RFID Pilot: Cardinal Health Completes

Cardinal Health completes its RFID pilot, which tested RFID tags for end-to-end pharma packaging and distribution business processes. The pilot tested the application of tags and the utilization of item level tracking techniques. Alien Technology, IBM, and Verisign provided hardware, software and implementation services. The application and encoding of the RFID tags approached 100 percent success rates. Reliable read rates were best achieved at the individual case level. The pilot was a fruitful learning experience for the pharma industry. ...

... "The pilot program tested whether ultra-high frequency (UHF) radio frequency identification (RFID) tags could be applied, encoded and read at normal production speeds during packaging and distribution of pharmaceuticals. Verifying the authenticity of medications along each step of the distribution process adds an additional layer of security to lessen the chance of counterfeit pharmaceuticals entering the supply chain. It is also hoped that RFID data could improve efficiencies in the supply chain. Pilot Program Background: In conducting the industry's first end-to-end pilot program, Cardinal Health used new technology to place RFID tags on the labels of brand-name solid-dose prescription drugs, then encoded the electronic product code (EPC) standard data at the unit, case and pallet levels during the packaging process. The products were shipped to a Cardinal Health distribution center in Findlay, Ohio, where the data was read and authenticated as products were handled under typical operating conditions. Normal procedures were enhanced with RFID hardware and software from Alien Technology Corporation and IBM along with project management support from VeriSign.

RFID Labeling and Online Encoding: Data collected from the pilot suggest that it is feasible for RFID tags to be inlaid into existing FDA-approved pharmaceutical label stock, and the tags can be applied and encoded on packaging lines at normal operational speeds. Online encoding yields were 95 percent to 97 percent, and fine tuning of the process is expected to produce yields that approach 100 percent. The RFID tag application and encoding requires minimal adjustments to current labeling and packaging lines.

RFID Read Rates: Unit-level read rate data varied widely depending on the locations and type of reading stations throughout the supply chain. Highly reliable unit-level read rates in excess of 96 percent were found when reading individual cases one at a time and when reading units mixed with other products in tote containers prepared for delivery to a pharmacy. However, as expected, unit-level read rates were not found to be reliable when attempting to read units within a full pallet of product. " ...

Via Cardinal Health: Cardinal Health Releases RFID Pilot Results ...

IBM RFID Pharma: Drug License Plate ...

IBM unveils RFID system that creates a digital license plate for drugs through the pharmaceutical supply chain. The system is comprised of software and services that leverage RFID technology to provide unique identification as the item and sku level. The identifier instantly connects the item to the proper pharmaceutical data. ...

... "The system makes it more difficult for counterfeit drugs to get to market, protecting consumers by helping ensure the drugs they receive match the prescription from their physician. With nearly 8 percent of the world's prescriptions proving counterfeit each year, the US Food and Drug Administration has cited RFID as the most promising technology to ensure that the medicine in the bottle is exactly what the doctor ordered. The global pharmaceutical supply chain is highly complicated. From the point of manufacture to the point of sale, drugs can change hands as many as ten times. IBM's software and services are designed to help manufacturers protect product from theft and fraud and avoid replacement costs for product recalls and tarnished brand value. The IBM RFID system for pharmaceutical track and trace uses blended RFID software and services to automatically capture and track the movement of drugs through the supply chain. RFID tags are embedded on products at the unit, case and pallet level and authenticate the product from manufacturer to wholesalers to hospitals and pharmacies. Each tag contains a unique identifier -- like a license plate -- that can be linked back to descriptive product information such as dosage and strength, lot number, manufacturer and expiration date. " ...

IBM RFID Pharma: Drug License Plate: Via IBM: IBM Taps RFID for Pharma Industry ...

RFID Chips Support Electronic Medical Records ...

VeriChip, Hackensack Medical Center, and Horizon BCBS NJ collaborate to enable an real-time on-demand electronic medical record through RFID technology, which will be accomplished through RFID implants in patients. ...

... "Horizon Blue Cross Blue Shield of New Jersey, the state's oldest and largest health insurer, announced a two-year collaboration with Hackensack University Medical Center, its physicians, and the VeriChip Corporation (VeriChip) to implant FDA-approved microchips in chronically ill patients enabling emergency room physicians to access those patients' medical record electronically. The microchips provide immediate access to family contact information and information about the patients' medical histories that could mean the difference between life and death in an emergency. Horizon BCBSNJ will make the new technology, developed by the VeriChip Corporation of Delray Beach, Florida, available to select members with chronic conditions. Those members who participate in the program will agree to have an implantable radio frequency identification device (RFID), the size of a grain of rice, placed under their skin. VeriChip calls the RFID a personal health record module. The information on the module will include medical information from Horizon BCBSNJ's claim records, such as lab test data and pharmacy prescription information. This module emits a 16-digit number that links the patient to their electronic medical record when a special hand-held scanner is waved over it. The pilot program will give Hackensack Medical Center physicians access to the member's electronic medical records and other vital information in the event the chronically ill member cannot respond during an emergency. The content of the electronic medical records will be approved by each member and include information about their condition, family contact information as well as lab test data and pharmacy information maintained by Horizon BCBSNJ. " ...

RFID Chips Support Electronic Medical Records: Via VeriChip: Horizon Blue Cross to Sponsor Two-Year Pilot With Hackensack to Implant Microchips in Chronically Ill Patients ...

RFID Drug Pedigree Accelerates ...

FDA accelerates the use of RFID technology to support the electronic pedigree for drugs. ...

... "Among other new measures, FDA will fully implement regulations related to the Prescription Drug Marketing Act of 1987, which requires drug distributors to provide documentation of the chain of custody of drug products -- the so-called pedigree - throughout the distribution system. FDA had placed on hold certain regulatory provisions because of concerns raised at the time about the impact on small wholesalers. Most recently, in early 2004, FDA delayed the effective date of certain regulatory provisions regarding pedigrees to allow the industry time to adopt electronic technology for tracking drugs through the supply chain.

Based on information from drug supply stakeholders, the FDA had expected this technology to be in widespread use in the drug supply chain by 2007, but it now appears that these expectations will not be met. Further, FDA has not heard that the concerns raised in the past regarding the impact on small wholesalers remains, and in fact, FDA was encouraged by most drug stakeholders to allow the hold to expire. Doing so would also provide clarity in the drug supply chain regarding who is and is not required to pass a pedigree. Continuing the hold would perpetuate the current confusion and further allow opportunities for counterfeit and diversionary practices. FDA has, therefore, determined that it can no longer justify not implementing these regulations. Accordingly, the hold, which will expire in December, will not be continued.

A potential new measure to safeguard the drug supply is the use of electronic track and trace technology, such as radio-frequency identification (RFID), which creates an electronic pedigree (e-pedigree) for tracking the movement of the drug through the supply chain. The FDA had expected this technology to be in widespread use in the drug supply chain by 2007. In early 2004 FDA delayed the effective date of the regulatory provisions regarding pedigrees to allow the industry time to adopt this technology. However, it now appears that FDA's expectations for adoption of the technology by 2007 will not be met. FDA therefore has determined it can no longer justify delaying implementation of the pedigree regulations. " ...

RFID Drug Pedigree Accelerates: Via FDA: FDA Announces New Measures to Protect Americans from Counterfeit Drugs

RFID GlaxoSmithKline Technology Test ...

GlaxoSmithKline tests RFID technology on HIV drug to combat counterfeiting. ...

... "GlaxoSmithKline has begun distributing a medicine tagged with radio frequency identification (RFID) technology as part of a pilot project to help protect patient safety. The tags will be placed on all bottles of Trizivir (an HIV medicine) distributed in the United States. When scanned at close range, the tags will help verify that the medicine bottle contains authentic Trizivir. This specific medicine was selected for the project because it has been listed by the National Association of Boards of Pharmacy as one of 32 drugs most susceptible to counterfeiting and diversion. The U.S. Food and Drug Administration (FDA) has asked the pharmaceutical industry to develop standards and pilot processes for RFID that may lead in the next few years to broad adoption and use of the technology. RFID uses a tiny silicon chip and antenna about the size of a postage stamp that is attached to each bottle of medicine. The chip stores a unique product code that reflects information about the drug's manufacturing and shipping history. The product code can be read by pharmaceutical wholesalers and pharmacists using a hand-held or stationary electronic device that is placed within 2-18 inches of the tag. The tag can be read by wholesalers when it is received from the manufacturer and when it is shipped to pharmacies, who would then record when they have received the medicine. This allows manufacturers to more precisely account for medicine as it moves through the distribution chain and to authenticate medicine at the point of dispensing. " ...

RFID GlaxoSmithKline Technology Test: Via GlaxoSmithKline: GlaxoSmithKline begins testing new technology ...

RFID Tracks Produce ...

ScoringAg addresses trackback needs in produce industry through RFID integration ...

... "ScoringAg's Point-to-Point Traceback system keeps the produce ID and/or RFID number from the field through the processing stage or storage, to the transporter's log through every processing stage, from the grower to the table, all for just pennies per record. Each produce label can carry an SSI-EID number and/or barcode that corresponds to that one item's total history of food handlers and its quality. " ...

Produce Handlers Using ScoringAg are Ready for FDA Traceback Regulations: Those nut, fruit, and vegetable operations that receive, hold, and ship raw agricultural commodities, such as sweet corn, green beans, carrots, alfalfa sprouts, peppers, apples and other crops, are mandated by the Bioterrorism Act of 2002 to register all their facilities, and keep proper records wherever food commodities and produce are received, cleaned, stored, blended, and processed, and then shipped again ...

FDA RFID Anti-Counterfeit Drug Workshop ...

Upcoming FDA workshop on RFID anti-counterfeiting for drugs ...

... "The Food and Drug Administration (FDA) is announcing a public workshop and vendor display on the use of electronic track and trace technology to combat counterfeit drugs. The purpose of the meeting is as follows: To identify incentives for widespread adoption of radio-frequency identification (RFID), as well as obstacles to the adoption of RFID across the U.S. drug supply chain and possible solutions to those obstacles; to solicit comment on the implementation of the pedigree requirements of the Prescription Drug Marketing Act (PDMA) and the use of an electronic pedigree (e-pedigree); and to learn the state of technology development related to electronic track and trace and e-pedigree technology solutions. To address these issues, we are inviting interested individuals, organizations, and other stakeholders to present information to FDA's Counterfeit Drug Task Force. We are also inviting vendors of track and trace technologies and e-pedigree solutions relevant to the drug distribution system to display their products for the educational benefit of FDA and attendees. (For this meeting, we are only interested in displays from vendors of track and trace technology and e-pedigree solutions for the PDMA requirement, as opposed to covert or overt counterfeiting technologies, such as holograms or colorshifting inks.)

2 DATES AND TIMES: The public workshop and vendor display will be held on February 8 and 9, 2006, from 9 a.m. to 5 p.m. See section V of this document for information on how to register to attend, present at the workshop, or participate in the vendor display. If you would like to present at the workshop or participate in the vendor display, you must register by January 27, 2006. " ...

Via FDA: Anti-Counterfeit Drug Initiative Workshop and Vendor Display ...

RFID People Chipping ...

RFID chipping of people is not very far away. Consumer items, passports, drugs, and other objects will have RFID tags and could serve as a mechanism for tracking and tracing people. In the references below, there are many examples where people RFID chipping is beginning. Mark Long explores the benefits and privacy concerns of RFID technology as adoption increases to solve various problems in society. ...

... "Nevertheless, the chipping of Americans may not be as far away as some people think. For one thing, RFID tags are likely to play a pivotal role in securing the next generation of American identity documents, said Bob McCullough, an analyst at The Yankee Group. " ...

RFID People Chipping: Tracked by a Tiny Chip: The Promise and Peril of RFID - Via Tech Trends - NewsFactor Network

Additional resources on the chipping of people with RFID:

Feds approve human RFID implants | Via The Register: "The US Food and Drug Administration (FDA) has approved a gimmick from Florida-based Applied Digital Solutions to chip people with RFID implants - previously confined to tracking animals - thereby making it easy to access their medical records, even when they cannot, or would rather not, cooperate."

EPIC RFID Privacy Page: "In comments to the Article 29 Working Group, an association of leading European privacy officials, EPIC has recommended strong safeguards for RFIDs and techniques to track the use of digital works. EPIC's Comments on RFID (pdf) recommend a prohibition on chipping people and warn that unencrypted RFID passports pose significant security risks. "

Japan: Schoolkids to be tagged with RFID chips - Hardware - News - Via ZDNet Asia: "The rights and wrongs of RFID-chipping human beings have been debated since the tracking tags reached the technological mainstream. Now, school authorities in the Japanese city of Osaka have decided the benefits outweigh the disadvantages and will now be chipping children in one primary school. "

RFID Emergency Card: Enables Electronic Health Record ...

MedicAlert will show its RFID-enabled smart-card for enabling emergency medical care through the use of identification and electronic health records. ...

... "MedicAlert will be showcasing technology products - the MedicAlert® E-HealthKEY, the Health Enhancement System (HES), and the RFID Emergency Card in response to the federal government’s goal to give all Americans electronic medical records in the coming years. Within a few years, one-third of all Americans will be elderly – about 77 million people – the single biggest demographic group in the country. Globally, the U.S. will have the largest population of elderly people in the history of the world. " ...

RFID Emergency Card: Enables Electronic Health Record: Via MedicAlert: MedicAlert® to showcase technology at the White House Conference on Aging ...

MedicAlert® is committed to providing technology-based solutions and is an active member and a leader in developing interoperability standards with all the major Healthcare IT standards organizations. The MedicAlert® repository uses Web service interfaces to support standard Electronic Health Records (EHRs), including electronic drug prescriptions and for patient record interoperability. These activities will ensure the rapid development and deployment of standards to improve the quality of care, lower healthcare costs while increasing patient safety. MedicAlert® is a nonprofit membership organization founded in 1956 with a mission to protect and save lives, is headquartered in the United States and has international affiliates in nine countries.

Additional resources on uses of RFID to support emergency health care or electronic health care identification:

Health Care CIO Runs Internal RFID Test - Computerworld: "Halamka said this month that when the chip is scanned by an RFID reader, an identifying number directs physicians to his medical records, which are stored electronically at CareGroup's Beth Israel Deaconess Medical Center in Boston. "

VeriChip launches secure database to consult health care data stored on implantable RFID chips: "VeriChip is a miniaturised, implantable, radio frequency identification device (RFID) which can be used in a variety of security, emergency, and health care applications. About the size of a grain of rice, each VeriChip is composed of FDA-accepted materials and contains a unique verification number which can seamlessly integrate to the GVS Registry."

RFID can be a matter of life and death in the medical world | WTN: "Radio frequency identification technology is often touted as a way to improve supply chain management. But in the health care world, the technology is bringing other, perhaps more important benefits: safety and security."

VeriChip RFID Medical Facility Adoption Grows ...

VeriChip continues to grow its RFID adoption in medical facilities. ...

... "VeriChip Corporation, a subsidiary of Applied Digital (NASDAQ: ADSX - News), a leading provider of identification and security technology, announced that 68 medical facilities, including 65 hospitals, have now agreed to implement the VeriMed System for Patient Identification. During the month of November, three additional hospitals agreed to adopt the System. Three additional healthcare organizations have recently agreed to adopt the System: one research center, one specialized care center, and one nursing home. " ...

VeriChip RFID Medical Facility Adoption Grows: Via VeriChip: VeriChip Corporation Expands Adoption of VeriMed System for Patient Identification: New Signings in November Increase Medical Facilities to 68 ...

VeriChip is a subsidiary of Applied Digital and the only company to provide both implantable and wearable RFID identification and security solutions for people, their assets, and their environments. From the world's first and only FDA-cleared, human-implantable RFID microchip to the only patented active RFID tag with skin-sensing capabilities, VeriChip leads the way in next-generation RFID technologies. Today, over 4,000 installations worldwide in healthcare, security, industrial, and government markets benefit from both the protection and efficiencies provided by VeriChip systems.

RFID Technology Enables Hospital Efficiency and Effectiveness ...

RFID technology can enable efficiency in hospitals through asset management and increase effectiveness, such as patient safety, through real-time patient information access that lower patient errors. Marisa Torrieri's article explores hospital RFID scenarios. ...

RFID Technology Enables Hospital Efficiency and Effectiveness: Via SecureID News: FDA-approved RFID technology eases E.R. visits, reduces wrong-site surgery ...

... "But let's say she's tagged with RFID and the hospital's medical staff is equipped with a reader that can pick up her medical history in one wave. Her diabetes would be detected immediately, and she'd get the right treatment right away that would decrease her emergency room stay. That's just one scenario made possible by RFID. " ...

Pharma Industry RFID Opportunity ...

Via Line56.com: Pharma RFID Opportunity ...

... "The FDA has been active in promoting RFID and other forms of Auto-ID, the State of Florida will be a passing a new drug pedigree law in June 2006 to secure and verify the chain of custody of all drugs shipped into the state, and retailer WalMart's RFID mandate extends to suppliers of Class II narcotics. " ...

FDA RFID: Drug Supply Safety ...

While no silver bullet exits, the FDA believes in a balanced technology-enabled approach to ensuring the safety of the nation's drug supply. RFID technology is one of multiple technical methods recommended for further consideration by the FDA. ...

FDA RFID: Drug Supply Safety: Via FDA: Ensuring the Safety of America's Drug Supply Speech by Dr. Scott Gottlieb on September 20, 2005

... "Many people believe that FDA interprets our counterfeit drug report that we issued to address this growing threat as saying that we want RFID implemented by 2007. We said that an electronic pedigree should be feasible by 2007, and right now, RFID is the most promising technology to help deliver on that need. We believe that we can accelerate the development, the testing, the feasibility testing and the cost-effectiveness testing, of many of these technologies that are in development today. And as we are trying to do in other areas of FDA activities where there are new technologies that can be valuable, we want to bring them to benefit patients as soon as possible. " ...

RFID Catheter Data Transfer ...

Catheter manufacturer integrates RFID chip technology into latest model to support data transfer ...

RFID Catheter Data Transfer: Via Volcano Corp: Volcano Corporation Announces FDA Clearance of the Revolution™ 45 MHz IVUS Imaging Catheter: Novel Design will Allow Use of Phased Array and Rotational Catheters on Same IVUS Console ...

... "The Revolution Catheter has a center operating frequency of 45 MHz, making it the highest frequency intravascular catheter approved for sale in the U.S. The Revolution is built on intellectual property and technology recently licensed and acquired from Philips NV of The Netherlands. Volcano expects this imaging technology will appeal to a number of physicians who have trained using high frequency rotating IVUS imaging catheters. The Revolution also incorporates enhanced polymer transitions for improved handling and trackability, RFID chip technology for catheter data transfer, and a reinforced telescoping region for more reliable performance and reduced peri-procedural catheter failure and breakage. " ...

Volcano Corp. is a privately held medical device company founded in 2001. With over 475 worldwide employees, Volcano is dedicated to providing technologies leading to optimal management of coronary artery and peripheral vascular disease. Volcano products include Intravascular Ultrasound (IVUS) systems and catheters, as well as physiology guide wires. With global distribution, Volcano is a leading provider of innovative therapy-enabling and therapy-guiding technologies to the interventional cardiology and peripheral vascular fields.

RFID Tags: Active Passive SemiActive ...

RFID Tags: Active Passive SemiActive: Via Compliance Policy Guides: Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs

... "A passive tag draws all of its power from the radio waves transmitted by an RFID reader. A semi-active tag uses a battery to run the microchip's circuitry, but not to communicate with the RFID reader. An active tag is powered entirely by battery to send and receive RFID information. " ...

RFID Verichip Hospital Growth Explodes ...

RFID Verichip Hospital Growth Explodes: Via VeriChip: VeriChip Corporation Adds 49 Additional Hospitals During Month of September That Have Agreed to Implement the VeriMed(TM) Patient Identification System; Total of 58 Hospitals Exceeds Company's Full-Year Guidance of 20 to 25 Hospitals ...

... "Overall, since the FDA clearance of VeriChip for medical applications, 58 hospitals have agreed to adopt the VeriMed System in their emergency departments. The Company had previously announced that it expected to have 20 to 25 hospitals agree to adopt the VeriMed System by the end of 2005. Most of the hospitals entering into agreements to implement VeriMed in September did so as a result of the Company's demonstration of the system at the American College of Emergency Physicians' (ACEP) Scientific Assembly that took place September 26-29, 2005 in Washington, D.C. " ...

VeriChip: The First RFID Company for People: VeriChip is a subsidiary of Applied Digital and the only company to provide both implantable and wearable RFID identification and security solutions for people, their assets, and their environments. From the world's first and only FDA-cleared, human-implantable RFID microchip to the only patented active RFID tag with skin-sensing capabilities, VeriChip leads the way in next-generation RFID technologies. Today, over 4,000 installations worldwide in healthcare, security, industrial, and government markets benefit from both the protection and efficiencies provided by VeriChip systems.

RFID Info Center: VeriMed ...

RFID Info Center: VeriMed: VeriMed Info Center: Providing everything you want to know about VeriMed™, the first and only FDA-approved patient identification system using implantable RFID technology ...

VeriChip establishes VeriMed Information Center focused on RFID technoloft for human implantation ...

... "The VeriChip(TM) RFID Microchip and Reader: The VeriMed(TM) is the world's first and only FDA-cleared, human-implantable RFID microchip. Approximately the size of a grain of rice, each VeriMed microchip contains a unique 16-digit VeriChip ID which can be read by a VeriMed reader. " ...

VeriChip is a subsidiary of Applied Digital and provides state-of-the-art RFID security solutions that identify, locate, and protect people, their assets, and their environments. From the world's first and only FDA-cleared, human-implantable RFID microchip to the only active RFID tag with patented skin sensing capabilities, VeriChip's technology ensures the safety and security organizations are looking for. Its market-leading infant protection, wander prevention, asset tracking, and patient identification applications make VeriChip the predominant RFID solutions provider in the healthcare industry. And today, VeriChip systems are installed in over 4,000 locations worldwide in healthcare, security, industrial, and government markets making it the world's premier RFID company for people.

VeriMed RFID Hospital Infrastructure: Healthcare Adoption Grows ...

VeriMed RFID Hospital Infrastructure: Healthcare Adoption Grows: Via VeriChip: VeriChip Expands Hospital Infrastructure: Trinitas Hospital Adopts the VeriMed(TM) System ...

The VeriMed RFID instructure for hospitals continues to be adopted in the healthcare industry ...

... "VeriChip Corporation, a subsidiary of Applied Digital (NASDAQ: ADSX - News) announced that Trinitas Hospital, a leading healthcare facility based in Elizabeth, New Jersey has agreed to implement the VeriMed(TM) microchip system and will initiate a clinical evaluation program of the System in its two Emergency Departments for rapid patient identification purposes. Upon implementation, each facility will be able to scan patients to obtain their VeriChip ID Number and utilize the associated database information. Trinitas becomes the sixth hospital that has agreed to adopt the VeriMed System in their emergency department in the last five months and the third hospital in the State of New Jersey to employ the VeriMed System. " ...

Established in January, 2000, following the consolidation of St. Elizabeth Hospital and Elizabeth General Medical Center, Trinitas Hospital is a full-service healthcare facility serving those who live and work in Eastern and Central Union County. Operating on two major campuses, Trinitas Hospital has 531 beds, including a 120-bed long-term care center. Trinitas Hospital is proud to offer state-of-the-art medicine backed by compassion and competence.

VeriChip is a subsidiary of Applied Digital and the only company to provide both implantable and wearable RFID identification and security solutions for people, their assets, and their environments. From the world's first and only FDA-cleared, human-implantable RFID microchip to the only patented active RFID tag with skin-sensing capabilities, VeriChip leads the way in next-generation RFID technologies. Today, over 3,000 installations worldwide in healthcare, security, industrial, and government markets benefit from both the protection and efficiencies provided by VeriChip systems.