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1. POINT OF CARE ENGINEERING AND TECHNOLOGY Blake W. Podaima,1, 2, 3 and Robert D. McLeod 2, 3 1. Virtuistix Inc., Winnipeg, Manitoba, Canada, R2G 0P5 2. TRLabs, 100-135 Innovation Dr., Winnipeg, Manitoba, Canada, R3T 6A8 3. Department of Electrical and Computer Engineering, University of Manitoba, R3T 2N2 E-mail: Bpodaima@virtuistix.ca; McLeod@ee.umanitoba.ca ABSTRACT implement “system changes” to reduce their occurrence and minimize their impact on patients. This Currently there is a heightened demand for perspective, which strives to catch human errors improvements in patient point of care (POC). Errors before they occur, or block them from causing harm, is and other incidents are inevitable in complex systems, argued to be more effective and realizable than and hence, the goal of this work is in mitigating attempting to create an error free or flawless system . medical errors through the use of technology and In this regard, technology engineering can be used in protocols via systems engineering. Over the past conjunction with HFE to improve the accuracy and several years there has been increased emphasis on efficiency of protocols and practice with a similar the reporting and analysis of POC errors. Some of the objective of reducing errors , . Systems Engineering more prominent errors are erroneous patient implies the increased use of tools such as those for identification, drug administration, and medication failure mode and effects analysis and root cause administration recording. This paper addresses analysis (FMEA and RCA) . specific smart Radio Frequency Identification (RFID) There are a number of mobile devices and enabled technology for improving patient POC. wireless communication technologies that will play a Keywords: RFID enabled devices, patient point of major role in modernizing medical and health systems care, adverse drug events, and medical compliance . Security is also an issue that needs to be addressed thoroughly and implemented properly to be effective 1. INTRODUCTION as Clinical Grade Networks are developed and It is estimated that approximately 36% of adverse deployed . drug events occur at the patient POC while only 2% 2. SMART RFID IN HEALTHCARE are intercepted . In addition to POC errors, there are other sources of errors including prescription, “Smart” RFID (devices) is another technology that transcription, and dispensing . Although this paper has the potential to improve patient safety and quality addresses specific technology for improving POC, it is of care. Promising technologies and methodologies for recognized that any effective system will need to be improving patient POC and reducing errors include integrated within the context of a complete patient care those based on barcodes and RFID , . These management system. technologies are not new and have been in The benefits to modernization of health commercial use for well over twenty years. They are management through information technology are often however becoming more main-stream as both easily seen only once adopted . An electronic records supporting electronic technology improves and system (ERS) introduces consistency into the process connectivity protocols become standardized . One of and with sufficient standards decreases errors in the problems with early adoption of both RFID and information gathering . Practitioners like the fact that if barcodes is that they are inherently submissive, they write a prescription ─ the prescription is allowing for identification with little or no support for automatically recorded. Furthermore, their PDA interactivity and automation. software can refer to the system’s database and list Conventional applications of RFID technology in any potential interactions between the prescribed healthcare are primarily those based upon medication and other medications that the patient may identification. These enable systems to be built around already be taking. inventory tracking and control. Extensions include Advancements in information and communication pharmaceutical supply chain inventory and tracking for technology (ICT) and their adoption in healthcare medical reconciliation. Tied into a hospital necessitate a “system’s approach.” System’s management system, they have considerable potential approaches include human factors engineering (HFE) to reduce adverse drug events at the patient POC. as well as technology engineering . HFE attempts to This is accomplished through corroboration of the identify situations that give rise to human errors and patient ID with the drug prescribed by the physician. CMBEC29 – Vancouver, BC; June 1-3, © 2006 1
Preparation POC system , . The designs discussed herein offer seamless integration with purposeful function, and an Overseeing Pharmacy Central Medical evolutionary path to improved overall medical Physician Processing compliance. Unit RFID (RFID) RFID Reader Reader Future RFID devices will extend beyond traditional Disposal + Sterilization uses — even the “smart” applications discussed here. Such RFID devices will incorporate various sensors and will be widely available as implantable devices . Care Provider Central Medical 3. RFID METHODOLOGY Hospital Supply Unit Mobile PDA RFID Information RFID technology utilization is gaining momentum Reader System RFID Reader and is being tailored to a number of applications. Although there are a variety of RFID tags and Monitoring systems, those best suited to healthcare have a Smart Medical Device number of differentiating characteristics. More Medical Patient specifically, an RFID transponder or tag in a medical Content/ RFID + application will require data capacities that range from Apparatus (RFID) Interface a few bytes to several kilobytes. In contrast, there are (RFID) 1-bit transponders which provide information only on their presence. Although inexpensive, and likely to be Figure 1: Medical Compliance Platform — POC widely applied in commercial environments, they are Interaction Components less likely to find much utility in a health setting. RFID transponders that allow for sufficient data This paper presents an overview of RFID require an integrated circuit and have more stringent technology within a medical context and introduces power requirements. This power can be derived novel designs using enhanced RFID devices (system through an interrogating electromagnetic field of an and methodology) for integration within evolving and RFID Reader, or supplied by an on-board battery. legacy POC systems. Figure 1 illustrates a conceptual Typically, an RFID transponder will interact with a overview of the point of care interacting components reader in one of two ways: either simultaneously within the medical reconciliation and compliance interacting (with a reader) over a modulated channel, platform. A smart medical device and its system of or in a sequential manner, where the reader switches deployment include methods of identification and off the interrogating field allowing for the transponder control for medical compliance. Identification is on the tag to respond during a quiescent period. accomplished with the aid of RFID, while control is In addition to requiring data storage, a health enabled through a mechanism that can be activated to related RFID system will also require security beyond prevent improper or unauthorized access. that found in many commercial applications. Security Smart RFID devices attempt to facilitate error-free protocols and their processing imply an additional dispensing and administration (of medication and/or constraint upon the energy requirements of the RFID medical supplies), and other clinical practices, to device itself. Many medical RFID devices will also be reduce or prevent adverse medical events, near required to interact with a sensor, activate a solenoid misses, or sentinel events. They incorporate an RFID or motor (or other electromechanical device) thereby enabled electromechanical lock or latch controlling increasing the power requirements still further. access and include smart medical containers, smart Medical RFID devices could also be pumps, smart clamps, smart valves, smart syringes programmable and reusable. The reuse implies an and pipettes, and smart bandages†. The RFID tags on additional constraint that may require the device to be these devices can be either active or passive, and the subject to temperature, chemical, and/or electronic control and communication can be derived from the processes, not otherwise needed in less sterile interaction of an RFID reader and tag in conjunction environments. As with other medical devices, Clinical with the associated electronics and overseeing Grade Smart Medical RFID devices will be required to medical information management system. meet the stringent standards of various governing RFID enabled devices come with an associated bodies and institutions of the healthcare industry. overhead, but are not superfluous in deployment, and Clinical grade RFID devices will also be required to can be used within the framework of an engineered meet rigorous EMI and EMC (electromagnetic interference and compatibility) guidelines . † Smart Devices under development at Virtuistix Inc. — The frequency of operation for RFID devices fall http://www.virtuistix.ca into several broad ranges reflecting that of the reader. CMBEC29 – Vancouver, BC; June 1-3, © 2006 2
These range from RF (MHz) to microwave (GHz). The approach can therefore be particularly attractive in physical operating proximity of devices is also an many instances since it may well capitalize on a important issue in a medical setting. It is likely that concomitant reduction in overhead, ease of fabrication, close coupling (<1cm) would contravene the existing and increased mechanical reliability. On the other protocol of a POC practitioner. Remote coupling hand, offering an automatic RFID triggered valve (0-1m) would allow for the functionality of the RFID pinch-off regulating mechanism offers the potential for device without compromising the protocol of the ease of field deployment and robustness. This practitioner who may be wearing the reader/ implementation, as shown in Figure 2, incorporates an transceiver on his or her wrist or belt. electromechanical solenoid (latch) and servo (motor) — acting upon a shaft fixed to a plunger in the form of 4. SMART RFID DEPLOYMENT a gate or cylinder in a sealed housing or chamber. For the purpose of discussion here, we will Port 1 introduce an RFID smart device and its method of Conduit Top deployment. The following “Smart Valve” extends the Electronics RFID View basic valve principle however it offers much greater Port 1 Electromechanical capability and purpose by including an RFID tagging Cylinder Valve device and microcomputer interface with bi-directional [Rotary] communication. The capability therein incorporates a Override Port 3 controller that authorizes the operation of a manual or Key Port 2 (into the Port 2 Port 3 page) not shown automatic mechanical valve with lockable-latch and pinch-off regulating mechanism — thereby modulating Power Lock/Unlock (Valve shown with flow through a tube. The smart valve incorporates an Mechanism Supply th ro u g h w a y o p e n ) RFID tag and accompanying interface (in situ and/or external) in a method and system to control the Figure 2: Smart Stop-cock Valve (multiport) mechanical operation of a valve: i) manually enabling or precluding an instance of user operation of the There are several in-field embodiments of design valve regulating mechanism; or ii), automatically pertaining to the definitive actuation or modulation of a enabling or precluding an instance of power assisted smart valve pinch regulating mechanism (plunger): in (eg., electromechanical) operation of the valve one mechanical instance of operation, the smart valve regulating mechanism. Hence, in addition to facilitating would simply provide a visual or audio status indicator flow by activating a valve regulating mechanism approving/disapproving the manual operation of the (opening, closing, or modulating), this smart valve valve regulating mechanism; in another mechanical assembly incorporates a lockable-latch which will instance of operation, the smart valve could physically prevent unauthorized, erroneous, or inadvertent unlock a latch mechanism that would permit the operation. In the field, information will be available as manual operation of the valve regulating mechanism; to the status of operation (metrics, performance), finally, in an electromechanical instance of operation, maintenance, and serviceability (replacement). the smart valve could physically unlock a latch The RFID smart valve can be identified with an mechanism and provide the actual electromotive force RFID reader (in the manifestation of a mobile or that would automatically modulate (drive) the valve stationary communicating electronic computing device) regulating mechanism. and used to “interrogate” valve status. The Used in a medical setting, an RFID smart valve communication and electromechanical control can be can be deployed to safely gate the release of a fluid as derived from the interaction of the RFID tag (and would be the case for Intravenous (IV) or Infusion associated electronics) and the RFID reader — and, in Therapy. Furthermore, the RFID smart valve can be some instances, an overseeing information used in conjunction with other RFID devices or tags as management system. Upon identification, part of an IV administration set. This will, in effect, corroboration, and authentication, the interrogating facilitate the means for medical compliance between RFID reader could be used to activate or preclude the patient RFID, IV RFID, and/or RFID devices used to latch and/or pinch-off regulating mechanism. sense the rate of drug delivery . By incorporating In effect, the smart valve assembly, method and indicators (sensors) on the devices, an RFID reader system, is used for both identification and as a means can pole the set and determine the operational efficacy of control for the enabling or preclusion of flow through of the system. In another instance of deployment, the a passageway. The manual user operated valve pinch- smart valve can be used in the handling, preparation, off regulation mechanism inherently offers a high or management, of various pharmaceuticals. Where degree of application flexibility and simplicity in design regulation and safety standards necessitate proper without necessarily compromising functionality. This CMBEC29 – Vancouver, BC; June 1-3, © 2006 3
handling and mixing protocols, as such, the smart  D. W. Bates, “Using information technology to reduce valve could be used in a myriad of medical settings. rates of medication errors in hospitals,” BMJ, vol. 320, pp. In general, smart devices can also include 788-791, 2000. auxiliary sensor information and memory that can be  D. W. Bates, D. J. Cullen, N. Laird, et al., “Incidence of adverse drug events and potential adverse drug events,” communicated to the RFID reader or vise versa, and if Implications for prevention. ADE Prevention Study Group, necessary, up through the information management JAMA. 1995; vol. 274, no. 1, pp. 29-34, 1995. hierarchy for re-programming, time stamping, data  T. Bell, “Medical records: from clipboard to point-and- collection, and/or (re)-evaluation. This sensor based click,” in IEEE: The Institute, vol. 29, no. 4, Dec. 2005. acquisition can include information such as  V. Berry, L. Smyrski, and L. A. Thompson, “From inquest temperature, pressure, flow rate, viscosity, humidity, to insight,” Designing an Agenda for Change, Healthcare chemistry, Ph, etc. Quarterly, vol. 8, pp. 115-118, Oct. 2005. The described method and system can be  J. Condurso, and C. Pait, “The value of point-of-care data envisaged to function within a ubiquitous or pervasive for clinical care and IT systems,” Enhancing Clinical Care, http://www.HCTProject.com, pp. 324-327, 2005. computing environment. In this manner, small  M. Dempsey, “Context-sensitive medicine,” A white embedded computers would respond to one’s paper: WP-CSM3/05, Radiance Inc., presence, desires, and needs, without the healthcare http://www.radiance.com, 2005. provider necessarily being solely responsible for all  J. A. DuBois, L. Dunka, T. Allred, et al., Point-of-care active manipulation within one’s environment. A connectivity; approved standard. POCT1-A, NCCL Exec. network of fixed and wireless devices would allow for Off. (CIC): Wayne, PA, USA, Vol. 21, No. 24, 2001. context aware communication , so as to seamlessly  S. S. Ehrmeyer, P. Hausman, and R. Lebo, “Using integrate the healthcare provider’s intentions and even technology to improve patient safety at point of care,” perform tasks automatically. This will rid the healthcare Point of Care Testing Journal, vol. 4, no. 4, pp. 146-149, Dec. 2005. provider of the more mundane and arduous tasks  A. F. Graves, B. Wallace, S. Periyalwar, et al., “Clinical freeing up time necessary to focus on the primary task grade — a foundation for healthcare communications at hand. Their work should be made easier, while their networks,” (reprint) 5th Int. Workshop: Design for Reliable presence is more transparent. Hence, this makes for a Communications Networks (DRCN), Naples, Italy, 2005. less intrusive and invasive practice, while delivering an  G. J. Kost, “Preventing medical errors in point-of-care improved quality of healthcare. testing: security, validation, performance, safeguards, and connectivity,” Arch Pathol Lab Med, vol. 125, pp. 5. CONCLUSION 1307-1315, Oct. 2001. This paper outlines a number of areas where POC  L. Lewis, (Ed.) “Technology and safe medication administration,” AJN, pp. 37-41, March 2005. engineering and technology are brought to bear on the  M.A. Munoz, M. Rodriguez, J. Favela, et al, ”Context- medical community with the overall goal of improving aware mobile communication in hospitals,” IEEE patient safety and quality of care. We ascertain the Computer, vol. 36, pp. 38-46 Sept. 2003. emerging field of RFID technology has the potential to  F. Poillon, (Ed.) To Err is Human: Building a Safer improve medical compliance via human factors Health System. Institute of Medicine, Nat. Acad. Press: protocols and practice at the patient POC. Within a Wash. DC, USA, 1999. ubiquitous or pervasive health computing environment,  A. C. Rao, and A. S. Dighe, “Radiofrequency novel RFID smart devices, in conjunction with wireless identification and point-of-care testing,” Point of Care PDAs, are proposed integrating identification, security, Testing Journal, vol. 3, no. 3, pp. 130-134, Sept. 2004.  RFID in Healthcare: Poised for Growth, Point of view: control, and actuation. Various POC embodiments technology infrastructure & integration, emerging along these lines are currently under development. technology, Bearing-Point Inc., PP. (8), 2006. ACKNOWLEDGEMENTS  A. Roberts, “Point-of-care IT: improving patient care,” Enhancing Clinical Care, http://www.HCTProject.com, pp. We would like to extend our thanks to Wayne 352-354, 2005. Johnston, Dr. David Gregory from the Faculty of  P. E. Ross, “Managing Care through the air,” Aging + Nursing at the University of Manitoba, and (Vasee) T. Technology, IEEE Spectrum, pp. 26-31, Dec. 2004. Vaseeharan of TRLabs-Winnipeg, for their beneficial  R. Traherne, and A. Diston, “Wireless Technologies in health care,” in Medical Device Technology, pp. 35-37, comments and insights. Jan. 2005. REFERENCES  D.Witters, “Medical Devices and EMI: the FDA Perspective”, http://www.fda.gov/cdrh/emc/persp.html  G. R. Baker, P. G. Norton, V. Flintoft, et al., “The  W. A. Zellmer, “Re-engineering the medication-use Canadian adverse events study: the incidence of adverse system,” in Proc. of Am J Health-Syst Pharm, vol. 57, pp. events among hospital patients in Canada,” CMAJ, vol. 537-541, March 2000. 170, no. 11, pp. 1678-1686, May 2004. CMBEC29 – Vancouver, BC; June 1-3, © 2006 4