FDA finalizes UDI system to identify medical devices
The U.S. Food and Drug Administration announced a final rule for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices.
The UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The
FDA has worked closely with industry, the clinical community and patient and consumer groups in the development of this rule.
The UDI system consists of two core items. The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier will also include production-specific information such as the product’s lot or batch number, expiration date, and manufacturing date when that information appears on the label.
The second component is a publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID) that will serve as a reference catalogue for every device with an identifier. No identifying patient information will be stored in this device information center.
The FDA plans to phase in the UDI system, focusing first on high-risk medical devices. Many low-risk devices will be exempt from some or all of the requirements. Once fully implemented, the UDI system rule is expected to have many benefits for patients, the healthcare system and the device industry. It will enhance the ability to quickly and efficiently identify marketed devices when recalled, improve the accuracy and specificity of adverse event reports and provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion. It will also offer a clear way of documenting device use in electronic health records and clinical information systems.
The FDA issued the proposed rule requesting input from industry, the clinical community and patient and consumer groups on July 10, 2012. The UDI system builds on current device industry standards and processes, and reflects substantial input from the clinical community and the device industry during all phases of its development. In addition, the FDA worked to reduce the burden on industry by building upon systems already in place. The UDI system is a key component of the National Medical Device PostMarket Surveillance System proposed in eptember 2012.
In general, high-risk medical devices (Class III) will be required to carry unique device identifiers on their label and packaging within one year and this number and corresponding device information must be submitted to the new database. Manufacturers will have three years to act for most Class II (moderate risk) devices. Manufacturers of Class I devices not exempt from UDI requirements will have five years to act. The rule may be accessed at www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM368961.pdf
Why healthcare needs the cloud
Cerner, Epic dominate EMR vendor market share
Electronic medical record systems (EMRs) from Cerner and Epic capture more than three-fourths of new large-hospital EMR contracts, according to a new KLAS report that examines the most widely purchased EMRs by acute care hospitals with more than 200 beds. Systems from Allscripts, McKesson, MEDITECH and Siemens are also included in the research.
The report, “Clinical Market Share 2013: More than Meaningful Use,” focuses on which vendors are capturing the most market share in the large-hospital space and which ones are struggling. Reasons behind the wins and losses are also profiled, as are usability and provider satisfaction.
“The HITECH Act that started this mass migration is clearly not over,” says report author Colin Buckley. “There are over 400 large hospitals that still do not utilize a currently marketed EMR and thus still face a decision. The question is, which way they will go, and which factors will guide that decision?”
Read more about the report at
Airstrip, Samsung partner for mHealth
AirStrip recently announced a strategic partnership with Samsung for the development and optimization of AirStrip ONE on Samsung tablets with Android and Windows 8.1 operating systems, as well as convertible and all-in-one desktop and laptop PCs with touch screens.
AirStrip ONE, unique in its ability to present clinicians with medical device and patient monitoring data along with historical and EMR data, was unveiled earlier this year. Dignity Health, a San Francisco-based health system with more than 300 care sites in 17 states, was its first implementation. Samsung will also support the development of a host of innovative AirStrip ONE features to be optimized on Samsung devices.
AirStrip is one of the first enterprise clinical mobility solution providers to join the Samsung Enterprise Alliance Program (SEAP) as a Gold Partner. SEAP is an ecosystem that supports partners in developing and providing the best customer experience for enterprises.
Learn more at www.airstrip.com.
Med students shed light on the future of care
What do the medical students of today think about patient-centered care, where patients and families are involved in treatment and decision-making? They’re (mostly) all for it, according to the eighth annual “Future Physicians of America” survey conducted by Epocrates, an athenahealth company. Seventy-two percent of medical students said they are likely to practice patient-centered care, cultivating solid and effective physician-patient relationships that aim to drive superior patient outcomes.
More than 1,000 medical students, representing all 50 U.S. states, shared their opinions about topics impacting the medical profession in the survey. Other key findings include:
• ACA: Both good and bad. Medical students indicated that the Affordable Care Act (ACA) will have both a positive and negative impact on the practice of medicine. Many anticipate that the ACA will result in practicing more preventative care (46 percent) and will offer expanded patient coverage (45 percent). However, students worry that they will have less time with patients (52 percent) and will lose clinical autonomy (34 percent).
• What’s an ACO? Despite being major emerging trends in healthcare, medical students are still perplexed when it comes to accountable care organizations (ACOs) and meaningful use. In 2011, 76 percent of students felt uninformed about ACOs, and two years later, they still feel they do not know enough about the topic (72 percent). Only 28 percent of students feel informed or somewhat informed about ACOs and meaningful use.
• Medical schools fail to prepare students for practice management. Only 17 percent of students plan to go into solo or partnership practice. One factor may be the lack of preparedness. Thirty-seven percent of medical students expressed dissatisfaction with the training they are receiving in practice management and ownership – business skills critical to the successful running of any healthcare enterprise – and 41 percent indicated they lack instruction in billing and coding.
Read more about the survey results at