情况

Iris Diagnostics(纽约证券交易所Beckman Coulter分部:BEC)是加州一家医疗诊断制造商，该公司希望将一个基于rfid的认证系统集成到其iQ200自动尿液分析系统中，为了确保只有经过认证的试剂配方薄片，Iris生产的产品与机器一起使用。

该公司决定开发一个认证系统，以防止假冒试剂。如果在虹膜尿液分析系统中引入假试剂，可能会给该公司带来严重的安全和财务问题。如果使用假试剂，虹膜诊断学将无法验证尿液分析测试结果的有效性。这可能对患者构成严重威胁，因为它可能导致基于错误测试结果的误诊。因此，要求患者再次去医院，重新进行检查。为了避免假冒试剂对公司造成潜在的财务和声誉影响，Iris主动联系JADAK，以确定RFID解决方案。

结果

Iris Diagnostics的iQ200自动尿液分析系统通过塑料管将测量到的试剂薄片吸入主分析机。在机器旁边的车厢里放着一堆薄板瓶。当所有的薄片都从一个瓶子里抽出来时，技术人员就把它取出来，把管子装进一个新的瓶子里。

该公司希望在应用程序中使用高频RFID标签，因为它希望读取范围很短，以确保只读取离阅读器最近的瓶子上的标签。

Iris与JADAK合作，将Skyetek M2高频RFID读取模块集成到尿液分析系统中。JADAK还向Iris提出了RFID标签的建议。然后Iris、JADAK和启用rfid标签的供应商以及打印机编码器合作，确定了一种解决方案，该解决方案利用在每瓶薄片上放置启用rfid标签。

打印机编码器使用Skyetek M2阅读器用嵌入式ICODE SLI应答器对标签进行编码。读取器通过ISO 13485认证，应答器符合ISO 15693标准，适用于项目级跟踪和安全应用。

JADAK解决方案实现了一种独特的安全/密钥交换算法，以防止接口的向后工程。该解决方案还允许远程字段升级加密密钥和算法，以防它们受到危害。

Skyetek M2询问器读取编码到每个瓶子标签内镶嵌物的数据，在Iris制造工厂打印标签时检查编码到标签上的数字签名。读者可以使用主密钥解锁此签名，使用基于键控散列消息身份验证代码(HMAC)的加密技术。如果没有看到数字签名，询问器将禁止系统将试剂从瓶子中取出，并向机器的技术人员发出警报，提高了试剂是假冒的可能性。

Iris和JADAK合作为运行在JADAK reader软件上的认证系统编写软件。该系统还运行尿检阅读器和打印机编码器中使用的其他程序，因为它们共享一个加密密钥基础设施。

RFID FOR MEDICAL DEVICES

Iris Diagnostics Uses RFID for Authentication

Situation

Iris Diagnostics (a division of Beckman Coulter, NYSE: BEC), a California manufacturer of medical diagnostic devices, wanted to integrate an RFID-based authentica?tion system into its iQ200 Automated Urinalysis System to ensure that only the certified reagent formula Lamina, which Iris produces, is used with the machine.

The company decided to develop an authentication sys?tem to protect against counterfeit reagents. If a counterfeit reagent were introduced to the Iris urinalysis system, it could raise serious safety and financial concerns for the company. If counterfeit reagents were used, Iris Diagnostics would not be able to verify the validity of the urinalysis test results. This could pose a serious threat to patients, since it could lead to a misdiagno?sis based on faulty test results. Thus requiring patients to revisit hospitals and have tests rerun. To avoid the potential financial and reputational impact of counterfeit reagents to the company, Iris proactively reached out to JADAK to identify a RFID solution.

Results

Iris Diagnostics’ iQ200 Automated Urinalysis System draws a measured amount of the reagent Lamina into the main analysis machine through plastic tubing. A stock of Lamina bottles is held in a carriage next to the machine. When all of the Lamina is drawn out of a bottle, a technician removes it and places the tube in a new bottle.

The company wanted to use high frequency RFID tags for the appli?cation because it wanted a short read range to ensure that only the tag on the bottle closest to the reader was read.

Iris worked with JADAK to integrate the Skyetek M2 high-frequency RFID reader module into the urinalysis system. JADAK also made RFID tag recommendations to Iris. Then Iris, JADAK, and the provid?er of the RFID-enabled labels and printer-encoders collaborated to identify a solution that utilized placement of RFID-enabled labels on each bottle of Lamina.

The printer-encoder used the Skyetek M2 reader to encode labels with embedded ICODE SLI transponders. The reader was ISO 13485 certified, and the transponders were compliant with the ISO 15693 standard and designed for item-level tracking and security applications.

The JADAK solution implemented a unique security/key exchange algorithm to prevent backwards engineering of the interface. The solution also allowed for remote field upgrading of the cryptographic keys and algorithms, in the event they were ever compromised.

The Skyetek M2 interrogator reads the data encoded to the inlay inside each bottle’s label, checking for a digital signature encoded to the label when it was printed at the Iris manufacturing facility. The reader can unlock this signature using a master key, with cryptography based on a keyed hash-message authentication code, or HMAC. If it doesn’t see the digital signature, the interrogator will prohibit the system from drawing the reagent out of the bottle and send an alert to the machine’s technician, raising the possibility that the reagent is counterfeit.

Iris and JADAK partnered to write the software for the authentication system, which runs on JADAK’s reader software. The system also runs the urinalysis reader and others used in the printer-encoders, since they share a cryptographic key infrastructure.

　　ThingMagic与JADAK的RFID技术结合，将产生更为强大助力，推动RFID行业的发展。

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