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and Johnson hip implant is one such example, which was withdrawn from the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
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