当前位置: 首页 > 新闻 > 信息荟萃
编号:10529641
无线传感器进入健康监护领域
http://www.100md.com 2003年12月28日
    

    Delivered by a specialized injection, the VeriChip is the first subdermal RF-based system designed for use in humans. The device, which is undergoing FDA approval, would be used as tool to obtain instantaneous access to patients medical histories with a simple scan. (Photo: Greg Whitesell)

    From patient care to pharmaceutical supply chains, RF sensors have made tremendous inroads into the realms of healthcare and biotech. No longer the premise of outlandish sci-fi novels, radio frequency identification (RFID) systems have galvanized the R&D community, federal regulatory agencies, and the public to debate and outline the benefits of this technology. The most common applications of RFID tags have been, for the most part, in the areas of anti-theft and animal tracking. Manufacturers have explored variations of its architecture, but the primary components of RFID systems have remained the same-- transceiver, a transponder (RF tag), and an antenna or coil.
, http://www.100md.com
    Brave new worldBiocompatible casings and decreased sizes have opened the door for these devices to penetrate different markets. Case in point, this past October, Palm Beach, Fla.-based, Applied Digital Solutions Inc., submitted a 510(k) application to the Federal Drug Administration (FDA) for their VeriChip. The chip, initially released in 2000, is the world抯 first subdermal RFID micro-chip, aimed at supplying healthcare professionals immediate access to a patient抯 entire medical history. The device is implanted via an injection, where the 12 mm x 2.1 mm chip takes up residence in the triceps area between the elbow and the shoulder of a patient抯 right arm.
, 百拇医药
    Each chip is programmed with a 16-digit ID number which is transmitted via an RF signal (125 kHz) to a handheld scanner, subsequently decoded, and authenticated in a database, which then downloads the patient抯 information to the reader.

    Last year, the FDA stated that the VeriChip is a regulated medical device "when marketed to provide information to assist in the diagnosis or treatment of injury or illness." The 510(k) document, often referred to as a "premarket notification submission," was the company抯 follow-up to the FDA抯 decision and is in the process of being reviewed for U.S. clearance.
, http://www.100md.com
    Manufacturers, such as Siemens and Leonhard Kurz,GmbH, are combining their efforts to create new polymer electronics which would serve as a backbone for RFID tag devices. (Photo: Siemens press picture)

    The U.S. may be behind in this process, however, as consumers in Europe have taken delivery of more than 400 VeriChip systems, while in Mexico, diabetes and heart patients have already had these transponders embedded.
, 百拇医药
    At AIM, Inc., Warrendale, Pa., the trade organization for the Association for the Automatic Identification and Data Capture Technologies (AIDC) industry, Dan Mullen, president, says that RF biosensors could become integrated with current biomedical devices as a means to monitor the devices?diagnostic performance.

    "Research is underway to develop RFID tags (transponder-based) as a method to identify implantable medical devices. This would allow positive identification of items such as artificial heart valves, pacemakers, replacement joints, etc., without invasive procedures," he adds.
, 百拇医药
    RF-based patient care has also prompted its use as an infant tracking system within hospitals. eXI Wireless Inc., British Columbia, Canada, has designed "smart" RF tags that transmit a pulsed signal every 16 sec to their infant tracking system, HALO. This system is connected to a hospital抯 floor plan to alert staff if a tag has been removed, or if an infant approaches within 7 m of a designated exit, or other unauthorized area. More than 300 U.S. facilities are now equipped with the HALO system. Alan Forster, president of eXI Wireless, adds that the federal government is initiating steps to increase the scope of this tool. "Rep. Sheila Jackson from Texas has introduced a bill that would require hospitals reimbursed under the Medicare systems to establish and implement security procedures to reduce the likelihood of infant abduction and baby switching," he says May I take your temperature?
, http://www.100md.com
    Earlier this year, the same company that delivered the VeriChip technology, was also granted FDA approval to market a similar RF biosensor with the added capability to measure and subsequently transmit a pet's body temperature. The device, called the Bio-Thermo chip, distributed by Digital Angel Corp., South St. Paul, Minn., is a battery-free RF tag which is implanted within a pet's neck area and activated by a designated scanner. The idea here is that owners and their vets will skip out on the unpleasantries of having your pet's temperature measured.
, http://www.100md.com
    "With this new technology, accurate temperature readings can be obtained by simply passing the company's proprietary handheld scanner over the animal or by having the animal walk through a portal scanner."

    The technology is slated for the U.S. commercial market next June and plans are to increase the breadth of its diagnostic capabilities to include sensing hormone levels, or in the long run, to detect specific viral pathogens.

, 百拇医药     More info: www.digitalangelcorp.com

    .

    From Patients to PackagesThis heightened level of activity has also impacted RF tag manufacturers. Bill Allen, communications manager for Texas Instruments (TI), says the company has produced more than 300 million RFID systems since 1990.

    Many of these systems have ended up as part of pharmaceutical supply chains or hospital inventories.
, 百拇医药
    Concepts such as the SecureCabinet from Mobile Aspects, Pittsburgh, Pa., are using RFID technology to automatically manage equipment and supply inventory. The system works by having hospital workers use their current magnetic-striped ID card or an RFID enabled card to access the cabinet. Proprietary software confirms the employee's level of access to the medicines before unlocking. Each supply is tagged with a TI ISO 15693 Tag it smart label, for which readers are supplied. Once an item is removed from the cabinet, the software requests a scan of all existing inventory, identifying all remaining items and noting which item was removed, by which staff member and at what timeno bar codes are used in this process.
, 百拇医药
    "The industry is moving away from point solutions using proprietary technology to integrated solutions based on open standards. Software and hardware providers and systems integrators are beginning to work more closely to implement enterprise-level solutions," says Allen.

    This shift in methodologies is reflected by organizations such as the Healthcare and Distribution and Management Association (HDMA), which has publicly held court about the use of RF sensors as a measure to ensure the integrity of drugs being shipped from pharmaceutical warehouses to pharmacies and hospitals alike. The HDMA Board, just recently, set a goal for pharmaceutical packagers and manufacturers to deploy RFID/Electronic Product Code technology at the selling unit level by 2007.
, http://www.100md.com
    Last month, the Dept. of Defense (DOD) also unveiled their new policy on RF sensors, stating that all DOD suppliers will now have to implement RF tags on all deliverables by January 1, 2005.

    Privacy & Profit

    Any technology, particularly those that deal with biotechnology and healthcare, is subject to stringent policies regarding their dissemination and applications. While there are no specific RF sensor guidelines, five U.S. Privacy Acts provide a framework for these sensors to follow. This number is sure to grow as the RF market expands and reaches its expected growth rate of $3 billion a year by 2008.
, http://www.100md.com
    Jeannette Mallozzi

    R&D, Reed Business Information, Morris Plains, NJEmail for more informationCompany's other productsEmail to a colleague, 百拇医药