Medical device designers can protect surgical tool data from the high-energy, disruptive gamma radiation used in sterilization, while also providing security with tools such as secure tool usage management and counterfeit prevention, with the DS28E83 DeepCover® Secure Authenticator from Maxim Integrated Products, Inc.As the industry's first secure authentication solution designed for exposure to gamma sterilization, it enhances patient safety and includes both the Elliptic Curve Digital Signature Algorithm (ECDSA) and cryptographic features based on the Secure Hash Algorithm 256 (SHA-256). The 1-Wire® interface allows for easy integration into existing designs.
Medical device manufacturers commonly sterilize limited-use surgical tools or sensors using a gamma ray or e-beam process. The high radiation exposure used in either process can disrupt and damage the non-volatile memory (NVM) used by electronic medical devices for automatic identification, as well as calibration and manufacturing data. This can compromise medical device data and patient safety, which are critically important to medical device manufacturers.
The DS28E83 secure authenticator integrates a radiation-resistant NVM to prevent data loss during sterilization. With this capability, device designers can implement cost-effective protection against unauthorized reuse and counterfeiting of non-genuine devices. By allowing electronic surgical instruments to undergo gamma ray or electron beam sterilization, the DS28E83 significantly enhances patient safety. Authentication is implemented through the application's efficient elliptic curve public-key cryptography to protect patients against the risks associated with unqualified counterfeit devices or incidental reuse. The IC, which is easy to integrate into a customer's design using Maxim's single-contact, one-wire interface, is applicable to medical surgical tools and sensor applications.
Key Benefits
• Enhanced patient safety: The robust NVM withstands exposure to radiation up to 75 kGy (kiloGray) used in medical gamma and e-beam sterilization.
• Protection against security breaches, overuse, and device counterfeiting:
o Secure asymmetric ECDSA P256 authentication
o Secure symmetric key authentication of SHA-256 hash-based authentication code (HMAC)
o National Institute of Standards and Technology (NIST SP) Special Publication 800-90B random true number generator for ECDSA signatures and HMAC operations
o A general-purpose input/output (GPIO) pin with selectable authentication control provides the option of a secure switch
o 10 kb of secure memory for keys, certificates, and user data
o Factory-programmed, readable unique serial number for tool identification and cryptographic operations.
• Easy integration: The single-contact, 1-wire interface allows for one connection for data, signaling, and power, while reducing the number of components in tool designs. surgical instruments with limited connections.
