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KSR Publishing, Inc.
Copyright © 2008

People, Places, Processes & Products that Influence the Supply Chain

INSIDE THE CURRENT ISSUE

April 2008

Products & Services

New Technology

Implantable medical devices may expose patients to security, privacy risks

Some medical devices such as implantable cardiac defibrillators and pacemakers are now equipped with wireless technology, allowing for remote device checks and freeing patients from repeated doctor visits. But this convenience may come with unanticipated risks. A team of researchers from three leading universities has demonstrated that patients’ private medical information could be extracted and their devices reprogrammed without the patients’ authorization or knowledge.

The study was led by two computer scientists, Tadayoshi Kohno of the University of Washington and Kevin E. Fu of the University of Massachusetts Amherst, and cardiologist Dr. William H. Maisel of the Beth Israel Deaconess Medical Center and Harvard Medical School.

Dr. Maisel, director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Boston, notes, "One of the purposes of this research is to encourage the medical device industry to think more carefully about the security and privacy of patient information, particularly as wireless communication becomes more common. Fortunately, there are some safeguards already in place, but device manufacturers can do better."

The team expects this issue to take on greater importance as implantable cardiac defibrillators operate wirelessly at greater distances. These devices typically receive short-range wireless signals over several feet, but new technologies are expanding that reach even farther, creating the potential for information to be intercepted en route.

The researchers’ experiments used an implantable cardiac defibrillator. The model used in the researchers’ experiment contained computers and radios that allow health-care practitioners to diagnose patients, read and write private medical information, and adjust the device’s therapy settings wirelessly.

The research team used an inexpensive software radio to intercept and capture signals sent from the implantable device. They were able to obtain detailed information about a hypothetical patient, including name, diagnosis, date of birth and medical ID number. Researchers could determine the make and model of the device and access real-time electrocardiogram results as well as data on the hypothetical patient’s heart rate and cardiac activity.

The team then mounted several attacks. Researchers were able to turn off the therapy settings stored in the implantable device, rendering it incapable of responding to dangerous cardiac events. Additional commands were delivered, resulting in the delivery of a shock that could induce ventricular fibrillation, a potentially lethal arrhythmia. Visit www.secure-medicine.org for more information.

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Boxed in or open door?

Modularity among tracking modes possible but not probable right now

by Rick Dana Barlow

As bar coding and radiofrequency identification (RFID), as well as real-time location systems (RTLS), may very well represent the present and potentially future technologies, respectively, for tracking products, healthcare facilities continue to debate the realistic merits of fully upgrading to chips and tags in lieu of stripes.

But when it comes to automated supply management technology – ranging from closed systems (computer-equipped cabinets) to open systems (buttons, keypads and wands on exposed shelving), why do healthcare facilities have to make an either/or choice?

Since their inception nearly two decades ago, closed- and open-system automated point-of-use supply management equipment has been used for PAR level inventory management, data tracking, product theft and waste reduction and patient safety. What fuels the data management engine in these high-tech products is bar coding.

The debut of RFID and RTLS capabilities in healthcare has motivated the manufacturers of closed and open system technology to research and develop chip- and tag-driven products for market once customers start demanding them.

If and when manufacturers offer healthcare facilities the option of investing in bar code-based systems or RFID-based systems how will either be promoted and cost-justified? Will bar code-based systems be earmarked for commodity items while RFID-based systems steered toward higher-cost pharmaceuticals and physician preference items?

Given the modular design of these systems, why can’t modularity be incorporated into the technology itself so that healthcare facilities can custom-design and order their own systems – just like they do computers – equipping the systems with bar code and RFID features together so that one unit could handle multiple functions?

Healthcare Purchasing News Senior Editor Rick Dana Barlow rounded up a small group of knowledgeable experts in the field to gain some insights.

HPN: How soon do you anticipate RFID-/RTLS-based closed and open systems will emerge in the healthcare market, based on your company’s internal market research of anticipated demand?

Jeff Bolton, regional director of operations – west,
PAR Excellence Systems, Cincinnati

Early adopters are already experimenting with these technologies with limited but promising success. Primary areas of focus have been high-value procedural products and business critical equipment management. Primary constraints continue to be high technology costs, marginalized labor savings and inconsistent data standards. The management of these constraints will drive the emergence and adoption of these systems.

Bryan Christianson, vice president, marketing, Mobile Aspects Inc., Pittsburgh, PA

As evidenced by Mobile Aspects’ own technology, as well as other vendors in the marketplace who are actively marketing, selling and installing the systems, I think it’s reasonable to conclude that RFID-based systems have already emerged into the marketplace. However, I think what’s more telling than the emergence of the technology is the level of maturity of the technology and its readiness for broad acceptance and deployment.

From vendor to vendor, I think you see a wide range of maturity. There are vendors who are still completing deployments as part of pilot or proof-of-concept projects, while others have demonstrated the ability to create measurable value and are deploying solutions on a much larger scale. Given healthcare’s pragmatic nature, I’m not sure we’ve seen the adoption levels of the technology move beyond the early adopters, however, based on our experience, we are starting to see the more pragmatic, value-driven hospitals ready to make decisions to acquire and implement the technology.

Joe Pleshek, business development director,
Terso Solutions Inc., Madison, WI

As hospitals continue to develop strategies to improve operational efficiencies and patient safety, the adoption of RFID and RTLS systems will continue to grow. We have already seen early implementations of these technologies with strong business cases delivering value to healthcare organizations.  In addition, medical device and supply manufacturers, as well as, pharmaceutical distributors are leveraging RFID to provide improved product distribution systems to thse same organizations.

Todd Tabel, vice president, enterprise resource planning (ERP) solutions,
McKesson Corp., San Francisco

The demand is here now, and the time-to-market for these products is nearing. Cost is an initial concern. Open systems that occupy little real estate will lead the way, as they allow facilities to reap the benefits of automating the product management workflow, while maximizing valuable space. But the effectiveness of these solutions will depend upon maximizing the reliability of RFID technology, reducing the price of RFID tags and increasing the participation of suppliers and distributors to RFID-enable their products.

Bryant Broder, senior product manager,
Skytron, Grand Rapids, MI

The supply chain for healthcare is the proverbial 10,000-pound gorilla with a multibillion-dollar impact. With millions of products, devices, and equipment to keep track of measurements on, monitor activity and improve practices, how can it be done? Is there one system, guru or purchasing entity that can do it all? It is very doubtful that you will able to find one system that will encompass everything that you will need to map, monitor, measure, and improve your supply chain management, but automation is one step in the right direction.

Automation of the supply chain has become the way of the here and now and will continue to propel supply chain management for the foreseeable future. Automation has taken on several faces over the last several years and will continue to morph as new technology is developed. Aided by the computer and software industry we have been able to start taking bytes out of the huge supply chain gorilla. The software folks have created sophisticated programs that have reduced the gray hairs of supply chain vice presidents, purchasing directors and material managers around the world. At the forefront of this technology wave are the Global Positioning Systems (GPS) and Radio-frequency Identification (RFID) systems.

Ever since [President] Ronald Reagan released the use of orbiting satellites for commercial use the pursuit has been on to develop systems that will track products through improved shipping and traffic management. These GPS units can be utilized to monitor many aspects of the supply chain, from when your containers of supplies were shipped to exactly what ocean or road the container is on, all the way to your dock, not to mention all the metrics you would ever want to know about that supply.

Where the GPS systems leave off the newest technology RFID is picking up. While the technology has been around since the 1930s refinements and advancements in computer chip technology have made Real Time Location Service (RTLS) of products and equipment within the hospital confines a reality.

The use of RFID technology can be divided into two distinct categories: Passive and active. Passive RFID systems are improving and automating upon what bar coding and automated supply lockers have been doing for the last several years. Active tags are going to provide the RTLS that a facility will want to track their mobile assets, devices or personnel. Systems have become so advanced that some can provide 1- to 3-meter or room-level accuracy. This level of accuracy brings into the spectrum of monitoring patient caregiver events all the way to billing for that supply or device and starting the supply chain cycle all over again.

How feasible is it for closed and open systems to incorporate bar coding and RFID in a single unit?

BOLTON: Conceptually, this is highly feasible. Current point-of-use systems are highly flexible in their data architecture and can adapt readily to new formats of information collection. It’s important to note that to realize the true potential of any of these technologies our industry must embrace data standards and the disciplines that go with it. It is this investment and the adoption of the HSCSC recommended GS1 standards that will enable our supply chains and their related technology to fulfill their potential.

CHRISTIANSON: It’s very feasible to incorporate both technologies into a single unit and in fact, it’s something that Mobile Aspects is providing today based on the requirements from several of our clients. The primary driver of the clients’ request is an interest in using a single solution to manage their inventory. Commonly, the RFID technology is designated to manage the more expensive inventory items, such as physician preference items, while the bar-code scanning technology is designated to manage the less expensive inventory items.

TABEL: Technologically, this is very feasible. However, an RFID cabinet/shelf will always cost more than a non-RFID cabinet/shelf. Will a facility want to sacrifice real estate in an RFID cabinet/shelf to hold non-RFID items? Once again, this decision will be measured primarily by the ROI of the solution, while also considering ease of use by clinicians.

PLESHEK: As these technologies mature, the ability to create menu-based, modular system designs which incorporate both RFID and barcode technologies will become more readily available. The capability to connect RFID based cabinets with smart shelves and bar-code scanners to provide a range of product identification and asset tracking services from a single hub is feasible. However, due to cost versus benefit realities this may take longer than expected. 

How much sense does it make for healthcare facilities to have the ability to interchange hardware and software components, installing and removing components in a cabinet or on a shelf as they would those first generation portable satellite radio receivers (from the car to the house and vice versa)?

BOLTON: Supply chain models of the future must have these features and functionality. PAR Excellence currently offers four distinct technologies for data collection. Prudent analysis is required when matching hardware and software components to the unique and often subtle requirements of each supply location. Equally important is the development of the business intelligence collected from these technologies. The business intelligence component will leverage this transactional knowledge into process improvement.

CHRISTIANSON: It could make sense for a system to support the interchange of either RFID or barcode scanning technology. However, the market seems to be more interested in two other needs. The first need is the ability for a system to support configuration changes as inventory needs evolve. For example, as they see changes to their product mix by introducing new products with different sizes and dimensions, they seek systems that can more easily accommodate these spatial changes without going through significant effort and cost to physically configure systems to store the new items.

The second need is for the system to have mobility and provide solutions that can get closer to the point-of-care. These solutions are materializing in the form of mobile carts, handheld devices and other form factors that can reduce the potential for error and inefficiency and be more user-friendly to the work flow of the care provider.

TABEL: As healthcare facilities constantly ‘remap their real estate’ to maximize patient revenue and quality of care, having the ability to interchange components can give them added flexibility. McKesson anticipates that manufacturers will offer modularity and flexibility in their solutions driven by market need. This will likely include the ability to swap cabinets, shelves and racks in and out of different applications, as well as modular software solutions geared towards the supply locations, such as central supply, the ED, nursing floors, cath labs, OR, etc.

Will they be able to custom-design and order these products as they would a computer but without a custom price? Why?

BOLTON: Perhaps. This market like most markets will mature into a space providing a broad spectrum of products. Ranging from ‘freeware’ to scaleable off-the- shelf technology, to one-of-a-kind custom configurations.

CHRISTIANSON: Although custom-designed solutions would be ideal for each hospital, the reality of creating affordable, custom-designed solutions reaches significant constraints when considering the fact that these technologies, and in particular RFID-based technologies, utilize sophisticated electrical components. Instead of custom-designed solutions, we see the market asking for more variety in the technology offerings. For instance, they have an expectation from vendors that the technology is offered in more than one form factor so that a variety of solutions can be deployed to accommodate the unique needs and characteristics of their clinical environment. Commonly this includes a combination of stationary cabinets, mobile carts, handheld applications and other solutions.

TABEL: If modularity and flexibility are required in the marketplace, manufacturers will offer these features. As with any product, the price will be determined by the cost to the manufacturer and the value derived by customers.

Why do healthcare facilities have to make an either/or choice between bar coding- and RFID-enabled cabinets or shelves?

TABEL: Facilities don’t have to choose between the two – bar coding and RFID technologies can co-exist. The main issue that will determine to what extent healthcare facilities choose to use each is cost, specifically the cost of the item being tagged. Bar codes make sense for tracking lower-cost items because the cost of a bar code is so low. RFID tags and chips make sense for tracking items that are more expensive. With active RFID tags running between $30 and $100 a piece, it’s cost-prohibitive to use RFID tags for bandages. It’s McKesson’s belief that these technologies will co-exist going forward, applied where they facilitate proper, timely delivery for a justifiable cost, and that McKesson’s clinical and back-office software will be enabled to make the most of them. 

If and when manufacturers offer healthcare facilities the option of investing in bar code-based systems or RFID-based systems, how will either be promoted and cost-justified?

TABEL: The decision between a bar code versus RFID supply automation solution will be driven off of three things: ROI, patient safety and the availability of bar codes/RFID tags on items from the manufacturers. A bar code approach will be promoted as a cost-effective solution for managing all items, particularly low-cost items that facilities don’t need to track in real time. An RFID approach will be promoted as a supply management tool that increases accuracy and compliance. It will be used to automate the management of high cost/risk products to ensure accuracy and real-time location status; for example, locating an IV pump or tracking a consignment item that has expired or been recalled. These items warrant RFID because of their high cost, but also because patient safety can be compromised if treatment is delayed due to ‘lost’ equipment or if recalled items are not identified before being used in a case.

As adoption of RFID increases, more manufacturers will offer RFID tags on items, the cost of the technology and the disposables will drop, and the overall investment will be reduced. Ultimately this will lower total supply costs and, more importantly, foster a safer patient care experience. In the end, the RFID opportunity to automate the management of high cost/risk product will more accurately expedite the reconciliation process for reimbursement, vendor consignment, expiration and product recalls.

Keith Gifford, vice president, marketing,
InnerSpace Corp., Grand Rapids, MI

Cost savings and financial returns will cost justify technologies such as RFID. Savings include but are not limited to increased charge capture, minimized losses due to expired products, improved accuracy, lower inventory levels, elimination of manual processes and the reduction of costly rush orders.

Will bar code-based systems be earmarked for commodity items while RFID-based systems steered toward higher-cost pharmaceuticals and physician preference items?

TABEL: In terms of generating an ROI, this is a likely scenario. Initially, RFID will be used for high cost/risk products, though the footprint of RFID will evolve and expand as market adoption increases.

GIFFORD: Driven by the cost of RFID technology, including RFID tags, it makes
financial sense to apply the technology to items that have the greatest impact on a hospital’s bottom line. On average, 65 percent of an acute care hospital’s supply costs are concentrated within three departments: Cardiology, radiology and surgery. Five percent of the total number of items in these departments account for 50 percent of
the total supply costs and 85 percent of the total chargeable value of supplies. Referencing the information above, it is the 5 percent of items that need to be kept secure, as well as tracked and managed with RFID. Until such time that the cost of RFID technology dramatically decreases and/or clinical device manufacturers begin applying RFID tags as part of their processes, the balance of clinical supplies have a cost/benefit curve that is better supported by bar-code systems.

Given the modular design of these systems, why can’t modularity be incorporated into the technology itself so that healthcare facilities can custom-design and order their own systems – just like they do computers – equipping the systems with bar code and RFID features together so that one unit could handle multiple functions?

TABEL: McKesson anticipates that modular approaches will be offered, and that ultimately, the modular design approach will prove to be the most successful. In some ways this is already happening — for example, there are tablet PCs just coming into use in hospitals that incorporate both bar-code scanners and RFID readers. Additionally, items that are bar coded can also have RFID tags on them — even RFID tags can be bar coded. 

GIFFORD: The two technologies can be easily integrated with respect to data reporting. However, there are fundamental differences with bar code and RFID technologies when it comes to data collection. Bar codes require line-of-site in order to be scanned versus RFID tags that can be read through most non-metallic materials. Bar codes can only be read one at a time where as many RFID tags can be read at the same time. RFID systems use antenna arrays – to create an RF field – and a reader – to decode the information embedded in the tags – to identify and track supplies. 

Depending on the RFID technology employed – high frequency versus ultra-high frequency – tagged items must be within a specific distance of antenna array in order to be read. Because of the costs associated with RFID systems, there is little to no financial justification for storing supplies using bar code and RFID technologies in the same physical space. As the adoption rate of RFID technology increases, associated costs will decrease to the point where it will make sense to track and manage even low-cost items using RFID.

For more information, visit the company Web sites at:
www.innerspacecorp.com
www.mckesson.com
www.mobileaspects.com
www.parexcellencesystems.com
www.skytron.us
www.tersosolutions.com