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U.S. Department of Health and Human Services

MedSun: Newsletter #7, September 2006

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Newsletter #7, September 2006

Articles

FDA Seeking Comments on Use of Identifier System for Medical Devices: Identifier System Could Be Important Tool for Patient Safety

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In an August 9, 2006, news release, the FDA announced a 90-day public comment period for collecting information on the feasibility, utility, benefits, and costs of developing and implementing a unique device identifier (UDI) system for medical devices. The development of complex medical devices has grown rapidly, and it is important for FDA to identify new hazards and to work with industry and device users to manage risks appropriately.

In meetings with FDA over the past year, stakeholders broadly supported the development of a UDI system as a means of improving patient safety. Stakeholders recognize that such a system could likely provide better management of purchasing, distribution, and use of medical devices. Two reports commissioned by FDA from outside experts also identified potential advantages of a UDI system. FDA continues to work with Federal partners to understand issues associated with use of a UDI system. A public meeting is planned in the fall, and FDA will use the public comments to help the agency determine the next steps.

According to Daniel Schultz, M.D., Director of FDA’s Center for Devices and Radiological Health, “A unique device identifier system could have broad applications in reducing medical errors, facilitating device recalls, improving medical device adverse event reporting, and encouraging cost effectiveness by improving delivery and supply chain efficiency.”

Additional Information:

For this FDA news release, go to
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108708.htm

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Association for the Advancement of Medical Instrumentation (AAMI) Conference and Expo 2006 Presentation About MedSun Project

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Three perspectives on the MedSun Project and its impact on medical device safety were presented during the Association for the Advancement of Medical Instrumentation (AAMI) Conference and Expo 2006, which was held June 24–26, in Washington, D.C.

The first perspective was that of Terrie Reed, FDA MedSun Device Safety Program Manager, who discussed MedSun’s adverse event reporting function and provided an overview of past reporting methods and regulations. She reviewed the challenges faced by FDA with traditional health care facility medical device adverse event reporting and explained that the need to respond to these issues served as a basis for the MedSun Project. MedSun works to improve report quality by developing interactive relationships between MedSun sites and the FDA. This communication presents opportunities to focus on high-risk products, to follow products to market, and to raise awareness of design issues associated with human factors. Ms. Reed also covered future MedSun goals related to specific MedSun subprojects: HeartNet, which will focus on electrophysiology and cardiac catheterization laboratory products; LabNet, which will spotlight laboratory devices; and an effort under development that will concentrate on medical products used for pediatric care (KidNet).

A second point of view was expressed by Cheryl Spencer, a Biomedical Engineer with FDA's contractor for MedSun, Social & Scientific Systems, Inc. Ms. Spencer reviewed the MedSun Project objectives—to improve the likelihood of detecting device problems, to understand events in clinical settings related to device use, and to share device safety information with the clinical world. She then explained the administrative elements of MedSun reporting and provided details on how MedSun facilitates information flow between the FDA and users. Ms. Spencer described the secure online reporting system capabilities; presented an overview of the report sections; and offered examples of high-quality, complete reporting. She explained that MedSun includes manufacturers in the reporting process by forwarding a copy of each report to the specific manufacturers as appropriate. Each incoming report is reviewed by skilled MedSun staff, including registered nurses with expertise in cardiac surgery care, neonatal and pediatrics care, and intensive care; biomedical engineers with a wide range of device experience; and a physician.

Their critical reviews of reports received often lead to work with FDA specialists on development of safety tips, audioconferences, and articles for the MedSun News. In addition, certain reports are earmarked for discussion with specialists such as those at ECRI. Glenn Scales, Patient Safety Specialist in the Department of Clinical Engineering of Duke University Health System, presented a third perspective, that of an active, hospital-based MedSun Representative. He emphasized the benefits from MedSun, the importance of selecting appropriate staff to report online, and training reporters and other clinical staff in what information is needed for complete reporting. Mr. Scales identified several minor challenges encountered during start-up of his MedSun activities, including integrating voluntary reporting system data into MedSun.

To maximize use of the feedback MedSun provides to participating sites, Duke University Health
System now incorporates the MedSun News and the FDA Patient Safety News into a broadcast to various departments. Mr. Scales noted that another key benefit is having FDA device-specific recall information sent directly to the reporter, enabling reporters to quickly find items of interest.

He said he and his staff also appreciate the ease of online reporting; the access to all reports in a central location; and the ability to broadcast a question, concern, or success story using the MedSun Device Safety Exchange.

Following their discussions, the presenters engaged in a question-and-answer session with the audience. In addition to this formal presentation, MedSun project staff also had the chance to meet with AAMI members informally at the project exhibit.

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FDA STATEMENT August 10, 2006 Regarding JAMA Article on Recalls and Safety Alerts Affecting Automated External Defibrillators

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Automatic external defibrillators (AEDs) are important medical devices. Numerous studies have shown that thousands of lives are saved each year using these devices to treat patients in sudden cardiac arrest. In the past decade, these devices have become simpler to use and have been placed in more public places like airports and schools.

A recent article in the The Journal of the American Medical Association (JAMA) titled “Recalls and Safety Alerts Affecting Automated External Defibrillators” helps inform the public about the safety of AEDs. FDA supports this kind of research, and most of the conclusions reached in the JAMA article are consistent with FDA's own findings. However, there are a few points on which the agency differs.

First, the authors assert that manufacturers are unable to track AED units, making it impossible to know how many AED units were actually fixed or taken out of service. However, under FDA regulations, manufacturers are required to track AEDs and are doing so with processes in place to identify the location of a device in the event of a recall. Our records show that these devices are being tracked with a high level of accuracy. In fact, more than 95 percent of the AEDs affected by Class I recalls in 2005 were returned to the manufacturers or taken out of service. Fewer than 3 percent were lost or stolen.

Second, the authors state that there has been an increase in the number of AEDs affected by advisories during the study period. This is true; however, FDA believes that improvements in the devices' ability to self-diagnose hardware and software problems may contribute to this trend. This capability may result in users reporting problems before a device is ever used on a patient. Also, while more than 21 percent of AEDs were affected by an advisory, it does not necessarily mean that they malfunctioned. A device advisory is issued when a medical device has the potential to exhibit a certain failure mode, not only when a device has, in fact, failed.

We continue to depend on our ability to work with owners of AEDs when these devices are subject to a recall and have taken steps in recent months to improve our communication and collaboration with the broader community. AED users should continue to report device malfunctions to the manufacturer and to FDA. In addition, users should heed device error messages and warnings during regular device self-checks and respond appropriately to recall notices and safety alerts.

A subscription for full access is required to view the JAMA full text article.

Additional Information:

To view the JAMA article, visit (requires a subscription for full acceess)
http://jama.ama-assn.org/cgi/content/full/296/6/655

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Pennsylvania Hospitals Work To Ensure Correct Use of Color-Coded Wristbands

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After a patient almost died in a Pennsylvania hospital because of confusion about the meaning of the colored wristband that had been put on the patient’s arm, the State Patient Safety Authority (PSA) took steps to alert the health care industry to the dangers of such confusion. Now hospitals in northeastern and central Pennsylvania are working together to develop standards for the use of color-coded patient wristbands in their facilities. A group of hospitals and other health care organizations formed the Color of Safety Task Force to develop detailed protocols, including a policy manual and training resources, to reduce the risk of medical error when using color-coded wristbands.

A new PSA Patient Safety Advisory provides information on the Task Force and on the Color-
Coded Wristband Toolkit the group has created to help providers and facility managers implement changes in their own institutions. The Toolkit includes: (1) an implementation and policy manual developed by the Task Force; (2) a brochure for provider and patient education; (3) presentations that can be used for educating staff and community members; (4) relevant Advisories from the Pennsylvania Patient Safety Reporting System; and (5) a related video from the Food and Drug Administration’s Patient Safety News that highlights the issue of wristband use.

Additional Information:

The new Advisory and the Wristband Toolkit are both available at the PSA Web site
http://www.psa.state.pa.us/psa

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News Items From the Agency for Healthcare Research and Quality (AHRQ) Electronic newsletter #206, August 4, 2006

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Obesity Surgery Complication Rates Higher Over Time

Four of every 10 obesity surgery patients develop a complication, such as a hernia, within 6 months of leaving the hospital, according to a new Agency for Healthcare Research and Quality (AHRQ) study. The study is the most extensive to date on post-surgical complications from obesity operations based on insurance claims data. The researchers found that the complication rate among non-elderly obesity surgery patients with private insurance increased by 81 percent following hospital discharge—from 22 percent while they were still hospitalized to 40 percent by the end of the 180-day study period. The study, Healthcare Utilization and Outcomes after Bariatric Surgery, was published in the August 2006 issue of Medical Care.


Task Force Issues Recommendation on Hereditary Hemochromatosis Screening
The U.S. Preventive Services Task Force has issued a new recommendation against routine genetic screening for hereditary hemochromatosis in the asymptomatic general population (Rating: D Recommendation). This is the first time the Task Force has made a recommendation on hereditary hemochromatosis screening. The recommendation appears in the August 1, 2006, issue of the Annals of Internal Medicine.

Additional Information:

Obesity Surgery Complications - Additional Information
http://www.ahrq.gov/news/press/pr2006/obessurgpr.htm

PubMed® Abstract
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt= AbstractPlus&list_uids=16862031&query_hl=3&itool=pubmed_docsum

Summary of Hereditary Hemochromatosis Screening Recommendations
http://www.ahrq.gov/clinic/uspstf/uspshemoch.htm

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Observations on Growth in the Medical-Device Industry

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This past spring, Boston Scientific, a large manufacturer of medical devices, successfully outbid Johnson & Johnson, an industry giant, to purchase Guidant Corporation. Now The New England Journal of Medicine, in its July 27, 2006, edition, builds on the Guidant acquisition to survey the issue of consolidation in the device industry and its ramifications for patient care.

In his Perspective article “The Price of Growth in the Medical-Device Industry,” Alan M. Garber,
M.D., Ph.D., notes that “Consolidation in the medical-device industry, like consolidation in the pharmaceutical industry, has multiple and sometimes unpredictable effects.” Although there is broad consensus that both industries will grow as baby boomers age, and profitable companies are more likely than unprofitable companies to invest in research and development that will lead to novel and beneficial devices, “industry consolidation is not an unmixed blessing for patients or their physicians. Diminished competition usually means higher prices—and possibly limited treatment options.”

Dr. Garber, director of the Center for Health Policy at Stanford University and a staff physician at the Veterans Affairs Palo Alto (California) Health Care System, analyzes the setting in which acquisitions such as that of Guidant by Boston Scientific occur:

For many small companies, the expense of sponsoring or conducting high-quality clinical trials is an insuperable barrier, and few have the experience to market their products effectively. Large companies can finance trials that are large enough to demonstrate efficacy, and they have broad marketing capabilities. By deterring small firms from entering the market with products that are similar or superior to their own, large companies protect their market share—hence the growing domination of the device industry by a small number of companies.

The author concludes his discussion on a cautionary note: “If the strategy of growth by acquisition permits the device industry to turn scientific advances into effective treatments for patients, it will ultimately succeed in the marketplace. But if this strategy brings about high prices without corresponding benefits, for patients as well as manufacturers, the price of growth will surely have been too high.”

The full text of Dr. Garber’s article appears in the July 27, 2006, edition of The New England Journal of Medicine.

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Medication Information That May Be of Interest for Pediatric Hospitals, as Well as Pediatric and Cardiology Departments

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FDA and GlaxoSmithKline notified health care professionals of changes to the BOXED WARNING,

WARNINGS, and PRECAUTIONS sections of the prescribing information for Dexedrine (dextroamphetamine sulfate), approved for the treatment of attention-deficit hyperactivity disorder and narcolepsy.

The warnings describe reports of sudden death in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems.

Read the complete MedWatch 2006 Safety summary, including links to the manufacturer's letter to health care professionals and the product's approved labeling, see Additional Information below.

Additional Information:

MedWatch 2006 Safety summaries
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150332.htm

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Best-Selling Book Encourages Consumers To Get Involved in Ensuring Safe Medical Care

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A new book developed by Joint Commission Resources (JRC), You: The Smart Patient: An
Insider’s Handbook for Getting the Best Treatment, is being recommended by Partnership for
Patient Safety, a patient-centered initiative, as an important tool for encouraging consumers to take an active role as partners in ensuring safe health care.

An affiliate of the Joint Commission on Accreditation of Healthcare Organizations, JRC works to
advance the reliability of health care systems worldwide. The group also supported the establishment of Consumers Advancing Patient Safety and the Patients for Patient Safety work strand of the World Health Organization’s (WHO) World Alliance for Patient Safety.

The book, which was written by best-selling physicians-authors Michael F. Roizen, M.D., and Mehmet C. Oz, M.D., has been on the New York Times best sellers paperback list for several months. Profits from book sales go to the WHO World Alliance.

Additional Information:

For more information about the book, go to
http://www.jcrinc.com/

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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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Questions:
What are the requirements for two-wire AC-powered medical equipment in the United States?
Please list regulatory references. Does the two-wire power cord need to be polarized?

Comment:
From FDA: These questions were forwarded to the Office of Science and Engineering Laboratories of the Center for Devices and Radiological Health. The answers are summarized here.

What are the requirements for two-wire AC-powered medical equipment in the United States? The FDA does not have a mandatory standard (requirement) for two-wire AC-powered medical equipment. It does, however, expect manufacturers to meet a recognized standard, such as IEC 60601-1 or the equivalent. A manufacturer may also provide test results to demonstrate that its equipment is electrically safe.

Does the two-wire power cord need to be polarized?
In some cases, yes, and in other cases, no. Polarization is necessary: 1) when one or more components in the device must be connected to the ungrounded conductor in a two-prong system; and 2) when reverse insertion of the pins of the two-prong plug could create a hazard— for example, making a light socket “hot” even when the light switch is off.

Polarization is not necessary: 1) when there is no need for circuit components to be connected to either the ungrounded or grounded conductor in a two-prong system; and 2) when the devices are double-insulated consumer types of components, such as power tools and portable electronics.

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Updated September 1, 2006

Return to MedSun: Medical Product Safety Network

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