U.S. Food and Drug Administration
Performance Plan
2002

Assuring Medical Product Safety

Desired Outcome

Assure the safety of medical products at all stages in the life cycle--production, distribution and consumption.

Why FDA's Contribution is Important

Consumers spend $326 billion annually in the U.S. on medical products. An estimated 1.3 million people are accidentally injured by medical therapy in the U.S. each year, and as many as 100,000 die as a result of preventable medical errors. FDA must be vigilant in monitoring the production, distribution and use of these products because FDA's presence raises the likelihood that public health and safety problems associated with these products will be addressed and because it is critical to citizen safety.

To ensure that these products are safe the Agency must oversee their entire life cycle--from production through distribution, and consumption/use. In the production and distribution phases of the cycle FDA must monitor over 40,000 establishments that manufacture these products. FDA is also responsible for ensuring the safe operation of some 10,000 mammography facilities. In addition, FDA must monitor over 2 million line entries of imported drugs, biologics, animal drugs and feeds, and medical devices that cross our borders annually.

Key Strategies

FDA's three primary strategies for ensuring medical product safety are to: a) enhance global vigilance over product manufacturing and distribution; b) strengthen and focus domestic industry monitoring; and, c) expand and automate the systems which report on adverse events associated with the use of medical products.

In the global arena, FDA plans to enhance the automated import monitoring system (OASIS) to improve cost effectiveness in screening unacceptable imports; and expand import coverage at ports. The Agency will also increase criminal investigations of fraudulent medical product imports. To improve public confidence in the safety of foreign medical products at the source, FDA will implement the European Mutual Recognition Agreement; participate in international standard setting forums such as the International Conference on Harmonization (ICH) to continue to advocate for rigorous standards; and increase the number of foreign inspections.

On the domestic front, FDA will continue to make the most effective use of limited inspection resources by implementing four key strategies: 1) Leveraging through contracts with the states, other third parties and outreach to small firms; 2) Focusing resources on the highest risk firms and medical products--areas which will bring the greatest health benefit; 3) Ensuring that inspectors have the scientific and technological support necessary to make quick and valid judgements about medical device compliance; and, 4) Reengineering the inspection process by implementing quality system inspections that will significantly reduce inspection time and increase effectiveness.

FDA's adverse event reporting strategies are intended to: develop a comprehensive adverse event reporting capability; analyze problems surfaced by these reports so that appropriate interventions can be designed; and educate both health professionals and patients about problems and solutions associated with appropriate product use. Two examples of strategies designed to develop more complete reporting are the Medical Device Surveillance Network (MeDSuN) System and the HHS Patient Safety Task Force. The MeDSuN System is a pilot program that educates and encourages hospital personnel to accurately identify and report injuries and deaths associated with medical products. This year FDA will implement the third phase of the (MeDSuN) to include drug products. FDA is also coordinating with the Department's Patient Safety Task Force to gain synergies from existing systems that are already collecting data on patient safety.

Current Status and Barriers to Future Progress

Global Vigilance -- Imports of all FDA regulated products have been increasing over the last several years--growing at an annual rate of 10 to 12 percent. In FY 2001, FDA physically examined less than one percent of all entries offered for import into the United States. A highly integrated web-enabled import monitoring system is required to allow the Agency to prevent unsafe import entries on a cost-effective basis. The proposed FY 2003 budget will fund the first steps toward establishing such a system. Alternatively, FDA would need restructured regulatory authority that would place more responsibility on exporters to assure that products entering the U.S. are safe.

Domestic Industry Monitoring -- The law requires that FDA inspect certain biologics, human and animal drug and feed, and medical device manufacturers at least once every 2 years. Although at least 50 percent of statutory establishments should be inspected annually, only 22 percent of human drug, and 13 percent of medical device statutory establishments were inspected in FY 2000. FDA will still fall far short of its statutory inspection requirements given current funding levels.

* FY 02 and FY 03 are still targets

Adverse Event Reporting -- The Agency has developed new standards for over-the-counter drug product labeling designed to increase patient knowledge about the medication and decrease errors in use. FDA is using a nationwide media campaign to inform consumers how to use the new labeling. But the adverse event reporting system must be significantly strengthened. Although we do not know the actual number of adverse events associated with medical products, just the reports we receive have more than doubled in the past ten years.

FDA needs more expertise in medical epidemiology and statistical analysis to evaluate adverse events associated with increasingly complex medical products, and more educational efforts to correct these problems.

Specific performance commitments for FY 2002 and FY 2003 and actual performance from FY 2001 are outlined in the table that follows.

Performance Goals Summary

Previous Section   |    Table of Contents    |   Next Section

Office of Planning Home Page
FDA Home Page | Search | A-Z Index | Site Map | Contact FDA

FDA/Office of Planning
Web page created by clb 2002-FEB-08.