Hyderabad: Illegal and unapproved diabetes management devices that are being sold in the market have been noted by the Food and Drug Administration (FDA). The FDA has warned healthcare professionals and also patients to check before using these devices.
The adverse effects of these devices were reported when they were used from unapproved sectors and that has raised doubts of the illegal manufacturers and marketers of these devices in the market.
The devices marketed for diabetes are: continuous glucose monitoring systems, insulin pumps and automated insulin dosing systems which if not from standardised companies can result into injury and also death.
The warning issued by the FDA on Monday stated that there was illegal manufacture and marketing of these devices by unauthorised companies and it was important that healthcare professionals and patients check its varsity before using it.
Non-standardised devices can give inaccurate blood sugar level readings and that can lead to unsafe insulin dosing which can cause injury and would require urgent medical intervention.
Dr Shyam Kalavalapalli, senior endocrinologist says the review by FDA has shown that there are illegal manufacturers of these devices and that compromises the safety and effectiveness of the device.
“The role of technology in diabetes management is on the rise. However, there is also an increase in unregulated use of substandard technologies, particularly those from China, that can pose a risk to patient health. Also, various organisations are trying to attract with fancy technologies,” said Dr Kalavalapalli.
The review has shown that faulty devices can harm the patient and will bring a bad name to the new technology which is assisting in managing the disease. These devices are presently used in hospitals where doctors and trained nurses handle them.
Dr Sridevi Patnala, senior endocrinologist said, “The norms for handling devices have to be strictly followed. They require proper monitoring and cannot be used at home. The device is not available off the counter and can be procured only at the hospital level.”
There are only two multi-national companies that manufacture the continuous glucose monitoring system.
This device uses a sensor and transmitter to continuously track the glucose level.
The insulin pump is a small computerised device which delivers insulin through a catheter placed under the skin.
In the automated insulin system the doses of insulin are automatically delivered based on the glucose levels.
With combination of devices being used without proper approvals, FDA is asking healthcare professionals to also check before using them.
