BIRMINGHAM, Ala.--(BUSINESS WIRE)--Aug 28, 2012--The coming mandate for Unique Device Identification (UDI) Systems for medical devices has left some providers wondering if they’re truly ready. The answer, if they’re already using a tracking solution like IMS ReadyTracker®-Tissue, is yes.
FDA recently released the proposed rule for UDI systems, (UDI), unleashing a flood of questions from healthcare providers.
“IMS ReadyTracker software already enables facilities to track any medical device or implant by serial or lot number, and to tie it to the patient,” said IMS Software Manager Kathy Mitchell. “In addition, ReadyTracker’s built-in recall functionality already helps facilities track and manage recalls and adverse events.” With certain exceptions, the proposed rule would require a UDI to include a device identifier, which is a unique numeric or alphanumeric code specific to a device model; and a production identifier, which includes a device’s current production information.
ReadyTracker software utilizes ISBT 128 barcoding, the standard the American Association of Tissue Banks is using for most North American tissue banks. “With our upcoming release, ReadyTracker will be offering GS1 formatted linear and the Two-Dimensional Symbol Label Design,” said Mitchell “We also offer consulting services to get your business up to date with UDI, including analysis of your inventory, creating labels, and a variety of services that will help you comply with the new guidelines.” The transition to UDI will offer numerous benefits for facilities and patients, including: More accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly. Reduced medical errors, with health care professionals and others enabled to rapidly and precisely identify a device and obtain important information concerning its characteristics. Consistent methods for entering information about devices in electronic health records and clinical information systems. A standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls. A foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies. Said Mitchell, “The IMS software team actively participates in the North American Tissue Technical Advisory Group and FDA User Conferences, to ensure that ReadyTracker users remain up-to-date on technical and regulatory changes.” To learn more, register for a free UDI Compliance session from IMS. Email email@example.com About IMS (Integrated Medical Systems International, Inc.): IMS provides surgical device and instrument management, as well as clinical consulting, for more than 2,500 healthcare facilities nationwide. With facilities in Alabama, Florida, Maryland, and Arizona, IMS provides instrument and device inventory management; real-time online data and tools to track instruments, tissue and implants; restoration of instruments to manufacturers' performance standards; and on-location clinical personnel to manage sterile processing and interface with the OR. To learn more, visit www.imsready.com.CONTACT: IMS Ready Whitney Ligon, 205-414-6869 firstname.lastname@example.org KEYWORD: UNITED STATES NORTH AMERICA ALABAMA INDUSTRY KEYWORD: SURGERY TECHNOLOGY DATA MANAGEMENT SOFTWARE HEALTH MEDICAL DEVICES SOURCE: Integrated Medical Systems International, Inc. Copyright Business Wire 2012 PUB: 08/28/2012 04:40 PM/DISC: 08/28/2012 04:40 PM http://www.businesswire.com/news/home/20120828006609/