SOLICITATION NOTICE
A -- Automated Medical Device Safety Monitoring
- Notice Date
- 5/14/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- 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
- 1042170
- Response Due
- 5/29/2008
- Point of Contact
- Joseph B Pishioneri, Phone: 301-827-7109
- E-Mail Address
-
joseph.pishioneri@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- The Food and Drug Administration is seeking a contractor for Automated Medical Device Safety Monitoring REQUEST FOR QUOTE (RFQ). This announcement constitutes the only solicitation and a written solicitation will not be issued. Requirements: Automated Medical Device Safety Monitoring 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. Researchers in Massachusetts have developed a computerized tool, 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 system has been tested and validated on a large clinical database at a single center within the domain of interventional cardiology and showed that the system was efficient in identifying very low frequency events. In addition these researchers have explored various alerting algorithms triggered by event trends. It has been proposed to extend the system surveillance system to monitor a Massachusetts state-wide mandated outcomes data registry in interventional cardiology that is rigorously collected according to national standards. The system supports continuous monitoring utilizing dichotomous and continuous outcome analytic methods. The system MUST use Mass-DAC data and also has the ability to capture state-wide hospital and discharge information. This automated safety monitoring system network may offer a valuable complementary approach to existing methods for medical device safety surveillance. This approach can be readily extended to monitor the safety of technologies outside of interventional cardiology as outcomes data repositories become available. Tasks: 1. Use this network to prospectively monitor the safety of new cardiovascular devices recently approved, including use profiles and rates of diffusion. 2. To assess what outcomes are optimal for surveillance (in terms of sensitivity, specificity, etc.) by device type It may be technically feasible to develop a modified version of the system for implementation at participating MedSun facilities that would have the following features: a) ability to locally or remotely configure prospective safety monitoring analyses as new devices are released or new concerns are raised b) ability to fully de-identify patient level information to forward to a central analysis in the system's server c) ability for an alert at one center to trigger (via both e-mail and analytic configuration) the detailed automated review of similar cases (devices or patient subsets) at other centers with the system. 5. Reporting Requirements and Deliverable Items: Quarterly reports which provide results of safety monitoring for recently approved cardiovascular devices and which outline what outcomes are optimal for surveillance by device type. 6. Duration of Base Project: Period of performance is September 1, 2008 to August 31, 2009 This proposal addresses two fundamental challenges of continuous medical device safety monitoring. The first is the necessary availability of a large scale, representative, high quality and granular outcomes registry. The Mass-DAC dataset, like other audited, regulatory mandated outcomes registries, is of extremely high data quality, primarily due to the threat of loss of licensure in the state if a center is non-compliant with the strict regulations of data collection and audit. The second challenge of the system network proposal is the timeliness of the information available for analysis. Since the system’s clients will be integrated into the routine real-time clinical data acquisition at the sites, the system will have outcomes information as they become available to the participating centers. The system will be "aware" of outcomes within 2-4 weeks of patient discharge. Importantly, the system network is secured and HIPAA compliant and the Mass-DAC central processing center receives de-identified data from each client site (allowing for rapid aggregated analysis). Therefore, the central analysis site will have an early warning system using de-identified data. This research proposal offers a unique and timely opportunity to develop, deploy and evaluate a dynamic safety monitoring system in an environment of mandatory high quality data collection. As such, it may serve as a useful model for future programs for continuous safety monitoring. REQUEST FOR QUOTE (RFQ) Any firm that believes it is capable of providing the required service as stated herein may submit a proposal to document its ability to provide the required services, which will be considered if received by the fifteenth (15th) calendar day following the appearance of this announcement. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. All responses or questions regarding this posting must be in writing and can be sent via email to joseph.pishioneri@fda.gov. No phone calls will be accepted. This sole source procurement will be awarded as a simplified acquisition for commercial items in accordance with FAR Subpart 13.5.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=2533eadea3abb8a9bfe24d742663a080&tab=core&_cview=1)
- Place of Performance
- Address: Piccard Dr, Rockville, Maryland, 20850, United States
- Zip Code: 20850
- Zip Code: 20850
- Record
- SN01573011-W 20080516/080514220337-2533eadea3abb8a9bfe24d742663a080 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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