SenoRx RFID Medical Tag

SenoRx will use the Congress of The Radiological Society of North America to study the market for its new radio frequency identification (RFID) tag for medical applications. ...

... "SenoRx will be conducting market research for its new RFID tag and accompanying handheld reader which the company believes may be the next generation lesion localization device. The company recently submitted a 510(k) application to the U.S. Food and Drug Administration. Because the RFID tag is completely contained inside the breast, SenoRx believes that the close schedule coordination which is currently required between the radiologist and the surgeon performing the two separate procedures is significantly reduced. " ...

Via CNN Money: SenoRx Market Research for Radio Frequency Identification (RFID) Tag Device

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.

Hospital RFID Technology Grows: Patient Identification Infrastructure ...

Hospital RFID Technology Grows: Patient Identification Infrastructure: VeriChip Corporation Announces Three Additional Hospitals Adopt the VeriChip(TM) System for Patient Identification During the Month of July: Total of Five Hospitals in the Targeted Boston to Washington Corridor Have Now Agreed to Adopt VeriChip System ...

Hospital RFID use grows as patient identification infrastructure is implemented ...

... "VeriChip Corporation Chief Executive Officer Kevin McLaughlin noted, There are currently 70 hospitals in the Boston to Washington corridor that are using VeriChip Corporation's Hugs(TM) and Halo(TM) external RFID technology in their maternity wards. The emergency departments of those hospitals are among those being targeted by our VeriChip sales force as we continue the initial rollout of VeriChip patient identification infrastructure. " ...

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.

Cephalon RFID Pilot: Drug Tracking ...

Cephalon RFID Pilot: Drug Tracking: Cephalon Selects OAT Foundation Suite for Item-Level Drug Tracking Pilot: OAT Foundation Suite Powers RFID Initiative to Drive Supply Chain Efficiencies and Ensure Patient Safety ...

Cephalon pilots RFID drug tracking as products move through the value chain to market. Broader RFID drug tracking implementation is expected, upon conclusion of the pilot period ...

... "OATSystems®, Inc., the recognized RFID framework leader, announced that Cephalon, Inc, an international biopharmaceutical company, has selected OAT Foundation Suite as the RFID software platform for use in a pilot program for tracking branded pharmaceuticals across the supply chain. For the pilot, OAT Foundation Suite will deliver end-to-end visibility of Cephalon’s products as they move across owned and outsourced facilities as well as selected drug wholesaler trading partners. Once the pilot project has proven successful, Cephalon will implement RFID utilizing the OAT Foundation Suite. " ...

OATSystems, Inc. is the recognized RFID framework leader with software that empowers businesses to achieve competitive advantage from radio-frequency identification (RFID). As pioneers in the development of RFID technology, OAT has been setting the standard in RFID for over half a decade and is responsible for industry firsts that include the largest scale and largest scope of deployments, as well as the most innovative approaches to providing enterprise-wide RFID solutions.

Additional resources on RFID pilots for drug tracking:

Purdue Pharma announced that it is placing RFID tags on bottles of the pain reliever OxyContin (oxycodone) to make it easier to authenticate, as well as to track and trace the medication. OxyContin, which is a controlled substance, has been subject to abuse, theft, and diversion. Based on the availability of sufficient RFID tags, Purdue also plans to tag bottles of Palladone (hydromorphone), a newly approved product to treat persistent moderate-to-severe pain.

Nine months after an FDA task force promoted the use of radio frequency identification (RFID) on drug packaging and labeling to prevent fake products from entering the supply chain, agency officials on November 15 announced that at least four pharmaceutical makers are participating in pilot projects or studies to test the effectiveness of RFID in combating counterfeiting.

GlaxoSmithKline [NYSE: GSK) announced that it will begin using radio frequency identification (RFID) tags in the next 12 to 18 months on at least one product deemed susceptible to counterfeiting in order to more effectively monitor its progress from the company to the patient. GSK is partnering in this pilot project with the US Food and Drug Administration, which is encouraging the use of RFID technology to protect American patients from the growing risk of counterfeit and diverted medicines.

Halamka RFID Experience: Human Implant

Halamka RFID Experience: Human Implant: VeriChip: New England Journal of Medicine Features Article on VeriChip Technology ...

Dr Halamka discusses his experience and intentions for RFID implantation in the New England Journal of Medicine ...

... "In the article, entitled Straight from the Shoulder, Dr. Halamka discusses his experience of being implanted with the VeriChip, the only FDA-cleared, human-implantable RFID microchip, and his reasons for doing so. " ...

VeriChip, The First RFID Company for People, 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.

RFID Bioterrorism Trace-Back Capability ...

RFID Bioterrorism Trace-Back Capability: US FDA/CFSAN - Transcript of Public Meeting: What You Need to Know to Ensure Compliance With the New FDA Establishment and Maintenance of Records Final Rule That Implements Section 306 of the Bioterrorism Act - Questions and Answers, Chicago, Illi

... "What you were saying about you can't trace it all the way to the ultimate consumer, do you think the advent of the RFID tags could some day be beneficial in helping you all the way through the entire chain? DR. BERU: Yes. We have had presentations about RFID and we have been told by industry that right now it is very expensive to implement, but with time the cost may come down enough for everyone to use it. We are hoping, you know, five years, ten years from now such a system will be able to be developed to help trace-back." ...

RFID Radiofrequency Identification Feasibility Studies ...

RFID Radiofrequency Identification Feasibility Studies: Compliance Policy Guides: Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs

... "RFID will be used only for inventory control, tracking and tracing of products, verification of shipment and receipt of such products, or finished product authentication. RFID will not be used to fulfill existing FDA regulatory requirements (e.g., fulfillment of labeling or Current Good Manufacturing Practice requirements, provision of chemistry, manufacture, and control information, storage of information in fulfillment of a regulatory requirement, or performance of label and product reconciliation). RFID will not be used in lieu of current labeling control systems to ensure correct labeling processes. " ...

RFID Automatic Identification Technology: EAN UCC

Combating Counterfeiting and Enabling Traceability in the Global Healthcare Supply Chain by using the EAN.UCC System

... "Automatic Identification is the umbrella term for technologies that allow machines (typically computers) to automatically identify objects. Radio Frequency Identification (RFID) is one type of automatic identification technology. Objects are labeled with "tags" (a microchip with a radio frequency antenna) that store data, which defines that object in a structured manner. Using radio waves, the reader wakes up the tags and automatically captures that data, which can then be processed. " ...

RFID Infant Protection Company Acquired ...

RFID Infant Protection Company Acquired: Applied Digital's VeriChip Corporation Acquires Instantel, Inc., Including Its Health Security Division Xmark, Expanding Company's Position in Healthcare Security ...

Verichip acquires RFID solutions company with track record in healthcare security through infant protection and patient tracking ...

... "Instantel Inc.'s Xmark division specializes in smart tag technology for protecting people and assets in healthcare environments. Its Hugs product line is a popular RFID system for preventing the abduction of newborn infants in hospital, while the WatchMate system is used in long-term care facilities to protect wander-prone residents. Instantel recorded revenue of $12.8 million for its fiscal year ended December 31, 2004 with EBITDA of approximately $3.6 million. During the past five years, Instantel's reported revenue reflects a compound annual growth rate of approximately 14%, with strong gross margins and EBITDA margins. " ...

VeriChip is a wholly owned subsidiary of Applied Digital and the only company to provide both implanted and external RFID 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 cost savings VeriChip's innovation delivers.

RFID Antenna Production: Secure Printing ...

Creo and XINK Laboratories Announce World's First Security Ink for High-Volume Flexographic RFID Antenna Production: New Covert Taggant Formulation Prevents Counterfeit RFID Tags ...

... "Creo Inc. (NASDAQ: CREO; TSX: CRE) and XINK Laboratories Ltd. presented a new class of secure flexographic radio frequency identification (RFID) antenna printing inks at the PISEC 6th World Product & Image Security Convention (www.pisec-world.com), held in Vienna, Austria recently. These new covertly tagged flexographic ink formulations target manufacturers and converters producing RFID-tagged smart packaging for use in supply-chains. This type of smart packaging has been mandated by Wal-Mart and, more recently, was recommended by the Food and Drug Administration (FDA) for pharmaceutical counterfeit protection. This new class of flexographic security inks and RFID tags is available exclusively through XINK and its worldwide authorized printing and manufacturing partners. Until now, one of the main concerns of the RFID industry has been the ability of counterfeiters to copy RFID tags by duplicating RFID numbering schemes. The new XINK antenna inks eliminate this possibility by integrating Creo Traceless covert tagging technology, elevating Traceless XINK-printed RFID tags into the same league as currency and security instruments. " ...

XINK advanced conductive and resistive ink formulations allow printing of complex electronic circuitry, including flexible paper sensors (package security), sensor grids (smart pharmaceutical packaging), keypads (electronic paper diaries), and UHF RFID antennas.

RFID Feasibility Studies

Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs ...

... "A manufacturer, repackager, relabeler, distributor, retailer, or others acting at their direction will attach RFID tags (chips and antennae) to only immediate containers, secondary packaging, shipping containers, and/or pallets of drugs that are being placed into commerce. There is no limit to the number of tags or readers that may be used in the study. The drugs involved will be limited to prescription or over-the-counter finished products. The drugs involved will not include those approved under a Biologics License Application or protein drugs covered by a New Drug Application. " ...

RFID Technology Event: Today...

RFID Tech Talk ...

... "RFID Event: May 23, 2005, RFID Tech Talk at the National Press Club, 6:30 PM, Call Jean at 202-662-7129 or e-mail opus@press.org

Sponsored by The National Press Club High Tech Committee, NPC Conference Rooms

TECH TALK on RADIO FREQUENCY IDENTIFICATION (RFID)

Speakers
Mr. Alan Estevez, Assistant Deputy Undersecretary of Defense Supply Chain Integration
Mr. Michael Meranda, President, EPCglobal Consortium
Dr. Sanjay Sarma, CEO, OATSystems, Inc.
Paula Bruening, J.D., Counsel, Center for Democracy and Technology
Dr. Robert Atkinson, VP, Progressive Policy Institute
Ilisa Bernstein, Pharm. D., J.D., Sr. Advisor for Regulatory Policy, Food and Drug Administration

RFID is a transformative technology that improves the delivery, safety and efficiency of how products get to consumers; RFID will dramatically improve in-transit visibility, the ability to see products as they move from point A to B, in the global supply chain costs the retail industry $180 billion-$300 billion annually, or 6 to 10 percent of total supply chain spending, and it is an important issue for the Department of Defense; RFID in US Passports and credit cards might be exploited by unscrupulous businesses and terrorists; How and why privacy advocates are attempting to curtail RFID deployment by raising a host of claims about the technology; Pharmaceutical drugs can be better tracked to prevent counterfeiting. Shipping containers that reach our ports can be checked for tampering. And best of all, products will be on the shelf when and where you want to buy them; " ...

The Club shall provide people who gather and disseminate news a center for the advancement of their professional standards and skills, the promotion of free expression, mutual support and social fellowship.

RFID Risk Management Program ...

RFID Risk Management Program: Corporate SOX Compliance: Reconnex Introduces North American Channel Partner Program: TSC to Provide Services that Enable Corporations to Respond and Report on Enterprise Risks by Integrating and Implementing the Reconnex inSight Platform ...

Visibility into network information is key to risk management in the application of RFID technology ...

... "Corporate risks extend far beyond those involved in Sarbanes-Oxley compliance and the financial marketplace – other regulations such as HIPAA, FDA, RFID, and other legal, technical, and environmental risks must be considered a part of risk assessment and management, said Malcolm Schwartz, senior vice president, compliance consulting group at TSC. Having visibility into all information leaving the corporate network so nothing goes unanalyzed can be a key element in a comprehensive risk management program. ” ...

Reconnex enables companies to guard against information security breaches that originate within an organization. Reconnex pioneered the only enterprise security platform of its kind that has the capacity to run at gigabit speeds, is non-invasive and can be deployed in hours not weeks; businesses now have a realistic and cost-effective solution to assess their operational and compliance risks. With Reconnex, companies across various industries and government agencies now have the demonstrable proof they are in continuous compliance with real-time monitoring, detection and reporting of compliance risks.

Drug RFID Technology Awareness ...

Pharmaceutical Education Associates Speech in 2005

Remarks by Lester M. Crawford, D.V.M., Ph.D., Acting Commissioner of Food and Drugs ...

... "In November, 2004, FDA stepped up its effort by issuing a compliance policy guide to facilitate pilot projects for the use of Radiofrequency Identification (RFID) Technology in the pharmaceutical sector. RFID is the cornerstone technology in the fight against counterfeit drugs because of its ability to track, trace and authenticate packages of drugs. Using state-of-art electronic technology on every product, RFID allows the creation of an electronic pedigree from the point of manufacture to the point of dispensing. An electronic pedigree is a record of all the places where drugs have been and who has had it. It will minimize fraudulent mishandling and mischief to occur to tagged drug products. I announced a few months ago that Pfizer and Purdue Pharma have already joined FDA action in implementing RFID and more are following suit. The FDA expects to see widespread adoption of RFID technology by the pharmaceutical industry by the year 2007. " ...

RFID Authentic Unit Drug Tracking ...

Panel 2--Anti-Counterfeit Drug Initiative--October 2003 Meeting

... "Track and trace technology supports the unique identification of each individual product unit, allowing distributors to easily identify and locate specific items in the supply chain. The technology HDMA believes holds the most promise is radiofrequency identification, or RFID. Using RFID technology, a tiny radiofrequency chip containing essential data in the form of an electronic product code will allow supply chain stakeholders to track every unit of medication in the country on an individual basis. By tying each product unit to a unique ID, any item can be tracked through the entire supply chain with an unalterable electronic pedigree. The EPC chip, which can be thought of as a product's DNA, will be equipped with high-technology security protection that will make it impossible to duplicate or steal the identity of an authentic unit. " ...

RFID EPC Anti-Counterfeit Drug Initiative

Panel 5--Anti-Counterfeit Drug Initiative--Meeting Minutes ...

... "The product of this research was electronic product code or EPC. The Auto-ID Center and its participating sponsor companies conducted extensive pilots on EPC technology to test its performance in real world supply chain applications. Since MIT and Auto-ID Center are research institutions, they wanted to license this technology to an organization that could commercialize the EPC for worldwide use. Since the Uniform Code Council was a founding sponsor and had a 30-year track record in standards, it was a natural next step that the UCC take a leading role in bringing the EPC to market. In May of this year MIT finalized an agreement with the UCC and its global partner, EAN International, to standardize this emerging RFID technology on a worldwide basis. In order to support this effort, the UCC and EAN formed a joint venture called EPCglobal to drive the commercialization of the EPC. In order to move this technology from the research phase to the real world of business, the EPCglobal organization is focused on working with industry users to develop the necessary standards to drive broad adoption. It is a multi-industry focus and the standards will be developed in a user-drive consensus-based process. " ...

RFID EPC Drug Imports

Comments for the Task Force on Drug Importation: Secure Symbology, Inc. is offering comments to the U.S. Food and Drug Administration (FDA) and the Task Force on Drug Importation as charged by HHS Secretary Tommy G. Thompson to study what it would take in terms of oversight and resources to safely import drugs ...

... "We recognize that the ultimate goal of RFID, through its data carrier, the Electronic Product Code (EPC™), is to serialize every manufactured product down to the item level. But because of the huge infrastructure costs, high tag costs, questions concerning ISO standards, hacking and privacy concerns, implementation to the items level is, by most standards, 5 – 10 years away. The ability to track, trace and provide an electronic database and an electronic pedigree cannot wait 5-10 years for item level serialization while U.S. states, counties and it’s citizens bring pharmaceutical products in from Canada and other foreign countries. DOD and Wal-Mart driven mandates may elicit some success in the next few years at the container and/or pallet level, but even at this level, data synchronization still is a major issue." ...

RFID Health Care Services ...

2004.12.31: HHS Highlights of 2004

... "FDA also launched a new initiative to allow pharmaceutical manufacturers and distributors to use radio frequency identification (RFID) technology to more precisely keep track of drug products as they move through the supply chain. RFID is a state-of-the-art technology that uses electronic tags on product packaging and is similar to the technology used for tollbooth and fuel purchasing passes. " ...

New RFID Distributors ...

New RFID Distributors: Applied Digital's VeriChip Corporation Subsidiary Expands ...

Verichip signs Asian and Middle Eastern distributors for their RFID products ...

From Business Wire (press release), CA ... The VeriChip product is a sub dermal RFID micro transponder that can be used in a variety of security, financial, emergency identification and healthcare ...

... VeriChip Corporation, a wholly owned subsidiary of Applied Digital (NASDAQ: ADSX), announced today that it has signed two new non-exclusive distributors for Taiwan and Saudi Arabia. SI&I (www.siikorea.com) will distribute the product in Taiwan, while Arabian Gulf Group. has been selected as a distributor in Saudi Arabia. ...

VeriChip Corporation is a wholly owned subsidiary of Applied Digital. The VeriChip product is a sub dermal RFID micro transponder that can be used in a variety of security, financial, emergency identification and healthcare applications. About the size of a grain of rice, each VeriChip device contains a unique verification number that is captured by briefly passing a proprietary scanner over the VeriChip. In October 2004, the U.S. Food and Drug Administration (FDA) cleared VeriChip for medical applications in the United States. VeriChip is not an FDA-regulated device with regard to its security, financial, personal identification/safety applications and is MRI compatible.

Complementary Drug RFID Technology: Combine tamper evidence with RFID drug pedigree management ...

Banner Soflet® Gelcaps Work With RFID Technology to Secure Drugs ...

... Banner's Soflet® Gelcaps can be used with Radio Frequency Identification Devices (RFID) to prevent drug counterfeiting. This patented technology works to provide tamper-evident security on drugs in tablet form. ...

Banner is a global company that researches, develops, and manufactures drug delivery technologies and proprietary healthcare products. With state-of- the-art, FDA-approved manufacturing facilities and significant investment in research and development, Banner provides innovative oral delivery solutions and unique products to the healthcare industry worldwide. A wholly-owned subsidiary of Sobel N.V., Banner has operations in the United States, Canada, Europe, Latin America, and Asia-Pacific.

Implantable Radiofrequency Transponder System

Implantable Radiofrequency Transponder System for Patient Identification and Health Information - Class II Special Controls Guidance Document ...

... "When discussing the issue of medical devices that store, access, and/or transfer information externally (RFID), you should address the concept of information security. Information security is the process of preventing the modification, misuse or denial of use, or the unauthorized use of that information. We recommend that your specifications for a compatible database address the following four components of information security: Confidentiality, Integrity, Availability, and Accountability (CIAA). " ...

Systematic Approach to RFID ...

Panel 5--Anti-Counterfeit Drug Initiative--October 2003 Meeting

... "What do we need to be able to deliver on the potential of the EPC network? We need a systematic approach to Radio Frequency Identification--or RFID for short--that is based on standards. This is a view of the EPC network components. Starting with Electronic Product Code or EPC, the EPC uniquely identifies the item. The tag is a small RFID chip with an antenna. In the EPC network, these tags can be as small as a dime and can be made to fit within the lid of a vial. Tags are excited by and broadcast their EPC information back to the reader. Savant is a set of functionality that serves as the real-time event manager or traffic cop in a reader network. Savant can be implemented in software or as a combination of software and firmware in the reader itself. ONS, the Object Name Service, provides a simple directory that can tell Savant where in the network information related to a particular EPC number can be found. ONS is very much like DNS, the Domain Name Service, that's part of the Internet. ONS and DNS share many of the same characteristics. " ...

Drug Supply Radiofrequency Identification Technology

FDA Announces New Initiative to Protect the U.S. Drug Supply Through the Use Of Radiofrequency Identification Technology

... "Purdue Pharma announced that it is placing RFID tags on bottles of OxyContin to make it easier to authenticate as well as track and trace this pain medication. Based on the availability of sufficient RFID tags, Purdue also plans to tag bottles of Palladone, a newly approved product to treat persistent, moderate to severe pain. Oxycontin, which is a controlled substance has been subject to abuse as well as theft and diversion. FDA also acknowledged the leadership of Johnson & Johnson in establishing standards for RFID technology and participating in RFID pilot studies. Johnson & Johnson will continue to collaborate with industry partners to develop standards for ePedigree." ...

RFID-Enabled Surgery ...

Testimony by Bruce Waxman for the January 11, 2005 NCVHS Subcommittee on Privacy and Confidentiality Hearings

... "SURGICHIP is an FDA approved, patent pending system using RFID technology to help prevent wrong-site, wrong-patient, and wrong-procedure surgery; it is a new use of preexisting technology. A computer chip encoded with the pertinent data is affixed to the skin with biocompatible adhesive and is removed prior to the incision; the chip is not implanted inside the body. SURGICHIP is used in addition to the other usual safeguards against wrong-site surgery, including the JCAHO Universal Protocol (yes or the surgeon's initials / signature are written on the incision site with indelible marker and a time out is taken to review the operative consent and verify the patient's identity). With SURGICHIP in place it is less likely that the surgical team will forget to check the operative consent or the patient's identifying wristband. The possibility that the wrong chart will be used and the incorrect procedure therefore performed is minimized since the chip, which has been verified by the patient while awake, does not physically leave the patient until the surgical prep begins. " ...

Hospital RFID Trial in Emergency Room ...

Hospital RFID Trial in Emergency Room: VeriChip Expands Hospital Infrastructure: Hackensack University ...

Verichip and Hackensack Hospital collaborate on RFID trial in emergency room ...

From Business Wire (press release), CA ... The VeriChip product is a sub dermal RFID micro transponder that can be used in a variety of security, financial, emergency identification and healthcare ...

... VeriChip Corporation, a wholly owned subsidiary of Applied Digital (NASDAQ: ADSX) announced today that Hackensack University Medical University (HUMC), Hackensack, New Jersey will initiate a clinical evaluation program of the VeriChip System in its Emergency Department for clinical use. The facility will now be able to scan patients to obtain their VeriChip ID Number and utilize the associated information. ...

VeriChip Corporation is a wholly owned subsidiary of Applied Digital. The VeriChip product is a sub dermal RFID micro transponder that can be used in a variety of security, financial, emergency identification and healthcare applications. About the size of a grain of rice, each VeriChip device contains a unique verification number that is captured by briefly passing a proprietary scanner over the VeriChip. In October 2004, the U.S. Food and Drug Administration (FDA) cleared VeriChip for medical applications in the United States. VeriChip is not an FDA-regulated device with regard to its security, financial, personal identification/safety applications and is MRI compatible.

RFID Authentication Technology ...

FDA Anti-Counterfeiting Task Force Interim Report Focuses on High-Tech Weapons and Other Promising New Counter Measures

... "Authentication technologies to assure that the drug is the real thing fall into three general groups: overt, covert and forensic. Track and trace technologies to help make sure that a product that finds its way to a consumer is a safe and effective drug include radio-frequency identification and barcodes." ...

EPC Electronic Product Code Supports Anti-Counterfeit Drug Initiative ...

Panel 5--Anti-Counterfeit Drug Initiative-- Meeting

... "UCC has launched a new entity named EPC Global. This new organization will lead the worldwide commercialization of the breakthrough electronic product code or EPC that has been researched and developed at the MIT Auto-ID Center. EPC technology will be complementary to our existing standards and provide greater ability to combat counterfeit drugs. While the UPC was originally developed for the U.S. grocery industry, its dramatic success quickly generated interest from other industries both here and around the world. The technology behind the UPC became the basis of the global EAN/UCC system, a system of open, multi-industry supply chain standards. The following information demonstrates the global strength of the EAN/UCC system. Our global standards are used by over 1 million members worldwide, and these would be primarily companies, distributors, et cetera, and other organizations. They are used by 23 major industries including health care to conduct business efficiently in 141 nations. These standards are at work in the hospital setting, pharmacies, health care manufacturers, distributors and stores for over-the-counter health care products today. " ...

Covert RF Tags: Anti-Counterfeit Drug Initiative ...

Panel 6--Anti-Counterfeit Drug Initiative--October 2003 Meeting

... "If you want to see the RF tags in operation, please go to the show room there. We have it in paper, we have it in labels, special packaging. We demonstrate that we can read an RF signature on a box 10 feet away or we can read 10 millimeters away, depending on what the requirement of the client is. It is RF. We don't use a chip. It's in the paper, as you can see here. We embed our resonators in paper, and when we illuminate the paper with low energy, you get a signature back. The signature is now interpreted as a number. The number remains as part of the database. We are deployed. We're in somewhere between 50- and 100 million items a year, more covertly. We're now looking into the overt market. It's easy to identify. We can create numbers as large as you'd like. And basically they are created randomly, chaotically random, so it makes it very difficult for anyone to know what the next logical number in a sequence is. Also, our database is variable. We're not fixed size. We can have 16 bytes up to 6,000 bytes, depending on what the client requires. " ...

RFID CPG ...

Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs ...

... "On February 18, 2004, FDA published a report entitled ‘‘Combating Counterfeit Drugs’’ which is available on the FDA Web site at http://www.fda.gov/oc/ initiatives/counterfeit. In that eport the agency identified RFID technology as the cornerstone in the fight against counterfeit drugs and announced our intention to facilitate the adoption of RFID technology by participants in the pharmaceutical supply chain. We also stated that widespread adoption of RFID technology was feasible by 2007. Recently, FDA has received inquiries focusing on whether certain regulatory requirements, including those related to labeling, electronic records, and product quality, apply to pharmaceutical manufacturers, repackagers, relabelers, distributors, retailers, or others who participate in feasibility studies and pilot programs (collectively ‘‘a study’’ or ‘‘studies’’) using RFID tags for drugs. This CPG describes how we intend to exercise our enforcement discretion regarding such studies. The exercise of such enforcement discretion expires on December 31, 2007. The goal of this CPG is to facilitate the performance of RFID studies and allow industry to gain experience with the use of RFID." ...

The goal of the CPG is to allow industry to gain experience with the use of RFID technology to ensure the long-term safety and integrity of the U.S. drug supply. DATES: You may submit written or electronic comments at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Division of Compliance Policy (HFC– 230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the guidance may be sent. Submit written comments on the guidance to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

SubDermal RFID Micro Transponder Marketing ...

SubDermal RFID Micro Transponder: Applied Digital's VeriChip Corporation Forms Medical Advisory ...

From Business Wire (press release), CA ... The VeriChip product is a sub dermal RFID micro transponder that can be used in a variety of security, financial, emergency identification and healthcare ...

... Applied Digital (NASDAQ: ADSX), a provider of Security Through Innovation(TM), announced today that its wholly-owned subsidiary, VeriChip Corporation, has formed a Medical Advisory Board to assist in expanding the adoption of VeriChip in the medical community. The Board's initial focus will be to advise the Company on ways to increase the acceptance and expand the marketing of VeriChip to practitioners, hospitals and makers of medical devices, insurance companies and Medicaid/Medicare. In addition, the Board will work closely with legislators and federal agencies to improve the quality of information technology in healthcare. Dr. Richard Seelig, Vice President of Medical Applications for VeriChip Corporation, will chair the Board. Other initial members are: Howard Weintraub, Ph.D., a principal in Landfall Therapeutics Consulting Group, LLC and Sameer Mehta, MD, FACC, MBA, a highly respected cardiologist and healthcare activist. ...

VeriChip Corporation is a wholly owned subsidiary of Applied Digital. The VeriChip product is a sub dermal RFID micro transponder that can be used in a variety of security, financial, emergency identification and healthcare applications. About the size of a grain of rice, each VeriChip device contains a unique verification number that is captured by briefly passing a proprietary scanner over the VeriChip. In October 2004, the U.S. Food and Drug Administration (FDA) cleared VeriChip for medical applications in the United States. VeriChip is not an FDA-regulated device with regard to its security, financial, personal identification/safety applications and is MRI compatible. Applied Digital develops innovative security products for consumer, commercial, and government sectors worldwide. The Company's unique and often proprietary products provide security for people, animals, the food supply, government/military arena, and commercial assets. Included in this diversified product line are RFID applications, end-to-end food safety systems, GPS/Satellite communications, and telecomm and security infrastructure, positioning Applied Digital as the leader of Security Through Innovation. Applied Digital is the owner of a majority position in Digital Angel Corporation (AMEX: DOC).

RFID Track and Trace Feasible for Drug Tagging ...

Combating Counterfeit Drugs: A Report of the Food and Drug Administration

From Combating Counterfeit Drugs: A Report of the Food and Drug Administration ...

... "The adoption and common use of reliable track and trace technology is feasible in 2007, and would help secure the integrity of the drug supply chain by providing an accurate drug pedigree, which is a secure record documenting the drug was manufactured and distributed under safe and secure conditions. Modern electronic technology is rapidly approaching the state at which it can reliably and affordably provide much greater assurances that a drug product was manufactured safely and distributed under conditions that did not compromise its potency. FDA has concluded that this approach is a much more reliable direction for assuring the legitimacy of a drug than paper recordkeeping requirements, which are more likely to be incomplete or falsified, and that it is feasible for use by 2007. Radiofrequency Identification (RFID) tagging of products by manufacturers, wholesalers, and retailers appears to be the most promising approach to reliable product tracking and tracing. Significant feasibility studies and technology improvements are underway to confirm that RFID will provide cost-reducing benefits in areas such as inventory control, while also providing the ability to track and trace the movement of every package of drugs from production to dispensing. Most importantly, reliable RFID technology will make the copying of medications either extremely difficult or unprofitable. FDA is working with RFID product developers, sponsors, and participants of RFID feasibility studies to ensure that FDA's regulations facilitate the development and safe and secure use of this technology. FDA is also working with other governmental agencies to coordinate activities in this area." ...

RFID was cited as being the technology with the strongest potential for securing the supply chain but that it was not ready for widespread commercial use with pharmaceutical products. Many costs, potential benefits, and unresolved issues related to RFID were cited. The potential benefits included the ability to control inventory and conduct rapid, efficient recalls, while costs that could hinder the adoption of RFID included purchase of tags and other hardware, integration into existing information systems, and compliance with regulatory requirements (e.g., labeling, electronic records). Important unresolved issues included the need to develop standards and business rules for RFID, the need to address database management issues, and the need to determine the effect of RFID on product quality.

RFID Technology Combats Counterfeit Drugs ...

Combating Couterfeit Drugs with RFID Technology

From FDA ...

RFID Issues that the FDA is Watching ...

Standards development:
should occur simultaneously with pilot studies, waiting to begin implementing RFID until standards are fully developed may be problematic

Technical issues:
optimal use of frequencies in the supply chain, obtaining 100% read rates

Product Quality:
voluntary collection of data on the effect of RF energy on drugs to inform future testing requirements (if any), special attention to liquids and biologics

Privacy:
Industry very sensitive to this issue

Database:
security, access, ownership

It is a reliable pedigree from the point of manufacture to the point of dispensing is essential to assuring a safe drug supply. RFID can provide such a pedigree. Therefore, FDA has identified RFID as the cornerstone in the fight against counterfeit drugs.

RFID Safety Inspection Program Support ...

RFID Safety Inspection Program Support: Project Group RFID Subsidiary to Implement Purchase Order from ...

From Business Wire (press release), CA ... (OTCBB:PJTG) announced today that the State of Indiana has awarded a purchase order for expanding the state's RFID based safety inspection program for ...

... The Project Group, Inc. (OTCBB:PJTG) announced today that the State of Indiana has awarded a purchase order for expanding the state's RFID based safety inspection program for amusement parks. The order will be implemented by its RFID solutions subsidiary, Pro Squared, Inc. ...

Pro Squared, Inc is a subsidiary of The Project Group focused on closed loop RFID solutions. RFID technology replaces traditional, unreliable bar codes and is rapidly becoming the state-of-the-art in supply chain management. RFID tags consist of silicon chips and an antenna that can transmit data to a wireless receiver. Recently, Wal-Mart has mandated that all major vendors utilize RFID and recently Pfizer, Smith Kline, Purdue Pharma and the FDA have all announced new RFID programs.

RFID Human Implantation ...

RFID Implantation: Chief Information Officer of Harvard Medical School Recieves ...

From Business Wire (press release), CA ... Included in this diversified product line are RFID applications, end-to-end ... revenues and earnings, and all other statements in this press release other than ...

... VeriChip Corporation, a wholly-owned subsidiary of Applied Digital (NASDAQ: ADSX), a provider of Security Through Innovation(TM), announced today that John D. Halamka, MD, MS, Chief Information Officer of Harvard Medical School, was implanted with a VeriChip(TM) in December 2004 and began an assessment of the technology. Prior to making a recommendation to a patient, Dr. Halamka wished to undergo the VeriChip "experience" so that, with his extensive clinical and information technology experience, he could make an assessment from all dimensions. ...

VeriChip Corporation is a wholly owned subsidiary of Applied Digital. The VeriChip product is a sub dermal RFID micro transponder that can be used in a variety of security, financial, emergency identification and healthcare applications. About the size of a grain of rice, each VeriChip device contains a unique verification number that is captured by briefly passing a proprietary scanner over the VeriChip. In October 2004, the U.S. Food and Drug Administration (FDA) cleared VeriChip for medical applications in the United States. VeriChip is not an FDA-regulated device with regard to its security, financial, personal identification/safety applications and is MRI compatible.

Additional resources on RFID implants:

RFID chips - ultimate human control: be required to have a microchip implanted in their ... are the only company today offering human implantable ID ... focuses of personal GPS devices and RFID chip firms ...

RFID: Getting Under Your Skin?: some 1000 people in the US and elsewhere have RFID chips implanted in their ... Drug Administration still hasn't given its approval for human injection of ...

Life Chip - RFID Report: of the transponder implants migrated from the implantation site ... Knowing that the RFID transponder fitted with Bio-Bond ... and eradication and to promote human safety ...

RFID in Surgery: FDA Clears New Surgical Marker; Uses RFID to Protect Patients

From FDA ...

... "The Food and Drug Administration (FDA) has cleared for marketing an external surgical marker tag intended to minimize the likelihood of wrong-site, wrong-procedure and wrong-patient surgeries. The device is the first such surgical marker to utilize radio frequency identification (RFID) technology to mark an anatomical site for surgery. It is intended to offer additional protection for patients who are undergoing surgery. The product is the SurgiChip Tag Surgical Marker system, manufactured by SurgiChip Inc., of Palm Beach Gardens, Fla. It consists of the tag, which is a smart label with an integrated passive transponder, along with a printer, an encoder and a RFID reader. Here's how it works: The patient's name and surgical site are printed on the SurgiChip tag. The inside of the tag is encoded with the date of surgery, type of procedure and name of surgeon. The tag is scanned with a desktop RFID reader for confirmation by the patient and is then placed in the patient's hospital file. On the day of surgery, the tag is removed from the file and scanned again, and the encoded information is verified by the patient. The tag, which has an adhesive backing, is then placed on the patient's body near the surgical site. In the operating room, the tag is again scanned and the encoded information is verified with the patient's chart. The tag is removed just before surgery and returned to the patient's hospital file. FDA cleared the device for marketing based on a review of safety, effectiveness and software validation information submitted by the manufacturer. " ...

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

RFID Electronic Pedigree for Drugs ...

From DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, 21 CFR Part 203, [Docket No. 1992N-0297] ...

... "To summarize, FDA has concluded that an electronic pedigree should accomplish and surpass the goals of PDMA and is potentially a more effective solution to tracing the movement of pharmaceuticals than a paper pedigree. As stated previously, it appears that industry will migrate toward and implement electronic track and trace capability by 2007. Therefore, to allow stakeholders to continue to move toward this goal, FDA has decided to delay the effective date of Sec. Sec. 203.3(u) and 203.50 until December 1, 2006. Before the effective date, FDA intends to evaluate the progress toward implementation of the electronic pedigree and its capacity to meet the intent of PDMA, and determine whether to further delay the effective date of the regulations or take other appropriate regulatory action." ...

FDA RFID FAQ's ...

From FDA's Counterfeit Drug Task Force Interim Report Questions and Answers ...

... "What is Radiofrequency Identification (RFID)? RFID is the placement of tiny electromagnetic tags on packages (or bottles, cases, and pallets) that transmit highly specific information about the contents of the package to an electronic receiver that in turn transmits the data to a database that keeps a record of the whereabouts of the package. RFID is currently undergoing testing to determine its feasibility, costs, and benefits in tracking and tracing the movement of drugs from the manufacturer to the dispenser." ...

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

Polymer RFID: XINK Laboratories Announces "InstaCure" Conductive Flexographic ...

From PR Newswire (press release) ... www.printelec.com ) on December 7. These new advanced polymeric formulations are targeted toward manufacturers and converters producing RFID tagged smart ...

... XINK Laboratories Ltd. of Ottawa, Canada ( http://www.xink.biz ) will launch its new line of InstaCure silver and carbon conductive flexographic printing inks at the Printed Electronics 2004 Conference in New Orleans ( http://www.printelec.com ) on December 7. These new advanced polymeric formulations are targeted toward manufacturers and converters producing RFID tagged smart packaging for use in supply-chain and pharmaceutical counterfeit protection, as mandated by Wal-Mart and, most recently, by the FDA. ...

The XINK™ approach to conductive ink provision is based on the understanding that at this pioneering stage of development for the Intelligent and Active Packaging industry there is no such thing as an "off the shelf product". XINK™ advanced conductive and resistive formulations allow printing of complex electronic circuitry, including flexible paper sensors (package security), sensor grids (smart pharmaceutical packaging), keypads (electronic paper diaries), and of course RFID antennas.

RFID Technology in Combating Counterfeit Drugs ...

From Report of the Food and Drug Administration ...

... "The adoption and common use of reliable track and trace technology is feasible in 2007, and would help secure the integrity of the drug supply chain by providing an accurate drug 'pedigree,' which is a secure record documenting the drug was manufactured and distributed under safe and secure conditions. Modern electronic technology is rapidly approaching the state at which it can reliably and affordably provide much greater assurances that a drug product was manufactured safely and distributed under conditions that did not compromise its potency. FDA has concluded that this approach is a much more reliable direction for assuring the legitimacy of a drug than paper recordkeeping requirements, which are more likely to be incomplete or falsified, and that it is feasible for use by 2007. Radiofrequency Identification (RFID) tagging of products by manufacturers, wholesalers, and retailers appears to be the most promising approach to reliable product tracking and tracing. Significant feasibility studies and technology improvements are underway to confirm that RFID will provide cost-reducing benefits in areas such as inventory control, while also providing the ability to track and trace the movement of every package of drugs from production to dispensing. Most importantly, reliable RFID technology will make the copying of medications either extremely difficult or unprofitable. FDA is working with RFID product developers, sponsors, and participants of RFID feasibility studies to ensure that FDA's regulations facilitate the development and safe and secure use of this technology. FDA is also working with other governmental agencies to coordinate activities in this area. b. Authentication technologies for pharmaceuticals have been sufficiently perfected that they can now serve as a critical" ...

Healthcare RFID: FDA Approves SurgiChip(TM) Solution -- Featuring RFID Technology ...

From Yahoo News (press release) ... FirstCall/ -- The Food and Drug Administration (FDA) today announced that SurgiChip(TM), a revolutionary radio frequency identification (RFID) solution that ...

... The Food and Drug Administration (FDA) today announced that SurgiChip(TM), a revolutionary radio frequency identification (RFID) solution that uses RFID printer/encoders and labels from Zebra Technologies (Nasdaq: ZBRA - News), has been cleared for marketing. The system embeds and prints information on an RFID "smart" label that travels with the patient into surgery to help prevent errors. Viewed as another vital safeguard to prevent wrong-site, wrong-patient and wrong-procedure medical errors, the SurgiChip can be programmed and used in many types of surgical procedures. ...

Zebra Technologies Corp. (Nasdaq: ZBRA) delivers innovative and reliable on-demand printing solutions for business improvement and security applications in 100 countries around the world. More than 90 percent of Fortune 500 companies use Zebra-brand printers. A broad range of applications benefit from Zebra-brand thermal bar code, smart label, receipt, and card printers, resulting in enhanced security, increased productivity, improved quality, lower costs, and better customer service. The company has sold nearly four million printers, including RFID printer/encoders and wireless mobile solutions, as well as software, connectivity solutions and printing supplies.

EPC RFID: EPCglobal US Supports FDA Initiative to Protect US Drug Supply ...

From Business Wire (press release), CA ... serving subscribers in the United States to help foster the adoption of the EPCglobal Network(TM) and leverage radio frequency technology (RFID) in the supply ...

... Addressing significant challenges facing the health and life sciences industries, such as counterfeiting, the EPCglobal Inc(TM) Healthcare and Life Sciences Business Action Group has made the tracking and tracing of pharmaceutical pedigree a top priority in the development of Electronic Product Code(TM) (EPC) technology. Today's announcement by EPCglobal US, an affiliate of EPCglobal serving subscribers in the United States to help foster the adoption of the EPCglobal Network(TM) and leverage radio frequency technology (RFID) in the supply chain, comes on the heels of the U.S. Federal Drug Administration's (FDA) announcement of a new initiative designed to protect the U.S. drug supply chain from counterfeit products. ...

EPCglobal is leading the development of industry-driven standards for the Electronic Product Code™ (EPC) to support the use of Radio Frequency Identification (RFID) in today’s fast-moving, information rich trading networks. The EPCglobal Network is an enabling technology that will transform the global supply chain through a new, open global standard for real-time, automatic identification of items in the supply chain of any company, in any industry, anywhere in the world. The EPCglobal Network was developed by the Auto-ID Centre, a global research team directed through the Massachusetts Institute of Technology with labs around the world.

FDA RFID Compliance: McKesson Supports FDA Compliance Policy on Radio Frequency ...

From Business Wire (press release), CA ... NYSE:MCK) today announced its strong support for the US Food and Drug Administration's initiative employing Radio Frequency Identification (RFID) technology to ...

... McKesson Corporation (NYSE:MCK) today announced its strong support for the US Food and Drug Administration's initiative employing Radio Frequency Identification (RFID) technology to create an electronic pedigree for pharmaceutical products. By using RFID technology to create an "electronic pedigree" -- a sort of living history of when and where the product was manufactured, its expiration date, when it was shipped, as well as its intended destination -- drugs can be tracked from factory to pharmacy, greatly reducing the chances of counterfeit products making their way into the supply chain. In addition, RFID tagging will allow for more rapid and accurate recalls, improve distributors' operational efficiencies and assist manufacturers, distributors, retailers and institutions in managing their inventories. ...

McKesson Corporation, ranked 16 on the Fortune 500, is a healthcare services and information technology company dedicated to helping its customers deliver high-quality healthcare by reducing costs, streamlining processes and improving the quality and safety of patient care. Over the course of its 170-year history, McKesson has grown to provide pharmaceutical and medical-surgical supply management across the spectrum of care; healthcare information technology for hospitals, physicians, homecare and payors; hospital and retail pharmacy automation; and services for manufacturers and payors designed to improve outcomes for patients.