Salient Characteristics Rb-82 Generator and Associated Accessories.pdf
PDF 128 KB Posted
- Solicitation number
- PANHCA26P0000029991
- Issued by
-
Department of the Army Medical Command
About this file
This is a Sources Sought notice issued by William Beaumont Army Medical Center (WBAMC) for a Rubidium-82 (Sr-82/Rb-82) Generator System and associated accessories for cardiac PET imaging. The procurement seeks a complete, FDA-approved Sr/Rb generator system compatible with the current Bracco Diagnostics CardioGen-82® Infusion System (Model 1701 or current standard) to enable continuous cardiac PET imaging services. The generator system must utilize a Strontium-82 parent isotope with approximately 25-day half-life to produce short-lived (~75-second) Rb-82 daughter isotope for producing Rb chloride injection for PET myocardial perfusion imaging. The system must support rapid sequential rest/stress imaging within 30-45 minutes, enable high-volume capability of 10-15+ patient studies per day, and provide accurate quantification of myocardial blood flow.
Required technical specifications include FDA-approved breakthrough level compliance adhering to ALARA principles, inclusion of current proprietary software such as HeartSee for imaging and automated quality control, and automated daily eluate testing with dose data reporting capabilities. The generator must provide a functional lifespan of 4-12 weeks with consistent Rb-82 yield and require regular replacement/reloading. Associated accessories must be included, comprising patient administration sets (42", 25 sets/box), vented caps for waste bottles (12 caps/box), 500mL waste bottles (2 bottles), elution vial shields, thermal printer paper (12 rolls/box), accessory tubing packs, elution test vials (25 vials/box 50mL), and saline tags (25 tags/box, CardioGen-82® compatible). The vendor must provide 24/7 technical support including emergency contact capability for generator malfunction or breakthrough alerts and ensure regular, timely replacement or reloading to prevent operational downtime.
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Rubidium-82 (Sr-82/Rb-82) Generator and Associated Accessories
1. Introduction/Purpose
William Beaumont Army Medical Center (WBAMC) is seeking sources capable of providing a Rubidium-82 (Rb) Generator System and associated accessories for cardiac PET imaging. The goal is to identify vendors who can supply a complete, integrated system compatible with current CardioGen-82® by Bracco procedures to ensure continuous cardiac PET imaging services.
2. Required Technical Specifications & Salient Characteristics
Scope of Requirements - Interested vendors must provide a system that meets the following minimum requirements:
• The contractor must provide a complete, FDA-approved Sr/ Rb generator system (generator column containing stannic oxide, self-contained, shielded cart) and all necessary accessories for producing Rb chloride injection for PET myocardial perfusion imaging (MPI).
• System Compatibility: Generator must be fully compatible with the current Bracco Diagnostics CardioGen-82® Infusion System (Model 1701 or current standard).
System must be fully compatible with, or equal to, the current CardioGen-82 system by Bracco Diagnostics, enabling rapid, on-demand serial rest/stress studies (30–35 minutes).
• Isotope Production: Generator must utilize a Strontium-82 parent isotope (approx. 25-day half-life) to produce a short-lived (~75-second) Rb-82 daughter isotope.
• Performance: Must allow rapid sequential rest/stress imaging (30–45 minute study time) and provide high-quality cardiac PET images.
• Safety Standards: Must meet FDA-approved specifications for breakthrough levels (adhering to ALARA principles).
• Clinical Efficacy: Must allow for accurate quantification of myocardial blood flow
(MBF).
• Essential Software: Must include current proprietary software (e.g., HeartSee) for imaging, data management, and automated Quality Control. Accessories: Must include all required infusion sets, patient administration sets, waste containers, vented caps, and printer paper.
• Generator Life: Generator must provide a functional lifespan ranging from 4 to 12 weeks, with consistent 82Rb yield, requiring regular replacement/reloading due to Sr-82 parent decay.
• High-Volume Capability: The system must allow for multiple consecutive patient studies (10–15+ per day) with rapid generation times.
• Daily QA/Safety: Must feature automated daily eluate testing and Dose Data reporting capabilities.
• Support: Must provide technical support, including 24/7 emergency contact in case of generator malfunction or breakthrough alerts.
3. Included Accessories & Support
The proposal must include the necessary accessories for operation, including but not limited to:
• Patient Administration Sets (42”): 25 sets/box (1 set required per patient)
• Vented Cap for Waste Bottle: 12 caps/box (
• Waste Bottle: 2 bottles 500mL
• Elution Vial Shield: 1 shield/box
• Thermal Printer Paper: 12 rolls/box
• Accessory Pack: 1 complete set of tubing for Infusion System
• Elution Test Vials: 25 vials/box 50 mL
• Saline Tags: 25 tags/box (Compatible with CardioGen-82®).
4. Generator Lifetime & Delivery
• The generator must be available for a typical lifetime of 4 to 12 weeks, with consistent yield throughout its life.
• Vendor must ensure regular, timely replacement or reloading of the generator to avoid operational downtime.
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