RFID醫療試劑防偽管理

情況

Iris Diagnostics(紐約證券交易所Beckman Coulter分部:BEC)是加州一家醫療診斷制造商，該公司希望將一個基于rfid的認證系統集成到其iQ200自動尿液分析系統中，為了確保只有經過認證的試劑配方薄片，Iris生產的產品與機器一起使用。

該公司決定開發一個認證系統，以防止假冒試劑。如果在虹膜尿液分析系統中引入假試劑，可能會給該公司帶來嚴重的安全和財務問題。如果使用假試劑，虹膜診斷學將無法驗證尿液分析測試結果的有效性。這可能對患者構成嚴重威脅，因為它可能導致基于錯誤測試結果的誤診。因此，要求患者再次去醫院，重新進行檢查。為了避免假冒試劑對公司造成潛在的財務和聲譽影響，Iris主動聯系JADAK，以確定RFID解決方案。

結果

Iris Diagnostics的iQ200自動尿液分析系統通過塑料管將測量到的試劑薄片吸入主分析機。在機器旁邊的車廂里放著一堆薄板瓶。當所有的薄片都從一個瓶子里抽出來時，技術人員就把它取出來，把管子裝進一個新的瓶子里。

該公司希望在應用程序中使用高頻RFID標簽，因為它希望讀取范圍很短，以確保只讀取離閱讀器最近的瓶子上的標簽。

Iris與JADAK合作，將Skyetek M2高頻RFID讀取模塊集成到尿液分析系統中。JADAK還向Iris提出了RFID標簽的建議。然后Iris、JADAK和啟用rfid標簽的供應商以及打印機編碼器合作，確定了一種解決方案，該解決方案利用在每瓶薄片上放置啟用rfid標簽。

打印機編碼器使用Skyetek M2閱讀器用嵌入式ICODE SLI應答器對標簽進行編碼。讀取器通過ISO 13485認證，應答器符合ISO 15693標準，適用于項目級跟蹤和安全應用。

JADAK解決方案實現了一種獨特的安全/密鑰交換算法，以防止接口的向后工程。該解決方案還允許遠程字段升級加密密鑰和算法，以防它們受到危害。

Skyetek M2詢問器讀取編碼到每個瓶子標簽內鑲嵌物的數據，在Iris制造工廠打印標簽時檢查編碼到標簽上的數字簽名。讀者可以使用主密鑰解鎖此簽名，使用基于鍵控散列消息身份驗證代碼(HMAC)的加密技術。如果沒有看到數字簽名，詢問器將禁止系統將試劑從瓶子中取出，并向機器的技術人員發出警報，提高了試劑是假冒的可能性。

Iris和JADAK合作為運行在JADAK reader軟件上的認證系統編寫軟件。該系統還運行尿檢閱讀器和打印機編碼器中使用的其他程序，因為它們共享一個加密密鑰基礎設施。

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.

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