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U.S. Department of Health and Human Services

MedSun: Newsletter #10, December 2006

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Newsletter #10, December 2006

Articles

CDRH Announces Medical Device Postmarket Transformation Initiative

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The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has announced that it is taking steps to increase its ability to identify, analyze, and act on postmarket information in order to improve the safety and effectiveness of medical devices and radiation-emitting products. In January 2006, the Center convened a senior leadership team, the Postmarket Transformation Leadership Team (PTLT), which included external medical device experts.

The team’s charge was to "evaluate the recommendations in the CDRH document ‘Ensuring the Safety of Marketed Medical Devices – Executive Synopsis and Recommendations’ (January 2006); collect additional data as necessary; supplement the recommendations, if needed; and propose a prioritized implementation plan for a transformed postmarket process."

The report recommendations elaborated on the four areas designated for improvement in the previous postmarket reports. They are:
•Create a Culture of Collaboration
The Center should transform its operations by adding a permanent matrix of crosscutting product-related groups over the current functionally based organizational structure to foster information sharing, collaboration, and, ultimately, more effective public health promotion and protection. The crosscutting matrix is designed to ensure that collaboration occurs not just in crisis situations, but also as a part of routine, day-to-day operations.
•Develop World-Class Data Systems
Data input, mining, analysis, and tracking systems should be strengthened, improved, or created as needed for postmarket issues. Improvements to the Center’s critical medical device data and information systems, including MAUDE and the MDR system, are highlighted, as is pursuing additional enhancements to enhance the Center’s analysis and tracking capabilities.
•Enhance Risk/Benefit Communication Efforts
CDRH should be a trusted, publicly identifiable source for safety information about medical devices and radiation-emitting products. To that end, an analysis of the communication needs of CDRH stakeholders should be performed, and a process for the development and dissemination of risk-benefit information should be done in collaboration with clinical practitioners and professional communities.
•Collaborate on Enforcement Strategies and Outcomes
Both the quantity and the quality of Center/Office of Regulatory Affairs (ORA) interactions should be transformed through increased collaboration among CDRH, ORA, and the Office of Chief Counsel (OCC). Postmarket data and information should be considered when prioritizing inspections, and the inspection preparation process should include a review of recent postmarket data. CDRH should develop ways to leverage the audit results obtained by accredited third-party auditing bodies. Enforcement data systems should be updated, and employees trained to use them. All available enforcement tools should be used, including civil money penalties.

Immediate priority actions were identified by the PTLT. They are to:
•Create a matrix of collaborative product groups to complement the largely functional organization of the Center
•Develop metrics and methods for tracking the handling of postmarket issues
•Pursue the development of unique identifiers (UDI) for medical devices
•Propose mandatory electronic MDR reporting
•Revise and update the MAUDE system, and expand the premarket data-warehousing project to include postmarket needs
•Increase the quality and quantity of Center/ORA/OCC interactions
•Develop and implement a risk-communication strategy
•Design a pilot project to test the usefulness of quantitative decisionmaking methods for medical device regulation across the total product life cycle
•Enhance the utility of MedSun programs.

Additional Information:

additional information on the issue of postmarket operations
http://www.fda.gov/cdrh/postmarket/mdpi.html

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FDA Convenes Advisory Panel Meeting To Assess Safety of Drug-Eluting Stents

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FDA convened a public meeting of the Circulatory System Devices Advisory Panel December 7–8 to discuss the safety of drug-eluting stents (DES). FDA has been closely monitoring DES since they came to the U.S. market in 2003 and 2004. Recent data have suggested a small but significant increase in late stent thrombosis in patients treated with DES. This panel of outside experts was brought together to assist the agency in the review and analysis of the available scientific data regarding the incidence and timing of stent thrombosis and the appropriate duration of treatment with clopidogrel bisulfate (Plavix®). Clopidogrel is the drug used in combination with aspirin to reduce and prevent clotting in both DES and bare metal stents (BMS) patients. FDA will post the advisory panel’s findings and recommendations on the Web site, but, in the meantime, patients should be aware of the importance of adhering to the recommended duration of antiplatelet therapy to reduce the risk of stent thrombosis. Also, patients should be advised to address concerns about their DES with their physicians.

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Study Finds Angioplasty/Stents Beneficial Only Within 12 Hours of Heart Attack

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The New York Times (November 14, 2006) has reported on a new study that challenges the conventional wisdom on when to conduct angioplasty in the setting of a heart attack. “Opening a blocked artery with balloons and stents can be lifesaving in the early hours after a heart attack,” writes Denise Grady, “but a new study concludes that it often does no good if the heart attack occurred more than 25 hours ago.”

Results of a clinical trial that measured the effectiveness of angioplasty and heart stents in 2,166 patients at 217 hospitals in the United States and abroad should change medical practice, researchers say, and may affect up to 50,000 patients a year in this country. Dr. Judith S. Hochman, director of the cardiovascular clinical research center at New York University medical school and leader of the study, presented findings from the 3-year clinical trial to the November 14 meeting of the American Heart Association. The New England Journal of Medicine published the results online and will cover the story in its December 7, 2006, issue.

The National Heart, Lung, and Blood Institute of the National Institutes of Health, which helped pay for the research, reports that about a million angioplasties are performed in the United States each year. The Times notes that Dr. Hochman emphasizes that “angioplasty is still the best treatment for many … patients who get to the hospital … within 12 hours of the onset of the attack. For them, (angioplasty) can restore blood flow and reduce damage to the heart muscle.

After 12 hours, however, it is too late to save the muscle.”

Additional Information:

Ms. Grady’s article appears in full at The New York Times Web site
http://www.nytimes.com/2006/11/14/science/15heartcnd.html

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AHRQ and Department of Defense Release New Team Training Tool for Health Care Settings

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November 2, 2006

The Department of Health and Human Services Agency for Healthcare Research and Quality (AHRQ) and the Department of Defense military health system today released TeamSTEPPS, a new evidence-based team training and implementation toolkit that demonstrates techniques of effective communication and other teamwork skills. The new toolkit, which responds to the Institute of Medicine's call for "interdisciplinary team training programs that incorporate proven methods for team management" to prevent medical errors, is designed to optimize team performance and outcomes across the health care delivery system.

"Patient safety is a national priority and one of AHRQ's most important commitments," said AHRQ Director Carolyn M. Clancy, M.D. "Our goal is to share this important new tool with every health care facility in America to help them create—and continue—team training systems." "The collaborative development of TeamSTEPPS is itself an example of teamwork," noted David Tornberg, M.D., Assistant Secretary of Defense for Health Affairs. "AHRQ and the Department of Defense have joined forces to bring a much-needed product into the public domain. We want to see TeamSTEPPS used in both military and community health settings." TeamSTEPPS is presented in a multimedia format, with tools to help a health care organization plan, conduct, and evaluate its own team training program. It includes the following components:
•An Instructor Guide that explains how to conduct a pre-training assessment of an organization's training needs, how to present the information effectively, and how to manage organizational change. The guide also provides an evidence base for each lesson.
•PowerPoint™ presentations that convey basic TeamSTEPPS principles.
•A DVD that contains nine video vignettes that show how failures in teamwork and communication can place patients in jeopardy and how successful teams can work to improve patient safety.
•A spiral-bound pocket guide that summarizes TeamSTEPPS principles in a portable, easy-to-use format.
•A CD-ROM that contains files of all print materials so that users of TeamSTEPPS can adapt the presentations to reflect their institutions' particular situations.
•A 17' x 22' poster to announce TeamSTEPPS activities in a heath care organization. TeamSTEPPS leverages more than 20 years' research on team performance in the military and in industry. It has been field-tested extensively in military and civilian health care facilities. Designed for high-stress situations such as hospital emergency departments, critical care units, operating rooms, and obstetrical suites, the curriculum can be tailored to any health care setting where communication and teamwork are important, including physicians' offices and ambulatory clinics.

The TeamSTEPPS tools can be viewed on the Web site of the Uniformed Services University of the Health Sciences. Single copies of the CD-ROM and DVD, the poster, and the pocket guide can be obtained free of charge from the AHRQ Publications Clearinghouse by sending an e-mail to AHRQPubs@ahrq.hhs.gov, or using the ordering form on the AHRQ Web site.

DVD, and printed materials in a 3-inch loose-leaf binder, are also available from the AHRQ Publications Clearinghouse, on a single-copy basis, at cost. Information on how to obtain multiple printed copies of TeamSTEPPS materials can also be found on the AHRQ Web site.

Additional Information:

The TeamSTEPPS tools can be viewed on the Web site of the Uniformed Services University of the Health Sciences
http://www.usuhs.mil/cerps/teamstepps.html

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FDA Deputy Commissioner Gottlieb Addresses FDA/CDRH on Risk Communication

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Food and Drug Administration (FDA) Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D., opened the September 26, 2006, Center for Devices and Radiological Health (CDRH) Workshop on Risk Communication in North Bethesda, Maryland. Noting FDA’s fundamental role of information management, Dr. Gottlieb applauded FDA’s staff as world-class in collection and analysis of data, understanding the risks and benefits posed by medical products, and providing recommendations on appropriate product use. “But,” he added, “when it comes to providing the information needed to help consumers make everyday choices and decisions about the health care products that they use, our analysis is only as valuable as our ability to effectively communicate it.”

For too long, according to Dr. Gottlieb, attention was focused on improving the hard sciences without working to advance the social sciences, particularly as regards risk communication. In the case of devices, for example, FDA must rethink the recall language “…as the complexity of the products that we regulate increases and the nature of the incremental innovation inherent in medical devices becomes an even more iterative process.” “What is the best way to communicate this information to patients and providers so they can most effectively incorporate this fundamental nature of device complexity into their decisions to use a medical product?” he asked.

Dr. Gottlieb then reviewed FDA’s application of new resources and new approaches to risk communication, including increased accessibility of senior scientific and medical staff during important safety-related announcements, media conference calls, direct outreach to physician groups, and provision of regular public health advisories. The growing complexity of FDA’s work and the concomitant communication demands are a challenge for the agency, which is increasingly called upon to discuss issues that are still under investigation. Full information must be available for patients and care providers on medical products, so FDA will develop communication means that carefully “calibrate the language and the tools” used to discuss risks involved in products or information.

“Overwarning about risk can be as dangerous as underwarning, by discouraging the safe use of medical products that we know have proven benefits. The exercise of speaking about these interim risks and unsettled science requires the agency to constantly strike to achieve clarity, candor, and humility in all of its communications,” said Dr. Gottlieb.

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Remote Monitoring Changes Lives

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Sophisticated new remote-monitoring systems are now allowing thousands of patients with chronic diseases such as heart failure, diabetes, and depression to have their conditions monitored on a regular basis as they go about their daily lives rather than in visits to their physicians’ offices. Barnaby J. Feder, writing in The New York Times (Business Section, September 9, 2006), reviews the health care ramifications of technologies being developed by medical device companies such as Medtronic, Boston Scientific, and Abbott Laboratories. These remote-monitoring devices are able to regulate heart rate and deliver shocks when necessary; provide wireless Internet communication between patients and their doctors; monitor blood pressure, weight, and glucose levels; and alert patients and physicians about lung and circulatory problems.

Mr. Feder reports that although the “main use of the data gathered by the newest devices is to reconstruct events that send patients to emergency rooms,” the “payoff for patients could be more effective use of drugs, fewer and shorter hospital stays, and longer stretches between routine visits to physicians’ offices.” He warns, however, that “the industry’s vision of an electronic healthcare network that never sleeps is a long way from reality. Even leading-edge systems … currently fail to provide a comprehensive picture of chronic diseases.” In addition, many physicians face a “pragmatic financial concern about gathering and reviewing remote data because many insurers are providing little or no reimbursement for such work.” Relying on data collection services run by the device companies and independent monitoring services only compounds this concern. The medical community fears “that plaintiffs’ lawyers will try to pin legal responsibility for recognizing warning signals on them, no matter who is collecting the data.”

Additional Information:

The complete text of Barnaby Feder’s article is available at The New York Times Web site
http://www.nytimes.com/2006/09/09/business/09node.html

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Hospitalists Replacing Family Physicians in Inpatient Care

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“Hospitalists,” physicians who specialize in caring for patients while they are in the hospital, are increasingly taking the place of private-practice physicians in providing care to hospitalized individuals. Anne Geggis, writing in the Daytona Beach (Florida) News-Journal (October 23, 2006), reports that some family practice physicians no longer perform hospital rounds, and that some hospitals in the United States have stopped allowing offsite primary care physicians to see patients in those hospitals. Increased costs and decreasing insurance reimbursements are given as explanations for the trend. The News-Journal piece cites Managed Healthcare Executive, an industry publication, in predicting a total of 30,000 hospitalists nationwide by 2010. The 2005 total of about 15,000 hospitalists represented an increase of more than 18 times the number in practice in the mid-1990s. Although the trend “lends greater efficiency to the entire medical system, whether or not this change improves patient care is still an unanswered question,” concludes Ms. Geggis.

Additional Information:

The complete article is available for a fee ($2.95) at the News-Journal’s Web site:
http://www.news-journalonline.com/search/

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CMS Planning To Incorporate Quality Measures for Outpatient Care in 2009

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In a November 1, 2006, announcement, the Centers for Medicare & Medicaid Services (CMS) unveiled changes to policies and payment for outpatient services. According to the statement, “In order to promote greater value in the purchase of hospital outpatient services for Medicare beneficiaries, the final rule ties OPPS [outpatient prospective payment system] rate increases to the reporting of quality measures beginning in 2009. The final rule announces CMS’ plans to develop additional quality measures that are specifically appropriate for hospital outpatient care, and will require hospitals to report the outpatient-specific measure beginning in CY [calendar year] 2009.”

Said CMS Acting Administrator Leslie V. Norwalk, Esq., “In this final rule, we are taking one more step toward rewarding hospitals for providing quality care, not just in the inpatient setting, but also in the outpatient department. While our primary focus is on quality care for Medicare beneficiaries, we expect that our quality initiatives will stimulate better care for all patients who come to the hospital outpatient department.”

Additional Information:

CMS Planning To Incorporate Quality Measures for Outpatient Care in 2009 Press Release
http://www.cms.hhs.gov/apps/media/press/release.asp?Counter=2042

The final rule is posted at
http://www.cms.hhs.gov/HospitalOutpatientPPS/01_overview.asp

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Updated December 1, 2006

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