Automated Medical Device Safety Monitoring

The FDA intends to issue a Request for Quotations (RFQ) to identify, describe, and evaluate potential data environments that could assist in adding value to the FDA's Post market surveillance of medical devices. Post-market safety surveillance of medical devices is a complex task compounded by rapid dissemination of new medical technology, lack of standards in data collection, and inadequate passive adverse event reporting mechanisms. While there are Federal and State regulations for reporting adverse events, there is no efficient way to gather and use that data in a way that will provide predictive data rather than old reactive data. The FDA has identified a computerized tool, DELTA (Data Extraction and Longitudinal Time Analysis system), that can monitor the adverse event rates of new medical devices through the continuous surveillance of clinical outcomes databases using a variety of statistical monitoring tools. The primary objective of this project is to use the existing automated surveillance system and extend that system beyond its current focus on interventional cardiology studies. The awardee will be required to complete the following tasks: 1. Study Initiation and Liaison a. Identify newly approved medical devices (within 2 years) b. Help identify potential collaborating institutions or organizations c. Initiate communications and meetings with the FDA Program office 2. Development of Materials a. Work with the FDA to develop a template for reporting data on newly approved medical devices i. I.e., Use profiles, rate of diffusion b. Develop or adapt existing data collection tools to allow for categorization based on medical, demographic or other factors. c. Modify existing data management needs for specific projects that facilitate quality control, automated data access, accuracy and rapid response. 3. Problem identification, a. Use statistical processes to develop methods to monitor safety of new cardiovascular devices b. Assess what outcomes are optimal for surveillance (in terms of sensitivity, specificity, etc, by device type.) 4. Quality Control and Reporting a. Quality Control of all aspects of data security, data collection and management is crucial. b. Provide Quarterly Reports and Annual Reports to the FDA Project Manager in a format that is mutually agreed upon. The anticipated Period of Performance is a 12 month base period with four option years from the date of award. The anticipated award type is Firm-Fixed-Price (FFP). There is no anticipated Set-Aside Designation. Competition is expected to be - Full and Open. The basis of the award is - Best Value. The primary location of performance is anticipated to be at the contractor's preferred location; however, the contractor may be required to travel to the Washington, DC/Maryland geographical area. The designated North American Industry Classification System (NAICS) code is anticipated to be: 541690 - Other Scientific and Technical Consulting Services. This industry comprises establishments primarily engaged in providing advice and assistance to businesses and other organizations on scientific and technical issues (except environmental). The Small Business Size Standard is $6.5 Million. This announcement is not a RFQ. FDA anticipates release of the RFQ on or around August 15 2008 and a subsequent award on 9/22/08. No other information is available at this time. It will be available on the Federal Business Opportunities Web Site Home Page: http://fedbizopps.gov.