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.