On February 5, 2025, the US Food and Drug Administration (FDA) issued three important updates regarding medical device safety. The FDA has reminded patients and caregivers to regularly check alert settings for diabetes-related smartphone devices, particularly following any hardware or software updates to their phones. Additionally, the agency has announced a recall of certain oxygen concentrators and issued a correction for ventilator systems. Steps should be taken to ensure the safety of residents using these devices.
The FDA has issued a reminder that those using diabetes devices, such as continuous glucose monitors (CGMs), insulin pumps, and automated insulin dosing systems, should regularly check smartphone alert settings. Reports have emerged where users did not receive or hear critical alerts, potentially leading to serious health consequences like severe hypoglycemia, hyperglycemia, diabetic ketoacidosis, and even death. Common causes of missed alerts include software configuration issues, operating system updates that are incompatible with the medical device app, and new hardware connections, such as wireless earphones or car audio, which can alter alert volumes. The FDA recommends that patients and caregivers follow the instructions from device manufacturers when setting up or updating mobile medical apps, verify alert settings after making changes to phone hardware or software, and regularly check settings at least once a month. If issues arise, patients should contact technical support for assistance.
The FDA has also issued a recall for the TRUAIRE-5 O2 CONCENTRATOR (Model: O2C5L) due to safety concerns. This device, used to provide supplemental oxygen to patients with respiratory conditions, has been found to pose a risk of fire and melting during use. Although no injuries or deaths have been reported, affected devices should be immediately removed from service and returned to Compass Health Brands.
Finally, the FDA has announced a correction for the Life2000 Ventilator System (Models: BT-20-0002, BT-20-0002A, and BT-20-0002AP) due to a defect in the battery charger, which may cause the device to become inoperable. This malfunction could result in deterioration of respiratory function, hypoxia, and severe health complications, including cognitive impairment, changes in blood pressure, or even coma. Baxter Healthcare has initiated a corrective action to replace the defective chargers, and affected ventilators should not be used until a replacement charger is provided. While no injuries or deaths have been reported, alternate means of ventilation or oxygen therapy should be available at all times.
For further information, refer to the full FDA communications regarding these recalls and corrections.
View the diabetes-related smartphone device alert here.
The oxygen concentrator recall can be accessed here.
And the continuous ventilator correction notice is available here.
Compliance Perspective
Issue
The FDA’s recent updates highlight critical safety concerns regarding the use of certain medical devices, including diabetes-related smartphone devices, oxygen concentrators, and ventilators. These issues could pose significant risks to resident safety, such as missed alerts on diabetes devices leading to life-threatening conditions like severe hypoglycemia or hyperglycemia, and potential malfunctions in oxygen concentrators and ventilators that may compromise respiratory care. Facilities should take immediate action to address these concerns, ensuring devices are properly configured, recalled products are removed, and any faulty equipment is corrected to prevent harm to residents.
Discussion Points
- Ensure that the facility’s policies and procedures regarding the use, maintenance, and monitoring of medical devices reflect the latest FDA recommendations. Policies should outline the steps for checking alert settings on diabetes-related devices and for promptly removing any affected oxygen concentrators or ventilators from service. Update policies to include instructions for verifying device functionality after hardware or software updates, and provide guidance for addressing device recalls and corrections.
- Train staff on the specific devices affected by the FDA’s recent updates, including the proper setup and maintenance of diabetes-related apps, the identification of recalled oxygen concentrators, and the steps for managing ventilator malfunctions. Ensure that all relevant personnel, including nurses, caregivers, and maintenance staff, understand how to configure device settings and what actions to take if issues are identified. Emphasize the importance of regularly checking devices for functionality and alert settings to prevent any safety issues from arising.
- Implement regular audits of the affected devices to ensure they are functioning correctly and in compliance with safety standards. This includes verifying alert settings for diabetes-related devices, inspecting oxygen concentrators for any safety hazards, and ensuring that ventilators are properly functioning after any necessary corrections. Monitor the ongoing use of these devices to identify any performance issues or safety concerns and immediately take corrective action when needed.
*This news alert has been prepared by Med-Net Concepts, Inc. for informational purposes only and is not intended to provide legal advice.*
