FY 2007 HHS Annual Plan

Strategic Goal 5
Improve the Quality of Health Care Services

On this page:
Program 5a: Medical Product Surveillance Network Food and Drug Administration (FDA)
Program 5b: Prevention Portfolio Agency for Healthcare Research and Quality (AHRQ)

Highlighted Programs:

• 5a. Medical Product Surveillance Network (FDA)
• 5b. Prevention Portfolio (AHRQ)

Improving the quality of life in the United States includes improving the quality of the health care services that individuals receive by reducing medical errors, improving consumer and patient information, and accelerating the development and use of electronic health information. To achieve this goal, HHS will continue implementation of a variety of strategies designed to improve the delivery of health care services. These strategies include the development and dissemination of evidence based practices, information systems, new technologies for the home and clinical setting, and improved reporting systems for medical errors and adverse events.

Health quality improvement at HHS also means translating new knowledge of effective health services into strategies, educational tools, and information to help clinicians and health care policy makers improve health care quality. HHS will work to expand provider networks to disseminate health care quality information, enabling consumers to make informed choices.

HHS will provide leadership to promote the development of a national health information infrastructure that takes advantage of the most current technology available. This will involve attention to the secure and confidential treatment of health information, adoption of national data standards, and research on the applications of a national health information infrastructure that informs consumers, patients, professionals, and other decision makers alike.

Over five HHS programs in five OPDIVs contribute to achieving this strategic goal. Two programs are highlighted in this strategic goal including FDA's Medical Product Surveillance Network and the Agency for Healthcare Research and Quality's (AHRQ) Prevention Portfolio.

Program 5a: Medical Product Surveillance Network
Food and Drug Administration (FDA)

Performance Measure: Expand actively participating sites in MedSun Network.

The FDA Modernization Act (FDAMA) mandates that FDA replace universal user facility reporting with the Medical Product Surveillance Network (MedSun), a network of user facilities that together will provide a representative profile of reports from major medical device product users such as hospitals. When fully implemented, MedSun will serve as an advance warning system for device problems and a laboratory for research and two-way communication between FDA and the user-facility community. Furthermore, MedSun will improve patient safety through recognition and management of use-related errors and offer feedback to manufacturers to improve device design.

MedSun is designed to improve FDA decision making about device problems by generating more useful and diverse reports from trained, engaged reporters. The program collects reports on deaths and serious injuries associated with the use of medical devices. Participating facilities are also highly encouraged to submit reports about close calls, which allow FDA to evaluate a device issue before patient injury occurs. Better information allows timelier signal detection and enhances FDA's ability to analyze and react to problems. A key component of MedSun is to offer easily accessible information related to safe device use. MedSun participants receive a continuous stream of feedback including newsletters, educational materials, publications and other information related to patient safety and device use. In 2006, an FDA MedSun web site will be developed so that this feedback, as well as other important device safety information learned through the MedSun system may be publicly available.

In FY 2005, FDA increased the number of facilities in the MedSun network to 354, thus completing the network. In FY 2006 and FY 2007, FDA will turn its focus to ensuring active participation (at least 1 report submitted a year by each site). In FY 2007, FDA will seek to expand the percentage of actively participating sites in the MedSun network to 76%. Active participation in the network will increase the number of reports and improve the likelihood that FDA will reduce device-related medical errors. Moreover, this will provide an advanced warning system among the facilities in the network and create a two-way communication channel between FDA and the user-facility community.

FDA plans to use the following strategies to accomplish this:

• FDA is currently piloting the use of 'Regional Representatives' to travel to the MedSun hospitals and work with their staff to encourage event reporting as well as solicit feedback for improvements to the system.
• FDA is currently piloting two new educational tools designed to increase device-problem reporting within facilities, and then encourage the facilities to submit those reports to MedSun. Based on the success of these pilot programs, FDA will distribute these tools throughout the MedSun network and provide special follow-up calls and visits to non-reporting sites.
• FDA is planning to add regional meetings to its current annual Users' Conference. It is anticipated that these meetings will promote best practices with medical devices as well as generate increased reporting. FDA will make special overtures to non-reporting sites to encourage them to attend these regional meetings. FDA will begin implementing regional meetings in FY 2006.

FDA will continue to recruit additional facilities to replace existing facilities that have decided to place a low priority on participating in this voluntary network. This will increase the overall effectiveness of the system while holding the total number of facilities to approximately 350, which FDA believes is the optimum size.

Some of the external factors that will influence the success of the MedSun program are awareness of hospital staff in recognizing medical device problems, fear that the hospitals might face legal action due to reporting an adverse event, and the burden of submitting reports. MedSun will minimize these factors by training hospital staff in the recognition and reporting of medical device problems, assuring reporting confidentiality, minimizing the burdens of participation, and providing timely feedback on device safety issues including monthly newsletters, clinical engineering audio-conferences, device safety exchanges, and surveys on high-profile safety concerns.

Program 5b: Prevention Portfolio
Agency for Healthcare Research and Quality (AHRQ)

Performance Measure: Improve the timeliness and responsiveness of the United States Preventive Services Task Force (USPSTF) to emerging needs in clinical prevention.

The Prevention Portfolio conducts comprehensive assessments of a wide range of preventive services including screening tests, counseling activities, immunizations, and preventive therapies. The United States Preventative Services Task Force (USPSTF) is a vital component of the Prevention Portfolio. The overall goal of the USPSTF is to provide evidence-based recommendations relevant to primary care providers. The Task Force works to improve the effectiveness and efficiency of healthcare delivery by promoting patient safety and by providing evidence-based recommendations for essential and non-essential clinical preventive services. One of the three overarching measures of success for the USPSTF is to improve the timeliness and responsiveness to emerging needs in clinical prevention. These needs include diseases that often are preventable, such as heart disease, diabetes, some cancers, and HIV/AIDS which result in premature deaths every year. By providing timely knowledge of clinical prevention, wider access and increase use of effective health care services is possible and thus could reduce health care costs.

In FY 2007, AHRQ will begin to decrease by 10% the number of USPSTF recommendations that are five years or older to ensure that recommendations remain current within National Guidelines Clearinghouse standards. In FY 2005, AHRQ worked to establish baseline measures for timeliness and responsiveness to the emerging needs of clinicians. AHRQ held stakeholder meetings to identify which recommendations were effective and what tools were needed to improve their quality and usability.

The portfolio was directed to develop both print and electronic forms of the recommendations. As a result, AHRQ released a clinical pocket guide work and began working on the expansion of a PDA as a clinical decision-making tool.

In FY 2006, AHRQ is working to increase the number of annual topics reviewed by the task force by 10 percent. To date, the USPSTF has reviewed over 70 topics in the area of primary and secondary clinical prevention that address issues of screening, counseling, and chemoprophylaxis. Moreover, the Task Force has eliminated its backlog of topics, as evidenced by the release of 20 new recommendations. It continues to engage primary clinicians to address the situation where there is insufficient evidence for the Task Force to make a recommendation. AHRQ continues to collaborate with other Federal agencies to shape research agendas in the area of clinical prevention by facilitating the communication of these research gaps directly to funding agencies.

2007 Annual Plan Home

HHS Home | Questions? | Contact HHS | Accessibility | Privacy Policy | FOIA | Disclaimers

The White House | USA.gov | HHS Archive | No FEAR Act

U.S. Department of Health & Human Services · 200 Independence Avenue, S.W. · Washington, D.C. 20201