Guidelines for the Use of RFID Technology in Transfusion Medicine

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14 Guideline6.1 General Risk AssessmentThe following risk analysis focuses on generic use of theRFID tags rather than risks for specific application use(Table 5, 6). It not intended to be a full-risk analysis, buthighlights potential risks and possible ways to mitigate orovercome them.Table 5 Definition of potential risksTermPotentialHazardConcernPossible ControlsDefinitionRepresents potential risks. The list ofpotential hazards is meant to beillustrative and not meant to be acomprehensive listUndesirable outcomes resulting from thehazardList of possible controls to mitigate the risk.These ideas are examples; there are anumber of different ways to mitigate risk.Risk can be mitigated with the tag or thesoftware that processes the dataPrivacy and security risks are also concerns with RFID aswell as with any other wireless technology. Those risksmust be addressed in transfusion medicine by safeguardingsensitive information and protecting individual privacy. Inaddition to using the special AFI for blood and adhering tothe security standards already implicit in the ISBT 128 dataset, the following must be considered:• Firewalls that separate and protect RFID databases;• Encryption of radio frequency signals when feasible;• Authentication of approved users of RFID systems;• Shielding RFID tags or tag reading areas with metalscreens or films to prevent unauthorized access;• Audit procedures, logging, and time stamping to help indetecting security breaches;• Tag disposal and recycling procedures that permanentlydisable or destroy sensitive data.6.2 Risk of RFID on BiologicsIn 2007 the US Food and Drug Administration (FDA)requested that the RFID consortium headed by BloodCenterof Wisconsin (BCW) subject blood products toradio energy under a worst-case scenario to determinewhether there was any adverse in vitro impact. As it is notpossible to test every different RFID configuration, theFDA guidance was to do worst case ‘‘limit testing’’ withthe assumption that as long as normal RFID operationsnever approached the tested limits, any impact of theRF reader field exposure on blood safety and efficacycould also be assumed to be acceptable. Limit testingincluded testing for product heating and key biochemicalchange outcomes from exposure to an intense RF magneticfield for far longer (23–25 consecutive hours) than wouldbe expected during normal blood banking operations(21 non-consecutive minutes maximum) and at magneticfield strengths (5 A ⁄ m = 134 dB lA ⁄ m) much greater thanTable 6 Risk analysis for implementation of Radio Frequency IDentification (RFID) technology in general and in health care environments [20–22]Potential Hazard Concern Possible ControlsTag data lost Incomplete information Barcodes on the blood bag and ⁄ or Unique Identification(UID) on the RFID tag allow restoration of informationfrom the application and creation of a new tagData transmission errorbetween tag and readerInaccurate dataTag communication protocols use Cyclic Redundancy Check16 (CRC-16) to detect transmission errorsData integrity on the tag Inaccurate data Using CRC-16 protocol to verify proper encoding of theRFID tagData verification against barcode and ISBT 128 standardUnauthorized data change Inaccurate data Password protection of the tagEncrypt data on the tagUsing CRC-16 protocol to verify proper encoding of theRFID tagUse write lock to protect dataUnwanted dataViruses, Trojans, Wormson the serverChecking the data with the same protection policy as otherexternal devices (CD, Disk, USB flash memory stick)Antivirus software and data firewallsElectromagnetic interference Medical device malfunction Site specific testing prior to deployment as required inexisting guidelines on the deployment of wirelesscommunication systems in health care environmentsIf interference occurs increase distance between equipmentand RFID device or use Barcodes.Ó 2010 The Author(s)Journal compilation Ó 2010 International Society of Blood Transfusion, Vox Sanguinis (2010) 98 (Suppl. 2), 1–24
Guideline 15the allowed (126 lA ⁄ m = 42 dBlA ⁄ m) from an FCC-compliantreader.The RFID Consortium conducted testing on red cell andplatelet products initially, with similar testing for plasmaproducts planned for the future. The testing followed twoFDA-approved protocols to assess:• temperature increase because of RF exposure and• cellular and ⁄ or protein degradation resulting from RFexposure.Acceptance criteria established for the testing included:• For red blood cells, the mean hemolysis of both the testand control groups would be £1% following 23–25 hours of very high RF exposure (5 A ⁄ m 2 ).• For platelets, the mean pH of both the test and controlgroups should be ‡6.2 following 23–25 hours of RFexposure.• The maximum temperature increase of the TESTunit relative to the CONTROL should not exceed 1.5°C atany period within 23–25 hours of continuous RFexposure.Cellular/Protein Testing ResultsFor red blood cells, the mean hemolysis of both the TESTand CONTROL groups was £1% following 23–25 hours of(very high) RF exposure (5 A ⁄ m). For platelets, the meanpH of both the TEST and CONTROL groups was ‡6.2following 23–25 hours of (very high) RF exposure(5 A ⁄ m).Temperature Testing ResultsThe maximum temperature increase of the TEST unitrelative to the CONTROL because of Joule heating did notexceed 1.5°C at any period within 23–25 hours of continuousRF exposure.Test ConclusionThe aforementioned study concluded that exposure tointense RF energy for extended periods has no adverseeffect on in-vitro cellular integrity of red cells or pooledplatelets, nor does it adversely impact the temperature ofthose products. The scope of the study was limited and didnot specifically address impact on aged products nearingexpiration. The FDA took no exception to these conclusionsand granted permission to proceed with an operational pilotusing transfusible blood products.Table 7 List of supply chain processes to be researchedBlood bank oriented processes7.1 Four Phase ApproachHospital oriented processesBlood DonationPatient AdmissionDonation TransportationTransfusion OrderingDonation ReceivingSample CollectionDonation TestingPatient Sample TestingProduct Manufacturing ⁄ Put Away Cross matchingInventory ControlIssue and ReleaseHospital Order Processing TransfusionOrder Allocation ⁄ Shipping Product OrderingHospital ReturnsRetest Product ABO ⁄ RhBlood DisposalAssign Product to Available InventoryReturn Product to Blood BankProduct DisposalReturn Product to Blood CenterInventory ManagementA four-phase approach for evaluation, development, anddeployment of RFID systems is suggested as depicted inFig. 11. This four-phase approach is based on research ofbest practices for systems design and implementation, andhas been successfully applied in the context of RFID applicationsin several industries, including retail, manufacturing,and transportation.7.1.1 Phase I–The Assess PhaseThe primary objective of Phase I is to assess the technicalfeasibility and impact of using RFID for automatic identificationand tracking of blood products throughout the transfusionmedicine supply chain. To achieve this objective, theproject team should conduct research from both a workflow⁄ process-oriented perspective as well as a technologicalsystems perspective.Method for Workflow ⁄ Process-oriented AnalysisBlood Center and transfusion service processes should beanalysed primarily from the point of view of RFID’s capabilitiesfor automatic identification, data capture, andtracking of blood products and how the use of this technologycan enable redesigned processes that have superiorsafety, quality and productivity.7. Implementation MethodologyThis guideline recommends the Four Phase approach forimplementing RFID solutions in blood banks. Further, achange control process including validation and qualificationis needed for a safe implementation in health careenvironments [7].Phase I Phase II Phase III Phase IVFig. 11 Four-stage methodology for Radio Frequency IDentification(RFID) system design and implementation. Source: University of WisconsinRFID Lab.Ó 2010 The Author(s)Journal compilation Ó 2010 International Society of Blood Transfusion, Vox Sanguinis (2010) 98 (Suppl. 2), 1–24
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