Due to recent investigations into possible cybersecurity threats related to certain products, the FDA (Food and Drug Administration) released a warning for health care providers and patients who use specific Medtronic MiniMed insulin pumps. Research has not shown any confirmed reports of harm related to this risk, but the pumps are being recalled as a precaution. Medtronic is working with the FDA to organize solutions to protect patients who are using the pumps.
The cybersecurity risk involves the wireless connection between the insulin pumps and devices such as glucose meters, monitors, remote controls and the CareLink device that works with the pumps. In addition to taking the product off store shelves, the FDA is recommending that patients switch to a model that protects against the risks.
An insulin pump is a small computer-operated device that utilizes an implanted catheter to deliver insulin to a patient throughout the day. For many patients, these pumps are a better way to receive insulin as needed throughout the day compared to periodic injections. A pump helps keep a diabetic patient’s insulin at a safe level.
The FDA’s concern regarding the specific MiniMed pumps is that because of the vulnerabilities they have identified in the device, an unauthorized person could connect to a pump and change the settings. This could lead to the patient receiving too much insulin or having the delivery stopped altogether.
The pumps included in the recall are the Medtronic MiniMed 508 and the MiniMed Paradigm series. It is estimated that around 4,000 patients in the United States could potentially be using these products and the company is working with distributors to identify others who may also be affected.
Unfortunately, Medtronic doesn’t have a way to update the pumps to address the vulnerability. However, for patients that already use the pumps, Medtronic is offering an alternative pump that has enhanced cybersecurity precautions in place. The FDA is monitoring the recall to assure that patients are given the opportunity to switch to newer models with a better focus on cybersecurity.
Issues like the Medtronic recall highlights the need for additional cybersecurity precautions in all markets. If you have questions about this specific recall or you would like to learn more about cyber risk services available, reach out to us at Highland Risk Services. We look forward to helping you by addressing the ever-growing need for cyber insurance across a wide range of industries.
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