/a>

\u201cThe FDA urges manufacturers everywhere to remain vigilant about their medical products\u2014to monitor and assess cybersecurity vulnerability risk, and to be proactive about disclosing vulnerabilities and mitigations to address them,\u201d said Suzanne Schwartz, MD, deputy director of the Office of Strategic Partnerships and Technology Innovation and acting division director for All Hazards Response, Science and Strategic Partnerships in the FDA\u2019s Center for Devices and Radiological Health.

\u201cAny medical device connected to a communications network, like Wi-Fi, or public or home Internet, may have cybersecurity vulnerabilities that could be exploited by unauthorized users,\u201d added Schwartz.

While the FDA says it is not aware of any confirmed reports of patient harm related to these potential cybersecurity risks, the agency notes that Medtronic is \u201cunable to adequately update\u201d the insulin pumps with any software or patch to address the vulnerabilities.

\u201cMedtronic is providing alternative insulin pumps to patients with enhanced built-in cybersecurity capabilities,\u201d according to the FDA\u2019s announcement. \u201cIn the U.S., Medtronic has identified 4,000 patients who are potentially using insulin pumps that are vulnerable to this issue. In addition, Medtronic is working with distributor partners to identify additional patients potentially using these pumps.\u201d","order":0,"get_parent":{},"attributes":[],"attributesType":{"content":{"type":"string","source":"raw"},"lock":{"type":"object"}},"dynamicContent":""}]

FDA issues cybersecurity warning about Medtronic insulin pumps

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