The GammaSafe memory token from Datakey Electronics is a
non-volatile, reprogrammable, portable memory device that survives gamma
sterilization with no loss of data. The GammaSafe data-carrier/receptacle
system allows medical device manufacturers to easily add anti-counterfeit and limit-use
capabilities to disposable attachments that are sterilized using gamma
radiation.
The SGT4Kb GammaSafe memory token contains four kilobits of
non-volatile, rewritable memory. The memory is accessed using an SPI bus and is
functionally similar to an SPI EEPROM. But unlike actual EEPROM devices, which
experience data loss and even device failure when exposed to significant doses
of gamma radiation, GammaSafe memory tokens have been proven to withstand up to
45 kGy (4.5 Mrad) of gamma radiation with no data loss.
Medical device manufacturers who produce single-use or
limited-use disposable attachments (e.g., catheters, filters, tubing, medical
lasers, etc.) that plug in to a base controller can now add a non-volatile
memory device to the attachment, even if their attachments contain no active
electronics. Adding a GammaSafe memory token to an attachment enables several
applications. For example, the GammaSafe memory token can store an encrypted
product authentication code to protect against counterfeit disposables. The rewritable
memory can also be used to limit the usage of the attachment, ensuring that it
is not used more than the prescribed number of times. The disposable’s model
number and associated parameters, along with calibration information can be
written to the GammaSafe token during production, then, in the field, this data
can be automatically transferred to the base controller unit, eliminating the
chance for human error from incorrect data entry.