A couple of months ago, I wrote a piece titled “RFID Technology and HIV Treatment: Is This Controversial? The premise of this piece was to explain the current use of RFID technology and pharmaceuticals; and the subsequent legal implications of this technology, as it relates to The Compliance Guide (CPG) published by the Food and Drug Administration (FDA). As health care providers attempt to increase their relative market share and weed out competition, RFID technology and bar coding have been hot topics as of late.
The Compliance Guide
In 2004, the FDA conducted a number of feasibility studies that focused on regulatory requirements including electronic records, labeling, product quality and applications to pharmaceutical manufacturers, repackagers and relabelers. The Compliance Policy Guide (CPG) which was developed as a result of several brain storming sessions with industry leaders. This Compliance Policy Guide (CPG) describes how the FDA intended to exercise their enforcement discretion regarding certain regulatory requirements that might otherwise be applicable to such studies. The goal of this CPG was to facilitate the performance of RFID studies and allow industry to gain experience with the use of RFID (Jacquescoley, 2006).
The most prevalent issues that surround the utilization of this technology are privacy and data collection methodologies (Heinrich, 2006). Moreover, while considering RFID technology and bar coding should be applauded: the complexity of health care operations have a tendency to be overlooked during implementation of such technical resources. For example, in Kelly Scheurenberg’s piece on “Bar Codes vs. RFID Technology” there was particular focus on a study conducted at Georgetown University Hospital Center’s Tranfusion Medicine. Gerald Sandler, Director of Transfusion Medicine impression favored RFID over Bar Coding. This analysis considered the application of “passive” RFID more suitable, due to the intergration of the other Information Technology (IT) concerns (patient tracking, medical administration, and validation).
There is a strking differnce between the two technologies. While bar coding is comprised of linear and two-dimensional. Linear codes store small bit of data in the widths and spacings of parallel lines (Schuerenberg, 2006). Two dimensional bar codes can contain several lines of text within a single image. What this means to the practioner, specifically, the transfusion nurse: Is how the scanning device is actually utilized. Already, there is complexity within this process. Depending on which type of coding is to scanned (linear or two-dimensional), the scanner may not read all the data (linear). There is also cost considerations. The average hands-free scanner can range from $59.00 to $225.00. Respective IT deparments must also do their share of assuring that the devices comply with HIPPA and hospital standards.
Active RFID Technology require radio frequency antennas installed on walls and ceilings. The RFID tags also contain batteries that send information to radio frequency readers in the installed antennas comapred with the “passive” technology which must utilized with a scanner. Once again, the cost issue surfaces. Hospital IT departments across the country have time, budget, and functional contraints. Furthermore, the XR400 RFID Reader (Symbol Technologies) average at $750.00 per reader and ciruclar patch antennas with 860-960 Mhz can range from $350.00 to $1500.00.
The Case Hospital Supply Chain Efficiency vs. Patient Care
RFID is making headlines in the business world as the “next frontier” of supply chain efficiency and hospitals across the country are beginning to take notice on how to effectively manage their assets. Due to the complexity of the health care infrastructure, HIPAA guidelines and delivery of care; this is a case against RFID technology and patient care…but I would advocate for hospital supply chain. It is also my opinion that RFID technology has not yet matured, to serve as an effecitive conduit in patient care. Even though, fewer errors are made with handheld scanners, the issues around patient privacy,security and data collection and mining are paramount; and should be the driving focal point in CIO’s offices across the country.
Consequently, as more hospitals begin to entertain the utilization of score cards which measure attributes from patient safety to medication errors…on a public medium, it is important that CIO’s, CEO’s and Medical Directors understand what is involved in the data storage, collection and mining process. If RFID technology is the catalyst of capturing patient data. The rationale is to allow RFID technology to natuarally mature with the complexity of health care delivery.
Food and Drug Administration. (2004).Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs.Guidance for FDA Staff and Industry.Compliance Policy Guides
Sec. 400.210.Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs
Retrieved June, 21 2006.
Jacquescoley, E. [Online]. RFID Technology and HIV Treatment: Is This Controversial? Retrieved from http://www.scienceblog.com/cms/rfid-technology-hiv-treatment-is-this-controversial-10857.html on December 11, 2006.
SAP. [Online]. Dialogue on RFID Privacy and Security. Retrieved from http://www.sap.com/community/pub/campaign/2006_01_innovation/index_rfid.epx?campaigncode=CRM-GM05-DIR-ONLQUAL-RFI&source on December 11, 2006.
Schuerenberg, S. (2006). Bar Codes vs. RFID: A Battle Just Beginning. Health Data Managment, 14,(10):33-42.