SOLICITATION NOTICE
B -- Automated Medical Device Safety Monitoring: Expanding Use of DELTA to Hip Implants
- Notice Date
- 8/3/2010
- Notice Type
- Presolicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-10-1076050
- Archive Date
- 9/2/2010
- Point of Contact
- ZetherineGore, Phone: (301) 827-5093
- E-Mail Address
-
zetherine.gore@fda.hhs.gov
(zetherine.gore@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- The Food and Drug Administration (FDA), Center for Safety and Radiological Health, pursuant to FAR 6.302-1 and 41 U.S.C. 253(c)(1), intends to modify its current contract with Brigham & Womens Hospital, Inc. for Automated Medical Device Safety Monitoring to include safety of orthopedic implanted devices (such as hip implants) surveillance. The current contract provides the use of a computerized tool, Data Extraction and Longitudinal Time Analysis (DELTA) system. The system can monitor the adverse events of new medical devices through the continuous surveillance of clinical outcomes databases using a variety of statistical monitoring tools. This automated safety monitoring system network offers a valuable complementary approach to existing methods for medical device safety surveillance. Postmarket 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. FDA is in the process of implementing the Sentinel Initiative, which is a national electronic system intended to augment the Agency's existing post-market (primarily passive) safety surveillance systems to allow the Agency to gather information about the post-market safety and performance of its regulated products. The initiative aims to develop and implement a proactive system that will complement existing systems that the Agency has in place to track reports of adverse events linked to the use of its regulated products. The objective of the additional work is to develop and assess active surveillance capabilities as applied to implantable devices; the specific case being hip implants (total and partial). The additional exploratory work will be conducted using DELTA capabilities. The scope of work of this specific project is the development, testing, and assessment of active surveillance capabilities applied to hip implants (total and partial), using both retrospective and prospective linked/integrated registry data. DELTA will provide the informatics and automated active surveillance expertise and capabilities. FDA seeks to use registry data sources that: (1) have continuous access to automated healthcare data systems; (2) provide a "laboratory" for developing and evaluating scientific methodologies; and (3) offer an opportunity to evaluate safety issues in existing automated healthcare data system(s) and to learn more about some of the barriers and challenges, both internal and external. Registry data sources that may be of value include orthopedic implant registries overseen by Kaiser Permanente (integrated into electronic healthcare records) and Weill Cornell Medical College (stand-alone). In addition to furthering active device surveillance capabilities, this effort will seek to build Medical Device Epidemiology Network (MDEpiNet) capacity by utilizing expertise within MDEpiNet institutions (e.g., Harvard, Cornell, and Duke). This is not a Request for Proposals. Sources interested in this requirement must a provide statement of capabilities in sufficient detail to determine if the requirements of this synopsis can be met. Interested parties must have in-depth knowledge of and access to the Massachusetts Data Analysis Center (MAS-DAC) registry; and must have experience in piloting the DELTA system with MAS-DAC registry. The North American Industry Classification System (NAICS) code is 541690 - Other Scientific and Technical Consulting Services. Responses must be in writing and must be received within fifteen (15) calendar days from the date of this announcement. A determination by the Government not to compete the proposed contract based on responses from this notice is solely within the discretion of the government. Information received will normally be considered solely for the purposed of determining whether to conduct a competitive procurement. See Numbered Note 22.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-10-1076050/listing.html)
- Place of Performance
- Address: Contractor's location, United States
- Record
- SN02226625-W 20100805/100803235122-660336020037ed8e64575dddde258c47 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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