Some current news on medical device quality

On Behalf of | Dec 27, 2021 | Product Liability

Society relies on thousands of medical devices that obtain better outcomes for people around the world. Sometimes, though, these devices have problems that could negatively impact the treatment of patients.

Medical professionals, medical facilities and manufacturers should stay informed on the efficacy of the medical devices they recommend for clients.

Device shortcomings

The Regulatory Affairs Professionals Society reports on important news regarding medical device warnings and authorizations. A recent report called attention to a cybersecurity vulnerability in certain devices monitored by the Center for Devices and Radiological Health. Software for some devices could interfere with login access or could allow remote users to hack into a device. The agency recommended continued vigilance regarding software security issues.

Another device warning involved the DeVilbiss oxygen concentrator and home usage. At least one unit became too hot to touch and even began smoking while in use at a patient’s home. Another of these devices reached temperatures hot enough to melt portions of the unit. Testing revealed the concentrator’s compressors frequently ran above-recommended temperatures.

Medical device warnings

The maker of a dental rinse product received an FDA warning letter for violations related to good manufacturing practices. The device failed to pass microbiological testing requirements. Germ agents grew in higher quantities and failed to meet compliance regulations. The FDA labeled the cleaning program for the device as “deficient.”

The diabetes division of  Medtronic received an FDA warning letter for quality management issues related to two insulin pumps. The issues concerned the recall of insulin pumps and remote controller devices. Consumers should always do their best to follow recall instructions on medical devices.


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