Rule would establish unique identifier system for medical devices   07/03/2012
The Food and Drug Administration today issued a proposed rule implementing a 2007 statutory requirement to establish a unique device identification system for medical devices. The rule would phase in, over seven years, a requirement that many device labels and packages include a unique device identifier based on international standards. Under the rule, some devices would need to be marked directly with the UDI, such as those that are implanted or are likely to become separated from their labeling. Each UDI would be provided in both plain-text and in a form that uses automatic identification and data capture technology, such as a barcode. In addition, information about each device would be submitted to a public database maintained by the FDA. Hospitals and other health care providers could use the UDI to more easily track devices and manage safety recalls, but are not required to do so. FDA said the system would reduce medical errors and help identify and correct problems relating to a particular device sooner. It will accept comments on the rule for 120 days after publication in the Federal Register, expected this week. AHA has long supported development of a UDI, and will provide a regulatory advisory on the proposed rule to members in the coming weeks.
States receive hospital, public health preparedness grants   07/03/2012
The Department of Health and Human Services yesterday awarded $352 million to states, territories and metropolitan areas for the Hospital Preparedness Program in fiscal year 2012, and $619 million for the Public Health Emergency Preparedness program. HHS has been working since December 2010 to align the two programs to support complementary preparedness capabilities and performance measures. While they remain separate programs, they are now both administered by the Centers for Disease Control and Prevention and have the same application and grant cycle. "The integration fostered by HPP and PHEP alignment is important in streamlining and strengthening the day-to-day relationships and cross-sector cooperation that are critical to achieving a resilient health system ready to face any health hazard and capable of providing the affordable, high-quality daily care that all Americans deserve," said Nicole Lurie, HHS assistant secretary for preparedness and response.
ACGME begins testing new system for residency programs    07/03/2012
The Accreditation Council for Graduate Medical Education this month will begin testing the site visit process for its new outcomes-based accreditation system for graduate medical education. Over the next several months, ACGME will work with several teaching hospitals that have volunteered to test the Clinical Learning Environment Review process before it launches in late September. Once implemented, the process will affect roughly 900 hospitals and require medical residents and fellows to demonstrate competency is six core areas: patient care, medical knowledge, practice-based learning and improvement, systems-based practice, professionalism, and interpersonal skills and communication. In addition, teaching institutions will be required to develop specific learning outcomes and document each resident's accomplishments in meeting benchmarks for physician competence. For more on the site visit process, visit www.acgme-nas.org/cler.html.
Reminder: Schedule H Project for tax-exempt hospitals reopened   07/03/2012
The AHA encourages hospitals to participate in year two of its Schedule H Project by submitting a copy of their 2010 Schedule H forms to a secure Ernst & Young website, available through Sept. 15. Participants in the project will receive a report summarizing the response of similar hospitals to questions such as total community benefit levels and percentages, bad debt expenses and community building activities. No participant's name or identifying information will be disclosed as part of any feedback or report. AHA will use the gathered information to advocate for needed improvements to Schedule H and to oppose changes to Schedule H or tax exemption based on misinformation about hospitals' commitment to providing benefits to their community. For more on the Schedule H Project, contact AHA Member Relations at (800) 424-4301. To view last year's Schedule H benchmark report, based on 600 Schedule H forms representing nearly 900 hospitals, visit www.aha.org/ScheduleHBenchmark.