Memory Device Withstands Gamma Sterilization of Disposables Without Data Loss

Disposable device manufacturers can now incorporate anticounterfeit and limit-use functionality into gamma-sterilizable attachments without the threat of data loss. Manufactured by Datakey Electronics (Savage, MN), the GammaSafe memory device can store an encrypted product-authentication code to protect against counterfeit disposables and can be employed to limit attachment usage to ensure proper use and patient safety.

Although functionally similar to SPI EEPROM devices, the reprogrammable, portable GammaSafe memory token can withstand up to 45 kGy of gamma radiation without compromising performance. EEPROM devices, in contrast, may experience significant data loss or even device failure when subjected to intense gamma radiation, according to Datakey.

The company also touts the simplicity of the device: It does not require integration of any complex circuitry into OEMs' embedded designs, unlike radiofrequency and other technologies. Instead, it requires the addition of one receptacle. "The contacts of the GammaSafe receptacle simply connect directly to the microcontroller's SPI port. When the GammaSafe memory token is inserted into the receptacle, the microcontroller can read and write to it just as if it was an SPI EEPROM IC soldered to the board. Further, because the GammaSafe system is contact-based, as opposed to wireless, there is no ambiguity as to which memory device is being read--a frequent concern with RFID and other wireless systems," the company notes. In addition, the token can be applied to disposable attachments such as tubing and filters, for example, that plug into a base controller, even if the attachments do not contain active electronics.

As an optional feature, the memory token can be equipped with a sterilization indicator that changes color to provide a quick visual cue that a product has been sterilized. It can also come with an optional integrated tether for easy attachment to disposable devices.

"Our rugged SlimLine memory tokens have been used with disposable medical devices for more than 15 years," says Paul Plitzuweit, business development engineer for the GammaSafe product line. "Our traditional SlimLine tokens survive both EtO and autoclave sterilization methods. Now, with the addition of the GammaSafe line, we have a portable memory solution for OEMs of medical disposables no matter which sterilization method they use--EtO, autoclave, or gamma."