Enhanced patient safety with form factors that are easily applied to surgical instruments and sensor products.

Maxim Integrated Korea has launched the DS28E83 DeepCover Secure Authenticator, the industry's first secure authentication solution designed for use in gamma-irradiation sterilization environments. Medical device designers can leverage the DS28E83 DeepCover Secure Authenticator to protect surgical instruments from memory corruption caused by high-energy gamma rays used for sterilization, while also providing secure instrument management and anti-counterfeiting capabilities.

Medical device manufacturers typically sterilize surgical instruments using gamma rays or electron beams. The high doses of radiation generated during this process can interfere with or damage the automatic identification, data correction, and non-volatile memory (NVM) used in electronic medical devices. This poses a threat to medical device data, which is crucial for medical device manufacturers, and to patient safety.

The DS28E83 security authentication device features a radiation-resistant NVM to prevent data loss during the sterilization process. This robust NVM can withstand up to 75 kGy (kiloGray) of radiation, which is used in gamma and electron beam medical sterilization. This allows designers to prevent unauthorized reuse of electronic surgical instruments and counterfeiting in the parts market. Additionally, the DS28E83 can sterilize electronic surgical tools with gamma rays or electron beams, significantly improving patient safety.

To protect patients from risks associated with counterfeit or unintended reuse of unauthorized devices, the DS28E83 secure authenticator provides authentication capabilities using industry-standard and ECDSA key encryption.

▲ECDSA (Elliptic Curve Digital Signature Algorithm) asymmetric security authentication
▲SHA-256 HMAC (Hash-based Message Authentication Code) symmetric key security authentication
▲NIST (National Institute of Standards and Technology) Special Publication (SP) 800-90B standard random number generator for ECDSA signature and HMAC operations
▲One general-purpose input/output (GPIO) pin with optional authentication control function
▲10kb of secure memory for keys, certificates, and user data
▲Prevents device counterfeiting, overuse, and security breaches by providing a unique read-only serial number for tool identification and encryption operations.

The DS28E83 security authentication device has a 1-wire interface that connects data, signaling, and power all at once, reducing the number of components required for surgical tool design.
“In the past, manufacturers would have to use gamma-ray technology,” said Nathan Sharp, business manager for the Micro, Security, and Software Business Unit at Maxim Integrated.“We could not incorporate secure and non-volatile memory into a product that undergoes an electron beam sterilization process,” he said. “The DS28E83 provides two important functions: protecting patients from infection and sterilizing surgical instruments to the highest standards.

“The certification feature helps medical professionals verify the quality of the equipment they use and ensure the highest level of precision for their devices,” he said.

For more information about the Maxim DS28E83 DeepCover Secure Authenticator, including high-resolution images, block diagrams, high-resolution images, and the DS28E83EVKIT evaluation kit, please visit the Maxim website.