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U.S. Department of Health and Human Services

MedSun: Newsletter #5, June 2006

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Newsletter #5, June 2006

Articles

FDA Announces CDRH Medical Device Innovation Initiative

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The Food and Drug Administration (FDA) has responded to the accelerating pace of medical invention with announcement of the Center for Devices and Radiological Health (CDRH) Medical Device Innovation Initiative. Over the next decade, medical technology innovations will fundamentally transform the health care and delivery systems, providing new solutions with medical devices that will challenge existing paradigms and revolutionize the way treatments are administered. The CDRH Initiative follows the FDA goal of protecting and promoting public health by working to ensure timely access to safe and effective innovative medical devices.

The Initiative includes three major areas of concentration: (1) promoting scientific innovation in product development, (2) focusing device research on cutting-edge science, and (3) modernizing review of innovative devices. CDRH intends to provide regulatory clarity by releasing guidance documents for innovative products, which will not only help guide developers of specific products but will also serve as templates for similar products in the pipeline. In collaboration with industry, the clinical community, and health research foundations, CDRH is modernizing the science for developing and evaluating new medical devices, particularly for areas of unmet clinical needs such as pediatrics. The agency is focusing as well on expanding and improving communications with its stakeholder groups, including updating its device recall procedures.

CDRH scientists are addressing challenging scientific issues that arise in considering new medical device technologies. Among these is the development of new models and methods for assessing computer-assisted diagnostic systems, which has greatly aided developers of these innovative imaging and CAD-assist devices. Laboratory staff involvement can help reduce the cost and time required to demonstrate the safety and effectiveness of new innovative technologies, thereby fostering their development and speeding patient access to these products.

In modernizing the review of innovative devices, CDRH has instituted an ongoing quality review program for premarket submissions that evaluates the quality of the agency’s scientific review in several key scientific areas. It has recently completed its first round of quality reviews in biocompatibility, sterilization, and statistical analysis, crosscutting areas that are common to many medical device submissions, and has developed milestones and improved management and oversight for the review of premarket submissions. Crosscutting and process-oriented guidances, which should facilitate and improve the consistency of the review process, are also being developed.

CDRH is undertaking a number of initiatives that leverage the use of modern information technology to improve patient safety and make the development process more efficient. In addition, the agency is using the resources made available through the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) to expand its access to outside experts with current knowledge of the latest technological and clinical advances.

Additional Information:

The complete text of the FDA announcement is available at:
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHInitiatives/ucm118252.htm

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Of Special Interest for Long-Term Care Facilities

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Long-term care facilities, whose elderly and often frail residents on average are prescribed more than six concurrent drug therapies, are especially vulnerable to serious adverse drug events. The Canadian Medical Association Journal (CMAJ) has highlighted a software application that is being used with success in acute care facilities to improve drug safety and that may have particular importance in long-term care. Computerized physician order entry (CPOE) with clinical decision support (CDS) is a system in which physicians enter patient prescriptions directly into a computer and receive immediate feedback about clinically important information that may improve their prescribing decisions. Specifically, an automated interface links the newly ordered drug therapy to clinical, drug, and laboratory information in a way that guides prescription decisions in the direction of increased safety and ultimately reduces the medication errors that lead to adverse events.

Most prescribing errors are made at the ordering and monitoring phases of the process of pharmacotherapeutic care. The staffing structure at long-term care facilities—limited access to physician time and relatively few registered nurses on staff—may contribute to the problem. CPOE-CDS implementation in these settings appears to be a logical next step. The fact that the number of long-term care beds exceeds those in acute care facilities underscores the importance of accessing CPOE systems to reduce adverse drug events among the long-term patient population.

The CMAJ authors are aware of two long-term care facilities, in Toronto and Connecticut, that have CPOE-CDS systems in place and could serve as models for other long-term care settings as they develop their systems. CPOE systems will need to build on the limited technological infrastructure that exists in many long-term care facilities, starting with finding ways to link the provider, pharmacy, and laboratory systems. Smaller long-term care providers are often part of larger organizations that work with a defined group of pharmacies and laboratories, which would allow the creation of CPOE-CDS systems across entire organizations.

Additional Information:

The complete CMAJ article can be read at
http://www.cmaj.ca/cgi/content/full/174/1/52

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NEJM Reviews Guidant Defibrillator Malfunction Report

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The New England Journal of Medicine (NEJM) on June 1, 2006, published the observations of several members of the independent panel created by Guidant Corporation to examine the company’s actions regarding the potentially fatal malfunctions of its implantable defibrillators. Panel members were asked to conduct an unbiased examination of the methods used to identify malfunctions and evaluate products in the postmarketing phase, and of policies regarding communication within Guidant and with physicians and patients. Recommendations for corrective actions were also requested.

Guidant has made the panel’s report available to the public, and the results of a concurrent study by a task force convened by the Heart Rhythm Society are available as well.

Additional Information:

Links to both of these documents, and the complete text of the article referenced above, can be found at
http://content.nejm.org/cgi/content/full/354/22/2309

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Physician Access to Health Information Technology Has Increased

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The Kaiser Family Foundation’s Kaisernetwork.org Web site reports on findings recently announced by the Center for Studying Health System Change (HSC) on physician access to health information technology (IT) from two telephone surveys. HSC, the Washington, D.C.-based, nonpartisan health policy organization, reported on physicians’ ability to employ IT to carry out five clinical functions: obtaining clinical guidelines, accessing patient information, writing prescriptions, exchanging clinical data and images with other physicians, and generating task reminders. HSC reviewed responses from members of the American Medical Association and the American Osteopathic Association in telephone surveys conducted with 12,000 physicians in 2000–2001 and more than 6,600 physicians in 2004–2005. HSC reported that doctors’ IT access to four of the five functions nearly doubled over the past 4 years. About 65 percent of respondents in the 2004–2005 survey said they had access to IT that can provide clinical guidelines, compared with 52.9 percent in the 2000–2001 survey, and approximately 21 percent of respondents in the 2004–2005 survey said they had IT capability to write prescriptions, compared with 11.4 percent in the earlier survey. Nearly 17 percent of doctors contacted in the 2004–2005 survey said they did not have access to IT to assist in any of the aforementioned clinical functions, and 20 percent reported having access to IT that can perform one of the functions.

Additional Information:

More information on the study is available in the Kaiser Network Daily Health Policy Report at
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=37768

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Providers' Treatment of Medical Errors Wrongly Charged to Medicare, Lawsuit Alleges

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Lawsuits in several States have been filed over allegations that a number of hospitals improperly billed Medicare for treatment of illnesses or injuries that resulted from medical errors. The story was reported on the Kaiser Family Foundation’s Web site, Kaisernetwork.org.

Kaisernetwork.org also reports that Mark McClellan, administrator of the Centers for Medicare & Medicaid Services (CMS), said that Medicare should not have to reimburse hospitals for treatment of injuries or illnesses caused by 27 categories of medical errors or so-called “never events.” This listing of medical errors was developed by the National Quality Forum with support from CMS. For complete details about “never events,” which CMS describes as serious and costly errors in the provision of health care services that should never happen, go to the CMS Web site.

Additional Information:

To read the full story go to
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=37763

For complete details about “never events” go to
http://www.cms.hhs.gov/apps/media/press/release.asp?Counter=1863

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DS-X Device Safety Exchange, a MedSun Program

DS-X Lessons Learned

Question of the Month with Comment

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Question:
We are having difficulty getting parts for a discontinued device. Is the original equipment manufacturer (OEM) required by law to provide service parts for 7 years from the date of last manufacture?

Comment:
There is no requirement under FDA regulations for an OEM to continue to provide service parts or service for devices once they are in the consignee’s (customer’s) possession. Issues of service and parts should be addressed in the contract for the purchase and sale of the product. A requirement to provide service and parts is a contract issue, not a regulatory issue.

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Updated June 1, 2006

Return to MedSun: Medical Product Safety Network

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