The US FDA has issued a warning against the use of unauthorized diabetes devices, insulin pumps and continuous glucose monitors as well as other nonapproved devices and algorithms used to create systems for automated insulin delivery.

As per the FDA statement “These unauthorized diabetes management devices have not been reviewed by the FDA to ensure they provide a reasonable assurance of safety and effectiveness for their intended use. Use of unauthorized devices could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to injury requiring medical intervention or death.”

The warning followed a case report of a patient using a system comprising an unauthorized insulin dosing device that receives electronic signals from an FDA-authorized glucose sensor and converts it to a glucose value using an unauthorized algorithm. The system gave the patient too much insulin in response to repeated incorrect high glucose values.

These devices were not designed to be used together and were combined in a way that had not been thoroughly tested for compatibility.

Off late we have been seeing cases of even FDA-approved device failures.

Johnson and Johnson hip implant is one such example, which was withdrawn from the market after complications that required revision surgeries.

Medtronic’s pacemaker security alert is another example, where the FDA said that Medtronic cardiac implants can be hacked and issued a warning about two dangerous security flaws affecting a number of implantable heart defibrillators and home monitoring systems.

While it is easy to track, compensate and correct in cases of approved devices, this is not the case with unauthorised devices. Using unauthorised devices therefore can be risky.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA